chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Polymerase chain reaction, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 73 year old female with hyperthyroidism, atrial fibrillation, hyperlipidaemia, Spinal stenosis, hypertension and a history of chicken pox who on 19-JUL-2007 was vaccinated with a dose of ZOSTER (658081/0743U) intramuscularly (instead of subcutaneously) in the left arm (deltoid). Concomitant therapy included CELEXA, ezetimibe (+) simvastatin (MSD), PERCOCET, LOPRESSOR, warfarin, TAPAZOLE, digoxin, ACIPHEX and diltiazem hydrochloride. On 20-JUL-2007 the patient developed a zoster-like rash on the right side of neck. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from physician indication that the patient was enrolled in the Varicella Zoster Virus identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV stain or with the OKA/Merck vaccine VZV strain. The date that the herpes zoster was diagnosed and sample of the lesion was collected on 20-Jul-2007. The sample was taken from vesicular lesion on the right side of the neck. The lesions were described as "3 cm of erythematous base and 4 lesions within a confluent patch". Other systemic symptoms were pruritis, but no pruritis at the injection site. The patient did not know if she was recently exposed to chicken pox. A direct fluorescent antibody test was not done. Specimen was not collected for PCR. A photo of the lesion was not taken. The patient did not recover at the time of the report. Follow-up information received regarding the PCR results for the specimen - result was WILD type VZV. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 73 year old female with hyperthyroidism, atrial fibrillation, hyperlipidaemia, Spinal stenosis, hypertension and a history of chicken pox who on 19-JUL-2007 was vaccinated with a dose of ZOSTER (658081/0743U) intramuscularly (instead of subcutaneously) in the left arm (deltoid). Concomitant therapy included CELEXA, ezetimibe (+) simvastatin (MSD), PERCOCET, LOPRESSOR, warfarin, TAPAZOLE, digoxin, ACIPHEX and diltiazem hydrochloride. On 20-JUL-2007 the patient developed a zoster-like rash on the right side of neck. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from physician indication that the patient was enrolled in the Varicella Zoster Virus identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV stain or with the OKA/Merck vaccine VZV strain. The date that the herpes zoster was diagnosed and sample of the lesion was collected on 20-Jul-2007. The sample was taken from vesicular lesion on the right side of the neck. The lesions were described as "3 cm of erythematous base and 4 lesions within a confluent patch". Other systemic symptoms were pruritis, but no pruritis at the injection site. The patient did not know if she was recently exposed to chicken pox. A direct fluorescent antibody test was not done. Specimen was not collected for PCR. A photo of the lesion was not taken. The patient did not recover at the time of the report. Follow-up information received regarding the PCR results for the specimen - result was WILD type VZV. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from a 77-year-old female with an allergy to procainamide, and has a concurrent medical condition of atrial fibrillation and premature ventricular contractions who on 02-APR-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, atenolol, NORPACE, simvastatin, aspirin and VOLTAREN. On 05-APR-2007, 3 days post vaccination, the patient developed "shooting pain" and "pins and needles feeling" in both legs. The "shooting pain" increased to include areas "from my neck down to my ankles". The patient was referred to a doctor for pain management therapy which included LYRICA, gabapentin and an epidural on 07-May-2007 and 09-Jun-2007. Laboratory diagnostic studies included an MRI and xray of the back and electromyography. The outcome was reported as not recovered, the symptoms have improved but the patient has residual pain in both legs with movement. No product quality complaint was involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram, Epidural anaesthesia, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Information has been received from a 77-year-old female with an allergy to procainamide, and has a concurrent medical condition of atrial fibrillation and premature ventricular contractions who on 02-APR-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, atenolol, NORPACE, simvastatin, aspirin and VOLTAREN. On 05-APR-2007, 3 days post vaccination, the patient developed "shooting pain" and "pins and needles feeling" in both legs. The "shooting pain" increased to include areas "from my neck down to my ankles". The patient was referred to a doctor for pain management therapy which included LYRICA, gabapentin and an epidural on 07-May-2007 and 09-Jun-2007. Laboratory diagnostic studies included an MRI and xray of the back and electromyography. The outcome was reported as not recovered, the symptoms have improved but the patient has residual pain in both legs with movement. No product quality complaint was involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, X-ray
Clinical narrative: Information has been received from a 77-year-old female with an allergy to procainamide, and has a concurrent medical condition of atrial fibrillation and premature ventricular contractions who on 02-APR-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, atenolol, NORPACE, simvastatin, aspirin and VOLTAREN. On 05-APR-2007, 3 days post vaccination, the patient developed "shooting pain" and "pins and needles feeling" in both legs. The "shooting pain" increased to include areas "from my neck down to my ankles". The patient was referred to a doctor for pain management therapy which included LYRICA, gabapentin and an epidural on 07-May-2007 and 09-Jun-2007. Laboratory diagnostic studies included an MRI and xray of the back and electromyography. The outcome was reported as not recovered, the symptoms have improved but the patient has residual pain in both legs with movement. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoacusis, Pain, Skin burning sensation
Clinical narrative: Information has been received from a 64 year old female with no allergies and a history of hypertension and hypercholesterolemia who on 19-JUN-2007 was vaccinated SC with a 0.65 ml single dose of Zostavax (Oka/Merck).  Concomitant therapy included "High blood pressure and cholesterol medication".  In June 2007, the patient stated that she was losing her hearing and developed skin burning all over her body.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  No further information was provided.  A product quality complaint was not involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoacusis, Skin burning sensation
Clinical narrative: Information has been received from a 64 year old female with no allergies and a history of hypertension and hypercholesterolemia who on 19-JUN-2007 was vaccinated SC with a 0.65 ml single dose of Zostavax (Oka/Merck).  Concomitant therapy included "High blood pressure and cholesterol medication".  In June 2007, the patient stated that she was losing her hearing and developed skin burning all over her body.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  No further information was provided.  A product quality complaint was not involved.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Skin lesion
Clinical narrative: This is in follow-up to report (s) previously submitted on 09/24/2007. Information has been received from a physician concerning an approximately 60 year old male who on 26-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 28-JUL-2007 the patient experienced pain and a rash that is typical of a classic case of shingles.  Unspecified medical attention was sought.  The outcome of the patient was not reported.  No product quality complaint.  Additional information has been requested. Follow-up information received from a medical record, dated 02-Aug-2007, indicating that the patient is a 72 year old male with cellulitis and a history of appendectomy, prostate cancer, heart attack, diabetes and general symptoms (unspecified history and events). On 02-Aug-2007, the patient complains of rash to torso. The patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) on Thursday. This following Saturday he noted pain to the torso, then the rash developed on Saturday pm. Rash looked like vesicular with redness and very painful. Denies fever, sweats of chills. Has been applying "bactroban" to the area. His LLE celulitis has resolved. He does continue to apply bactroban to any open areas or injuries. The patient was also being treated with FAMVIR and MUPIROCIN 2% OINT. No further information is expected.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash vesicular
Clinical narrative: This is in follow-up to report (s) previously submitted on 09/24/2007. Information has been received from a physician concerning an approximately 60 year old male who on 26-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 28-JUL-2007 the patient experienced pain and a rash that is typical of a classic case of shingles.  Unspecified medical attention was sought.  The outcome of the patient was not reported.  No product quality complaint.  Additional information has been requested. Follow-up information received from a medical record, dated 02-Aug-2007, indicating that the patient is a 72 year old male with cellulitis and a history of appendectomy, prostate cancer, heart attack, diabetes and general symptoms (unspecified history and events). On 02-Aug-2007, the patient complains of rash to torso. The patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) on Thursday. This following Saturday he noted pain to the torso, then the rash developed on Saturday pm. Rash looked like vesicular with redness and very painful. Denies fever, sweats of chills. Has been applying "bactroban" to the area. His LLE celulitis has resolved. He does continue to apply bactroban to any open areas or injuries. The patient was also being treated with FAMVIR and MUPIROCIN 2% OINT. No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash, Skin warm, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 74 year old female with allergies to "statins, Toprol, and uncoated aspirin" who on 26-JUL-2007 was vaccinated in the left arm with a single dose of Zostavax (Oka/Merck) "(Lot #0761V)".  Concomitant therapy included azithromycin, BENADRYL and KEFLEX.  Subsequently the patient developed extreme swelling, pain, and redness at the injection site.  The arm was also hot to the touch.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested. 06/01/2009: This is in follow-up to report (s) previously submitted on 9/24/2007. Information has been received from a licensed praactical nurse concerning a 74 year old female with allergies to "statins, toprol, and uncoated aspirin" who on 26-JUL-2007 was vaccinated in the left arm with a single dose of zoster vaccine live (Oka/Merck) (Lot #0761V). There was no illness at the time of vaccination. Concomitant therapy included azithromycin, diphenhydramine hydrochloride (BENADRYL) and cephalexin (KEFLEX). Subsequently the patient developed extreme swelling, pain, and redness at the injection site. The arm was also hot to touch. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No other information was provided. There was no product quality complaint involved. Follow up information from the LPN indicated that the patient had allergies to erythromycin, cephalexin (KEFLEX) (also reported as concomitant therapy), topical lidocaine, prednisone, solumedrol, cortisone and dextrose. On an unspecified date the patient recovered. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 74 year old female with allergies to "statins, Toprol, and uncoated aspirin" who on 26-JUL-2007 was vaccinated in the left arm with a single dose of Zostavax (Oka/Merck) "(Lot #0761V)".  Concomitant therapy included azithromycin, BENADRYL and KEFLEX.  Subsequently the patient developed extreme swelling, pain, and redness at the injection site.  The arm was also hot to the touch.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested. 06/01/2009: This is in follow-up to report (s) previously submitted on 9/24/2007. Information has been received from a licensed praactical nurse concerning a 74 year old female with allergies to "statins, toprol, and uncoated aspirin" who on 26-JUL-2007 was vaccinated in the left arm with a single dose of zoster vaccine live (Oka/Merck) (Lot #0761V). There was no illness at the time of vaccination. Concomitant therapy included azithromycin, diphenhydramine hydrochloride (BENADRYL) and cephalexin (KEFLEX). Subsequently the patient developed extreme swelling, pain, and redness at the injection site. The arm was also hot to touch. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No other information was provided. There was no product quality complaint involved. Follow up information from the LPN indicated that the patient had allergies to erythromycin, cephalexin (KEFLEX) (also reported as concomitant therapy), topical lidocaine, prednisone, solumedrol, cortisone and dextrose. On an unspecified date the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a female nurse practitioner who vaccinated herself subcutaneously with Zostavax (Oka/Merck).  Concomitant therapy included COUMADIN.  Subsequently the patient experienced a little pain at the injection site.  She also had leg cramps and muscle aches when she was trying to sleep at night which lasted for 10 days.  Subsequently, the patient recovered from the events.  Additional information has been requested. 12/21/2007 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a 60 year old female nurse practitioner with factor V Leiden deficiency who on 30-JUL-2007 vaccinated herself subcutaneously with ZOSTAVAX (Lot # 656858/0356U). Concomitant therapy included COUMADIN. On 01-AUG-2007 approximately 14 hours after the vaccination she awoke with severe, intermittent leg pain which was so severe she was unable to move. The patient also experienced pain, swelling and itching at the injections site which she thought was to be an expected reaction to the vaccine. The leg pains recurred nightly over several days, involving different areas of the leg. The pain resolved in approximatly 2 weeks. The patient recovered from the events. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Movement disorder, Muscle spasms
Clinical narrative: Information has been received from a female nurse practitioner who vaccinated herself subcutaneously with Zostavax (Oka/Merck).  Concomitant therapy included COUMADIN.  Subsequently the patient experienced a little pain at the injection site.  She also had leg cramps and muscle aches when she was trying to sleep at night which lasted for 10 days.  Subsequently, the patient recovered from the events.  Additional information has been requested. 12/21/2007 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a 60 year old female nurse practitioner with factor V Leiden deficiency who on 30-JUL-2007 vaccinated herself subcutaneously with ZOSTAVAX (Lot # 656858/0356U). Concomitant therapy included COUMADIN. On 01-AUG-2007 approximately 14 hours after the vaccination she awoke with severe, intermittent leg pain which was so severe she was unable to move. The patient also experienced pain, swelling and itching at the injections site which she thought was to be an expected reaction to the vaccine. The leg pains recurred nightly over several days, involving different areas of the leg. The pain resolved in approximatly 2 weeks. The patient recovered from the events. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from a female nurse practitioner who vaccinated herself subcutaneously with Zostavax (Oka/Merck).  Concomitant therapy included COUMADIN.  Subsequently the patient experienced a little pain at the injection site.  She also had leg cramps and muscle aches when she was trying to sleep at night which lasted for 10 days.  Subsequently, the patient recovered from the events.  Additional information has been requested. 12/21/2007 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a 60 year old female nurse practitioner with factor V Leiden deficiency who on 30-JUL-2007 vaccinated herself subcutaneously with ZOSTAVAX (Lot # 656858/0356U). Concomitant therapy included COUMADIN. On 01-AUG-2007 approximately 14 hours after the vaccination she awoke with severe, intermittent leg pain which was so severe she was unable to move. The patient also experienced pain, swelling and itching at the injections site which she thought was to be an expected reaction to the vaccine. The leg pains recurred nightly over several days, involving different areas of the leg. The pain resolved in approximatly 2 weeks. The patient recovered from the events. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 6 year old male who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck) rather than Varivax (Oka/Merck) (MSD).  The reporter noted that there was no product confusion and no problems were reported. The patient did not experience a reaction, local or systemic. The nurse reported in follow up that ZOSTAVAX and VARIVAX are packed in nearly identical containers so ZOSTAVAX was mistakenly administered instead of VARIVAX. This is one of several reports received from the same source.  Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 6 year old male who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck) rather than Varivax (Oka/Merck) (MSD).  The reporter noted that there was no product confusion and no problems were reported. The patient did not experience a reaction, local or systemic. The nurse reported in follow up that ZOSTAVAX and VARIVAX are packed in nearly identical containers so ZOSTAVAX was mistakenly administered instead of VARIVAX. This is one of several reports received from the same source.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARZOS, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female who was vaccinated with Zostavax (Oka/Merck).  The licensed practical nurse reported that the patient born 12-JUL-1995 received Zostavax rather than Varivax (MSD) on 17-AUG-2007.  No product confusion.  No problems reported.   No new information was available.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARZOS, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female who was vaccinated with Zostavax (Oka/Merck).  The licensed practical nurse reported that the patient born 12-JUL-1995 received Zostavax rather than Varivax (MSD) on 17-AUG-2007.  No product confusion.  No problems reported.   No new information was available.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, 6VAX-F
Symptoms: Autopsy, Death
Clinical narrative: SIDS (sudden infant death syndrome) few hours after receiving second-in-life routine "age 4 months'" vaccinations at her regular pediatrician's office near Hospital.  I (as on-call pediatrician at Hospital closest ER to her home) and ER staff MD attempted resuscitation of this infant brought in by paramedics in asystole, unresponsive to epinephrine doses. Father of deceased infant is Officer...was too distressed to recall name of regular pediatrician at whose office the vaccines had been administered a few hours prior.  Usual 4month vaccines are DTaP, HIB-C, HBV, IPV, possibly oral Rotvirus vaccine.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, 6VAX-F
Symptoms: Cardiac arrest, Pupil fixed, Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: SIDS (sudden infant death syndrome) few hours after receiving second-in-life routine "age 4 months'" vaccinations at her regular pediatrician's office near Hospital.  I (as on-call pediatrician at Hospital closest ER to her home) and ER staff MD attempted resuscitation of this infant brought in by paramedics in asystole, unresponsive to epinephrine doses. Father of deceased infant is Officer...was too distressed to recall name of regular pediatrician at whose office the vaccines had been administered a few hours prior.  Usual 4month vaccines are DTaP, HIB-C, HBV, IPV, possibly oral Rotvirus vaccine.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a 20-week-old male with no medical history, no respiratory issues, born full-term, who on 21-AUG-2007 was vaccinated with a dose of Rotateq (lot# 656837/0941U). Suspect vaccination included PedvaxHib. Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II or Varivax). The parents put the infant to sleep on his back. When the parents checked on him, he had stopped breathing. 911 was called and the infant was coded for 25 minutes. The infant died on 04-Sep-2007. Hospitalization was noted. An autopsy was performed and was negative. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will be provided when they become available. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Respiratory arrest, Sudden infant death syndrome
Clinical narrative: Information has been received from a physician concerning a 20-week-old male with no medical history, no respiratory issues, born full-term, who on 21-AUG-2007 was vaccinated with a dose of Rotateq (lot# 656837/0941U). Suspect vaccination included PedvaxHib. Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II or Varivax). The parents put the infant to sleep on his back. When the parents checked on him, he had stopped breathing. 911 was called and the infant was coded for 25 minutes. The infant died on 04-Sep-2007. Hospitalization was noted. An autopsy was performed and was negative. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will be provided when they become available. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Anterior cervical lymphadenopathy, L axillary lymphadenopathy, nausea, vomiting. Treated w/ ibuprofen and promethazine IM.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Coordination abnormal, Hypoaesthesia, Injected limb mobility decreased, Vaccine positive rechallenge
Clinical narrative: (I'm a FP Physician).  My daughter had the Gardisil vaccine twice, six months apart. The first time she had mild numbness and very mild weakness of her arm starting withing 5 minutes of vaccine admin. and continuing for several hours.  Otherwise she felt fine.  The second time (this time admin. with the Meningococcal vaccine), she had onset moderate numbness within 5 minutes of both her arm and leg on the affected side, and had difficulty using her arm (felt weak. No leg weakness, just numbness and some mild difficulty coordinating movements.  It was much worse than the first time she had the shot (and we won't be giving her the third shot!).  This lasted for about 2-3 hours and resolved, but was worrisome at the time. The second vaccine was about a month ago.  She's had no problems since or in-between shots.  She's very healthy and never had any problems with any vaccines before.  No fever, headache, dizziness, or other sxs assoc.  I wouldn't have reported it, but I saw the blurb about it on the FP news and thought you should know of this case too.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Autopsy, Peripheral coldness, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will provided when they become available. Additional information has been requested.  10/9/07 Reviewed pcp medical records which reveal patient was in good health on day of vax.  Vax records reveal RO lot # correct as reported & was Dose #2.  Other vax updated in VAERS database. 11/16/07 Received autopsy report which states COD as sudden unexplained death during infancy.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Autopsy, Sudden infant death syndrome, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will provided when they become available. Additional information has been requested.  10/9/07 Reviewed pcp medical records which reveal patient was in good health on day of vax.  Vax records reveal RO lot # correct as reported & was Dose #2.  Other vax updated in VAERS database. 11/16/07 Received autopsy report which states COD as sudden unexplained death during infancy.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Malaise
Clinical narrative: Information has been received from a consumer concerning her 91 year old mother with a morphine allergy and no pertinent medical history who on 28-AUG-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot#658085/0882U). There was no concomitant medication. On 01-SEP-2007 the patient felt ill and was taken to the emergency room. The next morning 02-SEP-2007 she was admitted into the hospital. Later that day she was diagnosed with shingles. Unspecified "blood tests" were performed. No results were reported. She was discharged from the hospital on 03-SEP-2007. At the time of this report the patient had not recovered. There was no further information provided. There was no product quality complaint involved. This report is serious due to hospitalization. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Respiratory distress, Swelling face
Clinical narrative: Information has been received from a physician concerning a female who in September 2007, was vaccinated SC with a dose of Zostavax. Soon after vaccination the patient experienced respiratory distress. It was reported that the patient's face and arm was swollen. The physician did send the patient to the emergency room. It was not known if the patient was admitted to the hospital. Unspecified medical attention was sought. A product quality complaint was not involved. The patient's experiences were considered to be life-threatening and disabling by the reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 17 year old female with no drug allergies or medical history who on 30-AUG-2007 was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #658556/1060U). The patient was vaccinated with the first dose on 21-JUN-2007 (lot#658556/1060U). Concomitant therapy included hormonal contraceptives (unspecified). On 30-AUG-2007, approximately three hours after vaccination, the patient developed a fine, red rash all over her body. The patient was seen in the physician's office and treated with methylprednisolone (MEDROL DOSEPAK). Subsequently, the patient recovered. The reporter considered the erythematous rash to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a nurse concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil, and subsequently developed flu-like symptoms. The patient also developed flu-like symptoms after getting the second dose of Gardasil. After getting the third dose of Gardasil, the patient developed kidney failure and underwent respiratory arrest resulting in hospitalization. At the time of the report the patient had not recovered. Additional information has been requested.  10/8/07 Patient demographics provided by CDC. 10/19/07 Reviewed hospital medical records which reveal patient experienced neck swelling, difficulty swallowing, cough, bloody sputum, facial pressure/pain, fatigue.  Admitted 5/25-5/31/2007.  ID & ENT consults done.  Tx w/IV antibiotics & developed red man syndrome, antibiotics changed.  Improved & d/c to home on continued IV antibiotics via PICC line.  To f/u w/ENT & ID, & have repeat CT scan done.  Records do not have evidence of respiratory arrest or renal failure reported by manufacturer. FINAL DX: Sinusitis, lymphadenitis, parotitis & Epstein-Barr virus. 11/16/07 Reviewed vax records from provider.  VAERS database updated w/same.
Age: 20.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Back pain, Balance disorder, Discomfort, Fatigue
Clinical narrative: pt felt off balance, dull tight feeling in head, tired, back pain, right elbow discomfort, jittery, muscle weakness
Age: 20.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Feeling jittery, Headache, Muscular weakness
Clinical narrative: pt felt off balance, dull tight feeling in head, tired, back pain, right elbow discomfort, jittery, muscle weakness
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid swollen and red.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Bladder catheter permanent, Herpes zoster, Pain, Rash
Clinical narrative: pt hospitalized 9/20/07-9/25/07 for RLQ pain, developed right T12 HZV rash on 9/27/07-tx'd with Acyclovir 1gm q 8 hr x 7d. Dx. Herpes zoster. 10/5/07 Reviewed hospital medical records which reveal patient experienced right sided abdominal pain & difficulty sleeping 9/19 while out of town.  Saw pcp on 9/20 & admitted 9/20-9/25/2007.  Urinary catheter inserted w/large residual.  Tx w/oral antibiotics.  Abdominal pain resolved.  FINAL DX: acute abdominal pain of unknown etiology; bladder outlet obstruction; hyponatremia. 11/9/07 Received pcp medical records which included vax record.  Confirms lot # as reported.  Seen s/p hospitalization on 9/26 & had developed right T12 HXV rash evening before with pain.  Tx w/antiviral & pain med.  Returned to pcp 10/3 still having pain.  Tx w/neurontin.  Returned to pcp 10/11.  Pain improved w/neurontin & pain med & was to start tapering both off as tolerated.  Returned to pcp  10/31 w/increased pain & med increased. FINAL DX: Zoster infection w/post herpetic pain. Per 60 day follow up: R thoracic post herpetic neuritis. 1/12/2010 Right lumbar postherpetic neurolgia on gabapentin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye rolling, Febrile convulsion, Loss of consciousness, Pyrexia, Tremor
Clinical narrative: He developed fever within 24 hrs after immunization T max 102. Mother started him on Tylenol. He had an episode of shaking of his arm and eyes were rolling lasted for approx 1 minute. Loss of consciousness. He was taken to ED with Dx Febrile seizure
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Full blood count, Headache, Liver function test, Metabolic function test, Pain
Clinical narrative: Patient here on Monday Sept 24th given Tdap and Menactra. One hour after vaccines developed severe headache and fever 103, headache so bad went to ED - left without being seen - wait to long - seen in office on 9/27/07. Afebrile with body aches and headache. 10/10/07-records received-well visit 9/24/07-returned 9/27/07-C/O headache, chills, fatigue diminished appetite began 1 hour after vaccinations. Assessment: viral reaction.  Visit 9/28/07-Fever and body aches, loose stools. Labs suggest viral etiology. Acute pharyngitis. Urinary tract infection. Hematuria.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Patient here on Monday Sept 24th given Tdap and Menactra. One hour after vaccines developed severe headache and fever 103, headache so bad went to ED - left without being seen - wait to long - seen in office on 9/27/07. Afebrile with body aches and headache. 10/10/07-records received-well visit 9/24/07-returned 9/27/07-C/O headache, chills, fatigue diminished appetite began 1 hour after vaccinations. Assessment: viral reaction.  Visit 9/28/07-Fever and body aches, loose stools. Labs suggest viral etiology. Acute pharyngitis. Urinary tract infection. Hematuria.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Tremor
Clinical narrative: Patient c/o of being dizzy 5 minute after immunization sat quickly due to feeling light headed. Patient shaking. Patient allowed to rest in a dim lit room approx 20 minutes. Patient up to bathroom, no complaints allowed to leave.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient c/o of being dizzy 5 minute after immunization sat quickly due to feeling light headed. Patient shaking. Patient allowed to rest in a dim lit room approx 20 minutes. Patient up to bathroom, no complaints allowed to leave.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Redness and swelling, min tenderness on upper right arm.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Rash, Rash erythematous
Clinical narrative: Eruptions, red and scabbed on Rt and Lt deltoid started after first injection was given 3-21-07 Did not report until 3 rd inj.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Patient became lightheaded after Gardasil and Flu vaccinations, BP lying down was 137/90, pulse 70, after 15 minutes, BP 132/88, patient c/o headache. Patient stated she felt better, after sitting up initially, BP 133/89, pulse 64, final BP 128/86. Pediatric vaccine information sheets given
Age: 82.0
Sex: M
Vaccine: DT, PPV
Symptoms: Urticaria
Clinical narrative: Urticarial rash developed the day after vaccination. He was examined 2 days after vaccination. By 5 days after, the rash had resolved
Age: 1.9
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left arm erythema/induration
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, red, swollen 3x3cm x 8 1/2 cm. (L) deltoid region of vaccine.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthropathy, Asthenia, Blister, Cervicobrachial syndrome
Clinical narrative: He has a history of neck, back and knee problems but stated that over the past year "my joints are being attacked". Stated he has been feeling weak and has seen rheumatology but to date he does not have a diagnosis. He received 6 anthrax vaccinations in 1999-2000 and he reported no problems with the vaccines other than slight redness and soreness. He noted anthrax vaccine and was wondering if this is what is responsible for his pain. He stated he has traveled three times. The first time was in 1988in which he reported he got sick and developed blisters all over his upper arms and back. He stated they were like water blisters. This was the only episode and it lasted a couple of days. Since that time he has had flu like symptoms and diarrhea that lasted approx 2 yrs when he eventually had his gallbladder removed because it was rotten. Over the past 1-11/2 years he has been experiencing pain every 3-4 days which affects mostly his knees, ankles, hands and elbows. He occasionally reports muscle soreness but states his joints are mostly affected. The pain will last 30 min to one hr and he states it is almost paralyzing. He reports a deep ache without redness, swelling or pain on movement. Symptom: Joint Pain, multiple joints Start: 2005
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Electromyogram abnormal, Erythema, Influenza like illness, Nerve conduction studies normal
Clinical narrative: He has a history of neck, back and knee problems but stated that over the past year "my joints are being attacked". Stated he has been feeling weak and has seen rheumatology but to date he does not have a diagnosis. He received 6 anthrax vaccinations in 1999-2000 and he reported no problems with the vaccines other than slight redness and soreness. He noted anthrax vaccine and was wondering if this is what is responsible for his pain. He stated he has traveled three times. The first time was in 1988in which he reported he got sick and developed blisters all over his upper arms and back. He stated they were like water blisters. This was the only episode and it lasted a couple of days. Since that time he has had flu like symptoms and diarrhea that lasted approx 2 yrs when he eventually had his gallbladder removed because it was rotten. Over the past 1-11/2 years he has been experiencing pain every 3-4 days which affects mostly his knees, ankles, hands and elbows. He occasionally reports muscle soreness but states his joints are mostly affected. The pain will last 30 min to one hr and he states it is almost paralyzing. He reports a deep ache without redness, swelling or pain on movement. Symptom: Joint Pain, multiple joints Start: 2005
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: He has a history of neck, back and knee problems but stated that over the past year "my joints are being attacked". Stated he has been feeling weak and has seen rheumatology but to date he does not have a diagnosis. He received 6 anthrax vaccinations in 1999-2000 and he reported no problems with the vaccines other than slight redness and soreness. He noted anthrax vaccine and was wondering if this is what is responsible for his pain. He stated he has traveled three times. The first time was in 1988in which he reported he got sick and developed blisters all over his upper arms and back. He stated they were like water blisters. This was the only episode and it lasted a couple of days. Since that time he has had flu like symptoms and diarrhea that lasted approx 2 yrs when he eventually had his gallbladder removed because it was rotten. Over the past 1-11/2 years he has been experiencing pain every 3-4 days which affects mostly his knees, ankles, hands and elbows. He occasionally reports muscle soreness but states his joints are mostly affected. The pain will last 30 min to one hr and he states it is almost paralyzing. He reports a deep ache without redness, swelling or pain on movement. Symptom: Joint Pain, multiple joints Start: 2005
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Induration, Mass, Tenderness
Clinical narrative: Left thigh minimal tender arm non indurated mass.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: Rec'd 1st 3 shots in anthrax series Jul-Aug 2000. I have shot record.  Noticed tingling and numbness (09/2000). Diagnosed with Multiple Sclerosis (01/2001) Injecting self w/Copaxone daily since.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TD
Symptoms: Burning sensation, Dizziness, Malaise, Pallor, Vomiting
Clinical narrative: 9/5/2007, 1:32 pm:  After receiving hepatitis B, IPV, MMR, MCV4 and Td, patient complained of not feeling well.  Brought back to exam room for observation.  Became ashen, complained of feeling lightheaded with burning sensation in both ears.  Vomited clear emesis.  Ice pack placed on forehead and brown paper bag given to patient for her to breathe into.  Color returned to pink after breathing into brown paper bag.  Nurse questioned patient about eating lunch and patient stated that she had not eaten anything since early breakfast.  Staff gave patient oatmeal bar and soft drink (COKE).  Stated felt much better.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Dizziness, Electrocardiogram, Fall, Head injury
Clinical narrative: patient came to office for second Gardasil injection on 9/25/07 at 11:00 am. The injection was administered to the patient IM Left deltoid without difficulty by Registered Medical Assistant. Patient was advised to wait 10 minutes in the waiting area after the injection as per protocal after receiving the gardasil injection. Five minutes later triage nurses were paged to the front desk by office staff, patient was found on the floor awake but slightly disoriented, diaphoretic and stating that she felt lightheaded. Front desk staff reports that patient was in the process of checking out and asked for orange juice because she felt a bit dizzy but then immediately passed out, fell forward onto front desk and then fell to the floor. At which time front desk staff called nurses for help. Nurses and Medical Assistants immediately used ammonia salts to help awaken patient and monitored vital signs, which were stable at BP-100/70 P-80 office staff  also immediately called 911. Ems arrived less than 10 minutes later and patient was transported to the ER. Information has been received from a Registered nurse concerning a 23 year old female student who on 24-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #654539/0742U, with no reaction noted. On 25-SEP-2007 at 11:00 a.m. she was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #654539/0742U). The nurse reported that the patient fainted after receiving the second injection, passed out about 5 minutes after the vaccination, and hit her head on the wall. Treatment included administration of "smelling salt". She was sent to an emergency room for evaluation for a head injury. Follow up information indicated that the patient was "awake, oriented, anicteric and conversational," with mo photophobia. The treating physician noted that the patient "needs something to eat. She had a vasovagal epidode." and added that there was no indication for laboratory tests or studies. Vital signs were as follows: temperature 97.8, pulse 93, respirations 20, blood pressure 131/67 mmHg. an electrocardiagram was ordered (results not provided). At the time of this report, the patient had recovered from the events (duration not specified). Additional information is not expected.