chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chills, Feeling hot, Heart rate increased
Clinical narrative: Reported 11/4/02 approximately 3-4 hrs after injection pt had chills for 2 hrs, then became warm, pain throughout back and weakness. Pt states she had a racing heart beat about 7 hrs after the shot. States by morning 11/1/02 at 8am heart rate was better. Pt discussed with nurse at MD's office on 11/1/02 her symptoms. Advised to contact MD office or go to ER if symptoms persist. MD office notified by RN.
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Pain
Clinical narrative: 11/6/02 client c/o upper and lower lip swelling, achey all over, c/o clearing throat more than usual c/o face swelling. Denies shortness of breath, no difficulty breathing. Client is slightly improving as time passes.
Age: 60.0
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Welt and red rash.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Oedema, Pain, Urticaria
Clinical narrative: Right arm red, swollen, painful, hives at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Received Influenza vaccine at approx 9:00AM.  Indicated approx 9:00PM (12 hours post vaccination) had severe itching of arms, greater on right than left and itching of upper abdomen.  Vaccine administered in left deltoid.  Self treated with OTC Bendadryl and symptoms resolved.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: fever overnight to 100 F., pain at the injection site and myaligias. 24 hours later, temp. 99.4 F. oral, and less muscle pain on Tylenol.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: On 11/11, parent noted some pruritis near injection site on left arm area the night after the injection.  On 11/13, parent noted severe swelling and redness from shoulder to elbow.  M.D. contacted.  M.D. advised to go to ER.  Treated with Benadryl and cortisone cream.  No rash or fever noted.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Respiratory failure
Clinical narrative: Patient received flu vaccine and a Rocephin injection after office visit. She developed an anaphylactic reaction and subsequently respiratory failure. Despite resuscitation attempts, patient died. Anaphylactic reaction.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Asthenia, Guillain-Barre syndrome, Paraesthesia, Pneumonia
Clinical narrative: Patient presented with complaints of weakness and tingling in arms and legs. She became progressively weak and required intubation. She was diagnosed with GBS. Intubated, ended up trached, required Pheresis. Developed pneumonia, anemia. No definate etiology for the GBS was noted, except that patient reports having a flu shot in October--not sure exact date. The MICU team felt the GBS was due to the flu shot.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Apnoea, Arthralgia, Encephalitis, Headache
Clinical narrative: Patient developed paralysis of legs and cervical spine swelling as appreciated on an MRI 1 week after receiving the flu vaccine.   The discharge summary states actue demyelinated encephalomylitis, transverse myelitis.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Malaise, Myalgia, Myelitis transverse, Paralysis
Clinical narrative: Patient developed paralysis of legs and cervical spine swelling as appreciated on an MRI 1 week after receiving the flu vaccine.   The discharge summary states actue demyelinated encephalomylitis, transverse myelitis.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pleural effusion, Swelling
Clinical narrative: Patient developed paralysis of legs and cervical spine swelling as appreciated on an MRI 1 week after receiving the flu vaccine.   The discharge summary states actue demyelinated encephalomylitis, transverse myelitis.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Cellulitis, Injection site reaction, Pruritus, Pyrexia
Clinical narrative: Adverse cellulitis on right upper arm measuremnt of 11in (from elbow to 2in under arm x 5in) On 14 Nov 02, patient stats upon waking up, arm had fever and itched. At approximately 1200, patient noticed spreading of cellulitis, fever and itching. On 15 Nov 02, upon waking up patient noticed cellulitis, itching, whole arm with aching. Patient state shoulder and elbow joints ache and arm has been falling asleep continuously - approximately 10 times. Patient reported to the Combined Task Force Clinic and referred her her for VAERS Reporting. Patient states she had no lump in right arm from #1 series given on 30 Oct 02 in same approximate area. Patient states #2 was injected approximately 1in high then the 1st shot.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling
Clinical narrative: Patient noticed knot or lump at site of injection last PM when friend grabbed his arm. Remains 90mm in diameter ordered Aristocort cream topically BID X pretreat for next dose. Allegra 180mg 2 tabs a day before nest dose.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of the left arm to slightly below the elbow, Tx: with Vioxx and Atarax
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has significant local reaction indicated by redness, swelling and fever at injection site. Swelling, redness measurement is 7.5 X 8 inches on arm. Pt states pressure with coolness "feels good". 3rd Anthrax shots in series.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Left arm swelling, pain left deltoid arm, inner arm and shoulder
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Rash
Clinical narrative: Both elbows painful, tender to palpation, red, rashy areas over both ante? areas left knee tender.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Received influenza and pneumonia vaccine on 10-25-02 at 9:30am, pneumonia given in right shoulder; influenza in left shoulder. 10-27-02 in morning, scattered red itchy pimples observed. 10-31-02 entire body covered with red itchy rash. Doctor was notified. Rx: methypremisolone 4mg PO dose pak ordered. 21 tabs was taken over a period of six days with good effect.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Joint range of motion decreased, Oedema
Clinical narrative: Soft tissue swelling, erythema, induration in upper right arm each compassing an area apprx. 10cm x 12cm. Pain in upper arm, shoulder and upper back. loss of normal range of motion. Symptoms of pain with injection. reaction as above in 2 hours.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Soft tissue swelling, erythema, induration in upper right arm each compassing an area apprx. 10cm x 12cm. Pain in upper arm, shoulder and upper back. loss of normal range of motion. Symptoms of pain with injection. reaction as above in 2 hours.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphonia, Injection site erythema, Injection site oedema
Clinical narrative: Tuesday pm reaction "size of grapefruit" swollen, hard and red. Wednesday, redness and swelling to elbow, Thursday/Friday underlying bruise. Some "hoarsness of lungs" Real lose cough. Used ice and benedryl. Reaction in right arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Eggsized rash the day after injection. Resolved on its own in a few days.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised, red, egg-sized area on arm. Resolved in a few days.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Light dizziness and nausea. Reaction to wearing glasses.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Pt called insisting that he had reaction to flu vaccine. Sx include nausea starting in evening and con't throughout the night. Improved somewhat by am of 11/07/2002
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Cyst, Dizziness, Erythema, Nausea, Pollakiuria
Clinical narrative: Starting feeling extremely nauseated 20 minutes after receiving vaccine. My right arm(lower) became itchy and red about 9:45am. I went to see Nurse to ask if symptoms were normal at 10am. I began vomiting and getting dizzy while talking the nurse. 10:05 am I was driven by friend to ER at 10:30am. Was seen by emergency room physician at 11am. My temperature was 99.15, dizzy, nauseated, rash on lower right arm and extreme need to urinate while at Hospital. I was given a shot in my left hip to counter act the Flu vaccine. I was observed for about 2-3 hours. I became clear minded and some what normal after 3 hours. I was given a prescription and order for bed rest for 24hours. After 24hours I felt back to my normal self, except continued bowel irritation and a cyst found(small) on my left shoulder where shot was given, and frequent need to go to the restroom to urinate.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: Starting feeling extremely nauseated 20 minutes after receiving vaccine. My right arm(lower) became itchy and red about 9:45am. I went to see Nurse to ask if symptoms were normal at 10am. I began vomiting and getting dizzy while talking the nurse. 10:05 am I was driven by friend to ER at 10:30am. Was seen by emergency room physician at 11am. My temperature was 99.15, dizzy, nauseated, rash on lower right arm and extreme need to urinate while at Hospital. I was given a shot in my left hip to counter act the Flu vaccine. I was observed for about 2-3 hours. I became clear minded and some what normal after 3 hours. I was given a prescription and order for bed rest for 24hours. After 24hours I felt back to my normal self, except continued bowel irritation and a cyst found(small) on my left shoulder where shot was given, and frequent need to go to the restroom to urinate.
Sex: M
Vaccine: FLUX
Symptoms: Drooling, Facial palsy, Hemiplegia, Hypokinesia
Clinical narrative: Bell's Palsy- Diagnosed Treatment Steriods. Abated in 2 months. Symptoms- left sided facial paralysis resulting in left side drooling, inability to smile symmetrically and difficulty chewing
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis, Muscular weakness
Clinical narrative: Note- did not eat breakfast 1. Symptoms: difficulty breathing, fats heart beat, dizziness, extremely weak, sweaty palms, shaking 2. With in 5 minutes of injection (reaction occurred) 3. Sat with legs up and drank juice/ ate crackers. took apprx. 10 hours (began to feel better apprx. 09:00 pm Went home rested had lots of fluids.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Note- did not eat breakfast 1. Symptoms: difficulty breathing, fats heart beat, dizziness, extremely weak, sweaty palms, shaking 2. With in 5 minutes of injection (reaction occurred) 3. Sat with legs up and drank juice/ ate crackers. took apprx. 10 hours (began to feel better apprx. 09:00 pm Went home rested had lots of fluids.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Cough
Clinical narrative: Within 48 hrs of receiving flu vaccine, pt develped sharp chest pain,non-productive cough. No fever/chills/SOB. CXR-neg. Dx. ?
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hot flush, Intestinal ischaemia, Menstruation irregular
Clinical narrative: Weakness 24 hours. Body shakes with standing. Fatigue 10 days after. Chills alternating with hot flashes. Increase BM. Early onset menstraul by 1 week. right roof mouth and right tongue feels burned
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia oral, Tremor
Clinical narrative: Weakness 24 hours. Body shakes with standing. Fatigue 10 days after. Chills alternating with hot flashes. Increase BM. Early onset menstraul by 1 week. right roof mouth and right tongue feels burned
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Wheezing
Clinical narrative: Pt presented with cough/wheezing. The next day post receiving flu vaccine was treated with Albuterol neb/prednisone.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Muscle spasms, Neuralgia
Clinical narrative: Sore arm 1 hour after shot- pain became worse went to ER on 10/21/2002. X-rays done. Feel nerve irratation- given Naprasyn and muscle relaxant (Flexeril). Also seen by MD group, Rx for Bextra. Going back to gruop, Wed 10/31/2002. States still has knot at injection. 10/28/2002 At 09:30 am, we received a telephone call from pt stating her left arm became very sore with radiating pain to her shoulder immediately after receiving her flu shot on Thursday, October 17, 2002. She states that she applied ice to her upper arm, and later heaat. However, paon became worse and she went to the emergency room at JFK on Monday, October 21,2002. She was given muscle relaxants and the doctor felt she developed a pinched nerve, advised her to see her private medical doctor. The pt states sh eonly has a cardiologist whom she has spoken to and he advised her to go to group. She was seen by MD, who also felt her spine was in spasm. She will be seeing another doctor in the group tomorrow. Pt states she has been out of work since 10/17/2002 as she could not use her left arm. i informed her that I did not feel the flu injection would cause a pinched nerve. Advised her to keep her appointment at the group and follow their instructions. I stated that I would speak to the nurse supervisor and call her back. RN.  10/28/2002 returned call to pt, she states that she didn't call sooner then 10/28/2002 as she felt the pain would go away. However, she has a knot in arm and shoulder is still painful. She states the arm never became red or swollen. Pt si an Orthrodontist Assistant and attending school. She states she hasn't been able to go to work and does not have any more sick time. Concerned she would not be able to complete her course, as it requires using both hands. She does have health insurance. Advised her to call the health depatment after her doctor appointment on Wednesday 10/30/2002. RN 10/30/2002 Telephone call to pt, states she was seen by MD, pain management physician, at group. Pt states MD stated injection caused problem with nerve in upper arm and pain in shoulder is due to muscle inflammation secondary to injection. MD ordered physical therapy for 3 weeks, 2-3 times a week. She will start therapy on Friday, November 1,2002 with . Pt stated she is going to try to return to work this afternoon. She questioned if she would be compensated finacially for money she was required to spend due to this incident. I advised her I would speak to my supervisor and get back to her. Also requested she call the health department to let us know how she was feeling after therapy. Per acknowlegdement letter- All missing information is already on form.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Pharyngolaryngeal pain
Clinical narrative: Chills beginning approximately 3 hrs after immunization. Temperature unknown. Developed sore throat during night. Throat still sore on 11/13/02, but no chills. Still with chills and "head cold" as of 11/15/02.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Employee was given flu shot. Arm where injection given became very red/raised area. She did not complain of pain. SOB, etc. Slight rash did appear.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Body temperature increased, Diarrhoea, Headache
Clinical narrative: Within 6-7 hrs, I developed a violent diarrhea, cramps, headache, muscle pain, joint pain and a 4 hour elevation in temperature. My MD saw me Monday. He believed that my reaction came either from the flu shot or a dormant virus which activated due to lowered immune response due to the shot.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Within 6-7 hrs, I developed a violent diarrhea, cramps, headache, muscle pain, joint pain and a 4 hour elevation in temperature. My MD saw me Monday. He believed that my reaction came either from the flu shot or a dormant virus which activated due to lowered immune response due to the shot.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: 3 hours after injection, felt burning. Next am, had swelling and redness approx. 2" diameter which was present for a week.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Reddened/painful arm followed by the hand and arm going numb. ER Rx'd antibiotics, Benadryl and ASA.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: Severe hives, itching and burning over whole body 4 hrs after flu shot. Took Benadryl 50mg every 6 hrs continued to get worse. Big red splotches all over. On 4th day, went to urgent care center, got injection of Kenilog and Keflex 80mg. Rx for prednisone and Keflex.
Sex: M
Vaccine: HEP
Symptoms: Erythema, Rash, Skin discolouration, Urticaria, Vomiting
Clinical narrative: Infant was given hep B vaccine at 0700, within 5 minutes a red rash with few whitish welts appeared all over the face, the infant had been fed part of his bottle and he began to vomit within 10 minutes of the immunization being given, at intermittent episodes his hands also turned purple 10 minutes after the immunziation was given. No other reactions were noted and the rash went away within 12 hrs of the initial episode.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pruritic rash-maculopapular-on buttucks and anterior R thigh approximately 10 hrs after vaccination. Tx: hydrocortisone cream 1%, fexofenadine 60mg bid x 5d.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Pt received DTap, Hib,IPV, Prevnar (1st doses each). Mother called me 11/14 with report of rash on face that looked like a bug bite, comes and goes. Into office 11/15 with ongoing rash of same description on face and trunk. Exam was normal, but descriptions is consistent with hives.
Age: 4.6
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: 1st lesion 2 days before office visit, more 2nd day more 3rd day, lesions on face, arm, neck and trunk. Various stages of healing. Tongue with sm. ulceration. Sympt Tx.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Immediately after IM inj in deltoid-area approx. 50mm x 30mm oval inflammation occurred. There was no paralysis, itching, tingling-and only slight tenderness at site. Applied ice and monitored v.s.-began resolving in 15-20 min. After 5 hrs reduced (stable) 80%-next day completely resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site inflammation, Injection site oedema
Clinical narrative: Inflammatory swelling with induration at half circumference rt deltoid region overnight.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R thigh reddened raised area.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Headache, Lymphadenopathy
Clinical narrative: Headache and swollen glands. Also sore neck and shoulders on 11/11/02. On 11/13/02, glands were less swollen. Treatment: Advil 300mg po Q6H PRN.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Mother came into clinic for booster DtaP on child and explained to nurse severe rash reaction in child post 2/8/02 MMR. Child had no fever, seizure-only rash covering body 12-24 hrs after imm. took child to PMD immediately-no recommendation from PMD or to further MMR's. M statees child not allergic to eggs.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: (+) 20 varicella lesion ext chest abdomen.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Headache
Clinical narrative: "Bad headache for three days."
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Varicella rash.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt given  DTaP (R lateral thigh); IPV on top of R thigh; MMR top of L thigh on 11/4/02. On 11/6/02 pt seen in office again due to swelling, redness, hardness at site of DTaP (8cm erythema); pt given Zyrtec and Zithromax to treat reaction.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site oedema
Clinical narrative: Left deltoid swelling and redness 4cm x 8cm area. blanchable. Will have f/u.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria on back and site of injection 36 hours after injection
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: About 10-15 minutes after the vaccine was administered, itchiness began at the site of the injection.  Over the next hour and a half the itching spread down the left arm and to the entire upper body.  The intensity of the itching also increased.  Hives developed.  MD examined me, checked my pulse and BP.  Both were normal.  He gave me a 12.5 mg tablet of Benadryl.  About 1 hour and 10 minutes later, the itching started to decrease.  About 3 hours later the itching started to increase again.  I took 2 Benadryl Allergy/Sinus Headache tablets (12.5 mg Diphenhydramine Hydrochloride,30 mg Pseudoephedrine Hydrochloride, 500mg Acetaminophen).  The itching competely stopped about 3 hours later. The follow up states, "I forgot to include in my summary that the physician who gave me the vaccine and responded/monitored my reactin recommended that I not take the flu vaccine again"."
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Oedema, Pain, Tenderness
Clinical narrative: the pt received an injection in his right arm.  he began to notice increasing pain and swelling of his right arm and chest muscles on the right side.  he presented to our emergency room and was found to have significant muscle swelling and tenderness of his right arm and right anterior chest wall.  he was also noted to be in rhabdomyolysis with ck's greater than 15,000.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Congenital anomaly, Pneumonia, Unevaluable event
Clinical narrative: Pt died 4 days after administration of vaccine
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Oedema, Pain
Clinical narrative: Patient developed local reaction at site of injection consisting of slight swelling, redness and soreness.  Patient was treated with tylenol and benadryl.
Age: 73.0
Sex: F
Vaccine: PPV, TD
Symptoms: Contusion, Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Significant pain, erythema, edema and warmth starting about one hour after co-administration of Pneumovax and dT in left upper arm.  Resolved to a bruise extending from elbow to site of injections after 48 hours of intermittent ice.  No evidence of cellulitis.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Skin nodule
Clinical narrative: Large Painful lump after 3 days of getting shot.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Rash
Clinical narrative: Approximately 5 hours after immunization patient's mother noted a slight red rash across chest. By the next AM body and head were covered in hive like rash, no respiratory difficulty. Rash lasted 3 days. Treated with Benadryl. This report was submitted in July and the Health Department is now sending it via the web.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Erythema, Feeling hot
Clinical narrative: Breathing difficulties, wheezing, coughing, tightness of chest for 3 hours after immunization, until medical help was sought.   Redness, heat and swelling at injection sight for 96 hours after immunization.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Wheezing
Clinical narrative: Breathing difficulties, wheezing, coughing, tightness of chest for 3 hours after immunization, until medical help was sought.   Redness, heat and swelling at injection sight for 96 hours after immunization.
Age: 55.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Carbon dioxide decreased, Diarrhoea, Fatigue
Clinical narrative: Report A0378150 describes Coxsackie viral infection in a 55 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history included left bundle branch block and allergies to penicillin and aspirin. She had experienced no known adverse events following previous immunizations. There was not known prior liver disease and no close contacts had hepatitis. The subject consumed one to two alcoholic beverages per week. Concurrent medications included estrogen replacement, calcium supplement, and multivitamins. She did not take paracetamol or nonsteroidal anti-inflammatory agents. In February 2002 and on 8/2/02, the vaccinee received her first and second injections of Havrix, respectively. On 8/3/02, the subject complained of malaise, nausea, and extreme fatigue. Laboratory analysis revealed alanine transaminase (ALT) 678 IU/L and aspartate transaminase (AST) 210 IU/L. Repeat analysis on 8/13/02 revealed ALT 389 IU/L and AST 126 IU/L. Bilirubin was within normal limits. On 8/14/02, cytomegalovirus IgM and IgG were negative. Hepatitis B core antigen IgM and hepatitis B surface antigen were negative. Total hepatitis A antibody screen was positive, but IgM was negative. On 8/20/02, laboratory analyses revealed decreased albumin and total protein, ALT 175 IU/L and AST 62 U/L. An abdominal sonogram performed on 8/22/02 revealed a normal liver. The physician made a diagnosis of acute hepatitis. Additional information was received on 11/12/02. The physician reported that the subject was admitted to the hospital in August 2002 with new-onset dilated cardiomyopathy. The reporting physician stated patient has recently been informed that her cardiomyopathy and LFT abnormalities are secondary to Coxsackie viral infection which was documented by her ID physician. However, the reporting physician also indicated that the hepatitis was possibly related to Havrix administration. As of 9/27/02, the hepatitis had improved. The outcome of the Coxsackie infection and cardiomyopathy were not specified. As a result of the new information received on 11/12/02, this report has been reclassified as serious, unexpected.
Age: 55.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Liver function test abnormal, Monocytosis, Myalgia, Nausea
Clinical narrative: Report A0378150 describes Coxsackie viral infection in a 55 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history included left bundle branch block and allergies to penicillin and aspirin. She had experienced no known adverse events following previous immunizations. There was not known prior liver disease and no close contacts had hepatitis. The subject consumed one to two alcoholic beverages per week. Concurrent medications included estrogen replacement, calcium supplement, and multivitamins. She did not take paracetamol or nonsteroidal anti-inflammatory agents. In February 2002 and on 8/2/02, the vaccinee received her first and second injections of Havrix, respectively. On 8/3/02, the subject complained of malaise, nausea, and extreme fatigue. Laboratory analysis revealed alanine transaminase (ALT) 678 IU/L and aspartate transaminase (AST) 210 IU/L. Repeat analysis on 8/13/02 revealed ALT 389 IU/L and AST 126 IU/L. Bilirubin was within normal limits. On 8/14/02, cytomegalovirus IgM and IgG were negative. Hepatitis B core antigen IgM and hepatitis B surface antigen were negative. Total hepatitis A antibody screen was positive, but IgM was negative. On 8/20/02, laboratory analyses revealed decreased albumin and total protein, ALT 175 IU/L and AST 62 U/L. An abdominal sonogram performed on 8/22/02 revealed a normal liver. The physician made a diagnosis of acute hepatitis. Additional information was received on 11/12/02. The physician reported that the subject was admitted to the hospital in August 2002 with new-onset dilated cardiomyopathy. The reporting physician stated patient has recently been informed that her cardiomyopathy and LFT abnormalities are secondary to Coxsackie viral infection which was documented by her ID physician. However, the reporting physician also indicated that the hepatitis was possibly related to Havrix administration. As of 9/27/02, the hepatitis had improved. The outcome of the Coxsackie infection and cardiomyopathy were not specified. As a result of the new information received on 11/12/02, this report has been reclassified as serious, unexpected.
Age: 55.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Fatigue, Hepatitis, Liver function test abnormal
Clinical narrative: Report A0378150 describes Coxsackie viral infection in a 55 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history included left bundle branch block and allergies to penicillin and aspirin. She had experienced no known adverse events following previous immunizations. There was not known prior liver disease and no close contacts had hepatitis. The subject consumed one to two alcoholic beverages per week. Concurrent medications included estrogen replacement, calcium supplement, and multivitamins. She did not take paracetamol or nonsteroidal anti-inflammatory agents. In February 2002 and on 8/2/02, the vaccinee received her first and second injections of Havrix, respectively. On 8/3/02, the subject complained of malaise, nausea, and extreme fatigue. Laboratory analysis revealed alanine transaminase (ALT) 678 IU/L and aspartate transaminase (AST) 210 IU/L. Repeat analysis on 8/13/02 revealed ALT 389 IU/L and AST 126 IU/L. Bilirubin was within normal limits. On 8/14/02, cytomegalovirus IgM and IgG were negative. Hepatitis B core antigen IgM and hepatitis B surface antigen were negative. Total hepatitis A antibody screen was positive, but IgM was negative. On 8/20/02, laboratory analyses revealed decreased albumin and total protein, ALT 175 IU/L and AST 62 U/L. An abdominal sonogram performed on 8/22/02 revealed a normal liver. The physician made a diagnosis of acute hepatitis. Additional information was received on 11/12/02. The physician reported that the subject was admitted to the hospital in August 2002 with new-onset dilated cardiomyopathy. The reporting physician stated patient has recently been informed that her cardiomyopathy and LFT abnormalities are secondary to Coxsackie viral infection which was documented by her ID physician. However, the reporting physician also indicated that the hepatitis was possibly related to Havrix administration. As of 9/27/02, the hepatitis had improved. The outcome of the Coxsackie infection and cardiomyopathy were not specified. As a result of the new information received on 11/12/02, this report has been reclassified as serious, unexpected.
Age: 55.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Malaise, Nausea, Viral infection
Clinical narrative: Report A0378150 describes Coxsackie viral infection in a 55 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history included left bundle branch block and allergies to penicillin and aspirin. She had experienced no known adverse events following previous immunizations. There was not known prior liver disease and no close contacts had hepatitis. The subject consumed one to two alcoholic beverages per week. Concurrent medications included estrogen replacement, calcium supplement, and multivitamins. She did not take paracetamol or nonsteroidal anti-inflammatory agents. In February 2002 and on 8/2/02, the vaccinee received her first and second injections of Havrix, respectively. On 8/3/02, the subject complained of malaise, nausea, and extreme fatigue. Laboratory analysis revealed alanine transaminase (ALT) 678 IU/L and aspartate transaminase (AST) 210 IU/L. Repeat analysis on 8/13/02 revealed ALT 389 IU/L and AST 126 IU/L. Bilirubin was within normal limits. On 8/14/02, cytomegalovirus IgM and IgG were negative. Hepatitis B core antigen IgM and hepatitis B surface antigen were negative. Total hepatitis A antibody screen was positive, but IgM was negative. On 8/20/02, laboratory analyses revealed decreased albumin and total protein, ALT 175 IU/L and AST 62 U/L. An abdominal sonogram performed on 8/22/02 revealed a normal liver. The physician made a diagnosis of acute hepatitis. Additional information was received on 11/12/02. The physician reported that the subject was admitted to the hospital in August 2002 with new-onset dilated cardiomyopathy. The reporting physician stated patient has recently been informed that her cardiomyopathy and LFT abnormalities are secondary to Coxsackie viral infection which was documented by her ID physician. However, the reporting physician also indicated that the hepatitis was possibly related to Havrix administration. As of 9/27/02, the hepatitis had improved. The outcome of the Coxsackie infection and cardiomyopathy were not specified. As a result of the new information received on 11/12/02, this report has been reclassified as serious, unexpected.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP
Symptoms: Anorexia, Fontanelle bulging, Pyrexia, Somnolence
Clinical narrative: A physician reported via manufacturer(Ref. No. HQ4918829OCT2002) the occurrence of a bulging fontanelle in a 4-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject's medical histroy, concurrent conditions, and concurrent medications were not reported. On 18 October 2002, the subject received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. One day later, on 19 October 2002, she experienced bulging fontanelle, fever, somnolence, and anorexia. As of 04 November 2002, the outcomes of the events were unknown. The report from the manufacturer stated, "Medically Important Event".
Age: 16.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Dysarthria, Eye movement disorder, Hyperhidrosis, Hyperventilation, Loss of consciousness
Clinical narrative: Hyperventilating
Age: 16.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Pain
Clinical narrative: Hyperventilating
Age: 16.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Hyperventilation
Clinical narrative: Hyperventilating
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Coma, Convulsion, Respiratory disorder
Clinical narrative: It was reported that a 26 year old female received Fluzone SV 2002-2003 USP (lot number U0924EA) administered IM in the left deltoid. Approximately 30 seconds after injection, the patient developed seizure activity, stopped breathing, and became unresponsive and cyanotic. Rescue breathing administered and the carotid pulse was present. The patient began Cheyne-Stokes breathing and gradually became responsive to verbal stimuli approximately 3-4 minutes after the injection. The patient recovered.  Reported on 03/04/2003: "From follow-up (follow-up #1) received from manufacturer on 02/24/2003, it was reported that the patient had a history of migraines.  No further information is provided. A 15-day follow up report received 9/12/2003 adds: From additional info received on 09/02/2003 from the reporter, no additional info is available. No further info is anticipated, this case is considered closed.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apnoea, Coma, Convulsion, Cyanosis
Clinical narrative: It was reported that a 26 year old female received Fluzone SV 2002-2003 USP (lot number U0924EA) administered IM in the left deltoid. Approximately 30 seconds after injection, the patient developed seizure activity, stopped breathing, and became unresponsive and cyanotic. Rescue breathing administered and the carotid pulse was present. The patient began Cheyne-Stokes breathing and gradually became responsive to verbal stimuli approximately 3-4 minutes after the injection. The patient recovered.  Reported on 03/04/2003: "From follow-up (follow-up #1) received from manufacturer on 02/24/2003, it was reported that the patient had a history of migraines.  No further information is provided. A 15-day follow up report received 9/12/2003 adds: From additional info received on 09/02/2003 from the reporter, no additional info is available. No further info is anticipated, this case is considered closed.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Laboratory test abnormal, Sudden infant death syndrome
Clinical narrative: From faxed correspondence received at manufacturer on 11/15/02 regarding an adverse event, which occurred during a Phase IV study for Daptacel. It was reported that a 4 mt old female received Daptacel. Pneumo Conjugate, IPV, PRP-T, and Hep B vax on 10/9/02. The PT expired on 10/30/02. "Per [a local county gov't office] provisionally diagnosed as SIDS death pending remaining test results from toxicology, etc." The event is not considered to be related to vax. Follow up info recieved on 12/11/02 included additional pt details, medical history, and atuopsy results. Info has been received from an investigator concerning a 4 month old female who received her second dose of Prevnar along with Tripedia, IPOL, ActHIB, and Engerix B vaccines on 10/9/02 as part of the Post-Marketing Safety Surveillance Trial. THe pt was a twin born prematurely at 31 weeks gestation to a mother with nail-patella syndrome in renal failure. At birth, the infant experienced respiratory insufficiency of prematurity, apnea, bradycardia and hyperbilirubinemia. During a well-child visiton 9/12/02, the infant showed early physical findings suggetive of nail-patella syndrome. On 10/30/02, the infant died. An autopsy was performed. The infant was described as well-nourished and well-developed. Findings included petechial hemorrhages on the thymus as well as pulmonary congestion and edema. There was no external or internal evidence of injury. The autopsy-reported cause of death was SIDS. Both the investigator and the medical monitor considered the SIDS death to be unrelated to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Death, Laboratory test, Sudden infant death syndrome
Clinical narrative: From faxed correspondence received at manufacturer on 11/15/02 regarding an adverse event, which occurred during a Phase IV study for Daptacel. It was reported that a 4 mt old female received Daptacel. Pneumo Conjugate, IPV, PRP-T, and Hep B vax on 10/9/02. The PT expired on 10/30/02. "Per [a local county gov't office] provisionally diagnosed as SIDS death pending remaining test results from toxicology, etc." The event is not considered to be related to vax. Follow up info recieved on 12/11/02 included additional pt details, medical history, and atuopsy results. Info has been received from an investigator concerning a 4 month old female who received her second dose of Prevnar along with Tripedia, IPOL, ActHIB, and Engerix B vaccines on 10/9/02 as part of the Post-Marketing Safety Surveillance Trial. THe pt was a twin born prematurely at 31 weeks gestation to a mother with nail-patella syndrome in renal failure. At birth, the infant experienced respiratory insufficiency of prematurity, apnea, bradycardia and hyperbilirubinemia. During a well-child visiton 9/12/02, the infant showed early physical findings suggetive of nail-patella syndrome. On 10/30/02, the infant died. An autopsy was performed. The infant was described as well-nourished and well-developed. Findings included petechial hemorrhages on the thymus as well as pulmonary congestion and edema. There was no external or internal evidence of injury. The autopsy-reported cause of death was SIDS. Both the investigator and the medical monitor considered the SIDS death to be unrelated to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Baby received the immunizations on 10/12/02 and was found lifeless in early morning of 11/13/02. Autopsy results are pending. Autopsy report received on 12/30/2002 indicates SIDS.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood creatine phosphokinase increased, Body temperature increased, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician concerning his wife, a 64 year old white female with hay fever and a pcn allergy who on 10/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641532/1353L). Concomitant therapy included Lipitor, Niaspan, Volmax, Mavik, Allegra, influenza virus vaccine and Foltx. Within six hours after the administration of her first dose of pneumococcal vaccine 23 polyvalent. On 10/18/02, the pt experienced pain and her right upper arm had swollen two to three times its size. She also develped erythema and heat with immobility of her right arm. The pt felt warm and may have had a low grade fever but measurements were not taken. The physician also noted that a blood test following the injection indicated that the pt's serum creatine kinase (CPK) was elevated to 512. Subsequently on 10/18/02, the pt was treated with rofecoxib 50mg tablet, 50mg once a day for two days. Thereafter, the dose of rofecoxib was decreased to 25mg once a day along with Vicodin. On 10/21/02, a complete blood count, "SMA-20," serum creatine kinase test, urinalysis and a serum immunoglobulin E test were all within normal limits. On 10/22/02, after four days of oral therapy, a heating pad four times a day and elevation of the right arm, the pt recovered from the pain, swelling, erythema, and heat with immobility of her right arm as she had remobilization of her right arm and the swelling was 80% down. The pt sought unspecified medical attention. The pain, swelling, erythema, and heat with immobility of her arm were considered to be disabling for 96 hours and other important emdical events (OMIC) by the physician. Additional info is not expected.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning his wife, a 64 year old white female with hay fever and a pcn allergy who on 10/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641532/1353L). Concomitant therapy included Lipitor, Niaspan, Volmax, Mavik, Allegra, influenza virus vaccine and Foltx. Within six hours after the administration of her first dose of pneumococcal vaccine 23 polyvalent. On 10/18/02, the pt experienced pain and her right upper arm had swollen two to three times its size. She also develped erythema and heat with immobility of her right arm. The pt felt warm and may have had a low grade fever but measurements were not taken. The physician also noted that a blood test following the injection indicated that the pt's serum creatine kinase (CPK) was elevated to 512. Subsequently on 10/18/02, the pt was treated with rofecoxib 50mg tablet, 50mg once a day for two days. Thereafter, the dose of rofecoxib was decreased to 25mg once a day along with Vicodin. On 10/21/02, a complete blood count, "SMA-20," serum creatine kinase test, urinalysis and a serum immunoglobulin E test were all within normal limits. On 10/22/02, after four days of oral therapy, a heating pad four times a day and elevation of the right arm, the pt recovered from the pain, swelling, erythema, and heat with immobility of her right arm as she had remobilization of her right arm and the swelling was 80% down. The pt sought unspecified medical attention. The pain, swelling, erythema, and heat with immobility of her arm were considered to be disabling for 96 hours and other important emdical events (OMIC) by the physician. Additional info is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 73 year old white female with an allergy to sulfamethoxazole (+) trimethoprim, erythromycin and penicillin vk, and a history of 2 prior vaccinations with pneumococcal vaccine 23 polyvalent who on 10/15/02 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (lot # 641130/1161L). Immediately after the administration of the vaccine, the patient developed a huge red and swollen area that extended all the way around her arm and into her armpit. The LPN reported that the area was hot and painful. In follow up, the LPN reported that the patient developed left axillary tenderness, as well as redness, swelling with pain at site, and that it continued around the patient's whole arm (orange size). The LPN also reported that the patient sought unspecified medical attention, and that, as of 10/17/02, the patient's reaction had not resolved. In follow up, the LPN reported that the patient's experience was considered to be an other important medical event, which required medical treatment. A concern was expressed regarding the lot number. Additional information has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain, Tenderness
Clinical narrative: Information has been received from a LPN concerning a 78 year old white male with a history of a prior vaccination with Pneumovax 23 who on 15-OCT-2002 was vaccinated IM with a dose of Pneumovax 23. On 16-OCT-2002, 24 hours after the administration of the vaccine, the pt developed a huge red and swollen area that extended all the way around his and into his "armpit". The LPN reported that the area was hot and painful. The LPN also reported that the pt sought unspecified medical attention, and that, as of 17-OCT-2002, the pt's reaction had not resolved. The reporter expressed a concern regarding the lot number. Conflicting information has been received from the LPN. The LPN reported that on 17-OCT-2002, the pt developed left axillary tenderness, redness, swelling with pain around site and the pt's "whole arm". The LPN described the swelling as "orange size". Subsequently, the pt recovered from the redness, tenderness, pain, and swelling. The LPN reported that the pt's reaction was an other important medical event (OMIC), which required medical treatment. No additional information is expected. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released.