chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Injection site rash, Weight increased
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9 week old female with no medical history who on 11 Dec 2006 was vaccinated PO with a dose of Rotateq (human bovine) (Lot#654504/0695F). Concomitant vaccines administered on that same day included a dose of Pediarix, a dose of Prevnar. The RN reported that on 11 Dec 2006, the patient was seen in the office and no fever was detected. At that time, the patient's diarrhea persisted, but it did not affect her weight as her weight had increased by three pounds since her previous visit. There were no reports of problems since her 14 Dec 2006 office visit. The patient was noted to be recovering. The RN also reported that the patient developed an injection site rash following vaccination with PedvaxHIB. (WAES #0612USA02954). Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 9 week old male, with no medical history and no allergies, who on 06 Dec 2006 was vaccinated with a first oral 2 ml dose of Rotateq (human bovine) (Lot# 654248/0577F). Concomitant vaccines administered on the same day  included a dose of Pediarix, a dose of Pedvaxhib and a dose of Prevnar. On 11 Dec 2006 or 12 Dec 2006 the patient experienced diarrhea. The patient had no diarrhea on 17 Dec 2006 or 18 Dec 2006. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Addition information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 2 month old patient who was vaccinated with an oral first dose of Rotateq. Within the last two months, in approximately October 2006, the patient experienced one to three days of diarrhea. It was noted that the series at the time of the report would be continued unless the physician decided otherwise. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning patients who were vaccinated with the first dose of Rotateq past 12 weeks of age. It was unknown if medical attention was sought. No further information is available.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Diarrhoea, Faeces discoloured, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old female, with a history of congenital suluxation of the hip, who on 06 Dec 2006, at 2:00pm, was vaccinated with a first oral dose of Rotateq (lot 654970/0777F). Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of Hib conj vaccine (manufacturer unknown), Hepatitis B vaccine (manufacturer unk) and a dose of Prevnar. At the time of vaccination the patient had an upper respiratory infection, after family contact, and esophageal reflux. The patient's parent reported to the office a three day history of watery diarrhea and vomiting beginning on 09 Dec 2006. The patient's mother described the diarrhea as water, frequent, and green. The patient's status was reported as unknown. There were no laboratory or diagnostic test performed. Medical attention was not sought. Additional information has been requested. Follow-up information form a physician indicated that the patient had watery diarrhea beginning on 09-DEC-2006. It was reported that the patient recovered on approximately 12-DEC-2006. Additional information is not expected.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Flatulence, Inappropriate schedule of drug administration, Infantile spitting up
Clinical narrative: Information has been received from a physician concerning a 4 month old male with no medical history who on 15 Dec 2006 was vaccinated with a first oral dose of Rotateq. Concomitant vaccination administered that day included a dose of Dtap, Comvax, Prevnar and Polio virus vaccine. Between 15 Dec 2006 and the morning of 16 Dec 2006 the patient developed spitting up and gas symptoms. The patient's mother phoned the physician on 16 Dec 2006 when she realized that her infant child could possibly be having an adverse experience related to the Rotateq vaccine. The physician was planning to continue with the Rotateq vaccination series. The patients outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 17 week old male with no medical history or allergies who on 20 Dec 2006 was vaccinated with an oral dose of Rotateq (lot 655175/0849F). There was no concomitant medication. On 20 Dec 2006 the patient vomited instantly after vaccination. Unspecified medical attention was sought. No laboratory diagnostic test were performed. The patient recovered the same day. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a registered nurse concerning a 17 week old male with no medical history or allergies who on 20-DEC-2006 was vaccinated with second oral dose of ROTATEQ (lot #655175/0849F). Concomitant vaccination administered that same day included a second IM dose in the left thigh of DAPTACEL (lot #C2650AA), a second IM dose in the left thigh of ACTHIB (lot #UE844AA), a second SC dose in teh right thigh of IPOL (lot #20018) and a second IM dose in the right thigh of PREVNAR (lot #B085708). On 20-DEC-2006 the patient vomited instantly after vaccnation, prior to receiving other vaccinations. Unspcified medical attention was sought. No laboratory diagnostic test were performed. The patient recovered the same day. It was noted that the patient was held for the first dose of ROTATEQ and was lying down for the second dose of ROTATEQ. There was no product quality complaint involved. Additional information is not expected.
Age: 0.56
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a mother concerning her 6-month- old who on 27-Nov-2006 was vaccinated PO with the second 2.0 mL dose of Rotateq (human bovine) after receiving the first 2.0 mL dose in July 2006 at 2 months of age. It was unknown if medical attention was sought. The patient did not experience and adverse event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow-up information was received from a registered nurse (RN) concerning a 7-month-old male who on 28-DEC-2006, at 1000, was vaccinated PO with the third 2.0 mL dose of ROTATEQ (Lot #655866/1110F). There was no illness at the time of vaccination. Medical attention was not sought and no adverse events occurred. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of Rotateq. The nurse reported that the patient subsequently regurgitated the Rotateq. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 16 week old patient who was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse event was reported. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning several infants who were vaccinated after the age of 12 weeks with an oral dose of Rotateq. No problems were  reported. It was not reported if medical attentions was sought. There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. 04/6/2010 Follow-up information from the registered nurse indicated that she would look for additional information regarding this caes. Attempts are being made to obtain additional identifying information to distinguish the individual patientd mentiond in this report. Additional information will be provided if available.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning children who were vaccinated PO with the first dose Rotateq (human bovine) after 12 weeks of age. It was unknown if medical attention was sought. No adverse event was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Sneezing
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 13 Dec 2006 was vaccinated PO with a dose of Rotateq (human bovine). The RN reported that on 13 Dec 2006, the patient sneezed after being administered Rotateq. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 5 year old patient who was vaccinated with an oral 2 ml dose of Rotateq. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Information has been received from a male dentist who on approximately 01 Nov 2006 was vaccinated with one dose of Zostavax. On approximately 01 Dec 2006 the patient developed 3 herpetic like lesions on his tonsil area. He was scheduled to have an appointment with and ENT physician on 01 Dec 2006. There was no product quality complaint involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a female with a history of shingles whose husband was vaccinated with a dose of Zostavas on an unspecified date. Subsequently, shortly after her husband's vaccination, she developed shingles on her face and eye. The patient was sent to an eye doctor for treatment. The patient's husband had no symptoms. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 84 year old female with high blood pressure and diabetes and a history of shingles in 1991 who on 26 Oct 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included "several medications" (not further specified). "About one month later, " on approximately 26 Nov 2006, the patient developed a new outbreak of shingles. The patient noted that she would be going to visit her doctor on 04 Dec 2006. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 35 year old male with diabetes and no allergies who on 01 Dec 2006 was vaccinated with a 0.65 mL dose of Zostavax (lot #652946/1012F). Concomitant therapy included Fortamet. On 01 Dec 2006, the patient felt an itch on his scalp and some body parts including his back, legs, and chest. There were no visible rashes. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a physician concerning his 69 year old white wife with no allergies or medical history who on 01 Dec 2006 at 5:25 PM was vaccinated SC in the "right" with a first dose of Zostavax (lot# 652936/0981F). Concomitant therapy included vitamins (unspecified). On 01 Dec 2006, the patient experienced an injection site rash. Immediately after vaccination, the patient noticed pain at the injection site. A few hours later on 01 Dec 2006, the injection site was red (red area about two inches in diameter), hot and itchy (felt like a bee sting). The rash was still present on 04 Dec 2006 but has decreased in size. It was still hot and itchy, but not painful.  No diagnostic laboratory tests were performed. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been receive from a physician who reported that the patient had a minor local reaction. The patient did not call the physician or seek medical attention elsewhere. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: Information has been received from a health professional concerning an 80 year old female with type II diabetes mellitus,  g glaucoma, hypertension, peripheral neuropathy, irritable bowel syndrome, and osteoporosis who on 20 Nov 2006 was vaccinated SC with a 0.65 mL dose of Zostavax. Concomitant therapy included 11 unspecified medications. On 04 Dec 2006, the patient called her physician's office to report that she had experienced a sudden loss of hearing in both ears. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician of dermatology concerning a female patient who was vaccinated with a dose of Zostavax. Subsequently, a few days later she "came down with a disseminated rash that resolved". There was no further information reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 78 year old female consumer with no known allergies or medical history who on 09 Oct 2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. Subsequently two weeks after vaccination on approximately 23 Oct 2006, the patient developed shingles. As of 06 Dec 2006 the patient's shingles persisted. Unspecified medical attention was sought. There was no  product quality compliant involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Additional information from the physician indicated that the patient broke out with shingles on 10-Nov-2006. The patient subsequently recovered in November 2006. No additional information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of Zostavax. In approximately October 2006, the patient developed shingles. Unspecified medical attention was sough. There was no product quality complaint involved.  No additional information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a male physician who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the physician experienced a varicella like rash. Unspecified  medical attention was sought. He recovered from on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female patient in her eighties with no medical history who on 14 Nov 2006 was vaccinated with a 0.65 mL dose of Zostavax. There was no concomitant medication. On 23 Nov 2006, the patient presented to the physician's office with a varicella like rash after vaccination. She had lesions all over her body. The reporter did not know the number of lesions. The lesions lasted three days and the patient completely recovered on 26 Nov 2006. A product quality complaint was not involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 61 year old female with an iodine allergy and no medical history who on 02 Dec 2006 was vaccinated SC with a dose of Zostavax. Concomitinat therapy included Effecor. On 05 Dec 2006, the patient developed redness and swelling at the site of injection. She also had a fever. No 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. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 05 Dec 2006 was inadvertently vaccinated with a dose of Zostavax (lot # 652936/0981F) instead of MMR II. Concomitant vaccination included influenza virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. The nurse was told they had the "new MMR varicella vaccine", she grabbed a vial and administered it to the patient without reading it and then realized it was Zostavax. No symptoms were noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.36
Sex: F
Vaccine: DTAP, HIBV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a healthcare professional concerning a 16 month old female patient with no known history who on 06-DEC-2006 at 16:30 was vaccinated with SC in the left thigh with a dose of Zostavax (Merck) (lot # 652965/0622F) instead of Varivax (Merck). Concomitant vaccination included a first dose of MMR II (lot # 653626/0426F) given SC in the right thigh, a fourth dose of PROHIBIT (lot # 4E955AA) given IM in the left thigh, and a fourth dose of TRIPEDIA (lot # U1891AB) given IM in the left thigh. Other concomitant therapy included TYLENOL or MOTRIN prn. There was no illness at the time of vaccination. The practice was out of Varivax vaccine (Merck) and the vaccines were stored side by side in the freezer. The administering nurse saw "varicella" on the vial and grabbed the vaccine without double checking. The child was fine the day of vaccination and the next day. No symptoms were noted. There was no product quality complaint involved. Additional information has been requested. Additional information indicated that the patient was given ZOSTAVAX (Merck) instead of VARIVAX (Merck) and wrong bottle was grabbed by the CMA in the freezer. No adverse events were noted after injection, the patient had no problems, Medical attention was not sought. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of Zostavax. Three weeks after vaccination, the patient was diagnosed with shingle. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of Zostavax. Three weeks after vaccination, the patient was diagnosed with shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 65 year old male with no allergies or medical history who on 13 Nov 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included Nasonex. On 06 Dec 2006, the patient developed a case of shingles on his back. The patient was seen by his physician who diagnosed him with shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. The patient developed redness at the injection site after receiving the vaccine.  Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old female consumer with a penicillin allergy and no other reported medical history who on 12 Oct 2006 was vaccinated with a dose of Zostavax. There was no concomitant medication. On 03 Nov 2006 the patient had an outbreak of shingles. She went to see her ENT specialist and her oncologist who diagnosed her. There were no laboratory tests performed. As of 12 Dec 2006 the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional informatin indicated indicated that there was no adverse reaction after appropriate evaluation. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning an adult male who developed shingles after his wife was vaccinated with a dose of Zostavax in approximately November 2006. Three days after his wife was vaccinated the patient developed what appeared to be a mild case of shingles. Unspecified medical attention was sought. As of 13 Dec 2006 the lesions were resolving and he was almost fully recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist concerning a female patient whose husband was vaccinated with a dose of Zostavax. Subsequently, the wife may have developed shingles. A product quality complaint was not involved. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 58 year old male who on 06 Dec 2006 was vaccinated SC with a dose of Zostavax (lot #652946/1012F). On 07 Dec 2006, the patient experienced pain after receiving the vaccine. It was not specified as to where the pain occurred. Unspecified medical attention was sought. The patient was given Vicodin for the pain. At time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Information has been received from a physician concerning a 76 year old female patient who in approximately November 2006 was vaccinated in the arm with a first dose of Zostavax (lot #652966/0722F), Two weeks after vaccination, in December 2006, the patient developed shingles. Follow up information indicated that the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 76 year old white female with allergies to mysoline and dilantin, and a history of hypertension, hyperlipidaemia, convulsion disorder, deep vein thrombosis recurrent, shingles (June 2006) and abdominal pain (hospitalization June 2006) who in approximately November 2006 was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  Two weeks after vaccination, in December 2006, the patient developed shingles.  Follow-up information indicated that the patient was recovering.  A product quality complaint was not involved.  Additional information indicated that the patient who on 22-SEP-2006 (previously reported as approximately November 2006) was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  On 26-SEP-2006 the patient developed injection site redness and inflammation which lasted 1 week.  The patient had a history of shingles in June 2006 and reported recurrent painful itchy spots in November 2006 which lasted for 2 weeks.  There has been no subsequent recurrrence.  No further information is expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a 76 year old female patient who in approximately November 2006 was vaccinated in the arm with a first dose of Zostavax (lot #652966/0722F), Two weeks after vaccination, in December 2006, the patient developed shingles. Follow up information indicated that the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 76 year old white female with allergies to mysoline and dilantin, and a history of hypertension, hyperlipidaemia, convulsion disorder, deep vein thrombosis recurrent, shingles (June 2006) and abdominal pain (hospitalization June 2006) who in approximately November 2006 was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  Two weeks after vaccination, in December 2006, the patient developed shingles.  Follow-up information indicated that the patient was recovering.  A product quality complaint was not involved.  Additional information indicated that the patient who on 22-SEP-2006 (previously reported as approximately November 2006) was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  On 26-SEP-2006 the patient developed injection site redness and inflammation which lasted 1 week.  The patient had a history of shingles in June 2006 and reported recurrent painful itchy spots in November 2006 which lasted for 2 weeks.  There has been no subsequent recurrrence.  No further information is expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pain of skin, Paraesthesia
Clinical narrative: Information has been received from a 79 year old female consumer with a history of an allergic reaction to estrogen and no other pertinent medical history who on 22 Sep 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included Pravachol. On 25 Sep 2006 the patient reported that she feels bad and has a prickly feeling going from hop down leg. As of 15 Dec 2006 she has not recovered. She reported that she has not seen a physician yet, but was scheduled to go in two weeks. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 1/16/2007.  Follow-up information indicated that on 24-SEP-2006 the patient developed pricly painful sensations from hip down through entire leg both left and right sides.  She reported that it was difficult to walk or stand for short and long periods of time.  The was treated with IBUPROFEN and rest.  The patient recovered in March 2007.  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 79 year old female consumer with a history of an allergic reaction to estrogen and no other pertinent medical history who on 22 Sep 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included Pravachol. On 25 Sep 2006 the patient reported that she feels bad and has a prickly feeling going from hop down leg. As of 15 Dec 2006 she has not recovered. She reported that she has not seen a physician yet, but was scheduled to go in two weeks. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 1/16/2007.  Follow-up information indicated that on 24-SEP-2006 the patient developed pricly painful sensations from hip down through entire leg both left and right sides.  She reported that it was difficult to walk or stand for short and long periods of time.  The was treated with IBUPROFEN and rest.  The patient recovered in March 2007.  Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a male physician in his early sixties who on approximately 17 Dec 2006 vaccinated himself SC in the abdomen with a dose of Zostavax. There was no concomitant medication. On approximately17 Dec 2006, the patient developed a localized reaction with redness and itching. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. At the time of the report, the physician had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 65 year old male with no known drug reactions or allergies who on 28 Nov 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included Zoloft. On 18 Dec 2006 the patient developed a unilateral vesicular rash with dermatonal distribution extending over his right hip. Unspecified medical attention was sought. As of 19 Dec 2006 the patient was recovering. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information indicated on 19-DEC-2006 the patient broke out in shingles. On 09-JAN-2007 the patient recovered. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Skin tightness
Clinical narrative: Information has been received from a 72 year old female consumer with no reported medical history or allergies who on 15 Dec 2006 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included alendronate sodium and an unspecified thyroid replacement. Twenty four hours after vaccination, the patient developed hugh swelling in the lower half of her upper arm, which was firm, red and hot. As of 19 Dec 2006 she had a redness at the injection site which was 2 inches in diameter and had some swelling. Medical attention was not sought and the patient was recovering. There was no product quality complaint involved. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a 72 year old female consumer with no reported medical history or allergies who on 15 Dec 2006 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included alendronate sodium and an unspecified thyroid replacement. Twenty four hours after vaccination, the patient developed hugh swelling in the lower half of her upper arm, which was firm, red and hot. As of 19 Dec 2006 she had a redness at the injection site which was 2 inches in diameter and had some swelling. Medical attention was not sought and the patient was recovering. There was no product quality complaint involved. No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Hyperaesthesia, Neuralgia, Rash
Clinical narrative: Information has been received from an 85 year old female consumer with pulmonary hypertension, a penicillin allergy and a codeine allergy who in October 2006, was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium, Lipitor, Coreg, Plavix, Accupril, Aspirin and hydrochlorothiazide. On 08 Dec 2006 the patient woke up from sleep because of intense pain in her right breast that rotated to the back onto the right arm to the elbow. It was reported that the pain would come and stab. The patients skin was sensitive to anything that would touch it. She went to the doctor and was diagnosed with neuralgia. On 18 Dec 2006 the patient noticed "raspberry marks" under her breast and on her back. She went back to the doctor and was diagnosed with shingles. There were 3 major rashes under the arm and others were scattered around the back. There was no product quality complaint involved. No additional information was available. 6/17/10 Additional information received from the physician indicated that on 22-SEP-2006, prior to vaccination the patient's VZ AS was 1.65 (>1.10). The patient was vaccinated SC in the left delotid with a dose of varicella-zoster virus vaccine live (Merck) on 04-OCT-2006. The patient began having symptoms on 11-DEC-2006, her zoster eruption began on 12-DEC-2006. The patient was diagnosed on 19-DEC-2006 with zoster at approximately TB on the right side. Additional labs were not performed. On an unspecified date the patient recovered. No additional information was available.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Sleep disorder
Clinical narrative: Information has been received from an 85 year old female consumer with pulmonary hypertension, a penicillin allergy and a codeine allergy who in October 2006, was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium, Lipitor, Coreg, Plavix, Accupril, Aspirin and hydrochlorothiazide. On 08 Dec 2006 the patient woke up from sleep because of intense pain in her right breast that rotated to the back onto the right arm to the elbow. It was reported that the pain would come and stab. The patients skin was sensitive to anything that would touch it. She went to the doctor and was diagnosed with neuralgia. On 18 Dec 2006 the patient noticed "raspberry marks" under her breast and on her back. She went back to the doctor and was diagnosed with shingles. There were 3 major rashes under the arm and others were scattered around the back. There was no product quality complaint involved. No additional information was available. 6/17/10 Additional information received from the physician indicated that on 22-SEP-2006, prior to vaccination the patient's VZ AS was 1.65 (>1.10). The patient was vaccinated SC in the left delotid with a dose of varicella-zoster virus vaccine live (Merck) on 04-OCT-2006. The patient began having symptoms on 11-DEC-2006, her zoster eruption began on 12-DEC-2006. The patient was diagnosed on 19-DEC-2006 with zoster at approximately TB on the right side. Additional labs were not performed. On an unspecified date the patient recovered. No additional information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a male who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient experienced a sore arm that lasted several weeks after vaccination. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 74 year old male consumer with no known allergies. Type II diabetes mellitus and a history of shingles who on approximately 21 Oct 2006 was vaccinated with a dose of Zostavax. Concomitant therapy included Actos. Subsequently, the patient got a rash. The patient reported I had shingles just before I got the shot. Unspecified medical attention was sought, no labs were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, Injection site reaction, No adverse effect
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old patient who on 14 Dec 2006 was vaccinated SC by the pharmacist with a dose of Zostavax (lot #654604/1406F). After vaccination, there was fluid leakage from the injection site. The pharmacist reported that he used a 5/8 inch needle and he gave the injection at a 45 degree angle. AS of 02 Jan 2007, the reporter noted that the patient has not reported any adverse experiences. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Lethargy, Memory impairment, Mental impairment, Reading disorder
Clinical narrative: Information has been received from a certified medical assistant concerning an 84 year old female with no allergies, a cognitive impairment, and a history of colon cancer who on 09 Nov 2006 was vaccinated SC with a 0.65 mL dose of Zostavax (lot # 652965/0632F). Concomitant therapy included Coumadin, Aricept, Namenda, Zoloft, and Temazepam. Sometime after vaccination, in approximately, November 2006, the patient's mental status began deteriorating. She became more lethargic and forgetful since the injections. According to the patients husband, she is no longer able to read and sits for hours staring into space. She became more dependent on others to do a common task, such as personal hygiene. Unspecifeid medical attention was sought. 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: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Staring
Clinical narrative: Information has been received from a certified medical assistant concerning an 84 year old female with no allergies, a cognitive impairment, and a history of colon cancer who on 09 Nov 2006 was vaccinated SC with a 0.65 mL dose of Zostavax (lot # 652965/0632F). Concomitant therapy included Coumadin, Aricept, Namenda, Zoloft, and Temazepam. Sometime after vaccination, in approximately, November 2006, the patient's mental status began deteriorating. She became more lethargic and forgetful since the injections. According to the patients husband, she is no longer able to read and sits for hours staring into space. She became more dependent on others to do a common task, such as personal hygiene. Unspecifeid medical attention was sought. 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: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature, Gait disturbance, Injection site pain, Muscular weakness
Clinical narrative: Information has been received from a physician concerning an 82 year old female with a sulfa allergy, breast cancer, fibrotic lung disease, insulin dependent diabetes, and a history of shingles who on 21 Dec 2006 was vaccinated SC with a 0.65 ml dose of Zostavax (lot #654604/1406F). Concomitant immunosuppressive therapy included methotrexate and prednisone. Other concomitant therapy included Acyclovir. On 21 Dec 2006, the patient had some mild tenderness and soreness at the injection site. On the morning of 22 Dec 2006, she felt weakness. There were no other symptoms. 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. Additional information has been received from the physician who reported that on 20-DEC-2006 (previously reported as 22-DEC-2006), the patient became weak several hours after the shot. The next morning, on 21-DEC-2006, she had a problem walking due to the weak legs. It was noted that patient was chronically weak form fibrotic lung disease, diabetes, and degenerative joint disease. The patient was anorexic, had mild confusion, had no focal defects, no fever, na no rash. She was considered recovered, feeling back to usual, an continues as pre-event.
Age: 13.0
Sex: F
Vaccine: HPV4, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a health professional and a pharmacist concerning a 13 year old patient who on an unspecified date was vaccinated with a dose of Zostavax. Unspecified medical attention was sought. The patient was not experiencing any know symptoms. it was reported that the error was not a result of product confusion. The patient's vaccination history reported to include a first dose of varicella virus vaccine live on an unspecified date, but not a second dose of varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Information has beenreceived from a health professional, a pharmacist and a physician concerning a 13 year old female who on 26-DEC-2006 was vaccinated with a dose of ZOSTAVAX (Merck) (reported to be an overdose) instead of GARDASIL. The treating physician reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) instead of a dose of VARIVAX (Merck). Medical attention was sought. One week after vaccination, on 02-JAN-2007, the patient developed what the physician described as a zoster rash, which was also reported to be a "raging case of chicken pox" by the office manager. It was reported that the zoster rash did not cause itching, but the patient experiecned general fatigue and pain in the muscles and joints of the knees, hips and shoulders. The patient was started on an unspecified antiviral therapy. It was reported that the physician would try to swab the lesion but the patient had already left the office. On an unspecified date the rash cleared but as of 24-JAN-2007 the muscle and joint pain continued. The patient was scheduled to have a follow up appointment on 29-JAN-2007. The patient's vaccination history was reorted to include a first dose of VARIVAX (Merck)on an unspecified date, but not a second dose of VARIVAX (Merck). It was reported that the administering employee did not follow the 5 R's, did not ask for assistance from another health care professional and "did not know what she was doing." It was confirmed that this was not a case of product confusion. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax vaccine. Subsequently the patient experienced shingles. No additional information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 64 year old female consumer with no known medical history or allergies who on 20-Dec-2006 was vaccinated with a 0.65 ml dose of Zostavax vaccine. On 20-Dec-2006 the patient experienced rash above the injection site. On 21-Dec-2006 the patient recovered. Medical attention was not sought and no lab tests were performed. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 65 year old female with coronary artery disease, Crohn's disease, osteoporosis, and hyperlipidemia who on 21-Dec-2006 was vaccinated SC in the left side of the abdomen with a dose of Zostavax vaccine (lot#652947/1212F). Concomitant therapy included calcium (unspecified), famotidine, rizatriptan benzoate, Vicodin, simvastatin, alendronate sodium, "Asapchol", and "Toperol". On 27-Dec-2006, the patient developed radiating arm numbness and back pain. Unspecified medical attention was sought and the patient was being seen a neurologist on 28-Dec-2006. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning his mother who in December 2006 was vaccinated SC with a first dose of Zostavax vaccine. Subsequently she experienced an injection site rash on her arm. As of Dec-2006 it was reported that the patient was recovering on an unspecified therapy. Medical attention was not sought and no laboratory diagnostic tests were performed. There was no product quality complaint involved. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female, who on 28-Dec-2006 was vaccinated IM with a 0.5 ml dose of Zostavax vaccine (lot#654603/1405F) instead of Gardasil vaccine (yeast). It was reported that this was a case of staff error, not product confusion. The administering medical assistant said that she thought the Gardasil vaccine (yeast) was stored frozen and she just grabbed the vaccine, which was Zostavax vaccine (lot#654603/1405F), from the freezer and gave that to the patient. No symptoms were noted. Unspecified medical attention was sought. There was no product complaint involved. No further information was provided. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, No adverse effect
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old patient who on 14-Dec-2006 was vaccinated SC by the pharmacist with a dose of Zostavax vaccine (lot#654604/1406F). After vaccination, there was fluid leakage from the injection site. The pharmacist reported that he used a 5/8 inch needle and he gave the injection at a 45 degree angle. As of 02-Jan-2007, the reporter noted that the patient has not reported any adverse experiences. There was no product quality complaint involved. No further information was available. Additional information has been requested.