chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Lethargy, Pyrexia, Somnolence
Clinical narrative: Stated really sleepy at 3:30 pm 12/6-lethargic all evening until 9:00 pm, woke up was ok for 30 min-went to bed at 9;30 pm-whimped all night, am of 12/7 cried-screamed-would not console for 2 hrs. temp 99 deg. Did give tylenol various times "acted normal 2:00 pm 12/7/05 no problem since-went to med. doctor 12/7 pm-MD  said pass reaction or getting a cold.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pallor, Pyrexia
Clinical narrative: Pallor, temperature 105.1. Father read our "after the shots" pamphlet and medical doctor told him what to look for. Saw face was pale took rectal temp and read 105. Gave Tylenol. Called about 2:50pm. Medical doctor told him to put in bath, review in 1/2 hour and call. Review temp was 99.8. Father insisted patient had been very pale and temp was 105, not 100.5.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MMR vaccine #2 given 3 weeks early. Date given for #2 1-17-07. Patient checked on 1-18-07 and found to have no adverse effects and no complaint of rash, pain, swelling of right arm at site of vaccine. CDC notified as well as MD. MMR vaccine given 1-17-07: Patient had no S/S of adverse events.  Report sent because MMR #2 given to soon after MMR #1 which was given 1-11-07.  Patient decided to get this in 6 wks rather than first repeating vaccine.  Reminder notice to get this sent to patient. RN
Age: 57.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Vomiting
Clinical narrative: vomiting, chills
Age: 0.38
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 1-23-07 mmr and varicella given to 4 month old.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, MMR
Symptoms: Contusion, Injection site erythema, Injection site oedema, Rash
Clinical narrative: Patient treated on 1/13/07 at Urgent Care Center for complaining of erythema, edema extending from left outer upper thigh down 2 inches above left knee and to left inner thigh excluding posterior thigh.  Was treated with 2 days of antibiotic. Rash resolved within 3 days. On the fourth day parents noted bruising where the rash had been. Bruising has since resolved.
Age: 53.0
Sex: M
Vaccine: HEPAB, IPV, TYP
Symptoms: Unevaluable event
Clinical narrative: I read the patient's obituary in the newspaper, please refer to primary care physician for more details. I never received any call regarding any adverse event regarding actual vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh red swollen, hot to touch x 1 day, no fever, Lump where injection given
Age: 1.26
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: vaccine given @ 4:15pm, mom reports redness and swelling noted to left thigh around 6:00pm..Tylenol and cold compresses applied, low grade fever, child seen in the office @ 8:45am local reaction noted, area tender and warm to the touch, moderate swelling noted. Dr. observed and rec. Benadryl and Tylenol
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site vesicles
Clinical narrative: Gardasil was given in office. Pt. reported only some irritation at site following the administration of vaccine. The following day she developed local erythema and sm. blister. She was seen again in the office on 1/25/07. Superficial blister/inflammation of approx. 0.5 x 1.5cm was noted. No cellulitis noted. Area was lt. pink in color. Advised pt. to keep area clean and dry, apply antibiotic oint. if desired. Only local treatment needed. No further treatment anticipated.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform, Vomiting
Clinical narrative: Periodic vomiting for 3 days after vaccinne, mild case of Rubella (German Measles) 8 days after vaccine that lasted 4 days, vomiting 11 days after vaccine.  Reporting the Rubella onset.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction at immunization site.  Erythema and induration of 10 cm with firmness.  Non-tender
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Erythema, Pruritus generalised, Rash macular, Vomiting
Clinical narrative: Client sick to stomach within 30 minutes after receiving the vaccine.  Later developed red blotches on face and hands and generalized itching.  Given Benadryl 50 mg orally with diminishing of symptoms.  Vomited small amount of pinkish saliva/mucous about 5 minutes after the Benadryl was given.  Advised seek medical attention if symptoms recur and continue Benadryl for 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Excessive redness/ swelling of thigh in region of vaccine administration
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria rash
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Muscle contracture, Neurological examination
Clinical narrative: Two weeks after tetanus vaccine started to develop contractures of the muscles of her face including the forehead, around the mouth and the jaw.  No systemic symptoms.  Contractures have continued for three months and does not seem to be resolving.  02/12/2007  MR received from Infectious Disease MD for c/o facial muscle spasms that began 2 weeks following multiple vax.    Pt. received multiple vax. in preparation for a trip to Africa.  No local reactions to vax. noted.  While in Africa pt. began noticing spontaneous contractions of the muscles of her forehead, which were also painful.  This progressed to the muscles of the eyes, face, and tongue.  The symptoms are bilateral. Spasms around the eyes, dry eyes, frontal headaches, night sweats, insomnia, leg cramps, and  occasional neck cramps have also been noted.   PE: WNL except for spasm of the muscles of the face which cause the forehead to wrinkle and the muscles around the mouth to contract making the mouth into an O shape. Assessment:  Muscle contractions of the face possibly due to the tetanus toxoid immunization. Doubt Myasthenia Gravis. F/U Exam  2 weeks later which notes that the frequency and severity of the spasms seem to be increasing. Assessment: Muscle spasms of the face and neck possibly due to tetanus immunization.  Pt. has been evaluated by a neurologist, records requested.   03/21/2007 TC to reporter to clarify neurologist. . Reporter stated that he saw the patient this week and she reports that symptoms have worsened. He now feels that because of this, the vaccine as cause is less likely. He reports that neuro tests have all been (-).  03/26/2007 MR received from Neuro. consult. Initial visit 1/23/07 for c/o facial twitching, dry mouth, jaw tightness. PE:  WNL.  Symptoms not occuring at that time. Assessment:  Cervical facial dystonia, etiology uncertain. F/U 1/30/2007 for cervical/facial dystonia and/or dyskenesia. PE: Facial movements noted that were asymetric, some grimacing.  They originally began near they eyelids and upper face, now spreading caudally to below the clavicles. They can be partially supressed.  Summary:  Dystonia vs. tic disorder.
Age: 1.27
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered a vaccination of gardasil by accident instead of the scheduled comvax. It was administer on 1/25/06.  It has been only one and no symptoms have been observed. Gardasil is approved for patients of 9 years to 26 years.  No studies have been done for a patient of 15 months.
Age: 36.0
Sex: M
Vaccine: ANTH, DT, HEP, HEPA
Symptoms: Arthropathy, Discomfort, Hypersensitivity, Muscle fatigue, Nasopharyngitis
Clinical narrative: MUSCULAR FATTIGE, JOINT DISCONFORT, COLDS AND ALERGIES OCCURRING MORE FREQUENTLY
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth, Tenderness
Clinical narrative: Pruritus at injection site immediately after administration.  Swelling and redness of 1 cm diameter or less up to 12 hours after administration that grew and worsened to 3 inches by 2 inch round red local swelling with tenderness and mild warmth.  Patient was examined for this reaction about 48 hours after administration
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Blood test, Memory impairment, Neurological symptom, Neuropathy
Clinical narrative: I have arthritis in my hips and arthritis symptoms in my shoulders. I have neuropathia in my feet and tingling pains running down my legs. I need a right hip replacement which I am going in for very soon. I also have neurological symptoms with my memory.  03/02/2007 MR received from PCP spanning 02/1999-11/2004, including an orthopedic consult regarding the reported symptoms of arthritis and arthritis pain on 7/13/2004.  Lymerix given 3/23/1999, 4/22/1999 and 2/17/2000. Multiple OVs for Diabetes and HTN F/U, as well as for several injuries, rectal bleeding and UTI. OV of 8/26/2002 for c/o 1-2 month hx. of right shoulder pain.  Impression:  Frozen shoulder tx'd with Celebrex. OV 3/13/2003 with c/o elbow pain. Seen by orthopedic surgeon 6/29/2004 following a fall in January for which he is still complaining of pain.  Impression:  Synovitis of the hip 2' to mild degenerative arthritis.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, X-ray
Clinical narrative: I have arthritis in my hips and arthritis symptoms in my shoulders. I have neuropathia in my feet and tingling pains running down my legs. I need a right hip replacement which I am going in for very soon. I also have neurological symptoms with my memory.  03/02/2007 MR received from PCP spanning 02/1999-11/2004, including an orthopedic consult regarding the reported symptoms of arthritis and arthritis pain on 7/13/2004.  Lymerix given 3/23/1999, 4/22/1999 and 2/17/2000. Multiple OVs for Diabetes and HTN F/U, as well as for several injuries, rectal bleeding and UTI. OV of 8/26/2002 for c/o 1-2 month hx. of right shoulder pain.  Impression:  Frozen shoulder tx'd with Celebrex. OV 3/13/2003 with c/o elbow pain. Seen by orthopedic surgeon 6/29/2004 following a fall in January for which he is still complaining of pain.  Impression:  Synovitis of the hip 2' to mild degenerative arthritis.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Diplopia, Myalgia, Pyrexia
Clinical narrative: Fevers, chills, myalgia and diplopia.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Excoriation, Injection site erythema, Injection site oedema
Clinical narrative: Patients wife phoned 11-3-06 said flu shot site reddened and swollen. Check up 11-6-06-redness lateral surface left arm; check up 11-9-06 redness Left posterior arm (abrasion); check up 11-14-06 left arm area healing nicely; check up 1-5-07 left arm posterior red. Note: Site of redness is not exact location of injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Clinical narrative: NONE specified. 1/30/07 T/C to reporter to request missing info from Box 7 on VAERS form.  States patient had local reaction & hives.  Was seen only by her PCP & treated w/steroids & antihistamines & recovered completely within 2 wks.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Agitation, Confusional state, Drug effect increased, Haemorrhoids, Malaise
Clinical narrative: About two hours following vaccination I had an apparent panic attack with confusion, agitation, and a tremendous feeling of discomfort. I had a horrible exacerbation of hemoroids and the effects of my diuretic were enhanced a great deal. This lasted about 6-7 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Panic attack
Clinical narrative: About two hours following vaccination I had an apparent panic attack with confusion, agitation, and a tremendous feeling of discomfort. I had a horrible exacerbation of hemoroids and the effects of my diuretic were enhanced a great deal. This lasted about 6-7 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Irritability
Clinical narrative: About two hours following vaccination I had an apparent panic attack with confusion, agitation, and a tremendous feeling of discomfort. I had a horrible exacerbation of hemoroids and the effects of my diuretic were enhanced a great deal. This lasted about 6-7 hours.
Age: 68.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Adult patient received Dtap instead of Tdap. No adverse reaction reported.
Age: 86.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Guillain-Barre syndrome, Oedema peripheral, Pain in extremity, Sensory loss
Clinical narrative: Both hands started swelling and hurt. Finger tips started loosing sensation making normal tasks like holding a glass, un-buttoning blouse, tying shoes, sorting vitamans and minerals, etc. This started the week of the vaccinations (one in each arm). This progressed and got worse over the month of November and on December 14th her Physician, a Holistic MD, made a house call.  1/29/07 T/C to reporter who is patients son.  States patient did not start on holistic meds until 1/07 due to not being available.  States patient has neither improved or worsened but remains about the same.  All s/s are in her hands/arms w/o difficulty ambulating.  States patient has not sought neuro consult & is waiting to see PCP when he returns from sabbatical on 2/6/07.  8/10/07 Received pcp medical records which reveal patient seen 11/16/06 after having received flu & pneumo vax 10/17 at outlying flu vax clinic.  Now w/left side paresis & discomfort at injection sites & numbness of both hand/fingers. 2-3 days s/p vax. Seen 12/14/06 w/continued peripheral neuropathy, decreased sensation to pin prick all extremities & leg spasms.  Advised to have Doppler study done but deferred.  Patient is homebound per son & physician made housecalls.  No neuro consult, no EMG/NCS studies were done.  FINAL DX: peripheral neuropathy & probable Guillian Barre syndrome.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: sx began 1d after injection to L dletoid - local redness, pain, swelling, heat and continued to time of visit on 1/27/07
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Amyotrophic lateral sclerosis, Eye pain, Fatigue, Headache, Irritable bowel syndrome
Clinical narrative: After receiving the anthrax vaccine, my husband's health begin to decline.  He had symptons such as fatigue, headaches, eye-aches, IBS, and muscle twitching.  He was finally diagnosed with ALS in 2005.  He died March 2006.  He was vaccinated with Lot # FAV017.  There is no history of ALS in his family.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise, Muscle twitching
Clinical narrative: After receiving the anthrax vaccine, my husband's health begin to decline.  He had symptons such as fatigue, headaches, eye-aches, IBS, and muscle twitching.  He was finally diagnosed with ALS in 2005.  He died March 2006.  He was vaccinated with Lot # FAV017.  There is no history of ALS in his family.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Lumbar puncture, Pyrexia
Clinical narrative: This female was enrolled in a prophylactic open study. On 11 July 2006, she received the 1st dose of rotavirus vaccine (HRV, po) (lot # AROTA033A), Pediarix, IM X thigh (lot # ACZIB071BA), ActHIB, IM X thigh (lot # UE864AA) and Prevnar, IM X thigh (lot # AZ5969K). The subject had a history of gastrointestinal reflux disease which started on 29 June 2006 and continued at the time of reporting. From 29 June 2006 to 30 June 2006, she was treated with Lansoprazole. On 20 July 2006, nine days after the 1st dose of Rotavirus vaccine, nine days after the 1st dose of Pediarix, nine days after the 1st dose of ActHIB, nine days after the 1st dose of Prevnar and 20 days after the last dose of Lansoprazole, this two-month old subject developed viral syndrome. She had fever (temperature of 36.9 C) and was hospitalized. The subject was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included a lumbar puncture and blood and urine cultures. The lumbar puncture was negative and all cultures were negative after 40 hours. No details of relevant assessments are available. on 21 July 2006, she received a second dose of ceftriaxone sodium. The subject was discharged from hospital on 21 July 2006 after the 3rd dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonable possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, HIB tetanus toxoid conjugate vaccine and pneumococcal vaccines and that the event was possibly due to the concomitant medication Lansoprazole and the subject's medical condition of gastroesophageal reflux disease. The investigator also replied that although it is possible that the child's fever was due to the rotavirus, vaccine, he believes that the possibility is quite small and more likely attributable to a viral syndrome. Further clarifications have been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Viral infection
Clinical narrative: This female was enrolled in a prophylactic open study. On 11 July 2006, she received the 1st dose of rotavirus vaccine (HRV, po) (lot # AROTA033A), Pediarix, IM X thigh (lot # ACZIB071BA), ActHIB, IM X thigh (lot # UE864AA) and Prevnar, IM X thigh (lot # AZ5969K). The subject had a history of gastrointestinal reflux disease which started on 29 June 2006 and continued at the time of reporting. From 29 June 2006 to 30 June 2006, she was treated with Lansoprazole. On 20 July 2006, nine days after the 1st dose of Rotavirus vaccine, nine days after the 1st dose of Pediarix, nine days after the 1st dose of ActHIB, nine days after the 1st dose of Prevnar and 20 days after the last dose of Lansoprazole, this two-month old subject developed viral syndrome. She had fever (temperature of 36.9 C) and was hospitalized. The subject was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included a lumbar puncture and blood and urine cultures. The lumbar puncture was negative and all cultures were negative after 40 hours. No details of relevant assessments are available. on 21 July 2006, she received a second dose of ceftriaxone sodium. The subject was discharged from hospital on 21 July 2006 after the 3rd dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonable possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, HIB tetanus toxoid conjugate vaccine and pneumococcal vaccines and that the event was possibly due to the concomitant medication Lansoprazole and the subject's medical condition of gastroesophageal reflux disease. The investigator also replied that although it is possible that the child's fever was due to the rotavirus, vaccine, he believes that the possibility is quite small and more likely attributable to a viral syndrome. Further clarifications have been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Blood culture negative, Culture urine negative, Lumbar puncture normal, Pyrexia, Viral infection
Clinical narrative: This female was enrolled in a prophylactic open study. On 11 July 2006, she received the 1st dose of rotavirus vaccine (HRV, po) (lot # AROTA033A), Pediarix, IM X thigh (lot # ACZIB071BA), ActHIB, IM X thigh (lot # UE864AA) and Prevnar, IM X thigh (lot # AZ5969K). The subject had a history of gastrointestinal reflux disease which started on 29 June 2006 and continued at the time of reporting. From 29 June 2006 to 30 June 2006, she was treated with Lansoprazole. On 20 July 2006, nine days after the 1st dose of Rotavirus vaccine, nine days after the 1st dose of Pediarix, nine days after the 1st dose of ActHIB, nine days after the 1st dose of Prevnar and 20 days after the last dose of Lansoprazole, this two-month old subject developed viral syndrome. She had fever (temperature of 36.9 C) and was hospitalized. The subject was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included a lumbar puncture and blood and urine cultures. The lumbar puncture was negative and all cultures were negative after 40 hours. No details of relevant assessments are available. on 21 July 2006, she received a second dose of ceftriaxone sodium. The subject was discharged from hospital on 21 July 2006 after the 3rd dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonable possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, HIB tetanus toxoid conjugate vaccine and pneumococcal vaccines and that the event was possibly due to the concomitant medication Lansoprazole and the subject's medical condition of gastroesophageal reflux disease. The investigator also replied that although it is possible that the child's fever was due to the rotavirus, vaccine, he believes that the possibility is quite small and more likely attributable to a viral syndrome. Further clarifications have been requested.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: rash-red, macular with suspicious borders on face, arms, legs, back, abdomen.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Eye oedema, Urticaria
Clinical narrative: Patient developed hives on face, arms, swelling around eyes. Benadryl given in office; patient sent to ER for EPI. Symptoms onset at minutes after shot.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Eye oedema, Injection site pain, Injection site swelling, Lip oedema, Paraesthesia oral
Clinical narrative: Patient called to say she experienced tingling and swelling of lower lip and swelling of eye approx 26 hours after receiving shots. But had also eaten nuts in ice cream same day of tingling/swelling. Also pain (swelling for 5 days at site of Tdap (left deltoid)).
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Hypersensitivity, Rash, Viral infection, Vomiting
Clinical narrative: A 2 year old who was seen earlier this morning for a well child check, she got a hep A vaccine. She went home to her granmother's house and grandmother had some barbecue chips, which she doesn't think she has ever had before. She ate those, she had lunch, had a burrito with chicken, rice and beans, which she has had many times before and then grandma noticed a little bit of a rash after the chips and before lunch on the left side of her face a little bit of erythema. She thought she had just laid on it. About half an hour ago, mom and grandma noticed that she seemed to have redness around her eyes bilaterally and that it seemed to be spreading. There has been no coughing, no shortness of breath. She has never had a hep A vaccine before and she hasn't had any other new exposures. She is not complaining of anything. Examination shows that she is quiet and cooperative. She has erythema on the lateral aspect of her face. It extends from the lateral canthus of her eye towards her ears kind of a triangular shape and on the left side, it goes up into her earlobe a little bit. There is a little dot on her nose. There is nothing on her trunk and this erythematous patch is not raised off the surface of her skin. It's quite flat. Her TMS looked fine. Her pharynx is normal. There is no swelling. There is no shortness of breath, and her lung fields are clear without wheezes. Likely allergic reaction possibly the hep A or to the barbecue chips. Mom and grandma can't think that she has been exposed to anything else that she could have gotten on herself or rubbed around her eyes, they were out at a toy store. I suppose she could have gotten some of the barbecue stuff on her hands and rubbed it. We'll write it up as an adverse reaction to the shop though I doubt that is the problem. We've given her  some  Claritin 5 mg here in the office. Mom will give Benadryl before bed, Clairitin tomorrow morning and just watch her. Certainly to be seen rapidly or activate EMS if any signs of shortness of breathe occurs. Mom and grandma seemed comfortable with the plan. Will follow up by phone. Started vomiting-possible viral syndrome.
Age: 3.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a health professional concerning a 22 year old female patient who on approximately 01-NOV-2006 was vaccinated with a first IM dose of GARDASIL vaccine (yeast). On approximately 01-NOV-2006 the patient experienced seizure. The reporter had no further information. It was noted that patient was 2 weeks late for her second dose of GARDASIL vaccine (yeast) and had not yet received it. Upon internal review, seizure is considered an other important medical event. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Condition aggravated, Crohn's disease
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) with Crohn's disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn's disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn's disease was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female (age unspecified) with unspecified history of drug reaction/allergies and no pertinent medical history who on an unspecified date was vaccinated with Gardasil vaccine (yeast) (lot# not reported) 0.5 ml by injection. Concomitant therapy was not reported. Subsequently, the patient experienced a seizure after the injection of Gardasil vaccine (yeast). Medical attention was sought. At the time of reporting, the patient had recovered. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 11-Jan-2007 was vaccinated with Gardasil vaccine (yeast), intramuscularly. Concomitant therapy included Allegra and Nuvaring. On 13-Jan-2007 the patient had a "rash from her neck down". The patient was seen in the emergency room and was given Prednisone. At the time of the report, the patient was recovering. The reporter was considering giving the patient Benadryl and Prednisone before the next vaccination with Gardasil vaccine (yeast). The patient's experience was considered to be an other medical event. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient (demographics not reported) who on 10-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot # not provided). Concomitant therapy included BOOSTRIX and hepatitis A virus vaccine (manufacturer unknown). On 10-JAN-2007 immediately post vaccination the patient "passed out and went into a seizure." The patient sought unspecified medical attention. At the time of this report it was not reported if the patient had recovered from her experience. Upon internal review the seizure was considered to be an other medical event. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Skin lesion, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 41 year old female who on 15-JAN-2007 was vaccinated with a dose of Pneumovax 23 vaccine. On 18-JAN-2007, 55 hours after vaccination, the patient developed four raised, inflamed and tender lesions on the inner aspect of her injection site arm. The patient was treated with topical diphenhydramine (BENADRYL), and the lesions flattened. The outcome of the patient's raised, inflamed and tender lesions was unknown. Raised, inflamed and tender lesions were reported as other important medical events. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a physician concerning an infant, a cousin to one of his patients, who may have been vaccinated with MMR II (manufacturer unknown). Concomitant therapy included several "unspecified immunizations". Subsequently the infant developed autism after receiving several unspecified immunizations. The physician was not sure if the patient received "MMR". The physician was contacted for additional details; however the physician stated that the infant was not one of his patient's, therefore had no additional information to provide. Upon internal review, the patient's autism was considered to be an other important medical event. No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 74 year old female with allergies to codeine and ciprofloxacin hydrochloride (CIPRO) and no other medical history who on 18-NOV-2006 was vaccinated SC in the arm with a dose of varicella-zoster virus vaccine live. Concomitant vaccination in the other arm on the same day included a dose of Pneumovax 23. Other concomitant medication included estrogens, conjugated (PREMARIN). On 20-NOV-2006, the patient developed a swollen right deltoid muscle and moderate erythema and swelling over the right elbow to mid forearm area. Unspecified medical attention was sought. The patient was told to have warm soaks in the shower, take over-the-counter nonsteroidal anti-inflammatory drugs, two tablets TID and diphenhydramine hydrochloride (BENADRYL) 25 mg daily BID. No diagnostic laboratory tests were performed. It was noted that the reaction on the arm was the one in which varicella-zoster virus vaccine live was given. The patient recovered on an unspecified date. A product quality complaint was not involved. The patient's experience was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a mother concerning her 2-month-old son who was vaccinated with a dose of Rotateq vaccine (human-bovine). The patient's mother reported that her son subsequently developed blood in the stool. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Upon internal review, blood in the stool was determined to be an other important medical event. No further information is available.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema, Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 6 month old female with no known allergies and acid reflux who on 19-DEC-2006 was vaccinated PO with the third dose 2.0 mL dose of Rotateq reassortant vaccine live (human-bovine) (lot # 655483/1116F) (1st dose administered on 29-AUG-2006, date of 2nd dose not reported). Concomitant therapy included Ranitidine HCl (ZANTAC). The MA reported that on 14-JAN-2007, the patient experienced abdominal pain. The patient was taken to the Emergency Room (ER), but not admitted. Abdominal x-rays were abnormal and the patient was sent to another ER. A barium enema was performed. The patient also noted to have had heme positive stool. The patient required no treatment and was not hospitalized. At the time of this report, the outcome was unknown. Upon internal review, heme positive stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: X-ray abnormal
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 6 month old female with no known allergies and acid reflux who on 19-DEC-2006 was vaccinated PO with the third dose 2.0 mL dose of Rotateq reassortant vaccine live (human-bovine) (lot # 655483/1116F) (1st dose administered on 29-AUG-2006, date of 2nd dose not reported). Concomitant therapy included Ranitidine HCl (ZANTAC). The MA reported that on 14-JAN-2007, the patient experienced abdominal pain. The patient was taken to the Emergency Room (ER), but not admitted. Abdominal x-rays were abnormal and the patient was sent to another ER. A barium enema was performed. The patient also noted to have had heme positive stool. The patient required no treatment and was not hospitalized. At the time of this report, the outcome was unknown. Upon internal review, heme positive stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a normal, healthy 2-month-old patient who was vaccinated PO with the first dose of Rotateq vaccine (human-bovine). The physician reported that, within 48 hours of being vaccinated, the patient developed  bloody stool. Unspecified medical attention was sought. Eventually, the patient's bloody stool subsided. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Back pain, Fatigue, Guillain-Barre syndrome, Hemiplegia
Clinical narrative: Initial information received from a health  care professional on 19 January 2007. A 42-year-old male patient a first dose of Fluzone SV 2006-2007, lot number U2253AA, on 05 December 2006, the  patient developed numbness and tingling in his feet. By 17 December 2006, his back hurt and he was fatigued. He was seen in an emergency room the following day and was admitted to the hospital because he could not walk. On 20 December 2006, the patient was transferred to the intensive care unit (ICU) and was treated with immunoglobulins and plasmapheresis. His right side was paralyzed, and he was in severe pain. He was treated with Percocet. He was diagnosed with Guillain-Barre Syndrome. The patient has a past medical history of poorly controlled diabetes. On 03 January 2007, the patient was transferred to a rehabilitation facility after having been hospitalized for 16 days. His recovery status is unknown.  3/15/07 Medical records reviewed which reveal patient experienced tingling sensation & numbness of palms of hands & soles of feet.  Then lower leg muscles became weak & he became unable to walk.  S/S began 4 days prior to admit on 12/20/06-1/3/07.  Treated w/IVIG but continued to worsen.  Treated w/plasmapheresis, pain management consult & PT.  Improved s/p 5th session plasmapheresis.  D/C to rehab facility. FINAL DX: Guillian Barre Syndrome.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulins, Pain, Paraesthesia, Plasmapheresis
Clinical narrative: Initial information received from a health  care professional on 19 January 2007. A 42-year-old male patient a first dose of Fluzone SV 2006-2007, lot number U2253AA, on 05 December 2006, the  patient developed numbness and tingling in his feet. By 17 December 2006, his back hurt and he was fatigued. He was seen in an emergency room the following day and was admitted to the hospital because he could not walk. On 20 December 2006, the patient was transferred to the intensive care unit (ICU) and was treated with immunoglobulins and plasmapheresis. His right side was paralyzed, and he was in severe pain. He was treated with Percocet. He was diagnosed with Guillain-Barre Syndrome. The patient has a past medical history of poorly controlled diabetes. On 03 January 2007, the patient was transferred to a rehabilitation facility after having been hospitalized for 16 days. His recovery status is unknown.  3/15/07 Medical records reviewed which reveal patient experienced tingling sensation & numbness of palms of hands & soles of feet.  Then lower leg muscles became weak & he became unable to walk.  S/S began 4 days prior to admit on 12/20/06-1/3/07.  Treated w/IVIG but continued to worsen.  Treated w/plasmapheresis, pain management consult & PT.  Improved s/p 5th session plasmapheresis.  D/C to rehab facility. FINAL DX: Guillian Barre Syndrome.
Age: 61.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: She had pain, the next day after the shot was done, on her left arm. The pain lasted 3 months. After that the pain started on her shoulder too. She is taking Tramaolol and Methylprednisdone. Per annual follow, hundreds of the same vaccine lot # and dose were administered without any negative complaints. Follow-up: Without further evaluation - one can not say with certain authority that this event was related to the Vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema, Pyrexia
Clinical narrative: 4 days-redness; 2-3 days-fever
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient got dizzy, passed out.
Age: 54.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Fatigue, Hypokinesia, Injection site pain, Injection site swelling, Musculoskeletal discomfort
Clinical narrative: Inj rec'vd wed. a.m. by thursday evening inj site (Tdap site) extremely swollen and painful, unable to reach/use arm overhead.  Neck and back also uncomfortable, very fatigued until Sunday.  Still swollen and painful today although somewhat diminished
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Contusion, Erythema, Insomnia, Paraesthesia
Clinical narrative: 1-5-07 Flu and Pneumonia admission in Right arm IM. 1-5-07 at health center patient reported to ER for bruising and redness on right upper arm. Patient was given steroid, antibiotic and Benadryl in ER. On 1-8-07 patient reported back to ER for complaining of tingling sensation from elbow to chest. Patient also states they're scared to sleep. Patient was given Valium. 1-8-07 in ER. Patient contacted health department today and states Valium didn't help. Patient referred to primary physician.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Started having diarrhea for 2 days after immunization on 10/18/06. Had 3-4 diarrhea diapers a day for 1 week. Also had vomiting 4 times 1 day for one week. Some diarrhea persisted for an additional week. Did not see doctor. Talked to him by phone and he decided milk and put baby on Pedialyte for a few days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Culture stool, Diarrhoea
Clinical narrative: Exactly 1 week from time of Rotavirus vaccine on 10/16/06 infant developed profuse diarrhea that was slimy and had horrible odor. Mother used 48 diapers in 2 days. Saw doctor 1 day after diarrhea started. States saw doctor 3 times during illness. Diarrhea lasted for one month.
Age: 0.89
Sex: F
Vaccine: FLU3, PNC, TD
Symptoms: Erythema, Immunisation reaction, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 12-14-06- redness, warm to touch, achy Left arm (lower deltoid); 12-15-06 warm(not hot to touch), red, edema. (red area measures approx 4.5x 2.5in) (edema approx 1.5x1in lower deltoid); 12-15-06 To ER, physician recommended Triamcinolone cream and told reaction to immunizations; 12-18-06 redness gone, arm better, no complaints.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Oedema peripheral
Clinical narrative: Immediately after shot pain radiated from left deltoid region to elbow to hand. Patient had difficulty moving arm. Around 3 pm noticed slight swelling in that hand.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site infection
Clinical narrative: Shot Tdap given 1/16/07. Shot site infected. Seen and treated 1/19/07 as add on patient.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Low grade fever, Tylenol etc. Local erythema/blistering at injection site-Topical bactroban. "chest tightness" resolving over weekend.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site mass
Clinical narrative: Subcutaneous firm mass at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling hot, Swelling, Tenderness
Clinical narrative: Local swelling, tenderness, some warmth beginning the evening of shot. Swelling was quite significant.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: left arm swelling up to neck.  Recommended to use ibuprofen
Age: 13.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Febrile convulsion, White blood cell count increased
Clinical narrative: Vaccine's given 3pm. Febrile seizure at 8pm same day.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Culture throat negative, Febrile convulsion, Full blood count normal, Influenza serology negative, Pyrexia
Clinical narrative: febrile seizure 1/20/07, fever developed 1/19/07, full seizure with fever spike lasted 3-4 min, 911-> ER
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Virus serology test, Visual acuity tests normal
Clinical narrative: febrile seizure 1/20/07, fever developed 1/19/07, full seizure with fever spike lasted 3-4 min, 911-> ER
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test, Electroencephalogram, Tonic convulsion
Clinical narrative: Patient had a tonic seizure 6 days after getting the vaccine Records requested and received.  Treated at facility Hospital for seizure with twitching of arms and jerks of trunk, Keppra prescribed and now complains of photophobia. To see neurologist at Medical Center  02/09/07-records received and reviewed from Dr. for DOS 01/08/07. Neuro consult-Impression:First convulsive seizure coccurring rather spontaneously with no evidence at present underlying neurological pathology. That is based on her normal function before and after the episode, normal CT scan and EEG normal to include photic stimulation and continued normal neurological examination. Having some apparent side effects from Keppra. Diagnostic possibilities include at least 50% chance this will be a single seizure and therefore not epilepsy. In that case the immunization might at most had a very minor role to play as would also be true of mild sleep deprivation. The lack of breakfast that morning and she had been up from bed very long and only had a normal blood sugar in ER, it does not appear to be likely issue. Stop the Keppra. Follow up in 4 weeks.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Tenderness
Clinical narrative: Tender feet (bottom of feet) onset 3 days after injection. Muscle weakness in arms and legs (dibiliting) 03/13/07-records received from PCP for DOS 11/27/06-02/01/07-Assessment:paresthesias of left hand. probable carpal tunnel syndrome. Myalgias. Hypertension. Hyperlipidemia. Rosacea. Osteoarthritis. C/O sense of weakness and pain in limbs. Seen by chiropractor in October or November.  PE:WNL.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nasopharyngitis, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: This is a 4-year-old white female who presents to the emergency department after having a flu shot and was started on Premarin cream today for labial effusion.  Second dose was at 10:30 p.m. About 45 minutes later the patient complained of being cold with her legs hurting, throat hurting, having headache and chills according to the mom.  She had no fevers. She has had no rash or wheezing. No hives, and now all has completely returned to normal with no complaints at all.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: Report of vomiting x2 on Jan 18, 2007, vomiting x 1 on Jan 19, 2007. Also complained of diarrhea. Mother also reported diarrhea x1 week prior to Jan 17, 2007 then improved.  Now symptoms occur again day after vaccinated.  Jan 23, 2007-reports improvement. States diarrhea getting better and no vomiting.
Age: 6.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Rt arm swelling and fever within 24 hours of vaccine, newly diagnosed, type I diabetes mellitus, on insulin for only 1 mo. Fever persisted x 24 hours but swelling decreased. Mother gave benadryl and fever med. Doing much better 48 hours post vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyspnoea
Clinical narrative: Approx 10 to 15 mins post vaccination mother returned with infant saying she was having a hard time to "catch her breath" and had spit. RRNL@ 38 heart rate nl at 138, no color change.  Infant belched in office and was almost immediately better. telephone call to mother later=infant acting NL nursing well doubt vaccine reaction.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Patient came to clinic on 01-25-07 inquiring about name and dosage of medication she received on 9/30/06. Patient stated had headache, chills, fever, fatigue and vomiting the day after vaccination. She did not seek medial attention. Instead she took some medication given by her mother. She stated felt better afterwards.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site movement impairment, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Pain and sensitivity at injection site, difficulty moving arm. Site felt warm to touch, slight swelling, feels tired. Had a similar reaction to a flu shot (per patient) will take Advil and use ice. Reaction lasted 12 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Had vaccinations on 1/23/07 and started complaining to mom on 1/25/07. Presents 1/26 with left deltoid warm and swollen. Recommended visit with doctor.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Talked with patient on 1/22/07. Patient said her arm was sore after taking the Flu shot, but soreness had gone away until she started working out. She said she had problem,s lifting her dumbbells. She also said she had problem putting her coat on. She says it doesn't bother her unless she lifts weights. Shot was given on 11/2/06 by a Nursing Student from Nursing School. She is just reporting this to the health department. Patient has not been to see MD for this problem. I instructed patient to see MD asap for evaluation. When I asked patient why she waited this long she said her husband kept telling her that it's ok and it will get better. I instructed her to see MD asap and not to wait any longer. When I asked patient if there was any redness, swelling or heat coming from her arm she said No.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Grand mal convulsion, Postictal state
Clinical narrative: 48 hours post injection-appeared to have witnessed tonic clonic seizures with postictal phase lasting less than 1 min. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting.
Age: 1.51
Sex: F
Vaccine: DTAPH
Symptoms: Body temperature increased, Erythema
Clinical narrative: Had Dtap/Hib vaccine to left thigh on 1/23/07. Several hours later mom noted increased volume to anterior thigh, erythema and increased tonsil temperature. No fever, patient playful with normal gait and eating well. Seen in clinic on 1/26/07 improved without antibiotics.