chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Antibody test negative, Cyclic citrullinated peptide A increased, Discomfort, Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: Patient received Gardasil vaccine on 3/20/2007 and 5/18/2007.  Developed seropositive RA by 6/2007.  Requires disease-modifying therapy.  1/29/08 Reviewed reporter's medical records which reveal patient seen 1/8/08 as arthritis second opinion.  Patient had experienced pain in hands & feet, CTS, elbow pain & morning stiffness beginning 6/2007.  Seen by specialist at that time who dx RA & had been on varying doses of steroids since 7/07.  Stated Plaquenil 10/07 but continued to have discomfort, stiffness & swelling of fingers & knees which interfered w/sleep & intermittent fine motor incoordination.  Numbness of lower arms & legs esp at night.  Hands were weak.  Additional meds had been recommended & sought second opinion at that time.  After exam, patient agreed to addition of Methotrexate & folic acid along w/serial labs.  Referred for baseline CXR & hand/foot x-rays to monitor progression. FINAL DX: Rheumatoid arthritis. 2/5/08 Reviewed med records from pcp which reveal patient experienced weakness & pain of right hand on 7/20/07 vs.  Dx w/CTS & tx w/meds & brace.  Returned on 8/22 w/complaints of increasing fatigue, joint pain & stiffness x 3 mos.  Had seen podiatrist & x-ray of feet abnormal.  Labs done & referred to rheumatologist.  10/22 vs for sinusitis & 12/13 for URI.  Referred to 2nd rheumatologist.  Vaccine date/lot # added to VAERS database. FINAL DX: Rheumatoid arthritis. 1/20/2010 Active rheumatoid arthritis.  02/03/2010 Patient has active rheumatoid arthritis (CCP anitbody positive, RF positive).
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: "I woke up itching the next morning. By the end of the day, my feet, legs, and arms were itching. The itching ended the 16th-17th. I saw a doctor on the 14th and 17th and had a shot and antibiotics and a pain reliever. My skin peeled on my legs, feet, and hands. I also took Ciprofloxacin for a UTI on the 10th and 11th.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Diarrhoea, Enema administration, Intussusception, Vomiting
Clinical narrative: Infant on 11/27/07 began having small amount of diarrhea (non bloody)and vomiting.  Later that evening there were no stools passed and worsening colicy abdominal pain and bilious vomiting.  Discovered to have an intussuseption unreducible via air contrast barium enema. Infant taken to OR immediately and intussuseption reduced surgically. 02/05/08-records received for DOS 11/27-11/28/07-DC DX: Intussusception, status post appendectomy and laparotomy with reduction of intussusception. Presented to ED with C/O abdominal pain and vomiting. PE: bloody mucous stool.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Back pain, Dizziness, Fall, Gaze palsy, Headache
Clinical narrative: 10/18/07 and 12/30/07 RE: 10/18/07 pt-Had 2nd Gardasil vaccine & Flu shot at about 5:15 PM. When I called to schedule her 2nd Gardasil shot, I asked if she could also receive her Flu shot at the same time. I was told "sure, no problem". On 10/18-when they were getting things ready-they mentioned that when pt returns for her 3rd Gardasil vaccine, she should also received her 2nd chicken pox vaccine. When the nurse took the vaccine out of the refridgerator, she dropped it. She then said "Oh, that's not good". I don't know which of the two vaccine she dropped. My daughter was sitting in the chair, she received one shot in each arm. (I don't recall which one first, or which one in which arm). She remained seated for a minute or two, then she got up & I sat down to get my flu shot. Just as my shot was complete, I was putting my shirt sleeve back in order, I heard a bang. It was daughter-she had fallen back, hit the wall, and had gone down to the floor. Her eyes were rolling back & she went out. The nurses & I got her flat & then raised her feet up onto a chair. She was out for a short time...when she "came to" we removed her jacket. Her head, neck, and back hurt. They called for a Dr. to come check her out. They looked into her ears, and eyes. They told me to keep an eye on her, and that she maybe sore from hitting the wall & going down. She had never had anything like this happen to her before, so she was quite shaken up. Then on Sunday 12/30/07-she had been snowmobiling with her Dad through out the day, up at his cabin (which is three hours away from home). They had slept in, went out for breakfast. Rode during the day, and had stopped for pizza around 5 PM. The pizza was just about to come out of the oven, and while she was standing up, she suddenly told her dad that she felt dizzy. As quick as he stood up, she had gone down (Again). They got her up & put her in a chair...they got her some water to drink. There happened to be a nurse there, and she said no, give her Orange Juice, that'd be better. The nurse suggested that she go to the ER. So, they borrowed someone's car and went to Hospital ER. They drew blood tested urine and checked her out. They could not find any apparent reason for the fainting. I did request and receive the records from them.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Neck pain, Syncope
Clinical narrative: 10/18/07 and 12/30/07 RE: 10/18/07 pt-Had 2nd Gardasil vaccine & Flu shot at about 5:15 PM. When I called to schedule her 2nd Gardasil shot, I asked if she could also receive her Flu shot at the same time. I was told "sure, no problem". On 10/18-when they were getting things ready-they mentioned that when pt returns for her 3rd Gardasil vaccine, she should also received her 2nd chicken pox vaccine. When the nurse took the vaccine out of the refridgerator, she dropped it. She then said "Oh, that's not good". I don't know which of the two vaccine she dropped. My daughter was sitting in the chair, she received one shot in each arm. (I don't recall which one first, or which one in which arm). She remained seated for a minute or two, then she got up & I sat down to get my flu shot. Just as my shot was complete, I was putting my shirt sleeve back in order, I heard a bang. It was daughter-she had fallen back, hit the wall, and had gone down to the floor. Her eyes were rolling back & she went out. The nurses & I got her flat & then raised her feet up onto a chair. She was out for a short time...when she "came to" we removed her jacket. Her head, neck, and back hurt. They called for a Dr. to come check her out. They looked into her ears, and eyes. They told me to keep an eye on her, and that she maybe sore from hitting the wall & going down. She had never had anything like this happen to her before, so she was quite shaken up. Then on Sunday 12/30/07-she had been snowmobiling with her Dad through out the day, up at his cabin (which is three hours away from home). They had slept in, went out for breakfast. Rode during the day, and had stopped for pizza around 5 PM. The pizza was just about to come out of the oven, and while she was standing up, she suddenly told her dad that she felt dizzy. As quick as he stood up, she had gone down (Again). They got her up & put her in a chair...they got her some water to drink. There happened to be a nurse there, and she said no, give her Orange Juice, that'd be better. The nurse suggested that she go to the ER. So, they borrowed someone's car and went to Hospital ER. They drew blood tested urine and checked her out. They could not find any apparent reason for the fainting. I did request and receive the records from them.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Small (1/2 end of finger) Red blotches-itched like the devil. Perhaps 7/8 at first; more later. Total approx. 15. Given Clobetasol .05% cream by dermatologist. Cleared them up-some still hang on.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever.  Symptoms lasted for 1-2 days after receiving vaccine.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Malaise, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: L arm pain, swelling, redness, warmth.  Malaise, fevers developing within 48-72 hours.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: L arm pain, swelling, redness, warmth.  Malaise, fevers developing within 48-72 hours.
Age: 8.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Developed Varicella like rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: 2 days after shingles vaccine developed itchy rash on neck - still has itchy rash. Advised to go to DP for evaluation of same.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Mom noticed on Saturday that patient had hives on her right thigh which is the leg where she received the vaccination Pediarix.  The hives were still on her leg on Sunday.
Age: 4.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: HIB vaccine #4 given (L) IM deltoid, immediately upper arm became bright red and swollen and warm to the touch. (2.25" of redness) pt given 1tsp. Benadryl. Monitored in office for 20 min. Ice compression used. Redness/Swelling subsided. Mom will monitor.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, PPV, TD
Symptoms: Bacterial culture, Blood test, Chest X-ray, Febrile convulsion, Pyrexia
Clinical narrative: She had seizures, very high fever, 2 times once on 1-10-08 lasting approx 12 min, 2nd time 1-12-08 lasting approx 5 min with low grade fever.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, PPV, TD
Symptoms: Urine analysis
Clinical narrative: She had seizures, very high fever, 2 times once on 1-10-08 lasting approx 12 min, 2nd time 1-12-08 lasting approx 5 min with low grade fever.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: An oval, red, hot, tender, swollen area about 15cm x 11cm on right doesun upper arm.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pruritus, Swelling, Throat tightness
Clinical narrative: Local reaction immediately after getting flu vac. Reddness, swelling, itching. 5 days later started breaking out in hives all over body and throat closing up
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Local reaction immediately after getting flu vac. Reddness, swelling, itching. 5 days later started breaking out in hives all over body and throat closing up
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis (L) upper arm and axilla s/p Pneumovax. Given Keflex.
Age: 1.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Erythema, Induration
Clinical narrative: Erythema & induration (1-1.5 in) with PCV.  Warm compresses.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Headache, Injection site pain, Pain, Pharyngolaryngeal pain
Clinical narrative: Dizziness, headaches, sore throat, tightness in throat, pain in arm (site) and all over aches.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Throat tightness
Clinical narrative: Dizziness, headaches, sore throat, tightness in throat, pain in arm (site) and all over aches.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash developing on neck, arms, and thighs.  On my neck 19Dec07 (after 1st shot) 12/17/07, arms & thighs 4Jan08 (after 2nd shot) 01/03/08.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus generalised
Clinical narrative: Received Varivax #1) 1/26/01 #2) 12/12/07 Onset Varicella vesicles-entire body-itchy-afebrile Tx: supportive ie Aveeno baths. Anti-itch topical Benadryl oral prn.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm got progressively more sore after injection.  Sought medical care and needed PT to work on Range of Motion and Darvocet for pain.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Left arm swollen, hot to touch, tender, painful with several blister like sores around site of injection with fever 99.7.  Mother alarmed at measureable edema 13x9cm.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Tenderness
Clinical narrative: Left arm swollen, hot to touch, tender, painful with several blister like sores around site of injection with fever 99.7.  Mother alarmed at measureable edema 13x9cm.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Returned 2 days after injection with c/o pain at injection site area swollen and warm to touch. Two areas of redness at the injection site 30 mm each.
Age: 43.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein normal, Complement factor C3, Complement factor C4
Clinical narrative: 1st episode of localized bilateral elbow (R>L) and left knee pain onset within 3 days following receipt of AVA #3 in Jul 1999, given in the left arm; pain was described as "arthritic"; no  associated joint swelling, redness or warmth, paresthesias or paresis; unable to fully extend right elbow for several days due to stiffness; elbow pain lasted several months and gradually resolved; the left knee pain resolved within 5-7 days. No symptoms consistent with a large local reaction, or other significant systemic symptoms. 2nd episode evolved similarly following receipt of AVA #4 given with Hep B vaccine in Nov 2007, both in the left arm. He did maintain full range of motion of his right elbow, and the left knee pain resolved within 3 days. He noticed increased pain in his right elbow with right-hand shaking and internal rotation. He denied previous trauma involving his neck, shoulders, or upper extremities  he did have a left knee ACL repair in 1997, but his knee was rarely bothersome since then. He has been able to perform all duty functions, and pass AFPTs despite symptoms. No underlying history of rheumatoid or connective tissue disorders, or history of adverse reactions to other vaccines received in either childhood or adulthood. The remaining ROS was negative.
Age: 43.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Full blood count normal, Joint stiffness, Red blood cell sedimentation rate normal, Rheumatoid factor, Tremor
Clinical narrative: 1st episode of localized bilateral elbow (R>L) and left knee pain onset within 3 days following receipt of AVA #3 in Jul 1999, given in the left arm; pain was described as "arthritic"; no  associated joint swelling, redness or warmth, paresthesias or paresis; unable to fully extend right elbow for several days due to stiffness; elbow pain lasted several months and gradually resolved; the left knee pain resolved within 5-7 days. No symptoms consistent with a large local reaction, or other significant systemic symptoms. 2nd episode evolved similarly following receipt of AVA #4 given with Hep B vaccine in Nov 2007, both in the left arm. He did maintain full range of motion of his right elbow, and the left knee pain resolved within 3 days. He noticed increased pain in his right elbow with right-hand shaking and internal rotation. He denied previous trauma involving his neck, shoulders, or upper extremities  he did have a left knee ACL repair in 1997, but his knee was rarely bothersome since then. He has been able to perform all duty functions, and pass AFPTs despite symptoms. No underlying history of rheumatoid or connective tissue disorders, or history of adverse reactions to other vaccines received in either childhood or adulthood. The remaining ROS was negative.
Age: 14.0
Sex: F
Vaccine: HPV4, IPV, MNQ, TDAP
Symptoms: Abdominal pain, Diagnostic procedure, Pelvic inflammatory disease
Clinical narrative: Mother states patient has developed lower abdominal pain since her HPV.  Saw PCP who ran several tests all negative, but believed she has PID.  Mother was instructed to take patient to GYN for exam and treatment.  Mother denies that daughter is sexually active.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Rash generalised, Rash pruritic, Similar reaction on previous exposure to drug, Vaccine positive rechallenge
Clinical narrative: Within a week of the shot I began to develop a rash on the thighs that became intensely itchy and has spread to the whole body by about 5 weeks later.  This may be the third year in a row that this has happened to me, and this year I noticed the temporal relationship and realized that this might be a reaction to the flu shot I received in early December 2007.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Full blood count, Pyrexia, White blood cell count increased
Clinical narrative: Fever 102 degrees F, WBC 27.7.  Admitted to r/o sepsis-blood cultures neg, urine cultures neg.  5/2/08 Reviewed hospital medical records of 1/4-1/6/2008. FINAL DX: viral illness, fever of unknown origin. Records reveal patient experienced cough/stuffy nose x 2 days & fever x 1 day.  Seen in ER on 1/3/08 & admitted to r/o bacteremia.  Temp 102.8 in ER.  Tx w/IM antibiotics. Improved & d/c to home.   Patient returned to ER on 1/14/2008 w/fever & cough x 1 day.  Tx w/oral hydration & antipyretic.  D/C to home. FINAL DX: viral URI.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Cellulitis, Erythema, Induration, Local reaction, Pyrexia
Clinical narrative: Increasing redness and induration over 1 week period with fever up to 101.2 on day number 6.  Cellulitis v reaction local).
Age: 46.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Redness and swelling began Wed. 16Jan08 then it became hard and warm to touch. Spreading beyond injection site per pt.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Redness, induration about inj. site.  Feeling bad & little fever onset 24hr after inj.  Next day induration 2" wide, 101 degree temp & aching in entire upper body.  Tylenol & cold compresses helped some.  Next day symptoms still there except generally feeling better.  Today (5 days after inj) all symptoms gone except for achiness in arm.  States last Td in 1995 caused same symptoms, but was much, much less severe.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: Rec. vaccines (Hep B) at 4:30 pm. 6-6:30 pm - achy, feverish, sweating, chills, wheezing more than normal. Soup eaten. 715 pm nausea and vomiting x3, diarrhea 230 AM 1/10/08 x 4.5. Used inhaler x1 - helped with wheezing. T-97.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Rec. vaccines (Hep B) at 4:30 pm. 6-6:30 pm - achy, feverish, sweating, chills, wheezing more than normal. Soup eaten. 715 pm nausea and vomiting x3, diarrhea 230 AM 1/10/08 x 4.5. Used inhaler x1 - helped with wheezing. T-97.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Fatigue, Myalgia, Pain
Clinical narrative: Fatigue, internal burning, ache, muscle ache.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Started with aches and tiredness, then into headache (severe), fever/chills, nausea and vomiting with diarrhea. Aches and pains started about 12-18 hrs after inoculation. Nausea and vomiting and fever persisted for about 36 hrs, with residual headache/body ache remaining for over 48 hrs.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Started with aches and tiredness, then into headache (severe), fever/chills, nausea and vomiting with diarrhea. Aches and pains started about 12-18 hrs after inoculation. Nausea and vomiting and fever persisted for about 36 hrs, with residual headache/body ache remaining for over 48 hrs.
Age: 32.0
Sex: F
Vaccine: ANTH, MNQ
Symptoms: Diarrhoea, Injection site erythema, Injection site warmth, Nausea, Oedema peripheral
Clinical narrative: Patient woke at 0730 on 12 Jan 08 and noticed left upper arm was swollen from top of shoulder to elbow.  Redness noticed from injection site to middle of upper arm.  Site was warm to touch and dry.  Patient also experienced nausea, diarrhea and fever.
Age: 32.0
Sex: F
Vaccine: ANTH, MNQ
Symptoms: Pyrexia
Clinical narrative: Patient woke at 0730 on 12 Jan 08 and noticed left upper arm was swollen from top of shoulder to elbow.  Redness noticed from injection site to middle of upper arm.  Site was warm to touch and dry.  Patient also experienced nausea, diarrhea and fever.
Age: 18.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral
Clinical narrative: Client called to report numbness in left arm, 2 hours after receiving shots on 1/2/08. Arm (Lt) is swollen and red; also she is unable to tolerate any pressure or carry anything heavy.
Age: 1.4
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Vaccine administration error.  Gave Tdap instead of DTaP.  No adverse event at this point.
Age: 44.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: C-reactive protein increased, Erythema, Full blood count, Laboratory test, Oedema peripheral
Clinical narrative: High fever, pain, redness, swollen on left arm from shoulder area to upper 3/4 of humerus area.
Age: 44.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: High fever, pain, redness, swollen on left arm from shoulder area to upper 3/4 of humerus area.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101.3-Tylenol given in ED & pt. discharged when fever reduced.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Back of left arm where varicella was given was swollen, red, hard, itchy.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Alanine aminotransferase normal, Arthralgia, Back pain, Basophil count increased, Blood alkaline phosphatase normal
Clinical narrative: Received AVA #4 on 3 Dec 07.  No problems with previous vaccinations.  Stated that he felt bad just after his shot and that symptoms worsened over the next several days.  He reported fever of 101-103, all joints painful, low back pain, headache and sore throat.  He went to the ER on 12 Dec 07 and they gave him fluids and antibiotics.  Currently he stated he is starting to feel better and he was told that he had a urinary tract infection.  Fever start - 12/04/2007, Joint pain, multiple joints start - 12/04/2007, Headache, general start - 12/04/2007, Pain start - 12/04/2007, Throat pain/sore throat.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Blood creatinine normal, Blood osmolarity decreased, Blood urea normal, Culture throat negative, Culture urine negative
Clinical narrative: Received AVA #4 on 3 Dec 07.  No problems with previous vaccinations.  Stated that he felt bad just after his shot and that symptoms worsened over the next several days.  He reported fever of 101-103, all joints painful, low back pain, headache and sore throat.  He went to the ER on 12 Dec 07 and they gave him fluids and antibiotics.  Currently he stated he is starting to feel better and he was told that he had a urinary tract infection.  Fever start - 12/04/2007, Joint pain, multiple joints start - 12/04/2007, Headache, general start - 12/04/2007, Pain start - 12/04/2007, Throat pain/sore throat.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Eosinophil count decreased, Feeling abnormal, Haematocrit increased, Headache, Lymphocyte count increased
Clinical narrative: Received AVA #4 on 3 Dec 07.  No problems with previous vaccinations.  Stated that he felt bad just after his shot and that symptoms worsened over the next several days.  He reported fever of 101-103, all joints painful, low back pain, headache and sore throat.  He went to the ER on 12 Dec 07 and they gave him fluids and antibiotics.  Currently he stated he is starting to feel better and he was told that he had a urinary tract infection.  Fever start - 12/04/2007, Joint pain, multiple joints start - 12/04/2007, Headache, general start - 12/04/2007, Pain start - 12/04/2007, Throat pain/sore throat.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Monocyte count normal, Neutrophil count increased, Pharyngolaryngeal pain, Pyrexia, Red blood cell count decreased
Clinical narrative: Received AVA #4 on 3 Dec 07.  No problems with previous vaccinations.  Stated that he felt bad just after his shot and that symptoms worsened over the next several days.  He reported fever of 101-103, all joints painful, low back pain, headache and sore throat.  He went to the ER on 12 Dec 07 and they gave him fluids and antibiotics.  Currently he stated he is starting to feel better and he was told that he had a urinary tract infection.  Fever start - 12/04/2007, Joint pain, multiple joints start - 12/04/2007, Headache, general start - 12/04/2007, Pain start - 12/04/2007, Throat pain/sore throat.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Red blood cell sedimentation rate normal, Troponin increased, Urinary tract infection, White blood cell count normal
Clinical narrative: Received AVA #4 on 3 Dec 07.  No problems with previous vaccinations.  Stated that he felt bad just after his shot and that symptoms worsened over the next several days.  He reported fever of 101-103, all joints painful, low back pain, headache and sore throat.  He went to the ER on 12 Dec 07 and they gave him fluids and antibiotics.  Currently he stated he is starting to feel better and he was told that he had a urinary tract infection.  Fever start - 12/04/2007, Joint pain, multiple joints start - 12/04/2007, Headache, general start - 12/04/2007, Pain start - 12/04/2007, Throat pain/sore throat.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid site of injection red, hot, swelling also at site, knot developed at site also.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: 01/18/2008 moderate Other Had 100-101 fever, reported that arm felt sore and had a lump on her lymph gland, went to her
Age: 36.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Swelling, X-ray
Clinical narrative: Pt c/o pain and swelling, that has been improving, from left to right shoulder area since 11/26/07 when he had immunizations here at medical center. He states he had a Tetanus shot on right arm and Hepatitis B on left arm. States that felt pain as he walked out of the door at medical center but the next morning he couldn't get out of bed and his fiancee, now his wife had to help him up. That next morning he felt like neck was going to 'snap'. Since then, pain has persisted from left to right shoulder. He reports area was swollen and stiff with extreme 'pain of muscle'. Pt states that there was 'air in the syringe'. Pt states he asked the nurse 'what was that?' and states she said 'there was air in the syringe.' he also states that "MA at PT said there was air that went in and was cause of swelling-aspiration.'. He states that as a result he did not enjoy his honeymoon out of country and 'couldn't perform'. States that he went to the emergency department on 11/29/07 as a result of the pain and was given medicine that made him feel 'out of it' out of country-ibuprofen and a muscle relaxant 'flexeril' (unknown mg for both). He states that he 'can't answer' if medicine helped 'because it puts you to sleep.' Since then he had a standing PT appt. scheduled by his neurologist for 'back and lower legs', related to his epilepsy. However, he has been treated by PT for his neck and receives stretches and electrical stimulation sessions 1-2 times per wk since January '08. He states that sessions have helped. In addition he decided to continue going to a masseuse for neck massages, which he had been attending previous to receiving his immunization at medical center. He continued to go because he thinks it'll help 'even more'. States that pain originally was a 5/5 and now a 3/5. Worse when he moves neck around but more so when he brings right ear to right shoulder. Pain is felt on right proximal shoulder/base of neck/back area-pinching. Denies numbness and tingling now but states there was 'numbness after the shot to the part of his back/neck/shoulder area'. Pt states that he is most concerned with talking to medical direction so that he can discuss having another reception and honeymoon because as a result of the above incident, he did not enjoy his wedding.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Arm was hot, red, indurated.
Age: 17.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: The pharmacy technician pulled the wrong product (Infanrix, DTaP) from the refrigerator to restock the pediatric emergency room refrigerators with Adacel (Tdap).  Pharmacy carries Adacel for pediatric ED and pediatric inpatient.  Pharmacy carries Infanrix only for the off-site practices the hospital stock meds for.  Once discovered by nursing when requesting restock, 3 weeks had passed.  Eight patients were potentially affected.  Upon review of the charts, only one patient actually got the DTaP instead of Tdap.  The patient's parents were notified, no adverse outcome to the patient.  The physicians were writing for the drug as Tdap, DTaP and Td, the medication is not listed in the pharmacy profile or the automated dispensing machines with these designations.  We also noted that adult physicians were still writing for Tetanus-Diphtheria (TD) for adolescent and not following the updated 2005 CDC guidelines for adolescent patients 11-18 to receive Adacel (Tdap).  Additionally during chart review, we found that the documentation was not consistently in the same place or done completely (drug name, site administered, lot number, expiration date).  And the vaccine information sheets were not routinely given to the patient.  Tdap and DTaP are currently not allowed abbreviations and the policy was bypassed.  Pharmacy segregated the two products in the pharmacy refrigerator.  Pharmacy changed the designation of the products to be consistent with the labeling on the packaging.  Pharmacy requested ED physicians to write ADACEL instead of Tdap; ED evaluating a trigger on the physician order sheet with Adacel preprinted.  Pharmacy to implement bar-coding of the automated dispensing cabinet to reduce stocking errors.  Documentation of the vaccination to be consistent and placed on the consent for immunization form with triggers for the required information and directions to provide the vaccination information sheet to be universal for the hospital and related sites.  The use of Adacel for all patients (11-64) is being evaluated by the ED leadership.  Vaccines are not emergent medications and are being evaluated pharmacy review instead of the override status the vaccines are currently in.  Education to be provided to all staff regarding the updated CDC recommendations the writing of brand name of the medication in the order.  Medication order writing policy to be enforced regarding the abbreviations.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic to beef, pork and dairy products.  Apparently the gelatin in the vaccine contains pork ingredients.  Had life threatening adverse reaction to the vaccine, was rushed to the emergency room and then admitted to the hospital for overnight stay for observation.   2/22/08-records received for DOS 1/16/08-observed overnight. Assessment:Anaphylactic reaction status post vaccine. Suspect this was due to a reaction to gelatin preservation in vaccine which was porcine.  C/O difficulty breathing, throat swelling. Shortness of breath. Hypotensive.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Anorexia, Lethargy, Pruritus, Pyrexia, Rash
Clinical narrative: Within 2 hours of the vaccination, patient became unusually lethargic with low grade fever but recovered 4 hours later. 8 days later continuing on to present time (1/19/08), patient develops fever whenever he sleeps. Fever has been up to 101.3 but has been controlled with infant Tylenol. Patient has also lost appetite, exhibited rash at hairline on 10th day after vaccine and exhibits itching during fever episodes.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Given vaccine at 10 pm noted R arm swollen at site, painful and warm to touch, states "I can't lift my arm" around 4am. Ice packs applied to site.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Pt had swelling and redness the evening the injection was given.
Age: 25.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Erythema, Incorrect dose administered, Nonspecific reaction
Clinical narrative: Mild/moderate reaction - redness but no swelling.  Within normal limits.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated with a third dose of ROTATEQ. Subsequently the patient experienced diarrhea. It was reported that the patient recovered and was not hospitalized. No other information was provided. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Dysphagia, Mastication disorder, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: Over the course of several days, symptoms worsened. Started with tingling in extremities, then uncomfortable feeling in abdomen (like a balloon was pushing up), then difficulty chewing, swallowing, inability to eat, felt like "a grapefruit" was in her neck, wrapping around it from the back. All sensations were like nothing she had felt before.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Rash maculo-papular
Clinical narrative: FEVER FOR 4 DAYS, 5 DAYS POST VACCINATION ASSOCIATED WITH REDNESS SLIGHT INDURATION ON SITE OF INJECTION, LEFT THIGH. FOLLOWED BY MACULOPAPULAR ERUPTION ON FACE TRUNK WHEN FEVER ABATED.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Developmental delay, Irritability, Pyrexia, Rash generalised, Speech disorder developmental
Clinical narrative: About 10 days after the vaccine was administered, the child got a red splotchy rash all over his body, mostly concentrated on the trunk (stomach and back).  Child was extremely fussy, and had a fever.  Child subsequently displayed developmental delays in speech and behavior, unsure if there is a correlation.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Anorexia, Arthralgia, Blood glucose normal, Blood pressure, Body temperature
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left deltoid with Gardasil (lot# 659439/1267U).  Concomitant therapy included Varivax, for the treatment of prophylaxis (duration and dose not reported).  Other concomitant therapy included MENACTRA.  On the evening of 27-NOV-2007 the patient experienced chills, dizziness, blurred vision and pain in the right wrist.  The patient had an emergency pediatric evaluation on 27-NOV-2007 and the results were: vision fine, blood sugar 104, hemoglobin 17.5 and hematocrit 40%, no fever, no redness and mild induration at the site of vaccination.  The patient had taken ADVIL.  On 28-NOV-2007 the patient experienced no appetite, lightheaded and nausea with no fever and no local reaction detected.  On 30-NOV-2007 the patient was seen in the office with symptoms of headache, nausea and chills.  Temporal temperature was 99.2 and blood pressure was "92/44."  The left arm had minimal tenderness and right arm was slightly tender where MENACTRA was administered.  Subsequently, the patient recovered from chills, dizziness, blurred vision, pain in the right wrist, no appetite, lightheaded, nausea and headache.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Chills, Dizziness, Haematocrit normal, Haemoglobin increased, Headache
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left deltoid with Gardasil (lot# 659439/1267U).  Concomitant therapy included Varivax, for the treatment of prophylaxis (duration and dose not reported).  Other concomitant therapy included MENACTRA.  On the evening of 27-NOV-2007 the patient experienced chills, dizziness, blurred vision and pain in the right wrist.  The patient had an emergency pediatric evaluation on 27-NOV-2007 and the results were: vision fine, blood sugar 104, hemoglobin 17.5 and hematocrit 40%, no fever, no redness and mild induration at the site of vaccination.  The patient had taken ADVIL.  On 28-NOV-2007 the patient experienced no appetite, lightheaded and nausea with no fever and no local reaction detected.  On 30-NOV-2007 the patient was seen in the office with symptoms of headache, nausea and chills.  Temporal temperature was 99.2 and blood pressure was "92/44."  The left arm had minimal tenderness and right arm was slightly tender where MENACTRA was administered.  Subsequently, the patient recovered from chills, dizziness, blurred vision, pain in the right wrist, no appetite, lightheaded, nausea and headache.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site pain, Nausea, Ophthalmological examination normal, Tenderness, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left deltoid with Gardasil (lot# 659439/1267U).  Concomitant therapy included Varivax, for the treatment of prophylaxis (duration and dose not reported).  Other concomitant therapy included MENACTRA.  On the evening of 27-NOV-2007 the patient experienced chills, dizziness, blurred vision and pain in the right wrist.  The patient had an emergency pediatric evaluation on 27-NOV-2007 and the results were: vision fine, blood sugar 104, hemoglobin 17.5 and hematocrit 40%, no fever, no redness and mild induration at the site of vaccination.  The patient had taken ADVIL.  On 28-NOV-2007 the patient experienced no appetite, lightheaded and nausea with no fever and no local reaction detected.  On 30-NOV-2007 the patient was seen in the office with symptoms of headache, nausea and chills.  Temporal temperature was 99.2 and blood pressure was "92/44."  The left arm had minimal tenderness and right arm was slightly tender where MENACTRA was administered.  Subsequently, the patient recovered from chills, dizziness, blurred vision, pain in the right wrist, no appetite, lightheaded, nausea and headache.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with sulfonamide allergy and drug hypersensitivity to codeine and a history of cystitis interstitial who on 06-DEC-2007 was vaccinated with a first dose of Gardasil (lot #659437/1266U) 0.5 mL IM.  Concomitant therapy included "Ditrapam" (therapy unspecified); the last dose was given on 09-NOV-2007.  On 09-DEC-2007 the patient developed itching fingers, toes and cheek bones.  The patient's toes and fingers felt tight but the nurse did not see a noticeable swelling.  The patient was taking diphenhydramine hcl (BENADRYL) and dexamethasone (DECADRON Dose Pack).  The patient was seen on 10-DEC-2007 and the itching was improving.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/15/2008. Initial and follow-up information has been received from a registered nurse concerning a 24 year old female with sulfonamide allergy and drug hypersensitivity to codeine and a history of cystitis interstitial who on 06-DEC-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 659437/1268U) 0.5 mL IM in the left deltoid. Concomitant therapy included "DITROPAN" (therapy unspec ified); the last dose was given on 09-NOV-2007. On 09-DEC-2007 the patient woke up and experienced itching fingers, toes and cheek bones, the patient's toes and fingers felt tight but the nurse did not see a notificeable swelling. The patient was taking BENADRYL and DECADRON Dose Pack. The patient was seen on 10-DEC-2007 and the itching was improving. On an unspecified date the patient recovered. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Patient came to clinic with complaints of swelling and discomfort to right arm. Minimal amount of swelling noted to right upper arm, nontender and no erythema. Advised patient to see PCP if redness or pain.[Additional Comments by: APRN (10/21/2007 1:55:23 PM)] 10/21/2007 patient came to clinic with complaints of redness, pain, tenderness and swelling to right upper arm. On examination, right upper arm erythematous, tender to touch, swollen, and warm to touch. Patient with history of diabetes. We referred him to Urgent Care for treatment. Stressed importance of being seen today for treatment, and following up with pcp.
Age: 58.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Increased redness, swelling, heat and tenderness. No fever or drainage noted to injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology positive, Herpes zoster, Rash
Clinical narrative: Vaccine administered 12/28/2007. Seen in Urgent Care clinic 1/05/2008 with facial rash, viral culture obtained verifying Herpes Zoster infection.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Deafness bilateral, Nuclear magnetic resonance imaging normal, Vertigo, Vestibular neuronitis
Clinical narrative: We received from a consumer via the Medical Communication the following information on 09 JAN 2008: A 56-year-old man, born on 29 JUN 1951, was vaccinated with Fluvirin, batch-no 79897, i.m. on 19 NOV 2007. Ten days after the vaccination he lost 100% hearing out of the left ear and 40% out of the right ear. He has been diagnosed with vestibular neuritis. The patient has not yet recovered at the time of report (09 JAN 2008). We received additional information on 14 JAN 2008: The patient was vaccinated on 18 NOV 2007 at 01:30 p.m. Approximately 8-9 days later he developed vertigo which on 30 NOV 2007 developed in a "full blown vertigo". Approximately 12 days after receiving the vaccine (30 NOV 2007) loss of hearing was reported which worsened over time. This was initially evaluated by a physician on 03 DEC 2007 and initially treated with an antibiotic. He went to ER on 04 DEC 2007 and was treated with Antivert, 25 mg three times a day and discharged. On 11 DEC 2007, CT scan was completed and negative. MRI was completed on 12 DEC 2007 and was also negative. The patient has had additional physician visits and was diagnosed as having vestibular neuronitis and viral labyrinthitis. The patient has not yet recovered at the time of report. 17 JAN 2008: Conclusion based on batch review - The batch review cannot conclude the reason for the reported adverse reactions.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Viral infection, Viral labyrinthitis
Clinical narrative: We received from a consumer via the Medical Communication the following information on 09 JAN 2008: A 56-year-old man, born on 29 JUN 1951, was vaccinated with Fluvirin, batch-no 79897, i.m. on 19 NOV 2007. Ten days after the vaccination he lost 100% hearing out of the left ear and 40% out of the right ear. He has been diagnosed with vestibular neuritis. The patient has not yet recovered at the time of report (09 JAN 2008). We received additional information on 14 JAN 2008: The patient was vaccinated on 18 NOV 2007 at 01:30 p.m. Approximately 8-9 days later he developed vertigo which on 30 NOV 2007 developed in a "full blown vertigo". Approximately 12 days after receiving the vaccine (30 NOV 2007) loss of hearing was reported which worsened over time. This was initially evaluated by a physician on 03 DEC 2007 and initially treated with an antibiotic. He went to ER on 04 DEC 2007 and was treated with Antivert, 25 mg three times a day and discharged. On 11 DEC 2007, CT scan was completed and negative. MRI was completed on 12 DEC 2007 and was also negative. The patient has had additional physician visits and was diagnosed as having vestibular neuronitis and viral labyrinthitis. The patient has not yet recovered at the time of report. 17 JAN 2008: Conclusion based on batch review - The batch review cannot conclude the reason for the reported adverse reactions.
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Hepatic enzyme increased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated liver function test in an adult female subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis.  On an unspecified date and 28 December 2007, the subject received 1st dose and 2nd dose of Engerix B (unknown).  On an unknown date, at an unspecified time after receiving the 1st dose of Engerix B, the subject experienced pain in her arm post vaccination.  The subject's arm hurt for one week after the injection and resolved.  On 4 January 2008, 7 days after 2nd vaccination with Engerix B, the subject experienced elevated liver function test, stiff neck, headache, and fatigue.  The reporting pharmacist did not know which liver enzyme(s) was elevated.  At the time of this report, no treatment had been necessary.  The pharmacist was unsure if the Engerix B series would be continued.  No other subject information was provided.  This case was assessed as medically serious by GSK.  At the time of reporting, the events associated with the 2nd dose of Engerix B were unresolved.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an unknown number of infants who were vaccinated orally with 2 ml of Rotateq and subsequently spit up vaccine after administration.  Follow up information was received from an LPN, who reported there was only one patient, a four month old male, who had spit up after receiving Rotateq.  No additional doses were given that day to the infant.  No additional patient details were available.  No further information is expected.
Age: 33.0
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye irritation, Eye pain, Eye pruritus, Foreign body sensation in eyes
Clinical narrative: Information has been received from a certified medical assistant concerning a 33 year old female nurse with drug hypersensitivity to DEMEROL and a flounder allergy who on 04-DEC-2007 administered a dose of Rotateq (lot# 657048/0909U) to an infant that spit the vaccine into the nurse's left eye.  The eye was immediately flushed with water but still irritated, stinging, itchy and felt like something was in it.  The nurse also experienced headache and she washed her face with alcohol.  The nurse sought medical attention in the physician's office.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 02/11/2010 Follow-up information from the reporting certified medical assistant indicated that upon administration to an infant (WAES# 0801USA0063) the 33 year old female nurse got a "spray" of ROTATEQ (lot# 657048/0909U) in her face and into her eyes (not sure how much). The patient experienced some irritation in the eye and stinging but was "fine after an hour or so." Additional information has been requested.