chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Aphasia, Blood pressure fluctuation, Eye movement disorder, Feeling hot, Flushing
Clinical narrative: Aphasia, paraesthesia, (L) eye not blinking on closing. Intermittent flushing of face and feeling of warmth. Unstable B/P; rapid pulse
Age: 59.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Heart rate increased, Paraesthesia
Clinical narrative: Aphasia, paraesthesia, (L) eye not blinking on closing. Intermittent flushing of face and feeling of warmth. Unstable B/P; rapid pulse
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain; Swelling; Right Arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Musculoskeletal pain, Pruritus, Rash
Clinical narrative: Right sided shoulder blade pain 9/10 and breast pain min severity; onset 4/23/07. On 4/24/07, rash noted posterior at shoulder blade (fist-sized area) and approx 2 lesions on (R) breast. All lesions itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Right sided shoulder blade pain 9/10 and breast pain min severity; onset 4/23/07. On 4/24/07, rash noted posterior at shoulder blade (fist-sized area) and approx 2 lesions on (R) breast. All lesions itchy.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: enlarge nodes Rt axilla, cervical and occipital area. (approx 20 min) fever, chills.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Neck pain, Pyrexia
Clinical narrative: 60-75 hours after Menactra,  elevated fever and weakness. Progressed to high fever 103 and neck pain. Fever resolved after 24 hours. Other child in family got fevers after immunizations.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Skin lesion
Clinical narrative: Patient had both vaccines given in his left arm. Within 24 hours developed an edematous, pruritic, erythematous 4.5 cm x 5cm circular lesion
Age: 30.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Bone pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Approximately 12 hours after receiving Tdap she had severe (L) arm pain, nausea, chills and fatigue. One day after receiving Tdap she reported (L) shoulder "felt like someone was cutting it off" and every muscle and bone hurt." By 4/30/07 symptoms improving but had headache.
Age: 30.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Nausea, Pain in extremity
Clinical narrative: Approximately 12 hours after receiving Tdap she had severe (L) arm pain, nausea, chills and fatigue. One day after receiving Tdap she reported (L) shoulder "felt like someone was cutting it off" and every muscle and bone hurt." By 4/30/07 symptoms improving but had headache.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site rash, Migraine, Rash erythematous, Rash vesicular
Clinical narrative: 5/3/07 developed rash 4 1/2 x 5 1/2 cm at site of varicella vaccination (booster dose), erythematous sl rash and diffuse sl raised vesicular rash on ant chest, bilat arms not itchy (+) F/C on 5/2 had recurrent migraine on 5/2 and received ibuprofen
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given 4-30-07. Redness, swelling, hot, tender (R) shoulder to elbow and across pectoral major.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: pt given Hep A 0.5 ml injection too early from initial injection. Only 2 months apart instead of 6
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient had a rash approximately the size of 1/2 dollar that was red and warm to the touch on Friday after vaccine given on Tuesday. Patient had taken Aleve previous day. I called Dr. and they suggested she come by and they would check it out.
Age: 0.5
Sex: F
Vaccine: PNC, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: While adm. 6 mo. shots to baby I gave her Tdap instead of DTaP. I spoke to doctor who said give next DTaP booster at 12 mo. instead of 18 mo
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Flatulence, Muscle spasms
Clinical narrative: Reported by mom on 5/7/07 that pt have cramping and gas for 2-3 hours after vaccine. No diarrhea or blood in stool, no vomiting.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Flatulence, Muscle spasms, Pyrexia
Clinical narrative: Reported by mom on 5/7/07 that pt have cramping and gas for 2-3 hours after vaccine. No diarrhea or blood in stool, no vomiting.
Age: 1.17
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Diarrhoea, Ear pain, Gait disturbance, Oral pain, Rash
Clinical narrative: On 4-5-07 pt presents to clinic, Dad states pt has had diarrhea x 3 days. Staggering like he doesn't have his Balance, vomiting. Had rash on Buttocks and facial cheeks, Pulling at his ears and acting like he has sharp pain in mouth. Mother states he could be teething.
Age: 1.17
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Teething, Vomiting
Clinical narrative: On 4-5-07 pt presents to clinic, Dad states pt has had diarrhea x 3 days. Staggering like he doesn't have his Balance, vomiting. Had rash on Buttocks and facial cheeks, Pulling at his ears and acting like he has sharp pain in mouth. Mother states he could be teething.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Musculoskeletal pain
Clinical narrative: severe headache and shoulder suprascapula pain started 4 hours after vaccine and lasted 2 days
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Itchy rash all over lower body, reported by patient only. Neither parent nor physician was shown the rash.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Hypoaesthesia, Injection site swelling, Nausea
Clinical narrative: 5/10/07 Telephone consult with patient stated nausea and extensive swelling at Tdap site (R) Deltoid. Described (L) sided numbness (L) leg and arm and buttocks, High fever, Headache, and extreme weakness. 48 hours later, most symptoms resolved but patient still c/o (L) shoulder swelling at site.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 5/10/07 Telephone consult with patient stated nausea and extensive swelling at Tdap site (R) Deltoid. Described (L) sided numbness (L) leg and arm and buttocks, High fever, Headache, and extreme weakness. 48 hours later, most symptoms resolved but patient still c/o (L) shoulder swelling at site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cold compress therapy, Erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/8/07-Pt called c/o pain, warmth, and swelling at injection site. Also c/o fever, chills, nausea, and vomiting. Office appt-pt instructed to ice arm, red, Medrol dosepak, tylenol, and Phenergan
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nausea, Pyrexia, Vomiting
Clinical narrative: 5/8/07-Pt called c/o pain, warmth, and swelling at injection site. Also c/o fever, chills, nausea, and vomiting. Office appt-pt instructed to ice arm, red, Medrol dosepak, tylenol, and Phenergan
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dermatitis allergic, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling of upper arm from elbow to shoulder. Warm to touch, pruritic (Left Arm) DX: Allergic Skin Reaction
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacteria stool test, Haematochezia, Neutropenia, Neutrophil count
Clinical narrative: Stools with blood 5/1/07. Neutropenia 5/1/07 which continued until 5/7/07. On 5/7/07 stools hemetest (+).
Age: 22.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: (L) deltoid with 50 mm x 50 mm redness and swelling 2 days after DTaP
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: approx 1 day after vaccine administered, child developed pain, redness, swelling at injection site (arm). Swelling extended from deltoid, to mid arm. Patient seen in area ER and was told had "infection" at site, child seen in our office 2d after vaccine given and showed one of edema, induration, redness of about 3x6 cm. Child was afebrile and acted well, but complained of itching, pain at vaccine injection site.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Pallor
Clinical narrative: Became very nauseated and pale
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Started at 1 AM with "chills, ? fever, headache, nausea, sore joints, achy, feels like the flu, jaw bone trying to lock up
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Trismus
Clinical narrative: Started at 1 AM with "chills, ? fever, headache, nausea, sore joints, achy, feels like the flu, jaw bone trying to lock up
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Cold sweat, Eye disorder, Hyperhidrosis, Skin discolouration, Syncope
Clinical narrative: Pinpoint eyes, sweating, clamy, skin discoloration, vomiting, fainting occurred within 10 min. of vaccination
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Pinpoint eyes, sweating, clamy, skin discoloration, vomiting, fainting occurred within 10 min. of vaccination
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5x4 cm red indurated area at vaccine site.
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: body aches fever (temp 101) localized injection site pain without erythema or swelling
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Varicella-like lesions over neck face trunk and extremities (<50) Last Lesion 5-30-07
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Lightheadedness Weakness Nausea
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Staphylococcal infection
Clinical narrative: Saw ER doctor due to possible staph infection.  Had blisters the crusted on both legs couple months after injection of varicella
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Hypokinesia, Injection site pain, Neck pain
Clinical narrative: Very painful at injection site, unable to lift arm for more than 24 hours, pain in neck, headaches, and fatigue.  Needed to take painkillers to sleep, work, and function properly.
Age: 42.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Abdominal pain, Body temperature increased, Chills, Nausea, Vomiting
Clinical narrative: On 5-10-07 @ 3:30 a.m., client's wife states her husband was sleep & awakened c/o abdominal cramping, chills, nausea & vomiting x2. No temp. was taken but wife states husband was warm. Denies redness and swelling at the injection site. Wife states at 9:30 a.m. husband was able to drink water & have a popsicle without having an emesis. Wife states husband's private physician was not notified.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Skin nodule, Swelling
Clinical narrative: Approximatley 12 hours after receiving the vaccination patient developed a hard, swollen red area the size of an apple on her left arm.  This area was not at the site of the injection but directly opposite it on the same arm.  Upon questioning, patient revealed that she had had a mastectomy many years ago on that side which she did not report to the vaccinator.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: AT INJECTION SITE, REDNESS AND WARM TO TOUCH. RX ZYRTEC BY DOCTOR AND TOLD TO GET RECHECKED IF NO IMPROVEMENT.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PAIN, SWELLING AND REDNESS ON LEFT ARM @ INJECTION SITE. REDNESS AND SWELLING MEASUREMENTS ARE 7CM X 8CM. SITE FEELS WARM TO TOUCH.                                               ADVISED TO APPLY ICE PACK TO THE SITE AND TO CALL BACK IF SYMPTOMS WORSEN.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: Pain, redness, swelling, headache, tiredness, hausea, diarrhea, stomach ache, chills, body aches, sore joints, rash, fever, paleness, dizziness.  On set of symtoms approximately 12 hours after injection.  Doctor precribed Benydryl for swelling and reddness at site of injection.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Pain, redness, swelling, headache, tiredness, hausea, diarrhea, stomach ache, chills, body aches, sore joints, rash, fever, paleness, dizziness.  On set of symtoms approximately 12 hours after injection.  Doctor precribed Benydryl for swelling and reddness at site of injection.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pallor, Pyrexia, Rash
Clinical narrative: Pain, redness, swelling, headache, tiredness, hausea, diarrhea, stomach ache, chills, body aches, sore joints, rash, fever, paleness, dizziness.  On set of symtoms approximately 12 hours after injection.  Doctor precribed Benydryl for swelling and reddness at site of injection.
Age: 1.5
Sex: F
Vaccine: PNC, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling around injection site approximately 2 cm high and 5-6 cm diameter
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Blood test, Pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin positive
Clinical narrative: No adverse events noted at time of vaccination.  PT diagnosed as positive for pregnancy immediately following vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular
Clinical narrative: Non-pruritic purple macules on bilateral inner thighs several hours after 3rd injection. No side effects with previous injections. No new irritants used. Symptoms persisting over 24 hours. No treatment used.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea, Reaction to previous exposure to any vaccine, Sleep disorder, Vomiting
Clinical narrative: TEMP. OF 103.0 TYMPANIC GIVEN 0.8 TYLENOL VOMITTED ALL WITHIN 10 SECONDS. iN AM HAD TEMP. OF 101.2. hAD DIARRHEA 2 DAYS AGO BUT NOT NOW. gAVE PEDIALYTE NIGHT OF TEMP. DIDNOT SLEEP WELL LAST NIGHT KICKING LEGS.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Malaise
Clinical narrative: pt had the adacel injection, she felt sick , and area was sore.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: pt was vomiting,fever x1 day.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Croup infectious, Dry throat, Dysphonia, Fatigue, Pyrexia
Clinical narrative: Patient was perfectly fine, was evaluated by the physician as a 6-year old checkup.  The vaccination was administered at approx 11:30 and by 12:30, she was becoming very hoarse.  By the time she returned home from school, she was very tired and was running a slight fever.  By bedtime her fever was 100.6.  She was awake every 1-1/2 hours or so all night long.  usually just to get a drink and then fell back to sleep.  I called the doctor the next morning and they had me bring her back in.  Her temp was 103.  They did a throat culture and after examining her, the doctor said she had croup.  He gave her a liquid steroid and told me to use a vaporizor for the next few nights.  Tylenol helped bring the fever down and she hasn't coughed at all.  She is still very hoarse and complains a little about a dry throat.  Therefore, I don't feel she has croup.  I think she is having a reaction to the vaccination.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Sleep disorder
Clinical narrative: Patient was perfectly fine, was evaluated by the physician as a 6-year old checkup.  The vaccination was administered at approx 11:30 and by 12:30, she was becoming very hoarse.  By the time she returned home from school, she was very tired and was running a slight fever.  By bedtime her fever was 100.6.  She was awake every 1-1/2 hours or so all night long.  usually just to get a drink and then fell back to sleep.  I called the doctor the next morning and they had me bring her back in.  Her temp was 103.  They did a throat culture and after examining her, the doctor said she had croup.  He gave her a liquid steroid and told me to use a vaporizor for the next few nights.  Tylenol helped bring the fever down and she hasn't coughed at all.  She is still very hoarse and complains a little about a dry throat.  Therefore, I don't feel she has croup.  I think she is having a reaction to the vaccination.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Nephrotic syndrome, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no pertinent medical history, and no drug reactions or allergies, who on 20-FEB-2003 was vaccinated intramuscularly into the left thigh with Varivax (Lot # 643590/0806M). On 26-FEB-2003, the patient developed nephrotic syndrome and was hospitalized for four days. The patient also developed an unspecified rash. The nurse reported that nephrotic syndrome is a life long condition and that the patient is treated with steroids from time to time. The patient had not recovered at the time of reporting. There was no concomitant therapy. Unspecified medical attention was sought. There was no product quality complaint. Nephrotic syndrome, which required hospitalization, was considered to be immediately life-threatening. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This case was received from another manufacturer (reference number WAES0703USA05296) on 26 April 2007. The following information is verbatim as if appears in the other manufacturer's report: "This is a follow-up to report (s) previously submitted on 4/2/2007; 4/12/2007. Information has been received from a licensed practical nurse concerning a infant female who on 29-MAR-2007 was vaccinated with the first oral Rotateq (Lot # 656188/1238F). There was not illness at the time of vaccination. Concomitant vaccinations on 29-MAR-2007 included the first doses of ACTHIB (Lot # UE975AA) IM, PEDIARIX (Lot21B084BA) IM and PREVNAR (Lot # B08691F) IM. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered to be an other important medical event. In follow-up, the nurse reported that on 02-APR-2007, the patient developed persistent non-stop diarrhea with one episode of blood in stool and fever 101.5. The patient went to the lab for blood work on 02-APR-2007. The patients anion gap was 15 mg/dl, blood urea nitrogen (BUN) 14 mg/dl, carbon dioxide 21 meq/L, chloride 102 mg/dL, sodium 138 meq/L and glucose 90 mg/dL. The patient's urinalysis was normal with only trace blood noted. Blood, urine, and stool cultures showed no growth. RSV antigen was negative. On 02-APR-2007, the patient went to the emergency room and received IV fluids. On 03-APR-2007, it was reported that the patient recovered. On 04-APR-2007, the patient had one episode of diarrhea during the night and it was noted "seems better" office visit for follow-up. Follow-up information received on 16-APR-2007 contained the following adverse experiences: blood calcium increased (02-APR-2007), blood creatinine decreased (02-APR-2007), and blood potassium increased (02-APR-2007). No further information is available. Medical records are attached as further documentation of the patient's event.". ActHib lot # UE975A corresponds to manufacturer lot # Z0667-2.
Age: 0.2
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anion gap normal, Blood calcium increased, Blood chloride normal, Blood creatinine decreased, Blood culture negative
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This case was received from another manufacturer (reference number WAES0703USA05296) on 26 April 2007. The following information is verbatim as if appears in the other manufacturer's report: "This is a follow-up to report (s) previously submitted on 4/2/2007; 4/12/2007. Information has been received from a licensed practical nurse concerning a infant female who on 29-MAR-2007 was vaccinated with the first oral Rotateq (Lot # 656188/1238F). There was not illness at the time of vaccination. Concomitant vaccinations on 29-MAR-2007 included the first doses of ACTHIB (Lot # UE975AA) IM, PEDIARIX (Lot21B084BA) IM and PREVNAR (Lot # B08691F) IM. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered to be an other important medical event. In follow-up, the nurse reported that on 02-APR-2007, the patient developed persistent non-stop diarrhea with one episode of blood in stool and fever 101.5. The patient went to the lab for blood work on 02-APR-2007. The patients anion gap was 15 mg/dl, blood urea nitrogen (BUN) 14 mg/dl, carbon dioxide 21 meq/L, chloride 102 mg/dL, sodium 138 meq/L and glucose 90 mg/dL. The patient's urinalysis was normal with only trace blood noted. Blood, urine, and stool cultures showed no growth. RSV antigen was negative. On 02-APR-2007, the patient went to the emergency room and received IV fluids. On 03-APR-2007, it was reported that the patient recovered. On 04-APR-2007, the patient had one episode of diarrhea during the night and it was noted "seems better" office visit for follow-up. Follow-up information received on 16-APR-2007 contained the following adverse experiences: blood calcium increased (02-APR-2007), blood creatinine decreased (02-APR-2007), and blood potassium increased (02-APR-2007). No further information is available. Medical records are attached as further documentation of the patient's event.". ActHib lot # UE975A corresponds to manufacturer lot # Z0667-2.
Age: 0.2
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This case was received from another manufacturer (reference number WAES0703USA05296) on 26 April 2007. The following information is verbatim as if appears in the other manufacturer's report: "This is a follow-up to report (s) previously submitted on 4/2/2007; 4/12/2007. Information has been received from a licensed practical nurse concerning a infant female who on 29-MAR-2007 was vaccinated with the first oral Rotateq (Lot # 656188/1238F). There was not illness at the time of vaccination. Concomitant vaccinations on 29-MAR-2007 included the first doses of ACTHIB (Lot # UE975AA) IM, PEDIARIX (Lot21B084BA) IM and PREVNAR (Lot # B08691F) IM. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered to be an other important medical event. In follow-up, the nurse reported that on 02-APR-2007, the patient developed persistent non-stop diarrhea with one episode of blood in stool and fever 101.5. The patient went to the lab for blood work on 02-APR-2007. The patients anion gap was 15 mg/dl, blood urea nitrogen (BUN) 14 mg/dl, carbon dioxide 21 meq/L, chloride 102 mg/dL, sodium 138 meq/L and glucose 90 mg/dL. The patient's urinalysis was normal with only trace blood noted. Blood, urine, and stool cultures showed no growth. RSV antigen was negative. On 02-APR-2007, the patient went to the emergency room and received IV fluids. On 03-APR-2007, it was reported that the patient recovered. On 04-APR-2007, the patient had one episode of diarrhea during the night and it was noted "seems better" office visit for follow-up. Follow-up information received on 16-APR-2007 contained the following adverse experiences: blood calcium increased (02-APR-2007), blood creatinine decreased (02-APR-2007), and blood potassium increased (02-APR-2007). No further information is available. Medical records are attached as further documentation of the patient's event.". ActHib lot # UE975A corresponds to manufacturer lot # Z0667-2.
Age: 0.2
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Culture urine negative, Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This case was received from another manufacturer (reference number WAES0703USA05296) on 26 April 2007. The following information is verbatim as if appears in the other manufacturer's report: "This is a follow-up to report (s) previously submitted on 4/2/2007; 4/12/2007. Information has been received from a licensed practical nurse concerning a infant female who on 29-MAR-2007 was vaccinated with the first oral Rotateq (Lot # 656188/1238F). There was not illness at the time of vaccination. Concomitant vaccinations on 29-MAR-2007 included the first doses of ACTHIB (Lot # UE975AA) IM, PEDIARIX (Lot21B084BA) IM and PREVNAR (Lot # B08691F) IM. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered to be an other important medical event. In follow-up, the nurse reported that on 02-APR-2007, the patient developed persistent non-stop diarrhea with one episode of blood in stool and fever 101.5. The patient went to the lab for blood work on 02-APR-2007. The patients anion gap was 15 mg/dl, blood urea nitrogen (BUN) 14 mg/dl, carbon dioxide 21 meq/L, chloride 102 mg/dL, sodium 138 meq/L and glucose 90 mg/dL. The patient's urinalysis was normal with only trace blood noted. Blood, urine, and stool cultures showed no growth. RSV antigen was negative. On 02-APR-2007, the patient went to the emergency room and received IV fluids. On 03-APR-2007, it was reported that the patient recovered. On 04-APR-2007, the patient had one episode of diarrhea during the night and it was noted "seems better" office visit for follow-up. Follow-up information received on 16-APR-2007 contained the following adverse experiences: blood calcium increased (02-APR-2007), blood creatinine decreased (02-APR-2007), and blood potassium increased (02-APR-2007). No further information is available. Medical records are attached as further documentation of the patient's event.". ActHib lot # UE975A corresponds to manufacturer lot # Z0667-2.
Age: 0.2
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urine analysis normal, Virus serology test
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This case was received from another manufacturer (reference number WAES0703USA05296) on 26 April 2007. The following information is verbatim as if appears in the other manufacturer's report: "This is a follow-up to report (s) previously submitted on 4/2/2007; 4/12/2007. Information has been received from a licensed practical nurse concerning a infant female who on 29-MAR-2007 was vaccinated with the first oral Rotateq (Lot # 656188/1238F). There was not illness at the time of vaccination. Concomitant vaccinations on 29-MAR-2007 included the first doses of ACTHIB (Lot # UE975AA) IM, PEDIARIX (Lot21B084BA) IM and PREVNAR (Lot # B08691F) IM. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered to be an other important medical event. In follow-up, the nurse reported that on 02-APR-2007, the patient developed persistent non-stop diarrhea with one episode of blood in stool and fever 101.5. The patient went to the lab for blood work on 02-APR-2007. The patients anion gap was 15 mg/dl, blood urea nitrogen (BUN) 14 mg/dl, carbon dioxide 21 meq/L, chloride 102 mg/dL, sodium 138 meq/L and glucose 90 mg/dL. The patient's urinalysis was normal with only trace blood noted. Blood, urine, and stool cultures showed no growth. RSV antigen was negative. On 02-APR-2007, the patient went to the emergency room and received IV fluids. On 03-APR-2007, it was reported that the patient recovered. On 04-APR-2007, the patient had one episode of diarrhea during the night and it was noted "seems better" office visit for follow-up. Follow-up information received on 16-APR-2007 contained the following adverse experiences: blood calcium increased (02-APR-2007), blood creatinine decreased (02-APR-2007), and blood potassium increased (02-APR-2007). No further information is available. Medical records are attached as further documentation of the patient's event.". ActHib lot # UE975A corresponds to manufacturer lot # Z0667-2.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Culture stool, Diarrhoea, Haematochezia, Infantile spitting up
Clinical narrative: Information has been received from a physician concerning a 9 week old healthy female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2 mL PO first dose (Lot # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about "six days". On 01-MAY-2007 the patient has two bloody stools and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Irritability, Occult blood negative, Rotavirus test negative, Virus culture
Clinical narrative: Information has been received from a physician concerning a 9 week old healthy female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2 mL PO first dose (Lot # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about "six days". On 01-MAY-2007 the patient has two bloody stools and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Haematochezia, Irritability, Occult blood
Clinical narrative: Information has been received from a physician concerning a 9 week old healthy female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2 mL PO first dose (Lot # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about "six days". On 01-MAY-2007 the patient has two bloody stools and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rotavirus test
Clinical narrative: Information has been received from a physician concerning a 9 week old healthy female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2 mL PO first dose (Lot # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about "six days". On 01-MAY-2007 the patient has two bloody stools and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Conjunctivitis, Eye infection, Periorbital oedema
Clinical narrative: HD was notified by Sebastopol Clinic that child reported to clinic with eyes swelling. Benadryl given PO.  S?S began to resolve. Have labeled records. Possible Neomycin allergy
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Drug hypersensitivity, Eye oedema
Clinical narrative: HD was notified by Sebastopol Clinic that child reported to clinic with eyes swelling. Benadryl given PO.  S?S began to resolve. Have labeled records. Possible Neomycin allergy
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Eye swelling
Clinical narrative: HD was notified by Sebastopol Clinic that child reported to clinic with eyes swelling. Benadryl given PO.  S?S began to resolve. Have labeled records. Possible Neomycin allergy
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Depression, Dysphonia, Fatigue, Flushing, Headache
Clinical narrative: Injection sight soarness for five days. Severe Headaches ongoing. Nauseous on & off for thirteen days. Flushing on & off for ten days. Itching for nine days/inside & out. Hives on & off for nine days. Irritability for nine days. Depression for thirteen days. Hoarsness onoing. Extreme fatique ongoing. Just not feeling right ongoing.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Irritability, Malaise, Nausea, Pruritus
Clinical narrative: Injection sight soarness for five days. Severe Headaches ongoing. Nauseous on & off for thirteen days. Flushing on & off for ten days. Itching for nine days/inside & out. Hives on & off for nine days. Irritability for nine days. Depression for thirteen days. Hoarsness onoing. Extreme fatique ongoing. Just not feeling right ongoing.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urticaria
Clinical narrative: Injection sight soarness for five days. Severe Headaches ongoing. Nauseous on & off for thirteen days. Flushing on & off for ten days. Itching for nine days/inside & out. Hives on & off for nine days. Irritability for nine days. Depression for thirteen days. Hoarsness onoing. Extreme fatique ongoing. Just not feeling right ongoing.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Malaise, Pruritus, Urticaria
Clinical narrative: Injection sight soarness for five days. Severe Headaches ongoing. Nauseous on & off for thirteen days. Flushing on & off for ten days. Itching for nine days/inside & out. Hives on & off for nine days. Irritability for nine days. Depression for thirteen days. Hoarsness onoing. Extreme fatique ongoing. Just not feeling right ongoing.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient felt tightness in neck while still in office on afternoon 4/9/07.  Patient states that awoke next am c/o pain, redness, and warmth at injection site.  Pt later seen at emergency room with temp to 103 per her report to MD office 4/17.  Patient treated with antibiotics and diagnosed with cellulitis as well as allergic reaction.  5/9 patient seen in f/u my office and still had palpable 2 cm firm knot in left upper lateral arm.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pyrexia, Skin nodule
Clinical narrative: Patient felt tightness in neck while still in office on afternoon 4/9/07.  Patient states that awoke next am c/o pain, redness, and warmth at injection site.  Pt later seen at emergency room with temp to 103 per her report to MD office 4/17.  Patient treated with antibiotics and diagnosed with cellulitis as well as allergic reaction.  5/9 patient seen in f/u my office and still had palpable 2 cm firm knot in left upper lateral arm.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Blood glucose abnormal, Cardiac stress test, Catheterisation cardiac, Computerised tomogram abnormal
Clinical narrative: CAME SICK, UPPER RESPITORY WITHIN 2 WEEKS/ CRONIC RETURN WITH SINUS PAIN AND BACK PAIN. STARTED HAVING PROBLEMS WITH TEETH/ POSSIBLE BEGINNING OF ABCESSED. PLACED ON ANTIBIOTICS/FLONAISE LATER ORDERED XRAYS FOR BACK (NEG) PATIENT HAS RECEIVED ONLY TWO FLU VAC IN PAST 30 YEARS. FIRST WHILE IN MILITARY DURNING 1976 SWINE FLU PANDEMIC AND WAS ORDERED TO RECEIVE VACINE. AND ON 10/17/2006 DUE TO PATIENT HIGH RISK TYPE 1 (INSULIN DEPENDENT) AVIAN FLU PANICDEMIC CONCERNS FOR UPCOMING FLU SEASON.  5/22/07 Received hospital medical records which were test results:  3/30/07 myocardial perfusion scan was WNL & unchanged from 10/05; 5/3/07 CT of c-spine revealed mature interbody fusion C6-C7, degenerative changes & posterior longitudinal ligament ossification combined w/congenitally fairly narrow canal cause spinal stenosis C4-C5 through C6-C7; 5/3/07 CT of head was WNL;5/9/07 MRI t-spine was WNL.  06/08/2007 Received medical records from 2nd hospital which consisted of Endocrinology consult of 6/5/07 & operative report of C4-5 cervical diskectomy of 6/5/07.  Consult indicates patient had NIDDM for 12-14 years after a bout of pancreatitis & had been on insulin x 2 years w/erratic control & peripheral neuropathy.  Recent cardiac cath revealed small lesions w/30% proximal stenosis in obtuse marginal branch of the left circumflex artery & had an ejection fraction of 60%.   Patient is a smoker of 1 1/2 pks/day & is enrolled in smoking cessation course.  Had a recent URI.  6/12/07 Received PCP medical records which consisted only of lab reports which reveal high triglycerides & cholesterol.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Sinus headache, Tooth disorder, Upper respiratory tract infection
Clinical narrative: CAME SICK, UPPER RESPITORY WITHIN 2 WEEKS/ CRONIC RETURN WITH SINUS PAIN AND BACK PAIN. STARTED HAVING PROBLEMS WITH TEETH/ POSSIBLE BEGINNING OF ABCESSED. PLACED ON ANTIBIOTICS/FLONAISE LATER ORDERED XRAYS FOR BACK (NEG) PATIENT HAS RECEIVED ONLY TWO FLU VAC IN PAST 30 YEARS. FIRST WHILE IN MILITARY DURNING 1976 SWINE FLU PANDEMIC AND WAS ORDERED TO RECEIVE VACINE. AND ON 10/17/2006 DUE TO PATIENT HIGH RISK TYPE 1 (INSULIN DEPENDENT) AVIAN FLU PANICDEMIC CONCERNS FOR UPCOMING FLU SEASON.  5/22/07 Received hospital medical records which were test results:  3/30/07 myocardial perfusion scan was WNL & unchanged from 10/05; 5/3/07 CT of c-spine revealed mature interbody fusion C6-C7, degenerative changes & posterior longitudinal ligament ossification combined w/congenitally fairly narrow canal cause spinal stenosis C4-C5 through C6-C7; 5/3/07 CT of head was WNL;5/9/07 MRI t-spine was WNL.  06/08/2007 Received medical records from 2nd hospital which consisted of Endocrinology consult of 6/5/07 & operative report of C4-5 cervical diskectomy of 6/5/07.  Consult indicates patient had NIDDM for 12-14 years after a bout of pancreatitis & had been on insulin x 2 years w/erratic control & peripheral neuropathy.  Recent cardiac cath revealed small lesions w/30% proximal stenosis in obtuse marginal branch of the left circumflex artery & had an ejection fraction of 60%.   Patient is a smoker of 1 1/2 pks/day & is enrolled in smoking cessation course.  Had a recent URI.  6/12/07 Received PCP medical records which consisted only of lab reports which reveal high triglycerides & cholesterol.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a nurse, and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received unspecified dose of Flu vaccine (unknown). The reporting nurse did not have the name of the Flu vaccine that was administered. At an unspecified time after vaccination with Flu vaccine, the subject experienced influenza and lack of efficacy. It was reported that the subject "died from the flu, however, it was unknown which strain of flu the subject died from". It was unknown whether an autopsy was performed. No further information was provided at the time of reporting.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Ectopic pregnancy
Clinical narrative: Information has been received through the manufacturer Pregnancy Registry from a certified genetics counselor concerning a 35 year old female, with no pertinent medical history, who on 24-FEB-2007 terminated a pregnancy. On 28-FEB-2007 the patient was vaccinated with Varivax. In March 2007, one month post vaccination, the patient was positive for pregnancy. On 16-APR-2007 an in-office pregnancy test was taken and the pregnancy was confirmed. An ultrasound is due to be completed to determine if the termination of the initial pregnancy had "failed", or whether this is a second pregnancy. Unspecified medical attention was sought. There was no product quality complaint. Follow up information has been received through the manufacturer Pregnancy Registry from a healthcare worker who reported that the patient, who had no previous pertinent medical history, developed an ectopic pregnancy, and was given methotrexate to induce an abortion. The patient was not recovered at the time of reporting. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RAB
Symptoms: Oedema peripheral, Palatal disorder, Pharyngolaryngeal pain, Swelling
Clinical narrative: Initial report received on 27 April 2007 from a health care professional. A patient (unknown gender and age) received in on an unspecified date ("days ago") in April 2007 a dose of rabies vaccine (unknown manufacturer) for unknown indication and experienced sore throat, swelling of the hand and soft palate. Reporter denied itchiness. The patient admitted to the hospital and treated with prednisone. The patient's outcome was unknown. No other information was provided.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female student (weight 113) who on 19-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the left deltoid (Lot number 657006/0188U). Concomitant medication was not reported. On 19-MAR-2007 in the evening, the patient developed a rash on her neck and abdomen. There was not reaction at the injection site. The patient was treated with Benadryl. Subsequently on 30-MAR-2007, the patient recovered from a rash on her neck and abdomen. Follow-up from a dermatologist indicated that the patient had a medical history of laser treatment to the cervix and was on birth control pill concomitantly. The patient was seen in the office on 02-APR-2007 with multiforme rash of the torso and neck. The dermatologist reported that the patient indicated that the rash began the evening that the patient was vaccinated. The rash started 2 weeks before it was assessed by the dermatologist. The physician reported that the patient was treated with oral steroids to prevent serious criteria. The patient has recovered. The dermatologist reported that the multiforme rash was an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil (Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus test
Clinical narrative: Information has been received from a physician concerning a 10 month old female who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# 654504/0695F, 654504/0695F, and 655863/1034F) on 04-AUG-2006, 03-OCT-2006, and 12-DEC-2006, respectively. On 29-APR-2007 the patient was hospitalized and diagnosed with rotavirus. It was unknown if the patient had recovered. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Stool analysis abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 10 week old female who on 18-APR-2007 was vaccinated with the first dose of Rotateq. On 26-APR-2007 the patient experienced rotavirus and was hospitalized. While in the hospital, the patient's stool was checked and was positive for rotavirus. Subsequently, the patient recovered from rotavirus. The patient was in the health care provider office to receive a second dose of Rotateq (date unspecified). There was no product quality complaint involved. Additional information has been requested.