chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 17-week-old patient who on 14-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656389/0031U). No symptoms have been reported. No further information is available. There was no product quality complaint. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 17-week-old patient with no pre-existing allergies, birth defects, or medical conditions who on 14-MAY-2007 was vaccinated PO with a first dose of ROTATEQ (Lot # 656386/0031U). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2628AA) administered IM, a second dose of IPOL (Lot # Z0548) administered IM, a second dose of ACTHIB (Lot # UE974AA) administered IM, and a second dose of PREVNAR (Lot # B08690C) administered IM. No symptoms have been reported. No further information is available. There was no product quality complaint. No additional information is expected.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Aspiration, Choking, Wheezing
Clinical narrative: Information has been received from a licensed practical nurse concerning a 2-month-old patient who was vaccinated PO with a first dose of Rotateq (lot number not available). Subsequently the patient choked, wheezed, and aspirated a little bit. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated with a dose of Rotateq. The physician reported that the patient threw up not long after being vaccinated. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 week female with no pertinent medical history or drug reactions/allergies who on 10-MAY-2007 was vaccinated with 2 ml of oral Rotateq (Lot # 656380/0029U) and experienced a rotavirus infection. There was no concomitant medication. Initially on 10-MAY-2007, the patient was experiencing 10 to 12 cases of watery stools per day. On 17-MAY-2007, the patient experienced vomiting. The patient was seen at the physician office on 19-MAY-2007, and at this point she was experiencing watery stools twice a day (approximately 12 hours apart). The physician instructed that the patient be on a diet of "Alimentum" baby formula and rice cereal. On 14-MAY-2007, a stool test was positive for rotavirus. At the time of the report the patient was recovering. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood electrolytes normal, Blood test, Dehydration, Diarrhoea, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 14-MAY-2007 was vaccinated with 2 ml of oral Rotateq (Lot 1231S, invalid). Concomitant therapy included PEDIARIX, PEDVAXHIB and PREVNAR. On 18-MAY-2007, the patient experienced vomiting and diarrhea. The patient's vomiting and diarrhea persisted. Unspecified blood work was performed. The patient's symptoms persisted and on 21-MAY-2007, the physician recommended that the patient go to the emergency room. It was not known if the patient was admitted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a physician concerning a 19-week-old white female who on 14-MAY-2007 was vaccinated PO with the first 2.0 mL of ROTATEQ (Lot # 656201/1231F).  Concomitant vaccinations administered on that same day included the second dose in the left thigh of PEDIARIX (Lot #AC21B113AA), the second dose in the right thigh of PEDVAXHIB (Lot #655396/1437F) and the second dose in the right thigh of PREVNAR (Lot #870143K).  On 18-MAY-2007, the patient developed vomiting, diarrhea and mild dehydration.  The patient was seen in the physician's office.  An electrolyte panel was within normal limits.  On 20-MAY-2007, the patient recovered.  Additional information is not expected.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 14-MAY-2007 was vaccinated with 2 ml of oral Rotateq (Lot 1231S, invalid). Concomitant therapy included PEDIARIX, PEDVAXHIB and PREVNAR. On 18-MAY-2007, the patient experienced vomiting and diarrhea. The patient's vomiting and diarrhea persisted. Unspecified blood work was performed. The patient's symptoms persisted and on 21-MAY-2007, the physician recommended that the patient go to the emergency room. It was not known if the patient was admitted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a physician concerning a 19-week-old white female who on 14-MAY-2007 was vaccinated PO with the first 2.0 mL of ROTATEQ (Lot # 656201/1231F).  Concomitant vaccinations administered on that same day included the second dose in the left thigh of PEDIARIX (Lot #AC21B113AA), the second dose in the right thigh of PEDVAXHIB (Lot #655396/1437F) and the second dose in the right thigh of PREVNAR (Lot #870143K).  On 18-MAY-2007, the patient developed vomiting, diarrhea and mild dehydration.  The patient was seen in the physician's office.  An electrolyte panel was within normal limits.  On 20-MAY-2007, the patient recovered.  Additional information is not expected.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood electrolytes, Blood urea, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 14-MAY-2007 was vaccinated with 2 ml of oral Rotateq (Lot 1231S, invalid). Concomitant therapy included PEDIARIX, PEDVAXHIB and PREVNAR. On 18-MAY-2007, the patient experienced vomiting and diarrhea. The patient's vomiting and diarrhea persisted. Unspecified blood work was performed. The patient's symptoms persisted and on 21-MAY-2007, the physician recommended that the patient go to the emergency room. It was not known if the patient was admitted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a physician concerning a 19-week-old white female who on 14-MAY-2007 was vaccinated PO with the first 2.0 mL of ROTATEQ (Lot # 656201/1231F).  Concomitant vaccinations administered on that same day included the second dose in the left thigh of PEDIARIX (Lot #AC21B113AA), the second dose in the right thigh of PEDVAXHIB (Lot #655396/1437F) and the second dose in the right thigh of PREVNAR (Lot #870143K).  On 18-MAY-2007, the patient developed vomiting, diarrhea and mild dehydration.  The patient was seen in the physician's office.  An electrolyte panel was within normal limits.  On 20-MAY-2007, the patient recovered.  Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood electrolytes normal, Blood test, Dehydration, Diarrhoea, Laboratory test
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 week female with no pertinent medical history and no known drug reactions or allergies who on 14-MAY-2007 was vaccinated with the first dose of Rotateq (Lot # 656101/1231F). There was no concomitant medication. On 18-MAY-2007, the patient experienced severe diarrhea and vomiting. On 21-MAY-2007, the child was taken to the emergency room for treatment of continued severe diarrhea and vomiting. It was not known if the child was hospitalized. Bun and electrolytes were performed (date and results not provided). Severe diarrhea and vomiting were other important medical events. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 week female with no pertinent medical history and no known drug reactions or allergies who on 14-MAY-2007 was vaccinated with the first dose of Rotateq (Lot # 656101/1231F). There was no concomitant medication. On 18-MAY-2007, the patient experienced severe diarrhea and vomiting. On 21-MAY-2007, the child was taken to the emergency room for treatment of continued severe diarrhea and vomiting. It was not known if the child was hospitalized. Bun and electrolytes were performed (date and results not provided). Severe diarrhea and vomiting were other important medical events. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood electrolytes, Blood urea, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 week female with no pertinent medical history and no known drug reactions or allergies who on 14-MAY-2007 was vaccinated with the first dose of Rotateq (Lot # 656101/1231F). There was no concomitant medication. On 18-MAY-2007, the patient experienced severe diarrhea and vomiting. On 21-MAY-2007, the child was taken to the emergency room for treatment of continued severe diarrhea and vomiting. It was not known if the child was hospitalized. Bun and electrolytes were performed (date and results not provided). Severe diarrhea and vomiting were other important medical events. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Foaming at mouth, Salivary hypersecretion
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with no medical history, who, on the week of 14-MAY-2007, was vaccinated with a first 2 ml oral dose of Rotateq (Lot# 656385/0030U). There was no concomitant medication. within a moment the patient experienced spitting and foaming at the mouth. No further adverse symptoms were noted. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Flatulence, Irritability
Clinical narrative: Information has been received from a physician concerning an approximately 6 month old male who in approximately January 2007 (about four months ago), was vaccinated with oral Rotateq (Lot # 655864/1082F). In approximately January 2007 (about four months ago), the patient was "gassy and irritable". The patient sought unspecified medical attention. Subsequently, the patient recovered from gassy and irritable. The patient's parents are refusing additional doses of Rotateq. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5, UNK
Symptoms: Hypotonia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 8 week old patient with no pertinent medical history and no drug reaction/allergies who was vaccinated with first oral dose of Rotateq. Concomitant therapy included the other two month vaccinations. Subsequently, the patient experienced vomiting and went limp several hours after receiving Rotateq live. Subsequently, the patient recovered from vomiting and went limp. The patient sought unspecified medical attention. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Conjunctival hyperaemia
Clinical narrative: Information has been received from a physician concerning a 40 year old female nurse who on 23-MAY-2007 was got Rotateq in her eye. On "22-MAY-2007" the patient had redness of the conjuctiva of one eye that had contact with Rotateq. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTP, HBHEPB, HEP, IPV, PNC, RV5
Symptoms: Abnormal faeces, Body temperature decreased, Diarrhoea, Faeces discoloured, Vomiting
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 9 week old female who on 30-APR-2007 was vaccinated with Rotateq (lot number reported as unavailable). Concomitant vaccines included DTP, Comvax, Recombivax, Poliovirus vaccine, Prevnar. On 03-MAY-2007 the nurse reported that the "patient experienced terrible vomiting and diarrhea (smelly, brown and liquidy)" and low temperature after receiving ROTATEQ. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from terrible vomiting, "diarrhea (smelly, brown and liquidy)" and low temperature. There was no product quality complaint involved. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 five or six month old male patient who were vaccinated with a second dose of Rotateq. It was reported that the patient was late for his second dose. He presented to the office later than 10 weeks post dose 1. The patient had no adverse experienced to report. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a second dose of Rotateq. The patient was late for the second dose. The patient presented to the office later than 10 weeks post dose 1. The patient had no adverse experienced to report. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a second dose of Rotateq. The patient was late for the second dose. The patient presented to the office later than 10 weeks post dose 1. The patient had no adverse experienced to report. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male infant who was vaccinated with a dose of Rotateq. Suspect vaccination administered that day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. Subsequently the patient developed a high fever, inconsolable crying and irritability. Subsequently, the patient recovered. It was unknown if medical attention was sought. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a 4 month old child who on 25-MAY-2007 was vaccinated with a first oral 2 ml dose of Rotateq. No adverse reaction was reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Off label use, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old male who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# 655174/0848F) on 21-JUL-2006, 18-SEP-2006, and 13-NOV-2006, respectively. On 01-MAR-2007 the patient experienced vomiting and diarrhea. The vomiting stopped after about four days. At that time the diarrhea persisted off and on. On 01-MAY-2007, the patient started having either vomiting or diarrhea every night. There was no dehydration. The patient was advised to be on soy milk and use Lactobacillus rhamnosus (CULTURELLE), sprinkled on food. The patient had a follow-up well visit on 17-MAY-2007. On 17-MAY-2007 the diarrhea symptoms had resolved. Additional information has been requested. 3/25/2010 Follow-up information from a registered nurse indicated that the patient recovered on 17-MAY-2007.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who in may 2007, was vaccinated PO with a 2mL forth dose of Rotateq. It was noted that the patient received the 3-dose series at 6 months old. No adverse reaction was noted. Unspecified medical attention was sought. No additional information was available at that time. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6-month-old female who on 22-MAR-2007 was vaccinated with the first dose of Rotateq. Unspecified medical attention was sought. No problems were reported. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first dose of Rotateq. Subsequently the patient vomited. It was noted that the patient refused the second and third dose of the vaccine. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site inflammation, Injection site pruritus, Medication error
Clinical narrative: Information has been received from a physician assistant concerning a 51 year old male with hypertension, first degree atrioventricular heart block and hypercholesterolaemia and a history of positive PPD skin test who on 24-JAN-2007 at 12:40 PM was vaccinated SC in the right upper arm with a dose of Zostavax (lot # 656413/1477F). There was no acute illness at the time of vaccination. It was noted that the vaccine was stored at above recommended temperatures. On 26-JAN-2007 at 06:30 AM, the patient experienced mild to moderate localized inflammation at the injection site and also complained of mild to moderate itching at the affected site. The symptoms resolved on an unspecified date without the need for medical intervention. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a 75 year old female consumer with no known allergies and a thyroid "condition" who on 01-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and atorvastatin calcium (LIPITOR). A few days after vaccination, on approximately 04-MAR-2007 the patient experienced a burning sensation and tingling over her entire body, and specifically her face and tongue. The patient saw a neurologist who prescribed gabapentin (NEURONTIN). The patient improved slightly however she was till experiencing these events at the time of the report. She was instructed to see an allergiest. No lab studies were performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007; 6/22/2007. Information has been received from a 75 year old female consumer with no known allergies, hyperlipidemia, a goiter, osteoporosis, and a thyroid "condition" who on 01-MAR-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, XANAX, alendronate sodium (MSD), and LIPITOR. A few days after vaccination, on approximately 04-MAR-2007 the patient experienced a burning sensation and tingling over her entire body, and specifically her face and tongue. The patient saw a neurologist who prescribed NEURONTIN. The patient improved slightly however she was till experiencing these events at the time of the report. She was instructed to see an allergist. No lab studies were performed. There was no product quality complaint involved. No further information was provided. Additional information has been received from a physician who reported that in March 2007, the patient experienced internal itching, stinging, diffuse skin itching and burning, and internal nerves pulsating since just after the vaccine was administered. The patient has persistent symptoms daily. The patient requires NEURONTIN for symptom control. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 69 year old male with an allergy to lisinopril (manufacturer unknown) (WAES # 0705USA02755) and no pertinent medical history who on 24-APR-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U). There was no concomitant medication. On 27-APR-2007 the patient developed severe right leg pain. Unspecified medical attention was sought. No treatment was recommended, but the patient was taking his wife's NEURONTIN. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/14/2007. The health care professional reported that on 27-APR-2007 the patient developed severe right leg pain. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her sixties with fibromyalgia, myalgia, and osteoarthritis and a history of multiple outbreaks of herpes zoster who on approximately 26-APR-2007 or 27-APR-2007 was vaccinated with a dose of Zostavax. Concomitant medication included hydrocodone bitartrate as needed. The nurse reported that 48 hours after vaccination, on approximately 28-APR-2007, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Chills, Computerised tomogram, Cough, Injection site erythema
Clinical narrative: Information has been received from a nurse in the physician's office and a 66 year old female nurse with diabetes, hypertension, asthma, allergic reaction to quinolones antibiotics, sulfonamide allergy, shellfish allergy, reaction to monosodium glutamate, allergy to pine nuts, soy products and mushrooms and a history of non-Hodgkin's lymphoma diagnosed in July 1996 who on 08-FEB-2007 was vaccinated IM in the left arm with a dose of Zostavax. Concomitant therapy included SYNTHROID, ALTACE, ATACAND, sitagliptin phosphate, PLAVIX, vitamins (unspecified), ubidecarenone (co-enzyme Q-10), aspirin, omega-3 marine triglyceride (fish oil) and TENEX. On approximately 09-FEB-2007, within 24 hours of vaccination, the patient developed a rash. The left arm injection site became red, inflamed and swollen. This reaction took a "few days to resolve." The patient was seen in the office at the end of February with complaints of sore throat, swollen glands, chills and coughing which was diagnosed as an upper respiratory infection (the patient reported that these symptoms started within 72 hours after vaccination and she felt that these symptoms in addition to feeling "wiped out" were symptoms of an asthma reaction). The patient was started on therapy with erythromycin. It was reported that the patient had to stop singing in the choir for the past six weeks due to the coughing. It was reported that the patient continued to have a dry cough. "In the past two weeks", starting on approximately 17-APR-2007 the patient developed night sweats. At the time of the report the patient was recovering, she had not been seen in the office since her last visit in the end of February 2007. There was no product quality complaint involved. It was reported that the patient's chemotherapy regimen for her non-Hodgkin's lymphoma was as follows: course 1 in the beginning of 2002, course 2 at the end of 2002, course 3 in the middle of 2003, course 4 at the end of 2003, course 5 in the middle of 2004 and course 6 in the beginning of 2005. The patient had a routine follow-up CT scan in January 2007 which was normal, she was due for a repeat CT scan in July 2007. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/14/2007. Additional information noted that the patient developed "asthma/bronchitis" with "coughing/wheezing." The patient followed up in the office on 07-MAY-2007 and it was noted that the erythromycin helped though the patient was reported to be not recovered. Lab test was "normal." No further information was provided. Additional information received noted that the patient recovered on 15-FEB-2007. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Lymphadenopathy, Night sweats, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a nurse in the physician's office and a 66 year old female nurse with diabetes, hypertension, asthma, allergic reaction to quinolones antibiotics, sulfonamide allergy, shellfish allergy, reaction to monosodium glutamate, allergy to pine nuts, soy products and mushrooms and a history of non-Hodgkin's lymphoma diagnosed in July 1996 who on 08-FEB-2007 was vaccinated IM in the left arm with a dose of Zostavax. Concomitant therapy included SYNTHROID, ALTACE, ATACAND, sitagliptin phosphate, PLAVIX, vitamins (unspecified), ubidecarenone (co-enzyme Q-10), aspirin, omega-3 marine triglyceride (fish oil) and TENEX. On approximately 09-FEB-2007, within 24 hours of vaccination, the patient developed a rash. The left arm injection site became red, inflamed and swollen. This reaction took a "few days to resolve." The patient was seen in the office at the end of February with complaints of sore throat, swollen glands, chills and coughing which was diagnosed as an upper respiratory infection (the patient reported that these symptoms started within 72 hours after vaccination and she felt that these symptoms in addition to feeling "wiped out" were symptoms of an asthma reaction). The patient was started on therapy with erythromycin. It was reported that the patient had to stop singing in the choir for the past six weeks due to the coughing. It was reported that the patient continued to have a dry cough. "In the past two weeks", starting on approximately 17-APR-2007 the patient developed night sweats. At the time of the report the patient was recovering, she had not been seen in the office since her last visit in the end of February 2007. There was no product quality complaint involved. It was reported that the patient's chemotherapy regimen for her non-Hodgkin's lymphoma was as follows: course 1 in the beginning of 2002, course 2 at the end of 2002, course 3 in the middle of 2003, course 4 at the end of 2003, course 5 in the middle of 2004 and course 6 in the beginning of 2005. The patient had a routine follow-up CT scan in January 2007 which was normal, she was due for a repeat CT scan in July 2007. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/14/2007. Additional information noted that the patient developed "asthma/bronchitis" with "coughing/wheezing." The patient followed up in the office on 07-MAY-2007 and it was noted that the erythromycin helped though the patient was reported to be not recovered. Lab test was "normal." No further information was provided. Additional information received noted that the patient recovered on 15-FEB-2007. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Upper respiratory tract infection
Clinical narrative: Information has been received from a nurse in the physician's office and a 66 year old female nurse with diabetes, hypertension, asthma, allergic reaction to quinolones antibiotics, sulfonamide allergy, shellfish allergy, reaction to monosodium glutamate, allergy to pine nuts, soy products and mushrooms and a history of non-Hodgkin's lymphoma diagnosed in July 1996 who on 08-FEB-2007 was vaccinated IM in the left arm with a dose of Zostavax. Concomitant therapy included SYNTHROID, ALTACE, ATACAND, sitagliptin phosphate, PLAVIX, vitamins (unspecified), ubidecarenone (co-enzyme Q-10), aspirin, omega-3 marine triglyceride (fish oil) and TENEX. On approximately 09-FEB-2007, within 24 hours of vaccination, the patient developed a rash. The left arm injection site became red, inflamed and swollen. This reaction took a "few days to resolve." The patient was seen in the office at the end of February with complaints of sore throat, swollen glands, chills and coughing which was diagnosed as an upper respiratory infection (the patient reported that these symptoms started within 72 hours after vaccination and she felt that these symptoms in addition to feeling "wiped out" were symptoms of an asthma reaction). The patient was started on therapy with erythromycin. It was reported that the patient had to stop singing in the choir for the past six weeks due to the coughing. It was reported that the patient continued to have a dry cough. "In the past two weeks", starting on approximately 17-APR-2007 the patient developed night sweats. At the time of the report the patient was recovering, she had not been seen in the office since her last visit in the end of February 2007. There was no product quality complaint involved. It was reported that the patient's chemotherapy regimen for her non-Hodgkin's lymphoma was as follows: course 1 in the beginning of 2002, course 2 at the end of 2002, course 3 in the middle of 2003, course 4 at the end of 2003, course 5 in the middle of 2004 and course 6 in the beginning of 2005. The patient had a routine follow-up CT scan in January 2007 which was normal, she was due for a repeat CT scan in July 2007. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/14/2007. Additional information noted that the patient developed "asthma/bronchitis" with "coughing/wheezing." The patient followed up in the office on 07-MAY-2007 and it was noted that the erythromycin helped though the patient was reported to be not recovered. Lab test was "normal." No further information was provided. Additional information received noted that the patient recovered on 15-FEB-2007. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Medication error
Clinical narrative: Information has been received from a female consumer with lupus erythematous and penicillin allergy who on 20-APR-2007 was vaccinated SC in the right upper arm with a 0.65 ml dose of Zostavax. Concomitant therapy included "KENILOG" injection. Subsequently the patient experienced a bruise at the injection site. Her rheumatologist told her that the "steroid shot" would cancel out the zoster vaccine live vaccination. Unspecified medical attention was sought. As of 01-MAY-2007 the bruise was improving, it was red at center and pink around the edges. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 66 year old female who in approximately March 2007 (about 2 months ago), was vaccinated with a dose of Zostavax. Concomitant therapy included "Blood pressure" medications (therapy unspecified) and "cholesterol" medications (therapy unspecified). Subsequently, soon after injection, the patient experienced redness, swelling, "heat" and pain at the injection site. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. No further information is available.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a male consumer who was vaccinated with a dose of Zostavax. The consumer stated, "The medication my doctor gave me for Shingles did not work." No further information available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced raised bump the size of a quarter after vaccination. Patient were advised to take non-steroidal inti-inflammatory drugs (NSAIDs) and apply ice to the site. The symptoms have occurred about a day or so after administration of the vaccine and dissipated a day later. VAERS reports have been already filed on the two cases. No product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, VARZOS
Symptoms: Medication error, Off label use, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant, a physician and the office manager concerning a 5 year old female with no known allergies or past medical history, who on 01-MAY-2007 was vaccinated IM with a 0.5 ml dose of Zostavax instead of varicella virus vaccine live. Concomitant vaccination included a dose of MMR II and poliovirus vaccine (manufacturer unknown). It was reported that the medical assistant (also reported as the nurse) thought Zostavax was the generic for the varicella virus vaccine live. It was reported that there was no prescribing information with the Zostavax vaccine because it was frozen and someone threw it away. It was reported to be "nurse error only." Unspecified medical attention was sought. No lab diagnostics were performed. The patient was not experiencing any known symptoms. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a medical assistant, a physician and the office manager concerning a 5 year old female with multiple food allergies and a possible tetanus reaction in 2003, who on 01-MAY-2007 at approximately 09:00 was vaccinated IM with a 0.5 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 656412/1476F) instead of VARIVAX (MSD). Concomitant vaccination included a dose of MMR II and poliovirus vaccine (manufacturer unknown). There was no illness at the time of vaccination. It was reported that the medical assistant (also reported as the nurse) thought ZOSTAVAX (Oka/Merck) was the generic for VARIVAX (MSD). It was reported that there was no prescribing information with the ZOSTAVAX (Oka/Merck) because it was frozen and someone threw it away. It was reported to be "nurse error only". Unspecified medical attention was sought. No lab diagnostics were performed. The patient was not experiencing any known symptoms. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist and a registered nurse (clinical coordinator) concerning a 75 year old female with a history of a rash on 27-FEB-2007 and herpes zoster who in April 2007, was vaccinated with a 0.65 ml dose of Zostavax. subsequently the patient presented to the emergency room with a mild case of shingles/herpes zoster. The patient was treated with acyclovir and told to follow-up with her family physician. It was reported by the nurse that the patient had not been seen in the office since February 2007. It was reported that the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, C-reactive protein, Full blood count, Polymyalgia rheumatica
Clinical narrative: Information has been received from a physician concerning a 64 year old female with allergies to sulfa, erythromycin, "Celebrex" and "Indocin" and a history of hypoparathyroidism, hypothyroidism and lumbar disc degeneration who on 12-FEB-2007 was vaccinated with a dose of Zostavax (lot# 656608/0032U). Concomitant therapy included levothyroxine Na (LEVOXYL) and acetaminophen/hydrocodone bitartrate (LORTAB). Subsequently, within a few weeks, the patient developed polymyalgia rheumatica within a few weeks after administration of the dose. The patient's polymyalgia rheumatica persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Information has been received from a physician concerning a patient with arthritis who on an unspecified date was vaccinated with a dose of Zostavax. It was reported that patient's arthritis condition became worse after vaccination. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.32
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a certified medical assistant concerning a 15 months old patient who on 01-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax (Merck) instead of dose of Varivax. A product quality complaint was not involved. Additional information has been requested.
Age: 1.32
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a certified medical assistant concerning a 15 months old patient who on 01-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax (Merck) instead of dose of Varivax. A product quality complaint was not involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 01-MAY-2007 was vaccinated with a dose of Zostavax (656861/029U). On 01-MAY-2007 the patient received Zostavax instead of Varivax. No adverse events reported. This is one of several reports received from the same source. Follow-up information received from the medical assistant indication that when she was getting the vaccination vials, she "saw the word vax and grabbed the wrong vial". She said that the office has labelled the boxes with "shingles" and "chicken pox" to avoid this in the future. She also stated that there were no adverse events reported. The patient's siblings also had a similar reaction after therapy with Zostavax (WAES# 0705USA00722).
Age: 1.3
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 01-MAY-2007 was vaccinated with a dose of Zostavax (656861/029U). On 01-MAY-2007 the patient received Zostavax instead of Varivax. No adverse events reported. This is one of several reports received from the same source. Follow-up information received from the medical assistant indication that when she was getting the vaccination vials, she "saw the word vax and grabbed the wrong vial". She said that the office has labelled the boxes with "shingles" and "chicken pox" to avoid this in the future. She also stated that there were no adverse events reported. The patient's siblings also had a similar reaction after therapy with Zostavax (WAES# 0705USA00722).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 72 year old female nurse with no medical history who on 26-APR-2007 was vaccinated with 0.65 ml Zostavax (Lot # 656395/0290U). Concomitant therapy included "Cynthorid", Simvastatin and alendronate sodium. On 28-APR-2007 the patient experienced some pain and redness at injection site. Unspecified medical attention was sought. No diagnostic laboratory procedures were performed. A product quality complaint was not involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 27-APR-2007 was vaccinated with a dose of Zostavax. It was reported that "a couple days after vaccination", the patient experienced a rash similar to chicken pox lesions. The patient did not experience a fever, hives or difficulty in breathing. The nurse reported that patient was not seen by a physician and it was not confirmed whether the rash was chicken pox lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site warmth, Myalgia
Clinical narrative: Information has been received from a 66 year old female with glaucoma, allergies to penicillin and epinephrine, and on hormone replacement therapy who on 23-MAR-2007 was vaccinated with dose of Zostavax. Concomitant therapy included Estradiol (ESTRACE) and latanoprost (XALATAN). After vaccination, on approximately 28-MAR-2007, the patient developed an injection site reaction of a lump, fiery redness, and was hot. The patient also reported that she has been experiencing muscle pain since receiving the injection that has not gone away. It feels like she has had the flu. The muscle aches are now in the lower extremities. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration, Off label use, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 01-MAY-2007 was vaccinated with a dose of Zostavax (656861/0329U). On 01-MAY-2007 the patient received Zostavax instead of varicella virus vaccine. No adverse events reported. No product quality complaint. This is one of several reports received from the same source. Follow-up information received from the medical assistant indicating that when she was getting the vaccination vials, she "saw the word vax and grabbed the wrong vial". She said that the office has labelled the boxes with "shingles" and "chickenpox" to avoid this in the future. She also stated that there were no adverse events reported. The patient's sibling also had a similar reaction after therapy with Zostavax (WAES0705USA00719). Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 01-MAY-2007 was vaccinated with a dose of Zostavax (656861/0329U). On 01-MAY-2007 the patient received Zostavax instead of varicella virus vaccine. No adverse events reported. No product quality complaint. This is one of several reports received from the same source. Follow-up information received from the medical assistant indicating that when she was getting the vaccination vials, she "saw the word vax and grabbed the wrong vial". She said that the office has labelled the boxes with "shingles" and "chickenpox" to avoid this in the future. She also stated that there were no adverse events reported. The patient's sibling also had a similar reaction after therapy with Zostavax (WAES0705USA00719). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Neuralgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 80 year old female who was vaccinated with a dose of Zostavax. Two weeks after vaccination, the patient experienced a low grade fever and flu-like symptoms. Upon examination, the physician diagnosed that the patient with a breakout of shingles without apparent rashes. The physician also reported that the patient had pain in the upper fifth region of the cranial nerve. The patient was treated with "antivirals". A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning himself who in April 2007, was vaccinated with a dose of Zostavax. In April 2007, the patient experienced soreness in the arm the vaccination was administered. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Pain, Pruritus
Clinical narrative: Initial and follow-up information has been received from a 78 year old female with irritable bowel syndrome, hypertension, peripheral neuropathy, IVP dye allergy and severe stomach nausea, pain and vomiting with many different prescription pain medicines and antibiotics and a history of two lumbar spinal fusion surgeries who on 24-APR-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, FLONASE, ALTACE, TOPROL XL TABLETS, meprobamate, CLIMARA AND amitriptyline HCL/ clordiazepoxide. On 27-APR-2007 the patient experienced stomach aches and nausea, itching and small rashes on her back, and headaches. She also said that at times she has felt achy all over but she has not had a fever. At the time of the initial report medical attention was not sought. In follow-up it was noted that a pathologist thought the patient's reactions were related to Zostavax. There were no lab tests performed. At the time of the report the patient was recovering, though it was noted that the rash on her back only lasted a few days after treatment with hydrocortisone cream. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  Follow up received 03/27/2009.  Additional information is not expected.