chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Lethargy, Urinary system X-ray, Vomiting
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old female, with no pertinent medical history, drug reactions or allergies, who on 08-NOV-2000 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). On 08-NOV-2007 the child was vaccinated subcutaneously in the left arm with her second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F). The child developed a raised, golf ball size lesion after her second dose with varicella virus vaccine live (Oka/Merck). Treatment was cool compresses. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#65456/1335F. Additional information has been requested. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question confirmed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old female, with no pertinent medical history, drug reactions or allergies, who on 08-NOV-2000 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). On 08-NOV-2007 the child was vaccinated subcutaneously in the left arm with her second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F). The child developed a raised, golf ball size lesion after her second dose with varicella virus vaccine live (Oka/Merck). Treatment was cool compresses. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#65456/1335F. Additional information has been requested. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question confirmed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Discomfort, Erythema, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old female, with no pertinent medical history, drug reactions or allergies, who on 31-OCT-2003 was vaccinated with her first dose of Varivax. On 06-MAR-2007 the child was vaccinated subcutaneously in the right arm with her second dose of Varivax (lot #654756/1335F). She also was vaccinated with Vaqta that same day. The child developed a red raised welt, about two inches in diameter after her second dose with Varivax. It was reportedly uncomfortable. Treatment was cold compresses. No lab diagnostic studies were performed. The patient's status at the time of the report was recovering. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot # 654756/1335F. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Cold compress therapy, Erythema, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old female, with no pertinent medical history, drug reactions or allergies, who on 31-OCT-2003 was vaccinated with her first dose of Varivax. On 06-MAR-2007 the child was vaccinated subcutaneously in the right arm with her second dose of Varivax (lot #654756/1335F). She also was vaccinated with Vaqta that same day. The child developed a red raised welt, about two inches in diameter after her second dose with Varivax. It was reportedly uncomfortable. Treatment was cold compresses. No lab diagnostic studies were performed. The patient's status at the time of the report was recovering. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot # 654756/1335F. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Surgery
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA04531. The initial and follow-up reporter to this manufacturer was the regulatory authority through the government. "Information has been received from the regulatory authority through the government concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot #655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received from the regulatory authority through the government concerning this 7 month old male (previously reported as 8 months) with no medical history or pre-existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot# 655865/1109F). It was reported that the patient was also vaccinated (Pediarix)/2AC21B092AA/ third dose, ActHIB (lot #UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no blood stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ilecolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern for intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussusception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." The manufacturer." The manufacturer lot number for the ActHIB administered on 02 March 2007 is Z1100-2.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Appendicectomy, Barium enema, Constipation
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA04531. The initial and follow-up reporter to this manufacturer was the regulatory authority through the government. "Information has been received from the regulatory authority through the government concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot #655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received from the regulatory authority through the government concerning this 7 month old male (previously reported as 8 months) with no medical history or pre-existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot# 655865/1109F). It was reported that the patient was also vaccinated (Pediarix)/2AC21B092AA/ third dose, ActHIB (lot #UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no blood stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ilecolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern for intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussusception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." The manufacturer." The manufacturer lot number for the ActHIB administered on 02 March 2007 is Z1100-2.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laparotomy, Ultrasound abdomen, Vomiting
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA04531. The initial and follow-up reporter to this manufacturer was the regulatory authority through the government. "Information has been received from the regulatory authority through the government concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot #655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received from the regulatory authority through the government concerning this 7 month old male (previously reported as 8 months) with no medical history or pre-existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot# 655865/1109F). It was reported that the patient was also vaccinated (Pediarix)/2AC21B092AA/ third dose, ActHIB (lot #UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no blood stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ilecolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern for intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussusception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." The manufacturer." The manufacturer lot number for the ActHIB administered on 02 March 2007 is Z1100-2.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Laparotomy, Ultrasound abdomen, Vomiting
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA04531. The initial and follow-up reporter to this manufacturer was the regulatory authority through the government. "Information has been received from the regulatory authority through the government concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot #655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received from the regulatory authority through the government concerning this 7 month old male (previously reported as 8 months) with no medical history or pre-existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot# 655865/1109F). It was reported that the patient was also vaccinated (Pediarix)/2AC21B092AA/ third dose, ActHIB (lot #UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no blood stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ilecolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern for intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussusception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." The manufacturer." The manufacturer lot number for the ActHIB administered on 02 March 2007 is Z1100-2.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Lip swelling, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: VACCINE ADM ON R UPPER ARM. REACTION ON L HAND, HIVES (LOCAL), ITCHY AND LOCALIZED SWELLING, GIVEN PREDNISONE 60mg, ZANTAC 150mg, BENADRYL 25mg, Pt stated that his lips and throat were swollen @ oooo 9Mar07 until 0130 same day, still states they itch localized swelling on right hand.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Lip swelling, Local swelling, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: VACCINE ADM ON R UPPER ARM. REACTION ON L HAND, HIVES (LOCAL), ITCHY AND LOCALIZED SWELLING, GIVEN PREDNISONE 60mg, ZANTAC 150mg, BENADRYL 25mg, Pt stated that his lips and throat were swollen @ oooo 9Mar07 until 0130 same day, still states they itch localized swelling on right hand.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner (NP) and a registered nurse (RN) concerning an 8-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 27-FEB-2007 at 15:50 was vaccinated subcutaneously in the left arm with a second dose of Varivax (lot# 656079/1306P). It was reported that she was vaccinated at her well child check-up. On 28-FEB-2007 the patient returned to the office with an 8 X 5 cm swollen, hard, red, hot area at the injection site. The patient's mother reported a decrease in swelling without treatment. It was reported that the patient recovered as of 03-MAR-2007. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 45 month old white male who was a premature baby and has a history of respiratory distress and bronchitis who on 06 Aug 2003 was vaccinated SC in the right leg with a first dose of Varivax ( Lot # 643541/0603M). There was no illness at the time of vaccination. Concomitant therapy that day included a third dose of Recombivax (Lot #641381/1333L) administered IM in the left leg. On 08 May 2006 the patient experienced rash, vomiting, and diarrhea that last lasted for at least 3 days. Treatment included over the counter care. The outcome was reported as unknown. The were no relevant diagnostic tests or laboratory data. It was noted that the patient developed swelling at the site with redness at the site after vaccination with the first dose of Recombivax given at birth (WAES#0606USA03026). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, HEP, VARCEL
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 45 month old white male who was a premature baby and has a history of respiratory distress and bronchitis who on 06 Aug 2003 was vaccinated SC in the right leg with a first dose of Varivax ( Lot # 643541/0603M). There was no illness at the time of vaccination. Concomitant therapy that day included a third dose of Recombivax (Lot #641381/1333L) administered IM in the left leg. On 08 May 2006 the patient experienced rash, vomiting, and diarrhea that last lasted for at least 3 days. Treatment included over the counter care. The outcome was reported as unknown. The were no relevant diagnostic tests or laboratory data. It was noted that the patient developed swelling at the site with redness at the site after vaccination with the first dose of Recombivax given at birth (WAES#0606USA03026). Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Aggression, Cough, Epistaxis, Head banging, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 22 month old white male with a history of toxic mold exposure, severe mold allergy and no pertinent medical history who on the morning of 14-APR-2006 was vaccinated in the right thigh with a dose of Varivax (lot # 651283/0916R). Suspect vaccination included a dose of MMR II (lot # 649225/0938P) given in the left thigh. Concomitant vaccination included a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) tetanus toxoid (manufacturer unspecified). The patient had a fever and was on antibiotics at the time of vaccination. Subsequently, after immunization, the patient did not sleep for three days, developed head banging, had aggressive angry behavior and delayed speech. The injection sites were also reported to be sore, red, inflamed, and swollen. The Varivax injection site was also reported to have a pus-like discharge. At the time of the report the patient was recovering. It was reported that the patient had not had any prior vaccinations due to religious exemption. No further information was available. The physician requested a lot check on lot # 651283/0916R and lot # 649225/0938P. There was no product quality complaint involved. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released by the regulatory agency. Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Injection site inflammation, Injection site reaction, Insomnia, Laboratory test, Learning disability
Clinical narrative: Information has been received from a physician concerning a 22 month old white male with a history of toxic mold exposure, severe mold allergy and no pertinent medical history who on the morning of 14-APR-2006 was vaccinated in the right thigh with a dose of Varivax (lot # 651283/0916R). Suspect vaccination included a dose of MMR II (lot # 649225/0938P) given in the left thigh. Concomitant vaccination included a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) tetanus toxoid (manufacturer unspecified). The patient had a fever and was on antibiotics at the time of vaccination. Subsequently, after immunization, the patient did not sleep for three days, developed head banging, had aggressive angry behavior and delayed speech. The injection sites were also reported to be sore, red, inflamed, and swollen. The Varivax injection site was also reported to have a pus-like discharge. At the time of the report the patient was recovering. It was reported that the patient had not had any prior vaccinations due to religious exemption. No further information was available. The physician requested a lot check on lot # 651283/0916R and lot # 649225/0938P. There was no product quality complaint involved. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released by the regulatory agency. Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Otitis media, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 22 month old white male with a history of toxic mold exposure, severe mold allergy and no pertinent medical history who on the morning of 14-APR-2006 was vaccinated in the right thigh with a dose of Varivax (lot # 651283/0916R). Suspect vaccination included a dose of MMR II (lot # 649225/0938P) given in the left thigh. Concomitant vaccination included a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) tetanus toxoid (manufacturer unspecified). The patient had a fever and was on antibiotics at the time of vaccination. Subsequently, after immunization, the patient did not sleep for three days, developed head banging, had aggressive angry behavior and delayed speech. The injection sites were also reported to be sore, red, inflamed, and swollen. The Varivax injection site was also reported to have a pus-like discharge. At the time of the report the patient was recovering. It was reported that the patient had not had any prior vaccinations due to religious exemption. No further information was available. The physician requested a lot check on lot # 651283/0916R and lot # 649225/0938P. There was no product quality complaint involved. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released by the regulatory agency. Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Aggression, Anger, Head banging, Injection site discharge, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 22 month old white male with a history of toxic mold exposure, severe mold allergy and no pertinent medical history who on the morning of 14-APR-2006 was vaccinated in the right thigh with a dose of Varivax (lot # 651283/0916R). Suspect vaccination included a dose of MMR II (lot # 649225/0938P) given in the left thigh. Concomitant vaccination included a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) tetanus toxoid (manufacturer unspecified). The patient had a fever and was on antibiotics at the time of vaccination. Subsequently, after immunization, the patient did not sleep for three days, developed head banging, had aggressive angry behavior and delayed speech. The injection sites were also reported to be sore, red, inflamed, and swollen. The Varivax injection site was also reported to have a pus-like discharge. At the time of the report the patient was recovering. It was reported that the patient had not had any prior vaccinations due to religious exemption. No further information was available. The physician requested a lot check on lot # 651283/0916R and lot # 649225/0938P. There was no product quality complaint involved. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released by the regulatory agency. Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Insomnia, Speech disorder
Clinical narrative: Information has been received from a physician concerning a 22 month old white male with a history of toxic mold exposure, severe mold allergy and no pertinent medical history who on the morning of 14-APR-2006 was vaccinated in the right thigh with a dose of Varivax (lot # 651283/0916R). Suspect vaccination included a dose of MMR II (lot # 649225/0938P) given in the left thigh. Concomitant vaccination included a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) tetanus toxoid (manufacturer unspecified). The patient had a fever and was on antibiotics at the time of vaccination. Subsequently, after immunization, the patient did not sleep for three days, developed head banging, had aggressive angry behavior and delayed speech. The injection sites were also reported to be sore, red, inflamed, and swollen. The Varivax injection site was also reported to have a pus-like discharge. At the time of the report the patient was recovering. It was reported that the patient had not had any prior vaccinations due to religious exemption. No further information was available. The physician requested a lot check on lot # 651283/0916R and lot # 649225/0938P. There was no product quality complaint involved. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released by the regulatory agency. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Baby was given 1st dose of RotaTeq at 20 weeks of age.  (First dose should not be given after 12 weeks of age.)  Baby did NOT experience any adverse events.
Age: 0.33
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: No adverse effect
Clinical narrative: Baby was given 1st dose of RotaTeq at 20 weeks of age.  (First dose should not be given after 12 weeks of age.)  Baby did NOT experience any adverse events.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from the regulatory authority through the government concerning a 15-week-old male who on 08-MAR-2007 was vaccinated PO with the first dose of Rotateq (Lot# 656101/1231F). Concomitant vaccinations that day included a first dose of DTaP, Pediarix (Lot #AC21B059cA), a first dose of Hib (Lot #655076/1272F), and a first dose of Prevnar (Lot# B08684D). On 24-APR-2007, 47 days post vaccination, the patient was treated for intussusception and was hospitalized. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. The event was considered to be life threatening.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Information has been received from the regulatory authority through the government concerning an 11 week old female patient who on 29-MAR-2007 was vaccinated with the first dose of Rotateq (LOT# 656189/1239F). Concomitant vaccinations included DTaP-IPV) (unknown manufacturer), HIB, poliovirus vaccine (unknown manufacturer) and pneumococcal (CRM197) (MSD). On 23-APR-2007 the patient experienced intussusception and was hospitalized and given an air contrast enema. On 25-APR-2007, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Barium double contrast, Barium enema, Flatulence, Haematochezia, Infantile spitting up
Clinical narrative: Information has been received from the regulatory authority through the government concerning an 11 week old female patient who on 29-MAR-2007 was vaccinated with the first dose of Rotateq (LOT# 656189/1239F). Concomitant vaccinations included DTaP-IPV) (unknown manufacturer), HIB, poliovirus vaccine (unknown manufacturer) and pneumococcal (CRM197) (MSD). On 23-APR-2007 the patient experienced intussusception and was hospitalized and given an air contrast enema. On 25-APR-2007, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Intussusception, Laboratory test abnormal, Pain, Screaming
Clinical narrative: Information has been received from the regulatory authority through the government concerning an 11 week old female patient who on 29-MAR-2007 was vaccinated with the first dose of Rotateq (LOT# 656189/1239F). Concomitant vaccinations included DTaP-IPV) (unknown manufacturer), HIB, poliovirus vaccine (unknown manufacturer) and pneumococcal (CRM197) (MSD). On 23-APR-2007 the patient experienced intussusception and was hospitalized and given an air contrast enema. On 25-APR-2007, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: YF
Symptoms: Anxiety, Cyanosis, Dizziness, Laboratory test, Raynaud's phenomenon
Clinical narrative: Within 15 minutes of Yellow Fever administration, patient experienced a significant Raynaud's phenomenon reaction to left hand. This was arm in which vaccine was administered. Patient did have a bilateral Raynaud's phenomenon to both hands, however only left hand displayed significant vasospastic responses with bluing color to palmar surface of hand and fingers. Patient was escorted to Emergency Room secondary to increased anxiety and feeling lightheaded.  Patient remained in ER for observation, lab tests to return, and was released to return home. No further signs/symptoms presented since.
Age: 52.0
Sex: U
Vaccine: YF
Symptoms: Vasospasm
Clinical narrative: Within 15 minutes of Yellow Fever administration, patient experienced a significant Raynaud's phenomenon reaction to left hand. This was arm in which vaccine was administered. Patient did have a bilateral Raynaud's phenomenon to both hands, however only left hand displayed significant vasospastic responses with bluing color to palmar surface of hand and fingers. Patient was escorted to Emergency Room secondary to increased anxiety and feeling lightheaded.  Patient remained in ER for observation, lab tests to return, and was released to return home. No further signs/symptoms presented since.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Choking, Cough, Crying, Foaming at mouth, Lethargy
Clinical narrative: Ashen appearance, lethargy, poor respiratory effort (no retractions, audible wheeze), diminished cap refill (approx 3 seconds)" that happened approx 15 minutes after getting 12 mos shots, MMR, VCV, Hib, and Hep A.  After leaving clinic here he was crying and screaming, then by the time he got to the Pharmacy he was more quiet and then mom got concerned enough as he was lethargic.  He was taken to ER.  Dr. was concerned with his poor initial response to stimuli she "thought" about intubating.   He slowly came too so to speak, she pumped him up with a neb as she wasn't sure if she heard a wheeze or not.  He received no fluids, no epi, just kinda came around and was back to himself after 45 minutes or so.  Any thoughts?  How do we advise this family?  I don't think this was a breatholding/vasovagal response but I guess it's possible.  I appreciate your input as I need to know what to tell mom when it comes to taking his next round of shots This child did not have any seizure activity, he has had jello already (no reaction), his vitals were as follows:  HR 174, no BP done, RR 24-27, sats 100% (they slapped him on 4L face mask right away), maybe some inspiratory wheeze, received two nebs, had nl soft tissue neck (no swelling).  Mom says he was coughing, choking, foaming a little at the mouth on the walk to the ER, faced him away as though he might puke.  He did gag a couple times.   She took him into the Pharmacy area, she looked down and he was listless and ashy colored.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Listless, Pallor, Retching, Screaming, Wheezing
Clinical narrative: Ashen appearance, lethargy, poor respiratory effort (no retractions, audible wheeze), diminished cap refill (approx 3 seconds)" that happened approx 15 minutes after getting 12 mos shots, MMR, VCV, Hib, and Hep A.  After leaving clinic here he was crying and screaming, then by the time he got to the Pharmacy he was more quiet and then mom got concerned enough as he was lethargic.  He was taken to ER.  Dr. was concerned with his poor initial response to stimuli she "thought" about intubating.   He slowly came too so to speak, she pumped him up with a neb as she wasn't sure if she heard a wheeze or not.  He received no fluids, no epi, just kinda came around and was back to himself after 45 minutes or so.  Any thoughts?  How do we advise this family?  I don't think this was a breatholding/vasovagal response but I guess it's possible.  I appreciate your input as I need to know what to tell mom when it comes to taking his next round of shots This child did not have any seizure activity, he has had jello already (no reaction), his vitals were as follows:  HR 174, no BP done, RR 24-27, sats 100% (they slapped him on 4L face mask right away), maybe some inspiratory wheeze, received two nebs, had nl soft tissue neck (no swelling).  Mom says he was coughing, choking, foaming a little at the mouth on the walk to the ER, faced him away as though he might puke.  He did gag a couple times.   She took him into the Pharmacy area, she looked down and he was listless and ashy colored.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Eyelid oedema, Vomiting
Clinical narrative: After receiving varicella vaccine patient had swelling of the right eye, broke in rash and vomited. Needed to be treated with benadryl and maxitrol eye drops.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Eye swelling, Rash, Vomiting
Clinical narrative: After receiving varicella vaccine patient had swelling of the right eye, broke in rash and vomited. Needed to be treated with benadryl and maxitrol eye drops.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Bone scan normal, Incorrect route of drug administration, Pain
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with sulfonamide allergy who on 09-FEB-2007 was vaccinated intra-articular in her left shoulder joint with a dose of  Pneumovax 23. On 09-FEB-2007 the patient experienced "terrible pain" that evening. on 12-FEB-2007 she was seen at the physician's office and was prescribed a steroid (unspecified) and pain reliever possibly Celebrex. She also went to the emergency room (ER) but was not admitted. She was given an injection of epivacaine and Kenalog. The physician said that the patient seemed to be doing better. The patient was recovering. The reporter considered the event to be disabling because the patient was unable to perform same physical activities such as gardening and kayaking. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, C-reactive protein normal, Chest discomfort, Dry eye, Dry mouth
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of oral candidiasis when on steroids and no allergies who on 01-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 04-MAR-2007, "few days after vaccination", the patient experienced shortness of breath, chest tightness, fatigue, dry tongue and rash on hands and arms. It was reported that these symptoms lasted for a week. On approximately 01-APR-2007, one month after vaccination, the patient's rash reappeared and the patient was treated with steroids. The rash was scaly like psoriasis, patchy, dry raised. The rash was not varicella. The patient also had dry eyes, nose and mouth. The symptoms were described as "sjogren like". The physician reported that patient had patchy areas on his tongue and ulcerations. On 08-MAY-2007 the patient was treated for oral thrush. The patient has several unspecified treatments of DIFLUCAN but there was no improvement. The physician thus believed that patient did not have oral thrush. The physician was also trying to determine if the symptoms were an auto immune process. At the time of report patient was not recovered. The patient was also seen by a dermatologist. A product quality complaint was not involved. Diagnostic laboratory test on an unspecified date included a complete blood cell count, erythrocyte sedimentation rate, serum C-reactive protein test and serum rheumatoid factor test. All laboratory values were reported as normal. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Exfoliative rash, Fatigue, Full blood count normal, Nasal dryness
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of oral candidiasis when on steroids and no allergies who on 01-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 04-MAR-2007, "few days after vaccination", the patient experienced shortness of breath, chest tightness, fatigue, dry tongue and rash on hands and arms. It was reported that these symptoms lasted for a week. On approximately 01-APR-2007, one month after vaccination, the patient's rash reappeared and the patient was treated with steroids. The rash was scaly like psoriasis, patchy, dry raised. The rash was not varicella. The patient also had dry eyes, nose and mouth. The symptoms were described as "sjogren like". The physician reported that patient had patchy areas on his tongue and ulcerations. On 08-MAY-2007 the patient was treated for oral thrush. The patient has several unspecified treatments of DIFLUCAN but there was no improvement. The physician thus believed that patient did not have oral thrush. The physician was also trying to determine if the symptoms were an auto immune process. At the time of report patient was not recovered. The patient was also seen by a dermatologist. A product quality complaint was not involved. Diagnostic laboratory test on an unspecified date included a complete blood cell count, erythrocyte sedimentation rate, serum C-reactive protein test and serum rheumatoid factor test. All laboratory values were reported as normal. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Psoriasis, Rash, Rheumatoid factor negative, Sjogren's syndrome, Tongue dry
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of oral candidiasis when on steroids and no allergies who on 01-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 04-MAR-2007, "few days after vaccination", the patient experienced shortness of breath, chest tightness, fatigue, dry tongue and rash on hands and arms. It was reported that these symptoms lasted for a week. On approximately 01-APR-2007, one month after vaccination, the patient's rash reappeared and the patient was treated with steroids. The rash was scaly like psoriasis, patchy, dry raised. The rash was not varicella. The patient also had dry eyes, nose and mouth. The symptoms were described as "sjogren like". The physician reported that patient had patchy areas on his tongue and ulcerations. On 08-MAY-2007 the patient was treated for oral thrush. The patient has several unspecified treatments of DIFLUCAN but there was no improvement. The physician thus believed that patient did not have oral thrush. The physician was also trying to determine if the symptoms were an auto immune process. At the time of report patient was not recovered. The patient was also seen by a dermatologist. A product quality complaint was not involved. Diagnostic laboratory test on an unspecified date included a complete blood cell count, erythrocyte sedimentation rate, serum C-reactive protein test and serum rheumatoid factor test. All laboratory values were reported as normal. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tongue ulceration
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of oral candidiasis when on steroids and no allergies who on 01-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 04-MAR-2007, "few days after vaccination", the patient experienced shortness of breath, chest tightness, fatigue, dry tongue and rash on hands and arms. It was reported that these symptoms lasted for a week. On approximately 01-APR-2007, one month after vaccination, the patient's rash reappeared and the patient was treated with steroids. The rash was scaly like psoriasis, patchy, dry raised. The rash was not varicella. The patient also had dry eyes, nose and mouth. The symptoms were described as "sjogren like". The physician reported that patient had patchy areas on his tongue and ulcerations. On 08-MAY-2007 the patient was treated for oral thrush. The patient has several unspecified treatments of DIFLUCAN but there was no improvement. The physician thus believed that patient did not have oral thrush. The physician was also trying to determine if the symptoms were an auto immune process. At the time of report patient was not recovered. The patient was also seen by a dermatologist. A product quality complaint was not involved. Diagnostic laboratory test on an unspecified date included a complete blood cell count, erythrocyte sedimentation rate, serum C-reactive protein test and serum rheumatoid factor test. All laboratory values were reported as normal. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy lip, Blister, Blood test, Candidiasis, Cardiolipin antibody positive
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of oral candidiasis when on steroids and no allergies who on 01-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 04-MAR-2007, "few days after vaccination", the patient experienced shortness of breath, chest tightness, fatigue, dry tongue and rash on hands and arms. It was reported that these symptoms lasted for a week. On approximately 01-APR-2007, one month after vaccination, the patient's rash reappeared and the patient was treated with steroids. The rash was scaly like psoriasis, patchy, dry raised. The rash was not varicella. The patient also had dry eyes, nose and mouth. The symptoms were described as "sjogren like". The physician reported that patient had patchy areas on his tongue and ulcerations. On 08-MAY-2007 the patient was treated for oral thrush. The patient has several unspecified treatments of DIFLUCAN but there was no improvement. The physician thus believed that patient did not have oral thrush. The physician was also trying to determine if the symptoms were an auto immune process. At the time of report patient was not recovered. The patient was also seen by a dermatologist. A product quality complaint was not involved. Diagnostic laboratory test on an unspecified date included a complete blood cell count, erythrocyte sedimentation rate, serum C-reactive protein test and serum rheumatoid factor test. All laboratory values were reported as normal. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.