chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Skin nodule
Clinical narrative: From initial information received on 1/4/05 regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a Fluzone vaccination, lot number not reported, administered IM, and a second dose of Pneumovax 23, lot number 649913/0577P, administered IM in the right deltoid on 12/16/04. On approximately 12/18/04, the patient developed redness in both arms and two red nodules on the lower portion of her right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. The patient's recovery status was unknown. The reporter of this case considered the redness in both arms and the two red nodules on the lower portion of the right arm to be other important medical events (OMIC).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site inflammation, Rash, Skin nodule
Clinical narrative: From initial information received on 1/4/05 regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a Fluzone vaccination, lot number not reported, administered IM, and a second dose of Pneumovax 23, lot number 649913/0577P, administered IM in the right deltoid on 12/16/04. On approximately 12/18/04, the patient developed redness in both arms and two red nodules on the lower portion of her right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. The patient's recovery status was unknown. The reporter of this case considered the redness in both arms and the two red nodules on the lower portion of the right arm to be other important medical events (OMIC).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Nasal congestion, Skin nodule
Clinical narrative: From initial information received on 1/4/05 regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a Fluzone vaccination, lot number not reported, administered IM, and a second dose of Pneumovax 23, lot number 649913/0577P, administered IM in the right deltoid on 12/16/04. On approximately 12/18/04, the patient developed redness in both arms and two red nodules on the lower portion of her right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. The patient's recovery status was unknown. The reporter of this case considered the redness in both arms and the two red nodules on the lower portion of the right arm to be other important medical events (OMIC).
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Cognitive disorder, Discomfort, Drug ineffective
Clinical narrative: Gradually lost cognitive ability, unable to stay awake, headaches, muscle and joint pains, unable to work and handle personal affairs, vertigo, SOB, and on and on. Medical Records received on 1/26/2005 states pt experienced fatigue, Raynaud's phenomena, insominia, hypersominia/narcolepsy, Lyme encephalopathy, night sweats since stopping hormones, and  IBS-Irritable Bowel Syndrome. Follow up: Chronic Lyme disease triggered by Lymerix, diagnosis given to pt approx May04. Note: Dose #1 Lymerix given 4/23/99 LY120G9. Follow up 02/02/05: lot number for vaccine number 1 is unknown. Per follow up report-Unable to work, extreme physical and mental fatigue. Pain and discomfort, insomnia, loss of intellect
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Dyspnoea, Encephalopathy, Gastrointestinal disorder, Headache, Insomnia
Clinical narrative: Gradually lost cognitive ability, unable to stay awake, headaches, muscle and joint pains, unable to work and handle personal affairs, vertigo, SOB, and on and on. Medical Records received on 1/26/2005 states pt experienced fatigue, Raynaud's phenomena, insominia, hypersominia/narcolepsy, Lyme encephalopathy, night sweats since stopping hormones, and  IBS-Irritable Bowel Syndrome. Follow up: Chronic Lyme disease triggered by Lymerix, diagnosis given to pt approx May04. Note: Dose #1 Lymerix given 4/23/99 LY120G9. Follow up 02/02/05: lot number for vaccine number 1 is unknown. Per follow up report-Unable to work, extreme physical and mental fatigue. Pain and discomfort, insomnia, loss of intellect
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Mental impairment, Myalgia, Night sweats, Pain, Peripheral vascular disorder
Clinical narrative: Gradually lost cognitive ability, unable to stay awake, headaches, muscle and joint pains, unable to work and handle personal affairs, vertigo, SOB, and on and on. Medical Records received on 1/26/2005 states pt experienced fatigue, Raynaud's phenomena, insominia, hypersominia/narcolepsy, Lyme encephalopathy, night sweats since stopping hormones, and  IBS-Irritable Bowel Syndrome. Follow up: Chronic Lyme disease triggered by Lymerix, diagnosis given to pt approx May04. Note: Dose #1 Lymerix given 4/23/99 LY120G9. Follow up 02/02/05: lot number for vaccine number 1 is unknown. Per follow up report-Unable to work, extreme physical and mental fatigue. Pain and discomfort, insomnia, loss of intellect
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Somnolence, Vertigo, Viral infection
Clinical narrative: Gradually lost cognitive ability, unable to stay awake, headaches, muscle and joint pains, unable to work and handle personal affairs, vertigo, SOB, and on and on. Medical Records received on 1/26/2005 states pt experienced fatigue, Raynaud's phenomena, insominia, hypersominia/narcolepsy, Lyme encephalopathy, night sweats since stopping hormones, and  IBS-Irritable Bowel Syndrome. Follow up: Chronic Lyme disease triggered by Lymerix, diagnosis given to pt approx May04. Note: Dose #1 Lymerix given 4/23/99 LY120G9. Follow up 02/02/05: lot number for vaccine number 1 is unknown. Per follow up report-Unable to work, extreme physical and mental fatigue. Pain and discomfort, insomnia, loss of intellect
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Arthritis, Hypokinesia, Pain, Viral infection
Clinical narrative: This is a non-serious spontaneous case from a consumer or other non-health professional in the USA of BURNING IN JOINTS. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a consumer that refers to a female aged 43 years. The patient's past medical history included auto immune thyroid disease, Grave's disease, and Hashimoto disease. She also had a viral infection several days prior to receiving FluMist. She received FluMist on 12/16/04 at 2 in the afternoon. The patient's concomitant medication included Levothyroxine Sodium. On 12/18/04 at approximately 6 in the evening, the patient's had complaints of intense burning and pain in her joints which caused loss of mobility. The reporter stated the pain at rest was rated a 4 and increased to an 8 with movement. The burning and pain began in the patient's wrist and ankles. Subsequently the burning and pain spread to her hands, arms, and legs. On 12/19/04, the patient was prescribed Naproxen for treatment. The reporter stated the Naproxen alleviated the patient's symptoms enough to rest that evening. On 12/20/04, the patient presented in the physician's office and was diagnosed with a viral infection. The reporter stated the attending physician concluded the events were due to the viral infection and not related to FluMist.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Rash papular
Clinical narrative: This is a non serious spontaneous case from a nurse in the USA of PAPULAR RASH. The reporter causality is related to FluMist. This case is being submitted according to the VAERS accelerated reporting agreement for FluMist. At approximately 8:30 AM on 12/8/04, a 45 year old female received FluMist intra-nasally and developed a very fine rash on her neck and chest the following morning. She had linear papulae on her neck and the rash was slightly itchy. As of 12/15/04, the rash was beginning to resolve after use of hydrocortisone cream for treatment. The reporter determined the events to be definitely related to FluMist. The patient has not yet recovered.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Vertigo
Clinical narrative: Vertigo, chills, sweats.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria, 2-3 hours after vaccination, with flu shot broke out in hives.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, slight swelling, tenderness 1.5 inch circular area with 3/4 surrounding swelling.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: 10/11/2004 2:00PM, Resident received Flu injection.  5:00PM resident was having some jerking, chills and fever.  Doctor notified.  Dr. said to monitor and give Tylenol 500 mg (2) for fever and comfort.  7:10PM temp. decreased to 103.2 - Family in.  8:00PM temp. 100.7 - patient rested all night.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bacterial infection, Pain, Pharyngolaryngeal pain, Swelling
Clinical narrative: 4 hours after receiving Flu shot in arm and pneumonia booster in right arm, arm swelled from elbow to shoulder.  Later in day and during night, pain.  Next day patient applied ice.  3rd day went to doctor at 10:00AM.  Doctor told patient she had staph infection.  Prescribed cefaoroxil 500 mg for 7 days.  Swelling and pain gone.  5 days later terrible sore throat.  Refilled prescription and as of 01/05/2005, still on meds.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Noticed sore, painful area under left arm, down arm and breast area.  Then rash developed short distance from injection site, below the deltoid, going under the arm, then breast area , on back, neck up into the hairline.  Denies fever, complaint of nausea and being very tired.  Has history of chronic head and aches.  Did not notice any change in headaches.   12/09/2004 Patient presented to health department for public health nurse to see rash.  Patient had rash (looked like hives) from just below the lower part of her bra up to her neck and some in hairline at back of head.  Had one area on back between shoulder blades approximately size of small orange.  The front chest area was pretty much covered up to the neck with a few areas on neck.  Public health nurse recommended patient see MD for evaluation of rash.  Patient unable to take Benadryl. 12/10/2004 Received phone call from patient stated she went to Pri-Med and saw MD who definitely thought patient had had a reaction to either the flu shot or to the Pneumonia shot.  Patient was given a cortisone injection at doctor's office and was given Claritin for Hives.  Patient states rash and symptoms are a lot better today.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: Noticed sore, painful area under left arm, down arm and breast area.  Then rash developed short distance from injection site, below the deltoid, going under the arm, then breast area , on back, neck up into the hairline.  Denies fever, complaint of nausea and being very tired.  Has history of chronic head and aches.  Did not notice any change in headaches.   12/09/2004 Patient presented to health department for public health nurse to see rash.  Patient had rash (looked like hives) from just below the lower part of her bra up to her neck and some in hairline at back of head.  Had one area on back between shoulder blades approximately size of small orange.  The front chest area was pretty much covered up to the neck with a few areas on neck.  Public health nurse recommended patient see MD for evaluation of rash.  Patient unable to take Benadryl. 12/10/2004 Received phone call from patient stated she went to Pri-Med and saw MD who definitely thought patient had had a reaction to either the flu shot or to the Pneumonia shot.  Patient was given a cortisone injection at doctor's office and was given Claritin for Hives.  Patient states rash and symptoms are a lot better today.
Age: 1.28
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Report received from school, unable to complete form in its entirety.
Age: 1.05
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information received from school- unable to complete form in its entirety.
Age: 0.24
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Bradycardia
Clinical narrative: Increase in episodes of bradycardia and desaturations. Recovered within 12 hours. Pre vaccination/bronch OA's, 1B, 1D, immediate post 1A, 6B and D; post 0 As, Bs, Ds (A-Apnea, B-Bradycardia, D-desats)
Age: 1.07
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Broke out in mild, vesicular rash on 12/30/2004. Seen in Dr office 1/3/05 dx varicella.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, PNC, VARCEL
Symptoms: Erythema multiforme, Injection site induration
Clinical narrative: There was a 2-3 cm ovoid patch of erythematous induration with vessicles and papules within, noticed on 12/17/2004.
Age: 1.02
Sex: F
Vaccine: HBPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Has chicken pox lesions on face, chest, abdomen and legs.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Breakthrough varicella with vaccine.
Age: 29.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site inflammation
Clinical narrative: States seeking medical care due to reported inflamation following Td injection.
Age: 1.38
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever up to 103.7 axillary, clear runny nose and congestion.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Capillary disorder, Erythema multiforme, Pharyngolaryngeal pain, Swelling face
Clinical narrative: Anaphylaxis with facial (especially eye) swelling, discomfort in throat, blotchy erythematous rash over entire body and prolonged capillary refill. These symptoms were treated with SQ Epi and Benadryl IM.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dermatitis bullous, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine was given 10/11/04. Complained of pox on 10/21 or 10/22, injection site red and swollen also. Developed more pox over the next week (>50-100). Complained of feeling tired and denied fever. Recovered by 11/05/04.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised area 4 inches in diameter on Lt thigh-red and warm to touch-saw doctor on 1-6-05, treatment- Keflex, Prelone, Motrin and heating pad.
Age: 1.52
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Mild generalized rash, classic for chicken pox, onset approximately 12/25/2004.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Dizziness, Headache, Injection site pain, Lethargy
Clinical narrative: Within 8 hours of administration c/o nausea, lethargy, headache, chills, and dizziness. Extreme site tenderness.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: Within 8 hours of administration c/o nausea, lethargy, headache, chills, and dizziness. Extreme site tenderness.
Age: 1.31
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Rash
Clinical narrative: MILD GENERALIZED RASH ON TORSO AND FACIAL AREA STARTING ON 1/6/05.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Leukocytosis, Leukopenia, Pyrexia, White blood cell count decreased
Clinical narrative: Received Pediarix, HIB, Prevnar on 12/13/04 in am (2nd series).  Developed uncontrollable crying and elevated temperature approximately 10 hours later.  Temperature spiraled to 104 degrees (R) Follow up report received 02/18/2005 Diagnosis was confirmed from medical records as Leukocytosis (not Leukopenia).
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pain, Rash, Rash macular, Swelling
Clinical narrative: Employee reports that her left arm, shoulder and neck up to her ear became very swollen and red with a blotchy rash.  Arm is still somewhat sore, but swelling and redness are gone.
Age: 39.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Eye swelling, Insomnia, Visual disturbance
Clinical narrative: Patient received Typhoid and Flu shot on 6 Jan 05, Patient stated puffiness both eyes, difficult to focus vision, difficulty sleeping.  Came into clinic as a walk in at 1300 almost 24 hours after shots given.  Still having focus problems. Patient currently taking Naproxen, Flexeril
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Loss of consciousness, Opisthotonus, Pallor, Syncope
Clinical narrative: This case described a 19 year old female patient who experienced a vasovagal reaction following the administration of hepatitis B vaccine recombinant. The report was initially received from a consumer (the grandmother of the patient) and was confirmed by the vaccine provider. Concurrent medications included a unspecified medication. On 10/15/04, the patient received the second dose of Engerix B. The patient's grandmother reported that at an unspecified time following the administration of Engerix B, on 10/18/04, the patient experienced pallor. The grandmother stated that the patient then passed out and her neck and back went backwards, she was pale and diaphoretic and starting throwing up. On 1/5/05, the vaccine provider reported that, "when the patient saw the needle and felt the stick, she experienced a vasovagal reaction with fainting." The physician reported that the patient, "recovered well immediately with supine positioning." Comment: Vasovagal reaction was assessed as medically serious (OMIC).
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Syncope vasovagal, Vomiting
Clinical narrative: This case described a 19 year old female patient who experienced a vasovagal reaction following the administration of hepatitis B vaccine recombinant. The report was initially received from a consumer (the grandmother of the patient) and was confirmed by the vaccine provider. Concurrent medications included a unspecified medication. On 10/15/04, the patient received the second dose of Engerix B. The patient's grandmother reported that at an unspecified time following the administration of Engerix B, on 10/18/04, the patient experienced pallor. The grandmother stated that the patient then passed out and her neck and back went backwards, she was pale and diaphoretic and starting throwing up. On 1/5/05, the vaccine provider reported that, "when the patient saw the needle and felt the stick, she experienced a vasovagal reaction with fainting." The physician reported that the patient, "recovered well immediately with supine positioning." Comment: Vasovagal reaction was assessed as medically serious (OMIC).
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site haemorrhage, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Patient experienced fever myalgia and pain at the injection site 2 days after injection of the vaccine. A temperature of 103 was reported and arthralgia but no cough, vomiting, diarrhea or abdominal pain. The patient's temperature in the office on 12/20/2004 was 102.5, she was noted to have an area of ecchymosis 4 inches in diameter at the injection site. There was no fluctuance, lymphadenopathy, icterus or rash.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Rash 24 hours after vaccination.
Age: 58.0
Sex: M
Vaccine: IPV, TD, TYP
Symptoms: Abdominal pain, Pain, Pyrexia
Clinical narrative: Constant, sharp, non-radiating left mid abd pain - onset approx 24 hour after 1st oral typhoid, negative for N,V,D,C ? fever. 2nd dose taken 01/03/05- pain cresenoed 01/04/05 and decrease but not resolved 01/06/05 after 3rd dose 01/05/05.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Rash erythematous
Clinical narrative: Rash- redness- on the side of ---------- about 6 cm in diameter erythmatous rash. Rx benadryl
Age: 70.0
Sex: M
Vaccine: IPV, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Awoke with redness, swelling and painful left upper arm. Forgot he had pneumovax 1998 and received number 2 1999. 01/06/2005 actually 3rd dose discussed this with MD 2 days after 3rd dose given. 01/07 placed on duricef and clarines 01/08/2005 redness/swelling slightly improved. Redness left shoulder and elbow
Age: 56.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: Cold sensation and at night use extra covers like field jacket and blanket or socks help ease tingling. Never went away but seemed to mitigate tingle, but returning more. The numbness in right thigh top side above knee first occurred briefly Feb but returned in April stayed awhile and this fall it returned and stays longer than an hour, a few times 1/2 day and whole day.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within the first 24 hours I developed a large, red inflamed area about 4" from top to bottom, at the site of the injection (right arm).  It became very red with a raised surface and very warm to the touch.  I took two Advil and two doses of Benadryl 25 mg each, and it has subsided somewhat, but is still sore 72 hours later.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Generalized myalgia symptoms occurring three months ago. Per patient started after third anthrax vaccination. Describes upper back, neck, bilat shoulder, knee, and foot pain. No noted history of trauma. No other known history for myalgia conditions.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Shoulder pain
Clinical narrative: Generalized myalgia symptoms occurring three months ago. Per patient started after third anthrax vaccination. Describes upper back, neck, bilat shoulder, knee, and foot pain. No noted history of trauma. No other known history for myalgia conditions.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Clinical varicella.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Face oedema, Oedema peripheral, Pyrexia, Rash
Clinical narrative: From initial information received on 12/29/04 from another manufacturer (WAES0309USA00742) regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a nine week old male patient received his first set of vaccines including a dose of IPOL, lot number not reported, a dose of COMVAX, lot number 644699/1215M, a dose of INFANRIX, lot number not reported, and a dose of PREVNAR, lot number not reported, administered on 8/28/03 at approximately 11:00 AM. Routes and sites of administration were not reported. Later that day, the patient developed a generalized rash, which his mother described as red, raised bumps as well as a fever of 102.5 degrees F, edema of the fingers and face, non stop crying and vomiting. The patient was taken to the emergency room and treated with acetaminophen. He was again taken to the emergency room on 8/29/03 and 8/30/03. On each of the three visits, the patient was seen by the same physician and was not admitted. On 8/31/03, the mother of the child woke up at 6:00 AM to check on the child and thought he was doing better. Reportedly, she went back to bed as the child was asleep in his crib. She woke up again around 8:00 AM and found the child dead in his crib. The cause of death is unknown at this time. An autopsy was done and as of 9/9/03 the results were still pending. The patient's events were considered to be immediately life threatening and disabling by the reporter. The physician reported that she was not able to provide any further medical information. There was no product quality complaint involved. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash erythematous, Vomiting
Clinical narrative: From initial information received on 12/29/04 from another manufacturer (WAES0309USA00742) regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a nine week old male patient received his first set of vaccines including a dose of IPOL, lot number not reported, a dose of COMVAX, lot number 644699/1215M, a dose of INFANRIX, lot number not reported, and a dose of PREVNAR, lot number not reported, administered on 8/28/03 at approximately 11:00 AM. Routes and sites of administration were not reported. Later that day, the patient developed a generalized rash, which his mother described as red, raised bumps as well as a fever of 102.5 degrees F, edema of the fingers and face, non stop crying and vomiting. The patient was taken to the emergency room and treated with acetaminophen. He was again taken to the emergency room on 8/29/03 and 8/30/03. On each of the three visits, the patient was seen by the same physician and was not admitted. On 8/31/03, the mother of the child woke up at 6:00 AM to check on the child and thought he was doing better. Reportedly, she went back to bed as the child was asleep in his crib. She woke up again around 8:00 AM and found the child dead in his crib. The cause of death is unknown at this time. An autopsy was done and as of 9/9/03 the results were still pending. The patient's events were considered to be immediately life threatening and disabling by the reporter. The physician reported that she was not able to provide any further medical information. There was no product quality complaint involved. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 20.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Asthenia, Blister, Fatigue, Headache, Injection site abscess
Clinical narrative: Patient is a 20 year old male who was vaccinated on 28 Dec 04 with the vaccinia virus.  He reports having severe body aches and fevers to 101.5 and headaches.   Nine days after vaccination he began to have headaches with subsequent vomiting.  He reports 5-6 episodes of emesis over the next 12-24 hours.  No blood.  He also complains of feeling weak and tired for the next 48 hours.  He reports the headaches lasted for four days and have since resolved in the last 12 hours.  The vaccination site was also the worst at that time with redness, tenderness, swelling, and oozing of the site.  Approximately 2 days prior to the headaches and peak of symptoms, he noticed small bumps scattered on arms, legs, back and chest.  One of the bumps on same upper arm as the vaccine developed into a blister.  The others continued with papules only.  In the last 12 hours his headaches have improved, the vaccination site has improved, no further vomiting, strength is slowly returning but the rash not improved.  Currently no fevers or chills, no vomiting, no diarrhea, headache is gone.  No sick close contacts MEDICATIONS: 1. Motrin  Supplements: None  No over-the-counter medications   PMH: 1. None  MED ALLERGIES: 1. NKDA   Social History Never smoked  No pets  No allergies  No history of problems with vaccines
Age: 20.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient is a 20 year old male who was vaccinated on 28 Dec 04 with the vaccinia virus.  He reports having severe body aches and fevers to 101.5 and headaches.   Nine days after vaccination he began to have headaches with subsequent vomiting.  He reports 5-6 episodes of emesis over the next 12-24 hours.  No blood.  He also complains of feeling weak and tired for the next 48 hours.  He reports the headaches lasted for four days and have since resolved in the last 12 hours.  The vaccination site was also the worst at that time with redness, tenderness, swelling, and oozing of the site.  Approximately 2 days prior to the headaches and peak of symptoms, he noticed small bumps scattered on arms, legs, back and chest.  One of the bumps on same upper arm as the vaccine developed into a blister.  The others continued with papules only.  In the last 12 hours his headaches have improved, the vaccination site has improved, no further vomiting, strength is slowly returning but the rash not improved.  Currently no fevers or chills, no vomiting, no diarrhea, headache is gone.  No sick close contacts MEDICATIONS: 1. Motrin  Supplements: None  No over-the-counter medications   PMH: 1. None  MED ALLERGIES: 1. NKDA   Social History Never smoked  No pets  No allergies  No history of problems with vaccines
Age: 20.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Rash, Rash maculo-papular, Vomiting
Clinical narrative: Patient is a 20 year old male who was vaccinated on 28 Dec 04 with the vaccinia virus.  He reports having severe body aches and fevers to 101.5 and headaches.   Nine days after vaccination he began to have headaches with subsequent vomiting.  He reports 5-6 episodes of emesis over the next 12-24 hours.  No blood.  He also complains of feeling weak and tired for the next 48 hours.  He reports the headaches lasted for four days and have since resolved in the last 12 hours.  The vaccination site was also the worst at that time with redness, tenderness, swelling, and oozing of the site.  Approximately 2 days prior to the headaches and peak of symptoms, he noticed small bumps scattered on arms, legs, back and chest.  One of the bumps on same upper arm as the vaccine developed into a blister.  The others continued with papules only.  In the last 12 hours his headaches have improved, the vaccination site has improved, no further vomiting, strength is slowly returning but the rash not improved.  Currently no fevers or chills, no vomiting, no diarrhea, headache is gone.  No sick close contacts MEDICATIONS: 1. Motrin  Supplements: None  No over-the-counter medications   PMH: 1. None  MED ALLERGIES: 1. NKDA   Social History Never smoked  No pets  No allergies  No history of problems with vaccines
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Injection site rash, Pain
Clinical narrative: Rash- about 4" diameter at injection site for 2-3 days after injection. Developed generalized aching on 3rd day after injection; lasted 2 days. Some relief with ibuprofen. No visits to a physician.
Age: 1.65
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Clinical shingles
Age: 3.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Restlessness
Clinical narrative: Patient received post-exposure rabies treatment -- 3 shots; 1 vaccine, 2 immunoglobulin.  Doctor informed us that she would need "adult dosage" of immunoglobulin.  12 hours later, patient was running high fever -- over 103 degrees and was restless.  1 & 1/2 tsp. of Children's Tylenol was administered.  Within two hours, the fever broke, and the patient rested comfortably.  Nighttime pediatrician oncall did not think it was related to rabies treatment.  There were no other signs of illness in the next week.  Doctor felt it may have been due to the high dosage of immunoglobulin or the combination of that with the vaccine.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal distension, Chills, Diarrhoea, Flatulence, Headache
Clinical narrative: Pt states FluMist taken approx 1330 on Jan 8, 2005.  Mid morning Sunday stomach/bloating/bad gas, queasy feeling began.  Headache then started took 2 Advils and about 1330 on her head hurt so bad that by 3pm she started vomiting. Then around 5 pm chills began 101 temp reported by pt. Diarrhea began. Headache still present. Taking Tylenol/Advil every 4-6 hours. Woke up today called in sick. I referred her to her doctor. Stated she understood.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt states FluMist taken approx 1330 on Jan 8, 2005.  Mid morning Sunday stomach/bloating/bad gas, queasy feeling began.  Headache then started took 2 Advils and about 1330 on her head hurt so bad that by 3pm she started vomiting. Then around 5 pm chills began 101 temp reported by pt. Diarrhea began. Headache still present. Taking Tylenol/Advil every 4-6 hours. Woke up today called in sick. I referred her to her doctor. Stated she understood.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin burning sensation
Clinical narrative: A facial rash appeared within a couple of hourse. This rash went down both sides of my face and across my chin with raised bumps. It burned, but did not itch. It lasted for about 2 weeks. I did nothing for the first days and then the clinic told me to take Benadryl and that worked within about 4 days.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Very sore, inflamed throat, runny nose, headache, stiff neck, fatigue.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Balance disorder, Confusional state, Dizziness
Clinical narrative: Approximately 2 -3  days after flu shot, patient started having pain - mainly lower torso, upper thighs, groin area - No longer has pain but now has progressed to vertigo like symptoms - weakness, equilibrium - can't walk, confusion, nausea, losing weight - Dr has done blood tests, 2 Ct's, chest x-ray, ekg and nothing abnormal - Information from medical records states pale, nausea,fatigue, dizziness.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pallor, Vertigo, Weight decreased
Clinical narrative: Approximately 2 -3  days after flu shot, patient started having pain - mainly lower torso, upper thighs, groin area - No longer has pain but now has progressed to vertigo like symptoms - weakness, equilibrium - can't walk, confusion, nausea, losing weight - Dr has done blood tests, 2 Ct's, chest x-ray, ekg and nothing abnormal - Information from medical records states pale, nausea,fatigue, dizziness.
Age: 0.49
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bronchitis, Pneumonia, Pneumonitis, Pulmonary oedema
Clinical narrative: 5 month old male afebrile (97.8), mild URI, immunized with DTaP, IPV, HIB, and PCV about 14-20 hours prior to sudden death. Found lifeless in crib. Autopsy Report received on 1/25/2005 states bronchial pneumonia, tracheitis, and pulmonary edema.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac arrest, Hypoglycaemia, Myocardial fibrosis, Myocardial ischaemia
Clinical narrative: From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50's received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Hypoglycaemia
Clinical narrative: From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50's received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Bradycardia, Erythema, Heart rate increased, Rash macular, Respiratory depression
Clinical narrative: Within minutes of receiving immunizations, developed marked respiratory depression, bradycardia, and fiery red macular rash on face, body and upper legs. Responded to stimulation; increased heart rate and respirations. Taken to ER and placed on monitor and Pulse oximetry. Given steroids and Benadryl. Admitted for observation.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Respiratory rate increased
Clinical narrative: Within minutes of receiving immunizations, developed marked respiratory depression, bradycardia, and fiery red macular rash on face, body and upper legs. Responded to stimulation; increased heart rate and respirations. Taken to ER and placed on monitor and Pulse oximetry. Given steroids and Benadryl. Admitted for observation.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood urea increased, Chills, Cough, Drug ineffective
Clinical narrative: Vaccine failure. Discharge Summary received on 1/25/2005 states pt experienced fever, chills, headache, cough, SOB, loss of consciousness, hypotension, increased BUN, and increased creatinine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Hypotension, Loss of consciousness, Pyrexia
Clinical narrative: Vaccine failure. Discharge Summary received on 1/25/2005 states pt experienced fever, chills, headache, cough, SOB, loss of consciousness, hypotension, increased BUN, and increased creatinine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac enzymes increased, Catheterisation cardiac normal, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: 10 days after vaccine administered, patient developed chest pain and shortness of breath. He was seen in the ER and found to have cardiac enzyme elevation. Hypokinesis noted on echocardiogram. Diagnosed with myocarditis. 4 day hospital stay. Normal cardiac cath. 1/04/09 On 7 Dec 2006 called regarding patient, who had an episode of myopericarditis in 2004 and since has had 2 episodes of pleurtic chest pain associated with dyspnea. He has been evaluated in the ED twisce since the initial adverse event in 2004; in Sept 2005 and in May 2006. Since then he has been doing well.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Myocarditis
Clinical narrative: 10 days after vaccine administered, patient developed chest pain and shortness of breath. He was seen in the ER and found to have cardiac enzyme elevation. Hypokinesis noted on echocardiogram. Diagnosed with myocarditis. 4 day hospital stay. Normal cardiac cath. 1/04/09 On 7 Dec 2006 called regarding patient, who had an episode of myopericarditis in 2004 and since has had 2 episodes of pleurtic chest pain associated with dyspnea. He has been evaluated in the ED twisce since the initial adverse event in 2004; in Sept 2005 and in May 2006. Since then he has been doing well.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: face/neck/ears reddened. Welts on forehead. Itching right ear, neck, back
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Oedema peripheral, Pyrexia
Clinical narrative: Severe pain in left arm within 2 hours of having injection. Began having swelling, redness and warmth in arm. Entire upper arm edematous. Went to MD today and was prescribed cephalexin. Arm continues to be red and edematous but edema has settled in the elbow area also reports running a low grade temp.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Pt states he received flu shot on 12/1/04. On 12/2/04 at 1:10PM c/o severe pain in L knee. Treated with ice pack and rest. At 2:30PM c/o severe pain in both knees. Denied pain at injection site in right arm. Mother was called and child was picked up from school. On 12/3/04 child states in AM and PM that he had no pain and that he received Tylenol at home.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Petit mal epilepsy
Clinical narrative: Child had petit mal seizure immediately after injection was given.
Age: 21.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Follow up - This is a non-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in "no definitive reason" why the FLUMIST was responsible for "these symptoms." HEPA filters were put into the environment and since then, nobody has gottensick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter will not give patient identifiers regarding this patient. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative.
Age: 21.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Follow up - This is a non-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in "no definitive reason" why the FLUMIST was responsible for "these symptoms." HEPA filters were put into the environment and since then, nobody has gottensick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter will not give patient identifiers regarding this patient. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative.
Age: 54.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, Headache, Throat irritation
Clinical narrative: This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into  these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Additional information receved on 05JAN05 and 19JAN05 incorporated into above narrative. Additional information received on 04MAY05: patient name, gender and DOB , vaccine lot number.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Follow up received states - This is anon-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE: (Unlabelled) to FLUMIST while vaccinating military personel. The reporter determined the events to be unrelated to FLUMIST adminstration. This case is submitted according to the VAERS Safety Surveillande accelerated reporting agreement for FLUMIST. A 26 year old male medical support member developed headache and scratchy throat after accidental exposure during FLUMIST adminsitration. Investigation into these events resulted in "no definitive reason" why the FLUMIST was responsible for "these symptoms." HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05: patient name, gender and DOB; vaccine lot number