chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PNC
Symptoms: Death, Respiratory arrest
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD died of respiratory arrest on the way to the hospital. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chest pain, Dyspnoea, Injection site swelling
Clinical narrative: swelling in left arm, chest pain, difficulty breathing
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Tightness in throat, mild difficulty breathing
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Rash generalised
Clinical narrative: Parent of child stated that he informed her that he had a rash on his neck and face approximately 24 hrs after receiving vaccine. Within 48 hrs the child had a rash that completely covered his body. When child returned to the clinic on 06/05/2008 he was given 12.5 mg of Benadryl and a prescription for home use.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Fall, Head injury, Heart rate normal, Hypotonia
Clinical narrative: Patient came to pharmacy to recieve the third in a series of Gardasil Shots.  She confirmed she had no ill responses from her first two shots (I had asked her as I had not given the first two shots).  I administered the vaccination, applied a bandaid to the injection site, and massaged the site briefly.  We stood there for a few minutes, so I could observe the patient, talking about her work.  After a few minutes she started to rub her arm, I asked her if it was bothering her more then the first two shots, and she said yes, that it was stinging a little more then the first two.  Her eyes began to flutter so I grabbed her by her wrists.  She begain to buckle at the knees and was falling towards the counter.  I caught her head with my forearms, then she went completly limp.  She then went backwards as she landed in a sitting position.  i tried to lay her out softly but lost my grip, falling the rest of the way and hitting the back of her head on the floor.  We raised her feet and called 911.  She had normal breaths and pulse until emergancy help arrived a few minutes later.  She came to and was coherent shortly after she had passed out.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness, Respiratory rate
Clinical narrative: Patient came to pharmacy to recieve the third in a series of Gardasil Shots.  She confirmed she had no ill responses from her first two shots (I had asked her as I had not given the first two shots).  I administered the vaccination, applied a bandaid to the injection site, and massaged the site briefly.  We stood there for a few minutes, so I could observe the patient, talking about her work.  After a few minutes she started to rub her arm, I asked her if it was bothering her more then the first two shots, and she said yes, that it was stinging a little more then the first two.  Her eyes began to flutter so I grabbed her by her wrists.  She begain to buckle at the knees and was falling towards the counter.  I caught her head with my forearms, then she went completly limp.  She then went backwards as she landed in a sitting position.  i tried to lay her out softly but lost my grip, falling the rest of the way and hitting the back of her head on the floor.  We raised her feet and called 911.  She had normal breaths and pulse until emergancy help arrived a few minutes later.  She came to and was coherent shortly after she had passed out.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abasia, Brain injury, Clonus, Diarrhoea, Diplegia
Clinical narrative: Lower Limb Paralysis, Demylination in lower extremeties, Intestinal Damage. 06/09/2008 MR received for 2 OVs 1/20/2007 and 6/20/2007. Pt seen 1/20/07 (prior to reported vaccine) with c/o not walking and not gaining weight.  Bilateral lower extremities with decreased tone on PE.  Assessment:  Hypotonia. Referral to neurologist. Seen for last time in this practice on 6/20/07 for 18mon WCC. Noted at 16 months was able to walk holding on. Gait is wide-based. Neuro eval noted Gross Motor Delay. DTaP given. Parent/reporter now believes sx r/t genetic/chromosomal origin.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Dysstasia, Failure to thrive, Food intolerance, Gastrointestinal disorder, Hyperreflexia
Clinical narrative: Lower Limb Paralysis, Demylination in lower extremeties, Intestinal Damage. 06/09/2008 MR received for 2 OVs 1/20/2007 and 6/20/2007. Pt seen 1/20/07 (prior to reported vaccine) with c/o not walking and not gaining weight.  Bilateral lower extremities with decreased tone on PE.  Assessment:  Hypotonia. Referral to neurologist. Seen for last time in this practice on 6/20/07 for 18mon WCC. Noted at 16 months was able to walk holding on. Gait is wide-based. Neuro eval noted Gross Motor Delay. DTaP given. Parent/reporter now believes sx r/t genetic/chromosomal origin.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Hypotonia, Muscle spasticity, Nerve injury, Rash, Weight gain poor
Clinical narrative: Lower Limb Paralysis, Demylination in lower extremeties, Intestinal Damage. 06/09/2008 MR received for 2 OVs 1/20/2007 and 6/20/2007. Pt seen 1/20/07 (prior to reported vaccine) with c/o not walking and not gaining weight.  Bilateral lower extremities with decreased tone on PE.  Assessment:  Hypotonia. Referral to neurologist. Seen for last time in this practice on 6/20/07 for 18mon WCC. Noted at 16 months was able to walk holding on. Gait is wide-based. Neuro eval noted Gross Motor Delay. DTaP given. Parent/reporter now believes sx r/t genetic/chromosomal origin.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: Myalgia, malaise, joint pain - started 48 hours after vaccine with yellow fever - seen 4 days after vaccine.  Treated with rest and Tylenol.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of redness around injection site approx. 7.5cm x 5.5cm with 3cm superficial induration
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed itching and swelling at injection site on the morning of 5-29-08.  Applied ice to area without improvement.  Upon exam at physician visit noticed erythema with induration measuring 8.5 cm.  Benadryl advised with antibiotic if no improvement.  On 5-30-08 redness had gotten larger and antibiotic was started.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatinine increased, Blood glucose increased, Complement factor C3 increased, Complement factor C4, Inflammation
Clinical narrative: Onset of sore throat 5 days following receipt of ZOSTAVAX left arm; progressed to development of necrotic soft, palpable ulcers (right, left, midline, & uvula); uvula lesion w/inflammation and erythema; last eruption on lower lip.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip ulceration, Lymphocyte percentage decreased, Mouth ulceration, Neutrophil percentage increased, Pharyngeal erythema
Clinical narrative: Onset of sore throat 5 days following receipt of ZOSTAVAX left arm; progressed to development of necrotic soft, palpable ulcers (right, left, midline, & uvula); uvula lesion w/inflammation and erythema; last eruption on lower lip.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngolaryngeal pain, Red blood cell sedimentation rate increased, Stomatitis necrotising, White blood cell count increased
Clinical narrative: Onset of sore throat 5 days following receipt of ZOSTAVAX left arm; progressed to development of necrotic soft, palpable ulcers (right, left, midline, & uvula); uvula lesion w/inflammation and erythema; last eruption on lower lip.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure normal, Choking sensation, Oxygen saturation normal, Pallor, Syncope vasovagal
Clinical narrative: Pt. experienced vasovagal episode, turned pale for about 5-10 seconds.  Vitals were taken and blood pressure and SpO2 were normal before leaving clinic.  Mother states that he said he felt like he was "choking" after he left clinic, he is okay now.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Autism, Developmental delay, Diagnostic procedure, Speech disorder developmental
Clinical narrative: Information has been received from a physician concerning an approximately 12 month old male child with no known allergies or pertinent medical history who on 29-MAY-2007 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  Additional suspect vaccination included PEDVAXHIB (MSD) (Oka/Merck).  Subsequently, the child developed autism.  It was noted that the child started to develop language problems at one year of age and at 15 months was noted as having a delay in language development.  Medical attention was sought.  The child was undergoing testing for autism (results not available).  There were no lab studies performed.  At the time of the report the patient had not recovered.  It was also noted that the child has a twin that did not develop autism.  There was no product quality complaint involved.  The patient went on to receive DTaP (manufacturer unknown) and PREVNAR on 24-AUG-2007.  The physician considered the autism to be disabling.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Computerised tomogram head, Ear pain, Endoscopy, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 71 year old female family member with no pertinent medical history who in approximately August 2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included unspecified blood pressure medication, CLARITIN, and meclizine.  The physician reports that the female family member developed tooth pain about a month to a month and one half after the administration of the vaccine.  The family member went to a dentist and was told that the tooth pain was related to "herpetic lesions" in the mouth.  The family member was directed to use a topical antiviral (unspecified) by the dentist, but decided to take VALTREX.  The mouth lesions "cleared" with the VALTREX (duration of treatment and time to resolution unspecified).  The family member developed jaw and ear pain described as a shooting pain with vertigo some time after the oral herpetic lesions cleared  (time to development uncertain).  The family member went to the emergency room due to vertigo and ear pain in January 2008), then to a neurologist, an otolaryngologist, and a gastroenterologist over a 5 month period all with negative findings, but with continued pain, nausea and weight loss of 22 pounds.  The family member also developed "linear lesions" of unspecified duration or location since vaccination (The physician did not see the lesions).  Diagnostic studies performed included an MRI, CT scan of the head and abdomen, endoscopy, and unspecified blood tests.  The physician considered the adverse experiences to be disabling.  No product quality complaint was involved.  The physician in the case is not the physician who administered the ZOSTAVAX (Oka/Merck).  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nuclear magnetic resonance imaging, Oral herpes, Pain in jaw, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 71 year old female family member with no pertinent medical history who in approximately August 2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included unspecified blood pressure medication, CLARITIN, and meclizine.  The physician reports that the female family member developed tooth pain about a month to a month and one half after the administration of the vaccine.  The family member went to a dentist and was told that the tooth pain was related to "herpetic lesions" in the mouth.  The family member was directed to use a topical antiviral (unspecified) by the dentist, but decided to take VALTREX.  The mouth lesions "cleared" with the VALTREX (duration of treatment and time to resolution unspecified).  The family member developed jaw and ear pain described as a shooting pain with vertigo some time after the oral herpetic lesions cleared  (time to development uncertain).  The family member went to the emergency room due to vertigo and ear pain in January 2008), then to a neurologist, an otolaryngologist, and a gastroenterologist over a 5 month period all with negative findings, but with continued pain, nausea and weight loss of 22 pounds.  The family member also developed "linear lesions" of unspecified duration or location since vaccination (The physician did not see the lesions).  Diagnostic studies performed included an MRI, CT scan of the head and abdomen, endoscopy, and unspecified blood tests.  The physician considered the adverse experiences to be disabling.  No product quality complaint was involved.  The physician in the case is not the physician who administered the ZOSTAVAX (Oka/Merck).  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache, Vertigo, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 71 year old female family member with no pertinent medical history who in approximately August 2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included unspecified blood pressure medication, CLARITIN, and meclizine.  The physician reports that the female family member developed tooth pain about a month to a month and one half after the administration of the vaccine.  The family member went to a dentist and was told that the tooth pain was related to "herpetic lesions" in the mouth.  The family member was directed to use a topical antiviral (unspecified) by the dentist, but decided to take VALTREX.  The mouth lesions "cleared" with the VALTREX (duration of treatment and time to resolution unspecified).  The family member developed jaw and ear pain described as a shooting pain with vertigo some time after the oral herpetic lesions cleared  (time to development uncertain).  The family member went to the emergency room due to vertigo and ear pain in January 2008), then to a neurologist, an otolaryngologist, and a gastroenterologist over a 5 month period all with negative findings, but with continued pain, nausea and weight loss of 22 pounds.  The family member also developed "linear lesions" of unspecified duration or location since vaccination (The physician did not see the lesions).  Diagnostic studies performed included an MRI, CT scan of the head and abdomen, endoscopy, and unspecified blood tests.  The physician considered the adverse experiences to be disabling.  No product quality complaint was involved.  The physician in the case is not the physician who administered the ZOSTAVAX (Oka/Merck).  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 22 year old female with a drug reaction to erythromycin (vomiting) with no pertinent medical history. The patient had done a few home pregnancy tests prior to the administration of the GARDASIL. On 09-APR-2007 prior to vaccination, the patient had a pregnancy test in the physician's office and was vaccinated intramuscularly, into the left arm with a 0.5 mL dose of GARDASIL, (Lot # 657617/0384U). There was no concomitant medication. It was reported that the patient was pregnant after receiving the vaccine. Follow up phone call information obtained from a registered nurse reported that the patient had an early termination of pregnancy. No complications were reported, and the patient subsequently finished the GARDASIL series. Upon internal review, early termination of pregnancy was considered to be an other important medical event. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hodgkin's disease
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown) who, on an unspecified date, was vaccinated with a first dose of GARDASIL.  Subsequently, the patient was diagnosed with Hodgkin's lymphoma.  The patient was seen at the office.  At the time of the report, the patient was in remission.  No product quality complaint was involved.  Upon internal review Hodgkin's lymphoma was considered to be an other important medical event.  This is an amended report.  The serious criteria of other important medical event was changed to yes for Hodgkin's lymphoma.  Additional information has been requested.  06/09/2008 MR received from oncologist which include PCP records as well as outside consultant records. Pt seen by pediatriction 2/27/07 with lymphadenopathy at the base of the neck. Initially thought to be r/t recent dx of mono in November 2006. RTO 4/10/07 with same, as well as chills and fatigue. Refered to oncologist and seen 5/2/2007. Dxd with Hodgkin's Disease following excisional lymph node bx. Staged at level IIA. Port placed for chemo-6 cycles of ABVD, which was successful in achieving remission. No evidence of recurrence at f/u visits.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician who reported to the company representative that she heard multiple patients who received GARDASIL and experienced seizure after the vaccination.  In a follow up telephone call to the physician she reported that "there was a little problem".  "This was all from rumors from her patients who heard kids at their school were receiving GARDASIL and having seizures."  The physician reported that not all the kids at the high school who had the seizures even received the GARDASIL vaccination.  The physician said "again a rumor going around."  She mentioned that she called the high school principal requesting further information about the events but she had not got any more information about patients and the events.  She reported that she had no problems with GARDASIL.  The physician would fax the local newspaper that talked about this incidence.  No further information was available at the time of this report.  The outcome was unknown.  Upon internal review seizure was determined to be an other important medical event.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female with acne who on 23-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 659437/1266U).  Concomitant therapy included BENZACLIN.  On 23-MAY-2008, immediately after vaccination, the patient seizure, fainted and lost consciousness while in the physician's office.  The patient sought medical attention in the physician's office.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient was recovering.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 21 year old female with acne who on 23-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 659437/1266U).  Concomitant therapy included BENZACLIN.  On 23-MAY-2008, immediately after vaccination, the patient seizure, fainted and lost consciousness while in the physician's office.  The patient sought medical attention in the physician's office.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient was recovering.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no specified pertinent medical history, who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL, lot # 654510/0962F, and she was reported as fine.  Subsequently, sometime later on an unspecified date, the patient experienced seizures.  On 17-NOV-2007, the client received her second dose of GARDASIL, lot # 657006/01884, and she is still experiencing some sporadic seizures/epilepsy activity.  The patient is recovering and is being seen by a neurologist for follow-up.  Upon internal review, seizures were considered to be an other important medical event.  Additional information has been requested. 7/4/08 Vaccination record reveals patient received HPV #1, lot #0962F, on 5/29/2007; and HPV #2, lot #0188U, on 9/7/2007.  7/15/08 Reviewed hospital medical records of 11/17-11/20/2007. FINAL DX: Conversion disorder Records reveal patient experienced syncope, right arm shaking, postictal confusion.  Seen by PCP w/o treatment.  Presented to ER w/right arm/leg weakness & unable to get OOB.  On exam, c/o right temporal HA, RUE & RLE slightly weak w/decreased sensory.  Gait was normal.  Neuro & psych consults done.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chest pain, Dysphonia, Eye swelling, Lip swelling, Respiratory distress
Clinical narrative: Anaphylaxis (eyes edematous, lips swollen, chest pain, weak voice, respiratory distress) following MMR+Varicella vaccine. This was the 2nd dose of both vaccines. No past history of anaphylaxis or egg allergy. Pt has had egg products without any reaction.  9/22/2008 MR received for o/n observation 5/20/08 with DX: Anaphylactic reaction to MMR & Varicella vax. Pt developed SOB, facial edema 20" after receiving vax. PE (+) for periorbital edema and lip swelling. Tx with Benadryl and steroids.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric dose of hepatitis A given instead of adult dose. CDC contacted 6/2/08 and instructed to give age appropriate dose. Will contact client.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Diarrhoea, Full blood count normal
Clinical narrative: Nausea, vomiting, diarrhea lasting 5 days, started 2 days after vaccination.  Elevated liver enzymes - persistent through hospitalization & will be rechecked in follow-up.  Mod-severe dehydration-hosp. 5/29/08->5/31/08.  6/10/08 Reviewed hospital medical records of 5/29-5/31/2008. FINAL DX: Elevated liver enzymes, N/V/D, dehydration, ataxia, bilateral OM. Records reveal patient experienced irritability, N/V/D, lethargy, pale, reduced oral intake, dehydration, decreased UO, balance difficulty x 3 days. Received IVF in ER & improved.  Admitted for observation & liver w/u. Clinically improved during hospitalization but liver enzymes remained elevated at D/C to home w/pcp & lab f/u.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Hepatic enzyme increased, Laboratory test normal, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea lasting 5 days, started 2 days after vaccination.  Elevated liver enzymes - persistent through hospitalization & will be rechecked in follow-up.  Mod-severe dehydration-hosp. 5/29/08->5/31/08.  6/10/08 Reviewed hospital medical records of 5/29-5/31/2008. FINAL DX: Elevated liver enzymes, N/V/D, dehydration, ataxia, bilateral OM. Records reveal patient experienced irritability, N/V/D, lethargy, pale, reduced oral intake, dehydration, decreased UO, balance difficulty x 3 days. Received IVF in ER & improved.  Admitted for observation & liver w/u. Clinically improved during hospitalization but liver enzymes remained elevated at D/C to home w/pcp & lab f/u.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Left deltoid red, swollen, warm and tender to touch, firm, painful.  Measures 7 cm x 5.5 cm.
Age: 12.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: DTAP administered inadvertently instead of Tdap. No adverse reactions known at time report was prepared.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, MEN
Symptoms: Incorrect dose administered, Laboratory test normal
Clinical narrative: Pediatric dose given for Hep A and Hep B, rather then adult dose. Patient notified, no adverse reactions noted. She will return to clinic for revaccination
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh - spotty redness and swelling with mild warmth.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood urine present, Contusion, Ear pain, Full blood count, Idiopathic thrombocytopenic purpura
Clinical narrative: Patient seen 5/30/08 for her routine kindergarten physical - no concerns noted, left. On 5/31, mom noted some bruising near shot site then noticed bruising on shoulders and skin. Continued to spread. By 6/4/08 c/o of ear pain and was seen in office. Diagnosed with ITP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising
Clinical narrative: Patient seen 5/30/08 for her routine kindergarten physical - no concerns noted, left. On 5/31, mom noted some bruising near shot site then noticed bruising on shoulders and skin. Continued to spread. By 6/4/08 c/o of ear pain and was seen in office. Diagnosed with ITP.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pallor, Skin discolouration, Staring
Clinical narrative: After child received 2 vaccines in clinic, he walked out to lobby with his dad, 2 siblings - 5-10 min's after shots - color grey - pale - staring - placed on floor awake slow to answer questions but given sucker; cool cloths - responded well - walked out 10 min's later.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema
Clinical narrative: Patient developed 3" red circle around injection site. On 5/29 was diagnosed with shingles infection
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site papule, Muscle swelling, Myalgia
Clinical narrative: Varicella injection on 5/20/08. Muscle swelled with pain; "pimple" noted at injection site during exam on 5/22/08.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presents to office with redness, itching, swelling on right upper thigh
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 5/27) pt had varicella vaccine.  5/28) pt noted inflammation, redness + pain at injection site.  5/29) pt came back to clinic - left upper arm 3x4" area of redness, warmth + edema.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Tdap ordered, DTaP given. No adverse reactions.
Age: 8.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Child received 2 Varicella vaccines. Presented today with >50 Varicella like lesions
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site at (L) deltoid red and swollen. Symmetrical circle about 8 1/2 cm. Began this AM (5/24). Received 5/22, went swimming 5/23.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, achy - ALEVE & heating pad.
Age: 0.37
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Convulsion, Diarrhoea, Pyrexia, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting - within 24 hrs of dose. Diarrhea - within 36 hrs of dose. Low grade temp. Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-MAY-2008 at 14:00 was vaccinated PO with the first and second dose respectively of ROTATEQ (second dose lot: 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 14 hours. On approximately 29-MAY-2008 (20 hours after receiving ROTATEQ the patient had diarrhea which lasted four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date and results not provided). The consumer reported that the patient recovered and returned to normal as of 03-JUN-2008. A product quality complaint was no involved. Follow-up information was received from a registered nurse who reported that the patient was also vaccinated on 26-MAY-2008 at 2:00 pm with the second IM (left thigh) dose of DTAP (Sanofi Pasteur) (lot # C2900AB1. The patient was seen in the office on 29-MAY-2008 and had vomited five times since 04:00 am, the patient was afebrile. No diarrhea, questionable tenderness in lower abdomen, questionable viral gastroenteritis and questionable vaccine reaction. An abdominal ultrasound was done on 29-MAY-2006, the results were reported no evidence of intussusception or enlarged tissue mass, normal visceral organ and liquid like stool in ascending colon. On 30-MAY-2008 the patient had no vomiting and had 3 loose stools per patients mother. The patient was reported as recovered at the time of this report. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Diarrhoea, Pyrexia, Ultrasound scan, Vomiting
Clinical narrative: Vomiting - within 24 hrs of dose. Diarrhea - within 36 hrs of dose. Low grade temp. Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-MAY-2008 at 14:00 was vaccinated PO with the first and second dose respectively of ROTATEQ (second dose lot: 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 14 hours. On approximately 29-MAY-2008 (20 hours after receiving ROTATEQ the patient had diarrhea which lasted four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date and results not provided). The consumer reported that the patient recovered and returned to normal as of 03-JUN-2008. A product quality complaint was no involved. Follow-up information was received from a registered nurse who reported that the patient was also vaccinated on 26-MAY-2008 at 2:00 pm with the second IM (left thigh) dose of DTAP (Sanofi Pasteur) (lot # C2900AB1. The patient was seen in the office on 29-MAY-2008 and had vomited five times since 04:00 am, the patient was afebrile. No diarrhea, questionable tenderness in lower abdomen, questionable viral gastroenteritis and questionable vaccine reaction. An abdominal ultrasound was done on 29-MAY-2006, the results were reported no evidence of intussusception or enlarged tissue mass, normal visceral organ and liquid like stool in ascending colon. On 30-MAY-2008 the patient had no vomiting and had 3 loose stools per patients mother. The patient was reported as recovered at the time of this report. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Diarrhoea, Ultrasound scan, Vomiting
Clinical narrative: Vomiting - within 24 hrs of dose. Diarrhea - within 36 hrs of dose. Low grade temp. Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-MAY-2008 at 14:00 was vaccinated PO with the first and second dose respectively of ROTATEQ (second dose lot: 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 14 hours. On approximately 29-MAY-2008 (20 hours after receiving ROTATEQ the patient had diarrhea which lasted four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date and results not provided). The consumer reported that the patient recovered and returned to normal as of 03-JUN-2008. A product quality complaint was no involved. Follow-up information was received from a registered nurse who reported that the patient was also vaccinated on 26-MAY-2008 at 2:00 pm with the second IM (left thigh) dose of DTAP (Sanofi Pasteur) (lot # C2900AB1. The patient was seen in the office on 29-MAY-2008 and had vomited five times since 04:00 am, the patient was afebrile. No diarrhea, questionable tenderness in lower abdomen, questionable viral gastroenteritis and questionable vaccine reaction. An abdominal ultrasound was done on 29-MAY-2006, the results were reported no evidence of intussusception or enlarged tissue mass, normal visceral organ and liquid like stool in ascending colon. On 30-MAY-2008 the patient had no vomiting and had 3 loose stools per patients mother. The patient was reported as recovered at the time of this report. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness at site at injection.
Age: 1.5
Sex: F
Vaccine: MEA
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: One day following measles vaccine, developed fever, diarrhea and vomiting at onset. Mother insists that we submit this report.
Age: 56.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Haemorrhage, Inflammation, Pruritus, Rash pruritic
Clinical narrative: Rash covering upper right arm & shoulder within 24 hrs of administration.  Inflamed, itchy & bleeding rash.  Treatment: antibiotics, antihistamine & topical lotion for itch.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain, Injection site erythema, Injection site pruritus, Injection site swelling, Skin test negative
Clinical narrative: Within about 1 hr of MMR + Varivax - developed abd pain - redness, swelling, itching of injection site - minimal wheezing, hives on face still. Rx Benadryl, Epi, Orapred, BP.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: Within about 1 hr of MMR + Varivax - developed abd pain - redness, swelling, itching of injection site - minimal wheezing, hives on face still. Rx Benadryl, Epi, Orapred, BP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Conjunctival hyperaemia, Eyelid oedema, Swelling face
Clinical narrative: Came back to office after immunizations with swollen eyelids, conjunctiva and red and swollen cheeks. Rx'ed Benadryl.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Right arm, 70-80mm induration, warmth, redness, 36 hours after vaccination. By 5-20-08 redness was decreasing and child "doing much better."
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Headache, Influenza, Oedema peripheral
Clinical narrative: Fever up to 104. Flu symptoms. Arm (L) swollen. Headache, dizziness, Vomiting and diarrhea. Seen by MD.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever up to 104. Flu symptoms. Arm (L) swollen. Headache, dizziness, Vomiting and diarrhea. Seen by MD.
Age: 33.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Ammonia normal, Anorexia, Anxiety, Aphasia, Blood culture negative
Clinical narrative: Vaccine 4/8/08. On 4/16, chilling, T=99. On 4/17 pt with body aches, skin hyperesthesia, T=101. Throughout the day, he had rapid, progressive confusion, headache, and anorexia. Presented to ER evening of 4/17/08 with T=99.4, aphasic, confusion to the point of inability to name self or spouse. On 4/18 mild headache, nausea, loose stools, improved confusion but still with word finding difficulty. On 4/18/08, pt received Decadron 20mg IV x1 and Ceftriaxone 1 gm IV x1. On 4/19/08, pt discharged home with improving transient confusional state. Pt did continue to experience tingling in ulnar area and in hands for 2 nights, as well as anxiety and insomnia through 4/23/08. In followup 4/25, pt felt back to baseline.8/1/08-records received for DOS 4/18-19/08-DC DX:allergic reaction to vaccine. Hypertension. Presented to ED with C/O confusion, headache, decreased appetite, increased sleep, fever 101. In ED somewhat aphasic saying only nonsense words. In morning alert oriented but still having some trouble finding words. C/O headache and feeling nauseous. Felt to have acute encephalomyelitis. Assessment-transient acute confusional state possibley due to recent yellow fever vaccination.
Age: 33.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Body temperature increased, CSF culture negative, Chills, Computerised tomogram normal, Confusional state
Clinical narrative: Vaccine 4/8/08. On 4/16, chilling, T=99. On 4/17 pt with body aches, skin hyperesthesia, T=101. Throughout the day, he had rapid, progressive confusion, headache, and anorexia. Presented to ER evening of 4/17/08 with T=99.4, aphasic, confusion to the point of inability to name self or spouse. On 4/18 mild headache, nausea, loose stools, improved confusion but still with word finding difficulty. On 4/18/08, pt received Decadron 20mg IV x1 and Ceftriaxone 1 gm IV x1. On 4/19/08, pt discharged home with improving transient confusional state. Pt did continue to experience tingling in ulnar area and in hands for 2 nights, as well as anxiety and insomnia through 4/23/08. In followup 4/25, pt felt back to baseline.8/1/08-records received for DOS 4/18-19/08-DC DX:allergic reaction to vaccine. Hypertension. Presented to ED with C/O confusion, headache, decreased appetite, increased sleep, fever 101. In ED somewhat aphasic saying only nonsense words. In morning alert oriented but still having some trouble finding words. C/O headache and feeling nauseous. Felt to have acute encephalomyelitis. Assessment-transient acute confusional state possibley due to recent yellow fever vaccination.
Age: 33.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Diarrhoea, Full blood count normal, Gram stain negative, Headache, Hyperaesthesia
Clinical narrative: Vaccine 4/8/08. On 4/16, chilling, T=99. On 4/17 pt with body aches, skin hyperesthesia, T=101. Throughout the day, he had rapid, progressive confusion, headache, and anorexia. Presented to ER evening of 4/17/08 with T=99.4, aphasic, confusion to the point of inability to name self or spouse. On 4/18 mild headache, nausea, loose stools, improved confusion but still with word finding difficulty. On 4/18/08, pt received Decadron 20mg IV x1 and Ceftriaxone 1 gm IV x1. On 4/19/08, pt discharged home with improving transient confusional state. Pt did continue to experience tingling in ulnar area and in hands for 2 nights, as well as anxiety and insomnia through 4/23/08. In followup 4/25, pt felt back to baseline.8/1/08-records received for DOS 4/18-19/08-DC DX:allergic reaction to vaccine. Hypertension. Presented to ED with C/O confusion, headache, decreased appetite, increased sleep, fever 101. In ED somewhat aphasic saying only nonsense words. In morning alert oriented but still having some trouble finding words. C/O headache and feeling nauseous. Felt to have acute encephalomyelitis. Assessment-transient acute confusional state possibley due to recent yellow fever vaccination.
Age: 33.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Insomnia, Laboratory test normal, Nausea, Pain, Paraesthesia
Clinical narrative: Vaccine 4/8/08. On 4/16, chilling, T=99. On 4/17 pt with body aches, skin hyperesthesia, T=101. Throughout the day, he had rapid, progressive confusion, headache, and anorexia. Presented to ER evening of 4/17/08 with T=99.4, aphasic, confusion to the point of inability to name self or spouse. On 4/18 mild headache, nausea, loose stools, improved confusion but still with word finding difficulty. On 4/18/08, pt received Decadron 20mg IV x1 and Ceftriaxone 1 gm IV x1. On 4/19/08, pt discharged home with improving transient confusional state. Pt did continue to experience tingling in ulnar area and in hands for 2 nights, as well as anxiety and insomnia through 4/23/08. In followup 4/25, pt felt back to baseline.8/1/08-records received for DOS 4/18-19/08-DC DX:allergic reaction to vaccine. Hypertension. Presented to ED with C/O confusion, headache, decreased appetite, increased sleep, fever 101. In ED somewhat aphasic saying only nonsense words. In morning alert oriented but still having some trouble finding words. C/O headache and feeling nauseous. Felt to have acute encephalomyelitis. Assessment-transient acute confusional state possibley due to recent yellow fever vaccination.
Age: 67.0
Sex: M
Vaccine: PPV, TD
Symptoms: Vaccination complication
Clinical narrative: Reaction to Tetanus/Diphtheria vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Fall, Head injury, Syncope
Clinical narrative: Pt fainted after GARDASIL vaccine injected. Pt fell to the floor. Pt helped back on table. Pt. c/o head injury, ice applied to bump in back of head, water, juice given. BP prior injection 106/60 and after injection 110/70 x 2. Pt to ER for evaluation and follow up.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Computerised tomogram normal, Fall, Headache, Impaired work ability
Clinical narrative: Pt fainted after GARDASIL vaccine injected. Pt fell to the floor. Pt helped back on table. Pt. c/o head injury, ice applied to bump in back of head, water, juice given. BP prior injection 106/60 and after injection 110/70 x 2. Pt to ER for evaluation and follow up.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck pain, Syncope
Clinical narrative: Pt fainted after GARDASIL vaccine injected. Pt fell to the floor. Pt helped back on table. Pt. c/o head injury, ice applied to bump in back of head, water, juice given. BP prior injection 106/60 and after injection 110/70 x 2. Pt to ER for evaluation and follow up.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Induration, Local swelling
Clinical narrative: Local swelling/induration (L) deltoid area. Tx - warm compress, Benadryl PRN.
Age: 64.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: 6/2/08-lg red swollen-warm area on R upper arm 5" at the widest by 4" at the longest.  Imm on 5-27 & on 6-2-08 (6 days later) noticed redness & itching.  6/2/08 went to doctor - he said to take BENADRYL.  Watch it - if it gets worse - come back to be put on steroids - no further treatment needed.  Called client 6-4 & was fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L thigh redness al thigh, thigh very warm to touch, tender to touch, L thigh edema.  Mother gave him TYLENOL yesterday.  This started day after vaccine given.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Full blood count, Pyrexia
Clinical narrative: PCV vaccine given 5-5-08.  Fever started that night per Mom and went up to 104.8 on 5-7-08 (ER visit to hospital).  Motrin and Tylenol given.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Measles, Rash erythematous
Clinical narrative: MMR induced measles - Erythematic rash on face, neck shoulders and body
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema, Irritability
Clinical narrative: Local erythema and irritability.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 3 1/2 x 5 inch pruritic, warm non-tender rash around the injection site on right leg, no Red streaks - alt. warm/cold compresses, Orapred,oral-BENADRYL. Motrin Tylenol PRN; mom stated on 5/30/08 looked "yellowish at injection site"
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh swollen, redness, and painful.
Age: 66.0
Sex: M
Vaccine: PPV, TD
Symptoms: Lymphadenopathy, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: (1)Starting next day, severe pain, stiffness of entire right shoulder, no focal, decreased movement (2) Right suboccipital lymph node enlargement (3) No reaction over injection site.
Age: 68.0
Sex: M
Vaccine: PPV, TD
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe pain R arm & shoulder - non focal bed movements & stiffness R shoulder.  No tenderness/redness over injection site.  Treated with NSAIDS.  Recovered gradually over 2 weeks.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Pallor, Syncope
Clinical narrative: Pt received HPV vaccine then attempted to leave clinic after 10 mins and had syncopal episode, pale low blood pressure - was back to normal in 15 min.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 6 1/2" width x 5 3/4" Length - reddened, hot area, symptoms started on 6-4-08 after receiving 2nd varicella vaccine, on back of right arm
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Fainting, layed down, BP taken, pulse taken.  Stable.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Local reaction, Pruritus
Clinical narrative: On 6-4-08, patient reported 1 1/2#, very red, and itching reaction at injection site of ZOSTAVAX sub-q injection.  No other symptoms have developed other than at injection site.  "Feels warm" and a "little itchy."  Not spreading however, as of 6-5-08, has not dissipated.  Probably a local reaction only.  Recommended oral Benadryl to relieve itchiness and redness.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Mother accompanied pt for appt. - handed nurse immunization card which showed last tetanus to be 4-4-96.  Given Tdap at approx 845AM with mothers consent.  No adverse effects - pt left office.  Went on line to chart & found out was given 7-20-06.  Called mother & advised no serious effects - may get local reaction (which advice) was obtained from CDC.
Age: 13.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I accidentally administered Tdap instead of Td for dose #2 of primary series.  (Received Tdap on 4-3-08).  6-4-08 - TC to mom - denies fever or swelling L arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Pallor, Syncope
Clinical narrative: Patient received HPV vaccine, then attempted to leave clinic after 10 minutes, and had syncopal episode, pale, low blood pressure - was back to normal in 15 minutes.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site starting 1 day after shot and worsening; numbness into hand.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Skin warm
Clinical narrative: Customer came in today to show me her arm which was warm to the touch and rash at injection site.  ZOSTAVAX was administered 6/2/08.  I told her that Benadryl may help and I called her physician to let her know.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Body temperature increased, Chest pain, Dizziness, Nausea, Pain
Clinical narrative: Patient describes immediate "sharp" pain to entire right shoulder and into right armpit.  Awoke from sleep after 3 - 4AM next morning from sharp, stabbing pain rotating down from right armpit and across low chest/upper abdomen.  Temperature 102, had nausea and was dizzy.  No further episodes after time of follow-up exam on 6/3/08 in office.  No source of fever, very painful to light touch on right side of chest (axillary line).  Received Reoprasin, Orservation.