chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 05-APR-2007 was vaccinated with zoster vaccine live (Oka/Merck). On 05-APR-2007 the patient experienced localized reaction of red hot tender from post area arm to elbow of 6 inches long and 2 to 3 inches wide after getting the zoster vaccine. Subsequently, the patient recovered from localized reaction of red hot tender from post area arm to elbow. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 05-APR-2007 was vaccinated with zoster vaccine live (Oka/Merck). On 05-APR-2007 the patient experienced localized reaction of red hot tender from post area arm to elbow of 6 inches long and 2 to 3 inches wide after getting the zoster vaccine. Subsequently, the patient recovered from localized reaction of red hot tender from post area arm to elbow. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site urticaria, Swelling
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 05-APR-2007 was vaccinated with zoster vaccine live (Oka/Merck). On 05-APR-2007 the patient experienced localized reaction of red hot tender from post area arm to elbow of 6 inches long and 2 to 3 inches wide after getting the zoster vaccine. Subsequently, the patient recovered from localized reaction of red hot tender from post area arm to elbow. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 60 year old white female with a history of allergy to glycerin who on 05-APR-2007 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) (lot# 656606/0033U). Concomitant therapy included simvastatin (MSD) and lisinopril (manufacturer unknown). No illness at the time of vaccination. The patient developed a 5 mm wheal at the injection site approximately 15 minutes post vaccination. No relevant diagnostic or laboratory tests performed. Swelling redness began to subside, responded to diphenhydramine hydrochloride (BENADRYL) symptoms resolved completely by 11-APR-2007. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 60 year old white female with a history of allergy to glycerin who on 05-APR-2007 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) (lot# 656606/0033U). Concomitant therapy included simvastatin (MSD) and lisinopril (manufacturer unknown). No illness at the time of vaccination. The patient developed a 5 mm wheal at the injection site approximately 15 minutes post vaccination. No relevant diagnostic or laboratory tests performed. Swelling redness began to subside, responded to diphenhydramine hydrochloride (BENADRYL) symptoms resolved completely by 11-APR-2007. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site urticaria, Swelling
Clinical narrative: Information has been received from a health professional concerning a 60 year old white female with a history of allergy to glycerin who on 05-APR-2007 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) (lot# 656606/0033U). Concomitant therapy included simvastatin (MSD) and lisinopril (manufacturer unknown). No illness at the time of vaccination. The patient developed a 5 mm wheal at the injection site approximately 15 minutes post vaccination. No relevant diagnostic or laboratory tests performed. Swelling redness began to subside, responded to diphenhydramine hydrochloride (BENADRYL) symptoms resolved completely by 11-APR-2007. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old white female with a penicillin allergy and gastrooesophageal reflux disease who on 26-MAR-2007 was vaccinated SC with a first dose of zoster vaccine (Oka/Merck) (lot # 656606/0033U). concomitant therapy included pantoprazole sodium (PROTONIX), lorazepam, byoscyamineSO4 (LEVSIN), calcium carbonate (+) cholecalciferol (+) phytonadione (VIACTIV SOFT CALICUM CHEWS), acetaminophen (TYLENOL), and ibuprofen (MOTRIN). There was no illness at the time of vaccination. The nurse reported that the patient called the physician's office on 28-MAR-2007 and complained of a red, swollen, tender warm area approximately 3 cm in diameter with erythema of the left posterior upper arm and a few vesicular lesions at the site of injection. The onset of the event was noted to be 27-MAR-2007. The patient was diagnosed with a robust reaction to zoster vaccine (Oka/Merck) versus cellulities and was treated with levofloxacin (LEVOQUIN) 750 mg PO daily. The symptoms resolved over the next days. The skin reaction completely resolved on 31-MAR-2007 and there were no further problems. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old white female with a penicillin allergy and gastrooesophageal reflux disease who on 26-MAR-2007 was vaccinated SC with a first dose of zoster vaccine (Oka/Merck) (lot # 656606/0033U). concomitant therapy included pantoprazole sodium (PROTONIX), lorazepam, byoscyamineSO4 (LEVSIN), calcium carbonate (+) cholecalciferol (+) phytonadione (VIACTIV SOFT CALICUM CHEWS), acetaminophen (TYLENOL), and ibuprofen (MOTRIN). There was no illness at the time of vaccination. The nurse reported that the patient called the physician's office on 28-MAR-2007 and complained of a red, swollen, tender warm area approximately 3 cm in diameter with erythema of the left posterior upper arm and a few vesicular lesions at the site of injection. The onset of the event was noted to be 27-MAR-2007. The patient was diagnosed with a robust reaction to zoster vaccine (Oka/Merck) versus cellulities and was treated with levofloxacin (LEVOQUIN) 750 mg PO daily. The symptoms resolved over the next days. The skin reaction completely resolved on 31-MAR-2007 and there were no further problems. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Injection site reaction, Injection site vesicles, Skin warm
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old white female with a penicillin allergy and gastrooesophageal reflux disease who on 26-MAR-2007 was vaccinated SC with a first dose of zoster vaccine (Oka/Merck) (lot # 656606/0033U). concomitant therapy included pantoprazole sodium (PROTONIX), lorazepam, byoscyamineSO4 (LEVSIN), calcium carbonate (+) cholecalciferol (+) phytonadione (VIACTIV SOFT CALICUM CHEWS), acetaminophen (TYLENOL), and ibuprofen (MOTRIN). There was no illness at the time of vaccination. The nurse reported that the patient called the physician's office on 28-MAR-2007 and complained of a red, swollen, tender warm area approximately 3 cm in diameter with erythema of the left posterior upper arm and a few vesicular lesions at the site of injection. The onset of the event was noted to be 27-MAR-2007. The patient was diagnosed with a robust reaction to zoster vaccine (Oka/Merck) versus cellulities and was treated with levofloxacin (LEVOQUIN) 750 mg PO daily. The symptoms resolved over the next days. The skin reaction completely resolved on 31-MAR-2007 and there were no further problems. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old white female with a penicillin allergy and gastrooesophageal reflux disease who on 26-MAR-2007 was vaccinated SC with a first dose of zoster vaccine (Oka/Merck) (lot # 656606/0033U). concomitant therapy included pantoprazole sodium (PROTONIX), lorazepam, byoscyamineSO4 (LEVSIN), calcium carbonate (+) cholecalciferol (+) phytonadione (VIACTIV SOFT CALICUM CHEWS), acetaminophen (TYLENOL), and ibuprofen (MOTRIN). There was no illness at the time of vaccination. The nurse reported that the patient called the physician's office on 28-MAR-2007 and complained of a red, swollen, tender warm area approximately 3 cm in diameter with erythema of the left posterior upper arm and a few vesicular lesions at the site of injection. The onset of the event was noted to be 27-MAR-2007. The patient was diagnosed with a robust reaction to zoster vaccine (Oka/Merck) versus cellulities and was treated with levofloxacin (LEVOQUIN) 750 mg PO daily. The symptoms resolved over the next days. The skin reaction completely resolved on 31-MAR-2007 and there were no further problems. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female with a penicillin allergy and a history of herpes simplex who on 13-APR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 17-APR-2007 the patient developed cold sores which were lesions on her lips and inside her nose. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female with a penicillin allergy and a history of herpes simplex who on 13-APR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 17-APR-2007 the patient developed cold sores which were lesions on her lips and inside her nose. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dysaesthesia, Dysphagia, Full blood count normal, Influenza like illness
Clinical narrative: Information has been received from a 64 year old male physician with an allergy to etodolac (LODINE) and no other pertinent medical  history who on 17-APR-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). There was no concomitant medication. On 19-APR-2007 the physician developed chills and myalgia in his neck, chest and back. He later experienced numbness and pain in his left and chin and pain in his right hand and right leg. A varicella like rash developed that he had "waves of feeling good" for 2 to 3 hours followed by "feeling bad" for 2 to 3 hours. On 21-APR-2007 he developed a fever blister and rash around both sides of his mouth. On 24-APR-2007 his lower lip swelled and he started predisone and acyclovir (ZOVIRAX). His lip swelling resolved four to five hours after starting the predisone. Unspecified medical attention was sought. His CBC (date not specified) was normal. All of his symptoms resolved by 25-APR-2007, except he still had a fever blister on his lip which he considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Liver function test normal, Metabolic function test normal, Myalgia, Pyrexia, Renal function test normal
Clinical narrative: Information has been received from a 64 year old male physician with an allergy to etodolac (LODINE) and no other pertinent medical  history who on 17-APR-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). There was no concomitant medication. On 19-APR-2007 the physician developed chills and myalgia in his neck, chest and back. He later experienced numbness and pain in his left and chin and pain in his right hand and right leg. A varicella like rash developed that he had "waves of feeling good" for 2 to 3 hours followed by "feeling bad" for 2 to 3 hours. On 21-APR-2007 he developed a fever blister and rash around both sides of his mouth. On 24-APR-2007 his lower lip swelled and he started predisone and acyclovir (ZOVIRAX). His lip swelling resolved four to five hours after starting the predisone. Unspecified medical attention was sought. His CBC (date not specified) was normal. All of his symptoms resolved by 25-APR-2007, except he still had a fever blister on his lip which he considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Chills, Feeling abnormal, Full blood count
Clinical narrative: Information has been received from a 64 year old male physician with an allergy to etodolac (LODINE) and no other pertinent medical  history who on 17-APR-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). There was no concomitant medication. On 19-APR-2007 the physician developed chills and myalgia in his neck, chest and back. He later experienced numbness and pain in his left and chin and pain in his right hand and right leg. A varicella like rash developed that he had "waves of feeling good" for 2 to 3 hours followed by "feeling bad" for 2 to 3 hours. On 21-APR-2007 he developed a fever blister and rash around both sides of his mouth. On 24-APR-2007 his lower lip swelled and he started predisone and acyclovir (ZOVIRAX). His lip swelling resolved four to five hours after starting the predisone. Unspecified medical attention was sought. His CBC (date not specified) was normal. All of his symptoms resolved by 25-APR-2007, except he still had a fever blister on his lip which he considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Lip swelling, Myalgia, Neck pain, Oral herpes
Clinical narrative: Information has been received from a 64 year old male physician with an allergy to etodolac (LODINE) and no other pertinent medical  history who on 17-APR-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). There was no concomitant medication. On 19-APR-2007 the physician developed chills and myalgia in his neck, chest and back. He later experienced numbness and pain in his left and chin and pain in his right hand and right leg. A varicella like rash developed that he had "waves of feeling good" for 2 to 3 hours followed by "feeling bad" for 2 to 3 hours. On 21-APR-2007 he developed a fever blister and rash around both sides of his mouth. On 24-APR-2007 his lower lip swelled and he started predisone and acyclovir (ZOVIRAX). His lip swelling resolved four to five hours after starting the predisone. Unspecified medical attention was sought. His CBC (date not specified) was normal. All of his symptoms resolved by 25-APR-2007, except he still had a fever blister on his lip which he considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash, Rash vesicular
Clinical narrative: Information has been received from a 64 year old male physician with an allergy to etodolac (LODINE) and no other pertinent medical  history who on 17-APR-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). There was no concomitant medication. On 19-APR-2007 the physician developed chills and myalgia in his neck, chest and back. He later experienced numbness and pain in his left and chin and pain in his right hand and right leg. A varicella like rash developed that he had "waves of feeling good" for 2 to 3 hours followed by "feeling bad" for 2 to 3 hours. On 21-APR-2007 he developed a fever blister and rash around both sides of his mouth. On 24-APR-2007 his lower lip swelled and he started predisone and acyclovir (ZOVIRAX). His lip swelling resolved four to five hours after starting the predisone. Unspecified medical attention was sought. His CBC (date not specified) was normal. All of his symptoms resolved by 25-APR-2007, except he still had a fever blister on his lip which he considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Acidosis, Anorexia, Cough, Diarrhoea, Feeding disorder of infancy or early childhood
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 13 Feb 2007 was vaccinated with one dose of oral Rotateq. The patient was healthy at the time of the vaccination. On 16 Feb 2007 the patient visited the physician's office with symptoms of diarrhea. The patient had four bouts of mild diarrhea on 16 Feb 2007, 3 bouts on 17 Feb 2007 and 18 Feb 2007, and 2 bouts on 19 Feb 2007. The patient was treated with Pedialyte solution and Carnation Good Start. No fever was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 9 week male who on 13-FEB-2007 was vaccinated with one dose of ROTATEQ.  Concomitant vaccines administered on the same day, in the morning, included a first dose in the rigth thigh of Comvax (Lot # 654994/1073F), a first dose in the left thigh of TRIPEDIA (Lot # C2405AA), a first sode in the right thigh of IPOL (Lot # Y1051) and a first dose in the left thigh of PREVNAR (Lot # B47442A.  The patient was healthy at the time of the vaccination.  On 16-FEB-2007 the patient visited the physician's office with symptoms of diarrhea.  The patient had four bouts of mild diarrhea on 16-FEB-2007, 3 bouts on 17-FEB-2007 and 18-FEB-2007, and 2 bouts on 19-FEB-2007.  The patient was treated with PEDIALYTE SOLUTION and Carnation Good Start.  No fever was reported.  Follow-up information from a physician indicated that the patient's parents reported that two days after vaccination with ROTATEQ, on 15-FEB-2007, the patient developed diarrhea which lasted seven days.  During that period the patient became very fussy during feeding and lost his appetite.  On the seventh day of his diarrhea, he was switched from his regular milk-based formula to a soy formula.  The diarrhea ceased, however the feeding issues remained.  The feeding resistance turned into an overall feeding refusal, in so much that he needed to fed asleep, or in a very near sleep stage.  It was noted that the patient also developed a cough and wheezing.  It was reported that labs were drawn weeks later and had been repeated several times since.  The results showed elevated liver enzymes and acidosis.  The physician noted that no labs were ordered by her as the patient's mother went to a different pediatrician who referred her to a gastroenterologist.  The patient's parents believed that the vaccination with ROTATEQ was responsible for the patient's experiences.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Hepatic enzyme increased, Irritability, Wheezing
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 13 Feb 2007 was vaccinated with one dose of oral Rotateq. The patient was healthy at the time of the vaccination. On 16 Feb 2007 the patient visited the physician's office with symptoms of diarrhea. The patient had four bouts of mild diarrhea on 16 Feb 2007, 3 bouts on 17 Feb 2007 and 18 Feb 2007, and 2 bouts on 19 Feb 2007. The patient was treated with Pedialyte solution and Carnation Good Start. No fever was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 9 week male who on 13-FEB-2007 was vaccinated with one dose of ROTATEQ.  Concomitant vaccines administered on the same day, in the morning, included a first dose in the rigth thigh of Comvax (Lot # 654994/1073F), a first dose in the left thigh of TRIPEDIA (Lot # C2405AA), a first sode in the right thigh of IPOL (Lot # Y1051) and a first dose in the left thigh of PREVNAR (Lot # B47442A.  The patient was healthy at the time of the vaccination.  On 16-FEB-2007 the patient visited the physician's office with symptoms of diarrhea.  The patient had four bouts of mild diarrhea on 16-FEB-2007, 3 bouts on 17-FEB-2007 and 18-FEB-2007, and 2 bouts on 19-FEB-2007.  The patient was treated with PEDIALYTE SOLUTION and Carnation Good Start.  No fever was reported.  Follow-up information from a physician indicated that the patient's parents reported that two days after vaccination with ROTATEQ, on 15-FEB-2007, the patient developed diarrhea which lasted seven days.  During that period the patient became very fussy during feeding and lost his appetite.  On the seventh day of his diarrhea, he was switched from his regular milk-based formula to a soy formula.  The diarrhea ceased, however the feeding issues remained.  The feeding resistance turned into an overall feeding refusal, in so much that he needed to fed asleep, or in a very near sleep stage.  It was noted that the patient also developed a cough and wheezing.  It was reported that labs were drawn weeks later and had been repeated several times since.  The results showed elevated liver enzymes and acidosis.  The physician noted that no labs were ordered by her as the patient's mother went to a different pediatrician who referred her to a gastroenterologist.  The patient's parents believed that the vaccination with ROTATEQ was responsible for the patient's experiences.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Acidosis, Cough, Decreased appetite, Diarrhoea, Feeding disorder
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 13 Feb 2007 was vaccinated with one dose of oral Rotateq. The patient was healthy at the time of the vaccination. On 16 Feb 2007 the patient visited the physician's office with symptoms of diarrhea. The patient had four bouts of mild diarrhea on 16 Feb 2007, 3 bouts on 17 Feb 2007 and 18 Feb 2007, and 2 bouts on 19 Feb 2007. The patient was treated with Pedialyte solution and Carnation Good Start. No fever was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 9 week male who on 13-FEB-2007 was vaccinated with one dose of ROTATEQ.  Concomitant vaccines administered on the same day, in the morning, included a first dose in the rigth thigh of Comvax (Lot # 654994/1073F), a first dose in the left thigh of TRIPEDIA (Lot # C2405AA), a first sode in the right thigh of IPOL (Lot # Y1051) and a first dose in the left thigh of PREVNAR (Lot # B47442A.  The patient was healthy at the time of the vaccination.  On 16-FEB-2007 the patient visited the physician's office with symptoms of diarrhea.  The patient had four bouts of mild diarrhea on 16-FEB-2007, 3 bouts on 17-FEB-2007 and 18-FEB-2007, and 2 bouts on 19-FEB-2007.  The patient was treated with PEDIALYTE SOLUTION and Carnation Good Start.  No fever was reported.  Follow-up information from a physician indicated that the patient's parents reported that two days after vaccination with ROTATEQ, on 15-FEB-2007, the patient developed diarrhea which lasted seven days.  During that period the patient became very fussy during feeding and lost his appetite.  On the seventh day of his diarrhea, he was switched from his regular milk-based formula to a soy formula.  The diarrhea ceased, however the feeding issues remained.  The feeding resistance turned into an overall feeding refusal, in so much that he needed to fed asleep, or in a very near sleep stage.  It was noted that the patient also developed a cough and wheezing.  It was reported that labs were drawn weeks later and had been repeated several times since.  The results showed elevated liver enzymes and acidosis.  The physician noted that no labs were ordered by her as the patient's mother went to a different pediatrician who referred her to a gastroenterologist.  The patient's parents believed that the vaccination with ROTATEQ was responsible for the patient's experiences.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Hepatic enzyme increased, Hepatic function abnormal, Irritability, Laboratory test abnormal, Wheezing
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 13 Feb 2007 was vaccinated with one dose of oral Rotateq. The patient was healthy at the time of the vaccination. On 16 Feb 2007 the patient visited the physician's office with symptoms of diarrhea. The patient had four bouts of mild diarrhea on 16 Feb 2007, 3 bouts on 17 Feb 2007 and 18 Feb 2007, and 2 bouts on 19 Feb 2007. The patient was treated with Pedialyte solution and Carnation Good Start. No fever was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 9 week male who on 13-FEB-2007 was vaccinated with one dose of ROTATEQ.  Concomitant vaccines administered on the same day, in the morning, included a first dose in the rigth thigh of Comvax (Lot # 654994/1073F), a first dose in the left thigh of TRIPEDIA (Lot # C2405AA), a first sode in the right thigh of IPOL (Lot # Y1051) and a first dose in the left thigh of PREVNAR (Lot # B47442A.  The patient was healthy at the time of the vaccination.  On 16-FEB-2007 the patient visited the physician's office with symptoms of diarrhea.  The patient had four bouts of mild diarrhea on 16-FEB-2007, 3 bouts on 17-FEB-2007 and 18-FEB-2007, and 2 bouts on 19-FEB-2007.  The patient was treated with PEDIALYTE SOLUTION and Carnation Good Start.  No fever was reported.  Follow-up information from a physician indicated that the patient's parents reported that two days after vaccination with ROTATEQ, on 15-FEB-2007, the patient developed diarrhea which lasted seven days.  During that period the patient became very fussy during feeding and lost his appetite.  On the seventh day of his diarrhea, he was switched from his regular milk-based formula to a soy formula.  The diarrhea ceased, however the feeding issues remained.  The feeding resistance turned into an overall feeding refusal, in so much that he needed to fed asleep, or in a very near sleep stage.  It was noted that the patient also developed a cough and wheezing.  It was reported that labs were drawn weeks later and had been repeated several times since.  The results showed elevated liver enzymes and acidosis.  The physician noted that no labs were ordered by her as the patient's mother went to a different pediatrician who referred her to a gastroenterologist.  The patient's parents believed that the vaccination with ROTATEQ was responsible for the patient's experiences.  Additional information has been requested.
Sex: F
Vaccine: RV5, RV5
Symptoms: Culture stool positive, Diarrhoea, Flatulence, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female with no pertinent medical history and no drug reactions/allergies who on 05 Apr 2007 was vaccinated PO with a first 2mL dose of Rotateq (lot #654504/0695F). There was no concomitant medication. On 08 Apr 2007 the patient experienced diarrhea. The patient had a laboratory test, and on 13 Apr 2007 was diagnosed as having rotavirus. Unspecified medical attention was sought. Subsequently, the patient recovered on 14 Apr 2007. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 08-APR-2007, the patient started with diarrhea and had some vomiting and was very gassy. Formula was changed from similac Advanced to Isomil along with pedialyte. On 13-APR-2007, the patient continued with very watery diarrhea 4-6 time/day. It was noted that it was difficult to collect a sample, but on 13_APR-207, rotavirus was detected in the stool. On 14-APR-2007, the patient had semi-solid stool. On 24-APR-2007, the patient had firm stoll. On 30-APR-2007, the patient started with projectile vomiting and diarrhea. There was a 1.5oz weight loss. On 01-MAY-2007, the patient had anothersick vimit with weight loss. The patient recovered with weight gain and no vomiting or diarrhea. There were no adverse events follow prior vaccinations of the patient of her siblings. Additional information has been requested.
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Flatulence, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female with no pertinent medical history and no drug reactions/allergies who on 05 Apr 2007 was vaccinated PO with a first 2mL dose of Rotateq (lot #654504/0695F). There was no concomitant medication. On 08 Apr 2007 the patient experienced diarrhea. The patient had a laboratory test, and on 13 Apr 2007 was diagnosed as having rotavirus. Unspecified medical attention was sought. Subsequently, the patient recovered on 14 Apr 2007. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 08-APR-2007, the patient started with diarrhea and had some vomiting and was very gassy. Formula was changed from similac Advanced to Isomil along with pedialyte. On 13-APR-2007, the patient continued with very watery diarrhea 4-6 time/day. It was noted that it was difficult to collect a sample, but on 13_APR-207, rotavirus was detected in the stool. On 14-APR-2007, the patient had semi-solid stool. On 24-APR-2007, the patient had firm stoll. On 30-APR-2007, the patient started with projectile vomiting and diarrhea. There was a 1.5oz weight loss. On 01-MAY-2007, the patient had anothersick vimit with weight loss. The patient recovered with weight gain and no vomiting or diarrhea. There were no adverse events follow prior vaccinations of the patient of her siblings. Additional information has been requested.
Sex: F
Vaccine: RV5, RV5
Symptoms: Vomiting projectile, Weight decreased
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female with no pertinent medical history and no drug reactions/allergies who on 05 Apr 2007 was vaccinated PO with a first 2mL dose of Rotateq (lot #654504/0695F). There was no concomitant medication. On 08 Apr 2007 the patient experienced diarrhea. The patient had a laboratory test, and on 13 Apr 2007 was diagnosed as having rotavirus. Unspecified medical attention was sought. Subsequently, the patient recovered on 14 Apr 2007. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 08-APR-2007, the patient started with diarrhea and had some vomiting and was very gassy. Formula was changed from similac Advanced to Isomil along with pedialyte. On 13-APR-2007, the patient continued with very watery diarrhea 4-6 time/day. It was noted that it was difficult to collect a sample, but on 13_APR-207, rotavirus was detected in the stool. On 14-APR-2007, the patient had semi-solid stool. On 24-APR-2007, the patient had firm stoll. On 30-APR-2007, the patient started with projectile vomiting and diarrhea. There was a 1.5oz weight loss. On 01-MAY-2007, the patient had anothersick vimit with weight loss. The patient recovered with weight gain and no vomiting or diarrhea. There were no adverse events follow prior vaccinations of the patient of her siblings. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: HIBV
Symptoms: Death, Irritability
Clinical narrative: Irritability and Death from unknown cause within 24-48 hrs of vaccine administration   5/29/07 Received hospital medical records which reveal patient experienced fussiness, crying & then stopped breathing.  EMS found patient in asystoly & started CPR & intubated.  Resuscitation effort were unsuccessful & patient was pronounced. 6/1/07 Received medical & vax records from PCP which reveal patient received only Hib, Lot # 0408F on 1/9/07.  VAERS database updated w/same.  Medical records were cardiology clinic reports to PCP. Last report was 1/17/07 which indicated the patient was doing well.  Weight was 3.6 kg. O2 sat was 86%.  Precordium was overactive & continuous murmur & shunt were noted.  Liver was not down.  Pulses were intact & accentuated throughout.  6/8/07 Received Death Certificate which reveals COD as cardiopulmonary arrest and congenital heart disease.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: Information has been received from a medical assistant concerning a patient who approximately one month ago on 03-APR-2007 was vaccinated with a dose of zoster vaccine live. Within a week, the patient died of a heart attack. No additional information was provided. Additional ifnormation has been requested.  5/18/07 Received records from reporter which included Death Certificate which reveals COD as Inferior myocardial infarction. Records from PCP incidate patient had tetanus updated 1/24/07. Records from ER of 3/16/07 indicate patient seen for syncope or unresponsiveness when passed out in church after complaining to friends that she did not feel well for several days because of her gallbladder.  EMS called.  BP was unobtainable.  Started on Dopamine & given IV fluid bolus.  Denied pain & good respiratory effort but restless.  O2 sats remained in high 80's but w/poor perfusion signal.  Preparing to administer thrombolytics when became unresponsive & lost pulse.  Intubated & coded but unsuccessful resuscitation. FINAL ER DX: acute myocardial infarction, perhaps remote w/continued expansion of infarct leading to cardiopulmonary decline.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypokinesia, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old male, with no medical history or allergies, was vaccinated with a first and second (0.5 milliliter, subcutaneous in left arm) dose of Varivax on 05-APR-1999 (lot number 627876/1241H) and 28-APR-2007 (lot number 654527/1043F), respectively. There was no concomitant medication. On 29-APR-2007 the patient experienced significant local reaction. The symptoms were described as hot, red, swollen left arm. The patient could not raise his arm. The patient missed school. Ibuprofen and warm soaks were ordered. Adverse event symptoms were reported to be recovered. Unspecified medical attention was sought. No laboratory tests were performed. No product quality complaint was involved. The nurse requested a lot check from the vaccine with lot number 654527/1043F. The reported felt the event was disabling. It was reported that the patient had no reaction after the first vaccination. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old male, with no medical history or allergies, was vaccinated with a first and second (0.5 milliliter, subcutaneous in left arm) dose of Varivax on 05-APR-1999 (lot number 627876/1241H) and 28-APR-2007 (lot number 654527/1043F), respectively. There was no concomitant medication. On 29-APR-2007 the patient experienced significant local reaction. The symptoms were described as hot, red, swollen left arm. The patient could not raise his arm. The patient missed school. Ibuprofen and warm soaks were ordered. Adverse event symptoms were reported to be recovered. Unspecified medical attention was sought. No laboratory tests were performed. No product quality complaint was involved. The nurse requested a lot check from the vaccine with lot number 654527/1043F. The reported felt the event was disabling. It was reported that the patient had no reaction after the first vaccination. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness and injection site night after injection. Taken to ER and referred to DR. Admitted for cellulitis. Discharged the next day (5/4/07) with IV antibiotics. 07/02/2007 MR received for overnight hospitalization for L deltoid injection site redness, swelling, and pain.  PE remarkable for a 10x15 cm oval area of edema, firmness, warmth, erythema, and tenderness of the L deltoid. Txd with abx and ice. Final DX:  Cellulitis of the arm- due to adverse reaction of immunization.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Dyspnoea, Pruritus, Rash, Throat irritation
Clinical narrative: 5-4-07 MMR given at 10:00AM, 45 minutes later at 10:45AM came back to office c/o rash, itchiness, scratchy throat to took pt to ER - given Solu Medrol IV, Benadryl IV - within hours started to increase pruritus, some burning, SOB - addition Solu med IV, oral prednisol. pepcid, Benadryl - admitted to hospital for overnight observation.  05/24/2007 MR received for an o/n admit (5/4-5/2007) for c/o rash and scratchy throat.  Symptoms improved somewhat with tx in the ER but then worsened to include pruritis, burning, and SOB. Pt. improved o/n and was D/C. Final Discharge DX: Allergic reaction.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema, Haematochezia, Intussusception, Pain
Clinical narrative: Patient was hospitalized for two days for bowel intussusception and pain (proven by barium enema). Patient had bloody bowel movement and pain. 06/12/07-DC Summary received for DOS 5/6-5/7/07-DC DX:Ileocolic Intussusception. S/P Barium Enema Reduction. Two day history vomiting and subsequent bloody stools
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Patient was hospitalized for two days for bowel intussusception and pain (proven by barium enema). Patient had bloody bowel movement and pain. 06/12/07-DC Summary received for DOS 5/6-5/7/07-DC DX:Ileocolic Intussusception. S/P Barium Enema Reduction. Two day history vomiting and subsequent bloody stools
Age: 62.0
Sex: M
Vaccine: PNC, TDAP, VARZOS
Symptoms: Headache, Local reaction, Myalgia, Pyrexia
Clinical narrative: Headache, low grade fever, myalgia localized reaction on right arm (Pneumovax, Zostavax side)
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, White blood cell count increased
Clinical narrative: Patient was on Rotateq on 5-11-07, on 5-12-07 developed fever up to 103.6, mom took to ER, CBC showed increased WBC 21,000, everything else normal, loose stools x 1 day, rechecked in doctor's office 5/14/07. Back to normal.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Fever up to 103 F, fatigue, malaise, body aches, redness and pain at Menactra site and pain in L axillary area for 26 hours. 2 cm area of erythema at vaccine site.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Fever up to 103 F, fatigue, malaise, body aches, redness and pain at Menactra site and pain in L axillary area for 26 hours. 2 cm area of erythema at vaccine site.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling hot, Head discomfort, Malaise, Photophobia
Clinical narrative: Not feeling well, his head was "heavy", felling hot and her photo phobia (not tolerate the light).
Age: 1.6
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: Redness around vaccine area on Lt thigh only. No fever.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hours of vaccination with 1st dose Gardasil developed left deltoid muscle pain, swelling and erythema. By 48 hours, developed numbness in left hand and diminished strength in left hand.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hours of vaccination with 1st dose Gardasil developed left deltoid muscle pain, swelling and erythema. By 48 hours, developed numbness in left hand and diminished strength in left hand.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Within 24 hours of vaccination with 1st dose Gardasil developed left deltoid muscle pain, swelling and erythema. By 48 hours, developed numbness in left hand and diminished strength in left hand.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: MMRV and Varicella given at same visit rather than MMR and Varicella.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area red, swollen and warm to touch, area on left arm size between baseball and golfball per mom.
Age: 25.0
Sex: F
Vaccine: ANTH, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Soldier c/o itchy whelp with redness and hardness on left deltoid. Soldier received Anthrax.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10 X 10cm area of erythema and induration at site of DTaP vaccine. Area or erythema and induration increased to involve erythema upper arm.
Age: 18.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Wrong drug administered
Clinical narrative: Patient was administered DTaP instead of Tdap - NO adverse effects as of 5/16/2007.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Mom stated "on Friday night I noticed her leg getting red." I looked at leg on Saturday a.m. and right leg is swollen, warm and redness the size of a softball around injection site. Mom called on 4-23-07 and site was back to normal.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: On 5-5-07 child had a "hot", swollen and red arm from shoulder to elbow. Child told parent arm hurt since evening of 5-3-07 when shot was given. Child given Tylenol on 5-4-07 and started on ibuprofen on 5-5-07. Mom was called on 5-7-07 and arm is lots better. Red at site of injection only.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: Urticaria immediately following injection of varicella vaccine Treatment: Benadryl 25g by mouth every hours.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Pain
Clinical narrative: Moderate localized reaction about 6 in diameter erythematous and painful no pruritis.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Red, swelling/painful area itching 5 1/2x3 cm. centralized tender to touch. indurated
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Tenderness
Clinical narrative: Red, swelling/painful area itching 5 1/2x3 cm. centralized tender to touch. indurated
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Asthenia, Erythema, Hypoaesthesia, Induration, Swelling
Clinical narrative: 8x5cm area swelling, redness, induration, numbness, weakness
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on torso and extremity approximately 4 hours after receiving 1st Havrix. Called her doctor (was traveling Thursday) and took by mouth Benadryl. Symptoms lasted 2 days but rash was still noticeable for 10 days.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient came in office to read TB test. While here dad alerted this writer to reaction localized at injection site of varicella #2. It appeared swollen, red, hurt to touch. Checked by MD
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema multiforme, Laboratory test, Rash
Clinical narrative: The night of the vaccines- 3/13/07 (Pediarix, Hib, Prevnar, RotaTeq) the baby got a rash that I saw on 3/17/07 and recognized as Erythema Multiforme Minor.  The child's rash was resolved by 3/19 by history.  I am unsure how to give the 4 month old shots.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: HAD MMRV 5/4/07 AND BROKE OUT IN RASH 5/11/07.SKIN REDDISH,PAPULAR/MACULAR TO VERSICULAR ERUPTION ALL OVER.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Enema administration, Intussusception, Pyrexia
Clinical narrative: Fever, diarrhea, diagnosis of intussusception.  6/1/07 Received vax record from CDC.  VAERS database updated.  8/7/07 Received hospital medical records which reveal patient experienced fever, vomiting & bloody stools.  Abdominal x-ray in ER revealed IS.  Admitted 5/15-5/18/07 & IS reduced by gastrograffin enema.  Also diagnosed w/UTI.  Progressed well & d/c to home on oral antibiotics for UTI. FINAL DX: Intussusception, s/p reduction by enema; fever; & UTI.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Fever, diarrhea, diagnosis of intussusception.  6/1/07 Received vax record from CDC.  VAERS database updated.  8/7/07 Received hospital medical records which reveal patient experienced fever, vomiting & bloody stools.  Abdominal x-ray in ER revealed IS.  Admitted 5/15-5/18/07 & IS reduced by gastrograffin enema.  Also diagnosed w/UTI.  Progressed well & d/c to home on oral antibiotics for UTI. FINAL DX: Intussusception, s/p reduction by enema; fever; & UTI.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Given Adacel Tdap, instead of Boostrix Tdap.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: given Adacel Tdap, instread of Boostrix Tdap
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: QUARTER SIZED PAINFUL, RED, FIRM MASS IN ARM WHERE VARIVAX GIVEN.