chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Received DTaP, IPV and MMR on 4/27/04. Developed erythematous macular rash with in 24 hours at DTaP injection site. size-3" x 2" No induration.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Varicella vaccine administered 4/15/04. Patient developed generalized vesicular rash and fever-103.9 4/25/04 Seen in ER. Dx-Viral Syndrome RIT Varicella Vaccine.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema
Clinical narrative: 10cmx15cm erythemic area Left lateral leg
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left upper arm with moderate swelling and mild redness and warmth also tender to palpate no respiratory sx's
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Pt was exposed to mumps case 4/10 by hugging. 4/10 came for immunization 4/22, no prc h/o immunization. Developed right peri-auricular lymphadenopathy x2
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema/edema left thigh at vaccination site.  Started on 04/28/04 with slight redness, 04/29/04 swollen and increased red.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: On 04/29/04, pt started itching around 09:15am.  Babysitter/aunt noticed rash on left arm around 9:30am.  Pt brought to us around 14:00pm.  Treatment: Ice and Benadryl as needed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Received DTAP #5 on 05/03/04.  Mom called 9:15am 05/04/04, arm red, swollen.  Progressed as day went on, seen in our office 7:00.  10cm erythema, warmth, and induration. Diagnosis with cellulitis.  Augmentin 400mg twice daily for 10 days.
Age: 3.0
Sex: F
Vaccine: HBHEPB, HEPA, IPV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: Swollen, red size 3x3.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Child received vaccine 05/04/04.  Mom noticed redness and swelling AM of 05/05/04 noted increased swelling and warm to touch AM 05/06/04.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash macular, Urticaria, Viral infection
Clinical narrative: Five macular-urticarial rash over trunk arms and legs, no mucous membrane instead mildy pruritic.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Complained of erythema, slight heat, edema to area just medial to puncture site - left upper leg.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Left lateral thigh with mild erythema, blotchiness, no tenderness.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: 2.5 days of high pitched screaming and generalized irritability, low grade fever (temperature not taken by parents), uneventful recovery. Seen in office 04/24, symptoms resolved by then.
Age: 14.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 6x6cm red, hot, varied induration, swollen, bandaid visible imprint left deltoid.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site warmth
Clinical narrative: Right arm inflammed/red, warm to touch 2x2 inch round knot.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox-modified about 20-25 pox 05/01/04.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Tender, erythematous area around injection site right deltoid 3cm around site of DTAP #4 injection.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Similar reaction on previous exposure to drug
Clinical narrative: Received vaccine, followed by redness, inflammation, heat to site, starting two days later.  Seen in ED diagnosed with cellulitis, given prescription antibiotics.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Asthma, Cough, Nasal congestion, Pain, Pharyngitis
Clinical narrative: Pt is a 39 year old female who was deployed on 19 Mar 03. On 25 Mar 03 she received anthrax # 1. Stated her arm was a little sore and within 48 hours she felt that she developed cold symptoms. She noticed that her head was congested, had nasal congestion, sore throat, and green sputum production. She denied fever. No other people in her unit had similar symptoms. No symptoms prior to receipt of anthrax. She went to the doctor 5 days later on 03 Apr 03 because she was not getting any better and thought that it was partly due to the fact that she was working constantly. She was prescribed antibiotics and after taking began to feel better. She finished her antibiotics and on 16 Apr 03 she received AVA # 2.  Patient reports that 48 hrs later she developed same symptoms as with AVA # 1 but this time the symptoms were worse. Stated she was waking up at night coughing. Went to the MD instead of waiting like before and was given different antibiotics, an expectorant, and 2 days of quarters. Did not require hospitalization. Symptoms resolved in mid May. She stated that everyone in her work group arrived at the same time and received anthrax.  She reported that 4 out of 5 in her work group developed similar symptoms.  States she has returned to normal and never had symptoms similar to this since May. When questioned about past or current episodes of shortness of breath or cough she reports that she has always had an occasional cough approximately a couple of times per week. States it does not wake her up at night. No PND. She experiences shortness of breath about 2 times a week and wheezes 5-6 times a month in which she rarely uses her inhaler. Stated she was diagnosed with asthma in 2002. In reference to exercise tolerance she states that she looses her breath at about 1¾ mile walking about 4-4.3 mph.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Pharyngolaryngeal pain, Productive cough, Rhinitis
Clinical narrative: Pt is a 39 year old female who was deployed on 19 Mar 03. On 25 Mar 03 she received anthrax # 1. Stated her arm was a little sore and within 48 hours she felt that she developed cold symptoms. She noticed that her head was congested, had nasal congestion, sore throat, and green sputum production. She denied fever. No other people in her unit had similar symptoms. No symptoms prior to receipt of anthrax. She went to the doctor 5 days later on 03 Apr 03 because she was not getting any better and thought that it was partly due to the fact that she was working constantly. She was prescribed antibiotics and after taking began to feel better. She finished her antibiotics and on 16 Apr 03 she received AVA # 2.  Patient reports that 48 hrs later she developed same symptoms as with AVA # 1 but this time the symptoms were worse. Stated she was waking up at night coughing. Went to the MD instead of waiting like before and was given different antibiotics, an expectorant, and 2 days of quarters. Did not require hospitalization. Symptoms resolved in mid May. She stated that everyone in her work group arrived at the same time and received anthrax.  She reported that 4 out of 5 in her work group developed similar symptoms.  States she has returned to normal and never had symptoms similar to this since May. When questioned about past or current episodes of shortness of breath or cough she reports that she has always had an occasional cough approximately a couple of times per week. States it does not wake her up at night. No PND. She experiences shortness of breath about 2 times a week and wheezes 5-6 times a month in which she rarely uses her inhaler. Stated she was diagnosed with asthma in 2002. In reference to exercise tolerance she states that she looses her breath at about 1¾ mile walking about 4-4.3 mph.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Myalgia, Skin burning sensation
Clinical narrative: 28-year-old male states that after receiving his 4th Anthrax Vaccine on 10/5/03 he started experiencing bone and muscle pain in his left shoulder, rib and arm.   States that one week after receiving the anthrax vaccine in the left deltoid he started experiencing a warm, burning sensation in his left shoulder, halfway down his left humerus and under left axilla halfway down ribcage.  Denies any numbness or tingling, headache, swelling of lymph nodes or fever.  Reports no other associated symptoms.  States that he went to an urgent care where x-rays were taken of his ribcage, which were negative.  Took over the counter Advil that helped with the bone and muscle pain.  States that the pain was constant for approximately one month.                                                      After receiving his 5th Anthrax Vaccine on 4/10/04, he states that the pain started again but this time it was bilateral including both shoulders, upper half of both upper arms and under both axilla down to the middle of the ribcage.  Pain was a little more intense on left side where he received his vaccine in the left deltoid again.  When the pain first started, he rated the rib pain as an 8 on pain scale 0-10 and shoulder pain as 4-5 on pain scale 0-10.  States that the pain is not as intense and constant as previously and rates it now as a 3 on pain scale 0-10.  Currently taking over the counter Advil for pain.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Oedema
Clinical narrative: 24 HOURS POST VACCINATION, INDIVIDUAL EXPERIENCING SWELLING APPROX 17CM BY 20 CM LEFT TRICEP DOWN TO ELBOW.  SITE REDDENED AND WARM TO TOUCH.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Hypokinesia, Pain
Clinical narrative: January 10 2003-  received first anthrax shot in left tricep.  Jan 11, 2003- upper left leg went numb and lasted three days. Jan 13, 2003- leg regained feeling but sharp pains began.  The sharp pains would last from minutes to hours.  every other week the stabbing pains would return.  Roughly in March and April the pains began to come about a week apart.  In June and July the pains would come bi-weekly and began to happen in my left arm.  In Aug-Sept the pains would come 3 to 4 times a week. Also the pains began to grow in strength.  I began to to also experience loss of feeling and a surging sensation through my left limbs.  Oct-Nov - the pains and loss of feeling would occur daily and I began to temporaily lose the ablity to move my left am and leg.  Dec-Jan2003-2004  The pains and loss of feeling began to happen in my right side as well and would occur multiple times a day up till present day.  currently my entire body aches constantly. Follow up 05/25/2004: Patient states he was diagnosed with neuropathy by EMG. He was treated for a time with Neurontin, but discontinued due to lack of effectiveness.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Arthritis, Confusional state
Clinical narrative: pain in knee and elbow joints - arthritis - pills and injections. memory loss/confusion in detailed situations-took less complicated job. tried to simplify my life
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Next day site of injection red and raised.  Child "picking", probably itchy.  Redness is 5 cm. in diameter, enduration (hardness) is 10 cm.in diameter.  No fever.  No other symptoms.  Phone physician who ordered Benadryl orally.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Redness, swelling and itching, with warmth in the affected area. Total affected area about 4 x 4 inches and raised approx. 1/2 inch. This report is being submitted 1 week after vaccination. Unknown when syptoms will subside.  Unsure as to actual vaccine brand administred.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Tenderness
Clinical narrative: Large local reaction: approximately 2 hours following receipt of vaccine, noted small area of redness and warmth. The following day (4/24/04) the area had increased to his elbow and by 4/26/04, erythematous area was approximately 140 x 300 with accompanying warmth and tenderness; difficult to bend elbow.
Age: 54.0
Sex: M
Vaccine: UNK, TTOX
Symptoms: Hypokinesia
Clinical narrative: Within 2 days of tetanus booster, developed severe pain in area of injection (left shoulder).  Lasted several weeks.  Followed by several weeks chronic fatigue, also developed 'frozen shoulder' immediately after shot-surgery required.
Age: 54.0
Sex: M
Vaccine: UNK, TTOX
Symptoms: Fatigue, Hypokinesia, Injection site pain
Clinical narrative: Within 2 days of tetanus booster, developed severe pain in area of injection (left shoulder).  Lasted several weeks.  Followed by several weeks chronic fatigue, also developed 'frozen shoulder' immediately after shot-surgery required.
Age: 70.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthritis, Hypokinesia, Pain
Clinical narrative: Arm stayed sore for months. Shooting pains woke me up at night. Lost strength in arm. When lying down, the muscle is notably weaker. Went to my doctor. Said it was probably arthritis. Mar 12, 2003 woke up with burning, itching , tingling in arm shot area. Stopped about 12hours later.
Age: 70.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypersensitivity, Muscular weakness, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: Arm stayed sore for months. Shooting pains woke me up at night. Lost strength in arm. When lying down, the muscle is notably weaker. Went to my doctor. Said it was probably arthritis. Mar 12, 2003 woke up with burning, itching , tingling in arm shot area. Stopped about 12hours later.
Age: 70.0
Sex: F
Vaccine: TD, TD
Symptoms: Tenderness
Clinical narrative: Arm stayed sore for months. Shooting pains woke me up at night. Lost strength in arm. When lying down, the muscle is notably weaker. Went to my doctor. Said it was probably arthritis. Mar 12, 2003 woke up with burning, itching , tingling in arm shot area. Stopped about 12hours later.
Age: 0.58
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Lung disorder, Sudden infant death syndrome
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a 7 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix).  The reporter was the foster parent of the child.  The pt's past medical history included birth twin, maternal drug exposure and prematurity. The reporter stated that the pt's "twin did not get his shots and he is doing fine."  On an unspecified date, the pt received the first dose of Pediarix.  At an unspecified time following the administration of Pediarix, on an unspecified date in April 2004, the pt died. The cause of death was not reported.  Follow up on 05/19/04: "Follow up information revealed that the child did not receive any vaccines manufacturered by this manufacturer. Therefore, this case will be voided."
Age: 0.58
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a 7 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix).  The reporter was the foster parent of the child.  The pt's past medical history included birth twin, maternal drug exposure and prematurity. The reporter stated that the pt's "twin did not get his shots and he is doing fine."  On an unspecified date, the pt received the first dose of Pediarix.  At an unspecified time following the administration of Pediarix, on an unspecified date in April 2004, the pt died. The cause of death was not reported.  Follow up on 05/19/04: "Follow up information revealed that the child did not receive any vaccines manufacturered by this manufacturer. Therefore, this case will be voided."
Age: 0.58
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a 7 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix).  The reporter was the foster parent of the child.  The pt's past medical history included birth twin, maternal drug exposure and prematurity. The reporter stated that the pt's "twin did not get his shots and he is doing fine."  On an unspecified date, the pt received the first dose of Pediarix.  At an unspecified time following the administration of Pediarix, on an unspecified date in April 2004, the pt died. The cause of death was not reported.  Follow up on 05/19/04: "Follow up information revealed that the child did not receive any vaccines manufacturered by this manufacturer. Therefore, this case will be voided."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Child developed red tender swelling left thigh which required hospitalization 04/21/04/23/04 at medical center . He did not have fever. Child was treated with IV antibiotic and discharged on oral Abx, Benadryl.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Pain
Clinical narrative: On 18Apr04 member was administered smallpox vaccine. On 23Apr04, member started experiencing pain in legs, progressing throughout body. Member reported to ER on 27Apr04 and was released same day.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy
Clinical narrative: Member has possible swollen lymph node on left clavicle, post smallpox vaccination.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Rash erythematous, Rash macular, Rash papular
Clinical narrative: Day 1 5/01:1-12mm Erythemic papular lesions with halo surrounding lesions over entire body involving 50-60% of skin. Day 2: spreading erythematous papular lesions covering 80% of body and on day 3 spread to 95% of skin and was confluent. Pt had been on Septra for 9 days for UTI and was office called upon first exam. Treated with antihistamine, with no benefit, started prednisone 5/3/04. Most likely drug reaction. Vital signs stable throughout.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Pt had rash and full body hives x 2 days. Itching and redness. Pt given Benadryl. Atarax and Allegra after seeing provider.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Client had influenza vaccine 10/11/03. Rash reported 10/12/03 at 9AM. Client also on TMP/SMX since 10/2/03. D.C. TPM/smx, give benadryl 50mg IM Stat and 25mg p.o. qidx 2 days. Rash reported as scattered wheal like to both arms, buttocks, back, both thighs. Wheals raised, red uneven borders, various sizes. No rash 10/19/03.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin discolouration, Skin nodule
Clinical narrative: Influenza Vaccine given 9/29/03. Client presents 10/6/03 with reddened purple non-tender nodules. .25-1.0 cm areas on palms and dorsum of hands and back. Client indicates it started 1 week prior. Physician indicates "probable erythem nodosum to flu vaccine. Gave Methylpred 60mg IM X1. Triamcinolone topical. Rash faded 10/14/03.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Respiratory disorder, Swelling face, Urticaria
Clinical narrative: Within 30 min of vaccine, pt began with non-stop coughing, red puffy face, scattered hives. Seen at 45min mark: no wheeze but prolonged expiratory phase. Received epinephrine shot (0.15ml), oral benedryl and oral prednisone.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Blister, Rash
Clinical narrative: Pt has a rash allover. Pt received vaccine on 4/27/04. Rash present itself on May 1, 2004. Upon examination, the pt had vesicles in different stages. Pt was febrile also.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pyrexia, Swelling
Clinical narrative: Fever 100-101 degrees. Mother states left upper arm with redness and swollen area 8x9cm- warm to touch at injection site of DTaP. Started with smaller area of swelling on 4/21/04 at about 8:00 am when mom noticed it.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pyrexia, Swelling
Clinical narrative: 1: Fever up to 103.7 degrees mother states. 2: 10x11 cm red +swollen area. Warm to the touch at the site of injection on left upper arm.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever, Redness and swollen thigh. Dr. give Rx Amoxicillin 250 1tsp tid only for increased redness, pain and fever. Warm soaks / compresses 15 min qid. No swollen or redness per mom. 5/3/04 at 5:28 PM.
Sex: U
Vaccine: IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever (103 degrees) oral 6-7 days past MMR
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction to right thigh 15x11 red, hot, swollen: DTaP
Age: 6.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Pharyngitis, Viral infection
Clinical narrative: Chicken pox started 4/28/04. Treated for Strep Pharyngitis 4/27/04.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash, Rash papular
Clinical narrative: Rash x 2 days (48 hours) around 100 small papular, vesicles, come crusting.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Local reaction: erythema, warmth over thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Slightly erythematous, indurated area where vaccine given: left upper arm and fever of 103.0 (temp)
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Pneumovax administered 5/5/04. 5/7/04 pt seen in office and complained of swelling and redness of left deltoid, denied other symptoms or complained of illness   etc (local reaction ).
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Hives on back : 24 hours past immunization given
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was seen on 5/6/04 and diagnosed with Chicken pox.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: Local reaction. 10x5 cm erythema, induration, pruritus
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt saw pediatrician 29April04-09:15 for preschool physical. Had "runny nose" clear. No fever. Immunization 4-6 yr old ordered by MD. Pt came to Imm 30Apr04 for shots. Still "running nose" . No fever for over 10days. Immunizations given at 09:30. Pt tolerated well. Sent home. Parent states approximately 18:30 -child complained of itching. Parent noted hives-called Peds 24hour line. Pt sent to doctor. No respiratory difficulties. Child placed on benedryl 15mgm po q 12hours for 5 days and prednisone x 10days. Child doing well on 5/3/04. Mother had given child Children's ibuprofen post vaccination.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pallor, Pruritus, Rash, Skin discolouration
Clinical narrative: Pt got immunizations at approx.  1400. Tolerated well. Pt had slight runny nose but no fever. Pt did get slightly pale after immunizations given, but was crying before hadn. Pt's mom noted he had rosy cheeks at 15:30, then at 16:30 child complained of itching all over and had fine , red flat rash on chest. Went to doctor- ws told to watch child and give Benedryl and tap (12.5mgm) bid. Pt did fine through night. No respiratory problems. Then next day after breakfast , had hives around face and chest. Back to doctor. Placed on Zyrtec 1tsp qdx10days. and Benedryl 1tsp q12 hrprn. Doing well today 5/7/04.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Pt got immunizations at approx.  1400. Tolerated well. Pt had slight runny nose but no fever. Pt did get slightly pale after immunizations given, but was crying before hadn. Pt's mom noted he had rosy cheeks at 15:30, then at 16:30 child complained of itching all over and had fine , red flat rash on chest. Went to doctor- ws told to watch child and give Benedryl and tap (12.5mgm) bid. Pt did fine through night. No respiratory problems. Then next day after breakfast , had hives around face and chest. Back to doctor. Placed on Zyrtec 1tsp qdx10days. and Benedryl 1tsp q12 hrprn. Doing well today 5/7/04.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: From initial information received on 26 Apr 2004 from a healthcare professional, regarding an adverse event occurring, it was reported that a four month old female patient received a second dose of DAPTACEL, lot number C1696AA, in the left thigh; a second dose of IPOL, lot number X0707-2, in the right thigh; and a second dose of COMVAX (manufacturer Merck), lot number 0026P, in the right thigh. The routes of administration were not reported. Approximately 12 hours later, the patient developed fever of 104 degrees F and had a seizure which lasted for 45 minutes. No other signs or symptoms were reported. Emergency services were called and the seizure was observed by the paramedics. The patient was transported to the emergency room and assessed by the emergency room physician. A CT scan and spinal tap were performed and were reportedly negative. The patient had been medicated with Tylenol prior to receiving the vaccines. It was not reported whether the patient recovered from this adverse event. The patient's twin sister also received DAPTACEL, IPOL and COMVAX on the same date. Approximately twelve hours later, the patient's twin experienced a fever of 102.7 degrees Fahrenheit. The details of this report are contained in case2004-01711. Follow up on 05/28/04 states: "From additional information received on 05/17/04 from another manufacturer (reference # WAES0405USA00328), it was reported that the pt recovered from these events."
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: This is a 38 year old male who developed body aches, muscle spasms, GERD and "pins and needles" sensations in his extremities and back in temporal association with receipt of his anthrax vaccinations. Patient states that following receipt of his first vaccination he developed GERD symptoms of nausea and heartburn. He denies any other symptom such as fever, chills; night sweats, nausea, vomiting or muscle/joint aches or pains.    However, his medical record reflects on 14 March 2003, that he reported night sweats for the previous 3-4 nights, inability to sleep well, loose stools for a couple of days and a mild rash on his abdomen and upper legs. The medical record describes the rash as "slightly raised papules in a line on abdomen, approximately one inch in length and what looks like mild folliculitis on thighs".  On 24 April 2004 he received his second anthrax vaccination. He states that he developed chills, night sweats and nausea beginning the same day and lasting approximately one week. Again he denies experiencing any rash, muscle aches or joint pain.  He received his third anthrax on 19 May 2003. He states that the same day he developed muscle spasms in his back, legs and arms with "pins and needles" sensation in the same areas. He states he also developed abdominal pain. These symptoms reportedly progressed over the next few days to feeling like he was "being jabbed with spikes", which reportedly last 3-4 days and slowly dissipated and subsided completely.  In August of 2003 the client relates that again he experienced a two-week episode of intermittent "pins and needles" sensation in his back, arms and legs. At this time he began seeing a doctor.  He also reportedly had a head cat scan done that was negative. His total cholesterol level at the time was 225. He was started on proton pump inhibitor for his GERD and Lipitor for his hyperlipidemia.  A letter dated 04/05/2004 from the doctor states that the client has "suffered from body aches, abdominal pain, dizziness, fatigue and odd twitching movements", he continues "based on his [the client's] description his extremity pain has consistently been neuropathic". He further relates that the client has been seen by a neurologist and diagnosed him with nocturnal myoclonus and a Pulmonologist who diagnosed an alpha-1-trypsin deficiency, not requiring management at this time.  Currently, he has been found fit for full duty and is awaiting reassignment to a ship. He states that the "pins and needles" sensation has not re-occurred for the past two weeks and prior to this has only been an isolated "jab" from time to time.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Folliculitis, Gastrooesophageal reflux disease, Muscle spasms, Myoclonus
Clinical narrative: This is a 38 year old male who developed body aches, muscle spasms, GERD and "pins and needles" sensations in his extremities and back in temporal association with receipt of his anthrax vaccinations. Patient states that following receipt of his first vaccination he developed GERD symptoms of nausea and heartburn. He denies any other symptom such as fever, chills; night sweats, nausea, vomiting or muscle/joint aches or pains.    However, his medical record reflects on 14 March 2003, that he reported night sweats for the previous 3-4 nights, inability to sleep well, loose stools for a couple of days and a mild rash on his abdomen and upper legs. The medical record describes the rash as "slightly raised papules in a line on abdomen, approximately one inch in length and what looks like mild folliculitis on thighs".  On 24 April 2004 he received his second anthrax vaccination. He states that he developed chills, night sweats and nausea beginning the same day and lasting approximately one week. Again he denies experiencing any rash, muscle aches or joint pain.  He received his third anthrax on 19 May 2003. He states that the same day he developed muscle spasms in his back, legs and arms with "pins and needles" sensation in the same areas. He states he also developed abdominal pain. These symptoms reportedly progressed over the next few days to feeling like he was "being jabbed with spikes", which reportedly last 3-4 days and slowly dissipated and subsided completely.  In August of 2003 the client relates that again he experienced a two-week episode of intermittent "pins and needles" sensation in his back, arms and legs. At this time he began seeing a doctor.  He also reportedly had a head cat scan done that was negative. His total cholesterol level at the time was 225. He was started on proton pump inhibitor for his GERD and Lipitor for his hyperlipidemia.  A letter dated 04/05/2004 from the doctor states that the client has "suffered from body aches, abdominal pain, dizziness, fatigue and odd twitching movements", he continues "based on his [the client's] description his extremity pain has consistently been neuropathic". He further relates that the client has been seen by a neurologist and diagnosed him with nocturnal myoclonus and a Pulmonologist who diagnosed an alpha-1-trypsin deficiency, not requiring management at this time.  Currently, he has been found fit for full duty and is awaiting reassignment to a ship. He states that the "pins and needles" sensation has not re-occurred for the past two weeks and prior to this has only been an isolated "jab" from time to time.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Night sweats, Pain, Paraesthesia, Rash
Clinical narrative: This is a 38 year old male who developed body aches, muscle spasms, GERD and "pins and needles" sensations in his extremities and back in temporal association with receipt of his anthrax vaccinations. Patient states that following receipt of his first vaccination he developed GERD symptoms of nausea and heartburn. He denies any other symptom such as fever, chills; night sweats, nausea, vomiting or muscle/joint aches or pains.    However, his medical record reflects on 14 March 2003, that he reported night sweats for the previous 3-4 nights, inability to sleep well, loose stools for a couple of days and a mild rash on his abdomen and upper legs. The medical record describes the rash as "slightly raised papules in a line on abdomen, approximately one inch in length and what looks like mild folliculitis on thighs".  On 24 April 2004 he received his second anthrax vaccination. He states that he developed chills, night sweats and nausea beginning the same day and lasting approximately one week. Again he denies experiencing any rash, muscle aches or joint pain.  He received his third anthrax on 19 May 2003. He states that the same day he developed muscle spasms in his back, legs and arms with "pins and needles" sensation in the same areas. He states he also developed abdominal pain. These symptoms reportedly progressed over the next few days to feeling like he was "being jabbed with spikes", which reportedly last 3-4 days and slowly dissipated and subsided completely.  In August of 2003 the client relates that again he experienced a two-week episode of intermittent "pins and needles" sensation in his back, arms and legs. At this time he began seeing a doctor.  He also reportedly had a head cat scan done that was negative. His total cholesterol level at the time was 225. He was started on proton pump inhibitor for his GERD and Lipitor for his hyperlipidemia.  A letter dated 04/05/2004 from the doctor states that the client has "suffered from body aches, abdominal pain, dizziness, fatigue and odd twitching movements", he continues "based on his [the client's] description his extremity pain has consistently been neuropathic". He further relates that the client has been seen by a neurologist and diagnosed him with nocturnal myoclonus and a Pulmonologist who diagnosed an alpha-1-trypsin deficiency, not requiring management at this time.  Currently, he has been found fit for full duty and is awaiting reassignment to a ship. He states that the "pins and needles" sensation has not re-occurred for the past two weeks and prior to this has only been an isolated "jab" from time to time.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: This is a 38 year old male who developed body aches, muscle spasms, GERD and "pins and needles" sensations in his extremities and back in temporal association with receipt of his anthrax vaccinations. Patient states that following receipt of his first vaccination he developed GERD symptoms of nausea and heartburn. He denies any other symptom such as fever, chills; night sweats, nausea, vomiting or muscle/joint aches or pains.    However, his medical record reflects on 14 March 2003, that he reported night sweats for the previous 3-4 nights, inability to sleep well, loose stools for a couple of days and a mild rash on his abdomen and upper legs. The medical record describes the rash as "slightly raised papules in a line on abdomen, approximately one inch in length and what looks like mild folliculitis on thighs".  On 24 April 2004 he received his second anthrax vaccination. He states that he developed chills, night sweats and nausea beginning the same day and lasting approximately one week. Again he denies experiencing any rash, muscle aches or joint pain.  He received his third anthrax on 19 May 2003. He states that the same day he developed muscle spasms in his back, legs and arms with "pins and needles" sensation in the same areas. He states he also developed abdominal pain. These symptoms reportedly progressed over the next few days to feeling like he was "being jabbed with spikes", which reportedly last 3-4 days and slowly dissipated and subsided completely.  In August of 2003 the client relates that again he experienced a two-week episode of intermittent "pins and needles" sensation in his back, arms and legs. At this time he began seeing a doctor.  He also reportedly had a head cat scan done that was negative. His total cholesterol level at the time was 225. He was started on proton pump inhibitor for his GERD and Lipitor for his hyperlipidemia.  A letter dated 04/05/2004 from the doctor states that the client has "suffered from body aches, abdominal pain, dizziness, fatigue and odd twitching movements", he continues "based on his [the client's] description his extremity pain has consistently been neuropathic". He further relates that the client has been seen by a neurologist and diagnosed him with nocturnal myoclonus and a Pulmonologist who diagnosed an alpha-1-trypsin deficiency, not requiring management at this time.  Currently, he has been found fit for full duty and is awaiting reassignment to a ship. He states that the "pins and needles" sensation has not re-occurred for the past two weeks and prior to this has only been an isolated "jab" from time to time.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Crying, Eye movement disorder, Pallor, Pyrexia
Clinical narrative: Patient had prolonged crying and screaming for > 2 hours. Later had an episode of unresponsiveness associated with staring, rolling up of eyes, pallor and fever. Was admitted for observation.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming, Staring
Clinical narrative: Patient had prolonged crying and screaming for > 2 hours. Later had an episode of unresponsiveness associated with staring, rolling up of eyes, pallor and fever. Was admitted for observation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash
Clinical narrative: PATIENT PRESENTED WITH RASH ON R LEG.  RED, BUMPY, NO PAIN AFTER 1 DAY.
Sex: M
Vaccine: MMR, TTOX
Symptoms: Rash, Swelling
Clinical narrative: 14 days later broke into rash covering arms, chest (front and back), legs, joint pain evident, knees swollen.
Sex: M
Vaccine: MMR, TTOX
Symptoms: Arthralgia, Oedema, Rash
Clinical narrative: 14 days later broke into rash covering arms, chest (front and back), legs, joint pain evident, knees swollen.
Age: 1.28
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR, HIBV, MMR
Symptoms: Bacterial infection, Hepatic enzyme abnormal, Parotitis
Clinical narrative: From initial information received on 4/27/04 regarding an adverse event occurring in the USA, it was reported that a 15 month old female patient received a fourth dose of ACTHIB, lot number VE140AA, administered IM in the left arm and a first dose of MMR II, lot number 641627/0666N, administered SC in the left arm on 3/18/04 at 11:00 AM. 21 days later, on 4/8/04, the patient developed swelling of the right cheek and swelling of the right lymph node of the neck. The patient was hospitalized on 4/8/04 and was diagnosed with right parotitis with secondary bacterial infection. The reporting nurse stated that the patient's serum amylase was abnormal, however no results were provided. The patient was discharged from the hospital on 4/9/04. The patient had a follow up visit at the physician's office on 4/12/04 and had recovered from parotitis and secondary bacterial infection. The lot number provided for ACTHIB did not match the product. The initial reporter of this case was contacted and she stated that the lot number was UE140AA. No other information was provided. From additional information received on 25/MAY/2004 from another manufacturer, it was reported that the patient also received a dose of GENHEVAC B, lot number, route and site of administration not reported, on an unspecified date. A telephone call was placed to the initial reporter of this case for clarification and she stated that the patient did not receive GENHEVAC B. The last hepatitis B vaccine that the patient received was on 29SEP2003, when she received a third dos eof ENGERIX B. No other information was provided at this time. From additional information received on 28MAY2004 from the initial reporter, the patient's name, addres and phone number were provided as well as a corrected phone number for the responsible physician. The patient was not on any other medications and did not have any illness at the time of vaccination. No further informaton is anticipated, this case is considered closed.
Age: 1.28
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR, HIBV, MMR
Symptoms: Bacterial infection, Lymphadenopathy, Parotitis, Swelling
Clinical narrative: From initial information received on 4/27/04 regarding an adverse event occurring in the USA, it was reported that a 15 month old female patient received a fourth dose of ACTHIB, lot number VE140AA, administered IM in the left arm and a first dose of MMR II, lot number 641627/0666N, administered SC in the left arm on 3/18/04 at 11:00 AM. 21 days later, on 4/8/04, the patient developed swelling of the right cheek and swelling of the right lymph node of the neck. The patient was hospitalized on 4/8/04 and was diagnosed with right parotitis with secondary bacterial infection. The reporting nurse stated that the patient's serum amylase was abnormal, however no results were provided. The patient was discharged from the hospital on 4/9/04. The patient had a follow up visit at the physician's office on 4/12/04 and had recovered from parotitis and secondary bacterial infection. The lot number provided for ACTHIB did not match the product. The initial reporter of this case was contacted and she stated that the lot number was UE140AA. No other information was provided. From additional information received on 25/MAY/2004 from another manufacturer, it was reported that the patient also received a dose of GENHEVAC B, lot number, route and site of administration not reported, on an unspecified date. A telephone call was placed to the initial reporter of this case for clarification and she stated that the patient did not receive GENHEVAC B. The last hepatitis B vaccine that the patient received was on 29SEP2003, when she received a third dos eof ENGERIX B. No other information was provided at this time. From additional information received on 28MAY2004 from the initial reporter, the patient's name, addres and phone number were provided as well as a corrected phone number for the responsible physician. The patient was not on any other medications and did not have any illness at the time of vaccination. No further informaton is anticipated, this case is considered closed.
Age: 1.28
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR, HIBV, MMR
Symptoms: Bacterial infection, Blood amylase increased, Lymphadenopathy, Parotitis, Swelling
Clinical narrative: From initial information received on 4/27/04 regarding an adverse event occurring in the USA, it was reported that a 15 month old female patient received a fourth dose of ACTHIB, lot number VE140AA, administered IM in the left arm and a first dose of MMR II, lot number 641627/0666N, administered SC in the left arm on 3/18/04 at 11:00 AM. 21 days later, on 4/8/04, the patient developed swelling of the right cheek and swelling of the right lymph node of the neck. The patient was hospitalized on 4/8/04 and was diagnosed with right parotitis with secondary bacterial infection. The reporting nurse stated that the patient's serum amylase was abnormal, however no results were provided. The patient was discharged from the hospital on 4/9/04. The patient had a follow up visit at the physician's office on 4/12/04 and had recovered from parotitis and secondary bacterial infection. The lot number provided for ACTHIB did not match the product. The initial reporter of this case was contacted and she stated that the lot number was UE140AA. No other information was provided. From additional information received on 25/MAY/2004 from another manufacturer, it was reported that the patient also received a dose of GENHEVAC B, lot number, route and site of administration not reported, on an unspecified date. A telephone call was placed to the initial reporter of this case for clarification and she stated that the patient did not receive GENHEVAC B. The last hepatitis B vaccine that the patient received was on 29SEP2003, when she received a third dos eof ENGERIX B. No other information was provided at this time. From additional information received on 28MAY2004 from the initial reporter, the patient's name, addres and phone number were provided as well as a corrected phone number for the responsible physician. The patient was not on any other medications and did not have any illness at the time of vaccination. No further informaton is anticipated, this case is considered closed.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, VARCEL, DTAPH, MMR, VARCEL
Symptoms: Dermatitis bullous, Erythema, Infection, Pruritus, Pyrexia
Clinical narrative: On 4/16/04 mother called to report child temp of 102 degrees. 2-3 red "itchy" spots to face and on chest area. Varicella vaccine administered on 04/05/04. Advised mother to take child to pediatrician ASAP for assessment. ON 4/19/04 mother states pediatrician diagnosed chickenpox. Comfort measures advised for itching.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, VARCEL, DTAPH, MMR, VARCEL
Symptoms: Drug ineffective, Pruritus, Pyrexia, Viral infection
Clinical narrative: On 4/16/04 mother called to report child temp of 102 degrees. 2-3 red "itchy" spots to face and on chest area. Varicella vaccine administered on 04/05/04. Advised mother to take child to pediatrician ASAP for assessment. ON 4/19/04 mother states pediatrician diagnosed chickenpox. Comfort measures advised for itching.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Laboratory test abnormal, Pain, Pruritus, Rash
Clinical narrative: MMR given 4/19/04 at 1:30 PM. 4/29/04 developed body ache and itching. Used Eucerin cream (thought itching was from dry skin. 5/1/04 Above symptoms continued. First papule appeared. 5/2/04 More rashes. 5/3/04 More rashes. To ER for treatment of rash and itching. 5/6/04 Rash and itch continues when effects of Benadryl subside.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pain, Pruritus, Rash
Clinical narrative: MMR given 4/19/04 at 1:30 PM. 4/29/04 developed body ache and itching. Used Eucerin cream (thought itching was from dry skin. 5/1/04 Above symptoms continued. First papule appeared. 5/2/04 More rashes. 5/3/04 More rashes. To ER for treatment of rash and itching. 5/6/04 Rash and itch continues when effects of Benadryl subside.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain, Colitis ulcerative, Diarrhoea, Flatulence, Haematochezia
Clinical narrative: This case was reported by a medical assistant and described the occurrence of ulcerative colitis in a 56 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine. Concurrent medications included Protonix, Effexor, Lactinex and Questran. Medical history was notable for no bowel problems prior to administration of Twinrix. On 3/10/04, the patient received the first dose of Twinrix. Approximately one day following the administration of the first dose of Twinrix, on 3/11/04, the patient developed blood in the stool, rectal bleeding, abdominal pain/cramping, gas and diarrhea. On 3/17/04, the patient was hospitalized with a diagnosis of ulcerative colitis. The colitis resolved on 3/19/04 and the patient was discharged from the hospital. On 4/9/04 the patient received the second dose of Twinrix. The following day, on 4/10/04, the patient experienced return of blood in the stool, rectal bleeding, abdominal pain/cramping, gas and diarrhea. She was hospitalized on 4/12/04 and prescribed prednisone, 40mg daily. By 4/20/04, she was supposed to begin tapering her dose of prednisone. By 4/22/04, when her dose of prednisone was tapered to 6 tablets, her symptoms began to return. As of 4/29/04, she was experiencing gas and white mucous in stools. Outcome of the other reported events was not specified.