chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a male with no medical history or allergies who on 31 Oct 2006 was vaccinated with PO with a dose of rotavirus vaccine. Concomitant vaccinations administered on that same day included a dose of Hib (manufacturer unknown), a dose of poliovirus vaccine (unspecified), a dose of Prevnar and a dose of Dtap. The RN reported that on 07 Nov 2006, the patient was seen in the physicians office because he had become fussy and very irritable, and had developed a fever and diarrhea. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 2-month-old female with no medical history or allergies who on 31-AUG-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ. There was no concomitant therapy. The physician reported that on approximately 01-NOV-2006 the patient developed a rash around her mouth. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. In November 2006 the patient's rash resolved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: RV5
Symptoms: Eye irritation, Feeling hot, Medication error
Clinical narrative: Information has been received from a 23 year old female nursing student, with no medical history and no allergies, who on 08 Nov 2006, was vaccinating a baby with a dose of rotavirus vaccine and the baby spit up some of the vaccine and it went into her left eye. There was no concomitant medication. The nursing student felt warmth in her eye. She immediately washed her eye out with water and felt burning. The nursing student reported no other symptoms. The patient reported that her eye felt fine later the same day. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced a low grade fever and crankiness. It was reported that 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: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Diarrhoea, Flatulence, Muscle spasms, Nasal congestion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 week old white male patient with no medical history or allergies who on 01-NOV-2006 at 10:15 am was vaccinated PO with a first dose of ROTATEQ (lot # 655174/0848F). Concomitant vaccination administered that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, Hib conj vaccine (OMPC) (manufacturer unknown) and PREVNAR. Concomitant therapy included 0.9 mL of ZANTAC. There was no illness at the time of vaccination. On 04-NOV-2006 the patient was crampy, drawing legs up as if in pain, shrieking and had a congested nose. These symptoms resolved on 06-NOV-2006. On 06-NOV-2006 at 11:00 am the patient developed diarrhea and was gassy "all day." The patient was crying for 6.5 hours. Unspecified medical attention was sought. The patient's outcome was recovered. There was no product quality complaint involved. The patient did not experience any adverse events after prior vaccination. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pain, Screaming
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 week old white male patient with no medical history or allergies who on 01-NOV-2006 at 10:15 am was vaccinated PO with a first dose of ROTATEQ (lot # 655174/0848F). Concomitant vaccination administered that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, Hib conj vaccine (OMPC) (manufacturer unknown) and PREVNAR. Concomitant therapy included 0.9 mL of ZANTAC. There was no illness at the time of vaccination. On 04-NOV-2006 the patient was crampy, drawing legs up as if in pain, shrieking and had a congested nose. These symptoms resolved on 06-NOV-2006. On 06-NOV-2006 at 11:00 am the patient developed diarrhea and was gassy "all day." The patient was crying for 6.5 hours. Unspecified medical attention was sought. The patient's outcome was recovered. There was no product quality complaint involved. The patient did not experience any adverse events after prior vaccination. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml PO dose of ROTATEQ. Subsequently, the patient developed diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from diarrhea after a couple of days. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Accidental exposure, Cough, Eye irritation, Headache
Clinical narrative: Information has been received from a health professional described herself as a sensitive individual who can only take penicillin with no medical history or history of immunocompromise who on 14-NOV-2006 was splashed in both eyes with Rotateq. There was no concomitant medication. She said it felt like "ground glass" in her eyes. She immediately irrigated both eyes with water. The eye wash "did not help much". It was reported that she began coughing for approximately 2 minutes. At the time of the report she had a frontal headache and her eyes felt "30%" better. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. Followup information from the rigistered nurse indicated that her eyes bothered her for two week and "even now" they remained slightly sensitive. Additional information has been requested.
Age: 0.23
Sex: M
Vaccine: RV5, UNK
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 12 week old male, with no medical history and no allergies, who on 31 Oct 2006 was vaccinated with a first oral 2 ml dose of Rotavirus vaccine (lot # 654970/0777F). Concomitant vaccines included "his other 2 month vaccines." On 01 Nov 2006 the patient developed diarrhea. It was noted that the patient had persistent diarrhea for 6 days. It was reported that the patient recovered on 08 Nov 2006. 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: Medication error
Clinical narrative: Information has been received from a health professional concerning a greater than 12 week old patient who, on an unknown date, was vaccinated with an oral dose of ROTATEQ. No adverse experience was related to this event. No other information has been provided. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a greater than 3 month old male who was vaccinated with ROTATEQ. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 month old female who was vaccinated PO with the first dose of Rotavirus vaccine. The NP reported that the patient subsequently vomited for a week and developed loose stools. Unspecified medical attention was sought. The patient's symptoms subsequently improved. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an unknown number patients whoafter the age of 12 weeks were vaccinated with an oral first dose of Rotateq (human bovine). No problems were reported. It was not reported if medical attention was sought. There was no product  quality complaint involved. Additional information is not expected.
Age: 0.55
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 21-SEP-2006 was vaccinated with a dose of ROTATEQ (lot # 654970/0777F). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 21 Sep 2006 was vaccinated with a dose of Rotateq (human bovine) (Lot# 654970/0777F). Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 20 week old female who on 21-SEP-2006 was vaccinated with a dose of ROTATEQ (lot # 654970/0777F). Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 6 month old female who on 21-SEP-2006 was vaccinated with a dose of ROTATEQ (lot #654970/0777F). Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pain
Clinical narrative: Information has been received from a physician concerning a 4 month old female who was vaccinated with a first and second PO dose of ROTATEQ. There was no concomitant medication. It was noted that the patient had diarrhea 2 days prior (approximately 01-NOV-2006) to second vaccination, and subsequently recovered. "Two weeks ago," on approximately 03-NOV-2006, the patient developed diarrhea for 2 days. The patient also experienced pain. At the time of the report the patient was recovering. Medical attention was sought. The physician was considering discontinuing further series of the vaccine. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first 2.0 mL PO dose of Rotateq (human bovine). Subsequently the patient developed vomiting and diarrhea. The patient recovered in three days. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of Rotateq (human bovine). The physician reported that the patient was taken to the hospital due to diarrhea and vomiting. The patient was not admitted. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 10 Nov 2006 was vaccinated PO with a 2.0 mL dose of Rotateq (human bovine) (Lot #654352/0410F). The physician reported that on 16 Nov 2006, the patient developed diarrhea. Unspecified medical attention was sought and the patient tested negative for rotavirus. At the time of this report, the patient was noted to be recovering on therapy (not further specified). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain, Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of ROTATEQ. The physician reported that the patient subsequently developed abdominal cramping. The patient was taken to the Emergency Room (ER), but it was not known if the patient was hospitalized. The ER physician stated he "believed this to be a case of intussusception, but made no concrete diagnosis." The patient's symptoms improved and the patient was removed from receiving further doses of ROTATEQ. The reporting physician noted that he only saw the patient after the adverse reaction occurred but the patient was not seeing him prior to the adverse reaction. No further information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 month old male who, "about one month ago", on approximately 21 Oct 2006, was vaccinated orally with 1 tube of Rotateq (human bovine) (Lot # 655175/0849F). No symptoms were noted. No other information was provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Drug ineffective, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old male who on 17 Nov 2006 was vaccinated with a first oral dose of Rotateq (human bovine). No problems were reported. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning a 2 month old female with no known medical history or allergies who on 16 Nov 2006 was vaccinated with a 2mL orafirst dose of Rotateq (human bovine). There was no concomitant medication. On 17 Nov 2006, 24 hours after vaccination, the patient developed a rash on her stomach and back. Unspecified medical attention was sought. At the time of the report the patient had not yet recovered. No labs were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5, UNK
Symptoms: No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old female who was vaccinated with a first oral 2ml dose of Rotateq (human bovine) and a second oral 2 ml dose on 16 Nov 2006. Concomitant vaccinations administered on 16 Nov 2006 included "other shots". "About two hours later", on 16 Nov 2006, the patient severely vomited three times. The patient went to an urgent care clinic and did not need any intravenous fluids. The reported said the patient "seemed fine" when she saw her, but was "concerned about giving the third dose" of Rotateq (human bovine). It was reported that the patient recovered later on 16 Nov 2006. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from a physician concerning a 17 week old female, with no medical history and no allergies, who was vaccinated with a first oral 2 ml dose of ROTATEQ and a second oral 2 ml dose (Lot# 654247/0600F) on 17-NOV-2006 (originally reported as 16-NOV-2006), at 3:00 pm. Concomitant vaccinations administered on 17-NOV-2006 included "other shots". There was no illness at the time of vaccination and no adverse events following prior vaccination. "About two hours later", on 17-NOV-2006 (originally reported as 16-NOV-2006), the patient severely vomited three times. The patient went to an urgent care clinic and did not need any intravenous fluids. The reporter said the patient "seemed fine" when she saw her, but was "concerned about giving the third dose" of ROTATEQ. It was reported that the patient recovered later on 18-NOV-2006 (originally reported as 17-NOV-2006). There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that on 17-NOV-2006, at 3:30 PM, the patient vomited repeatedly and was seen in the emergency room.  The patient recovered on 18-NOV-2006.  Additional information is not expected.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Drug ineffective, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 16 week old patient who on 06 Nov 2006 was vaccinated with a first dose of Rotateq (human bovine) (lot # 653915/0389F). No symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Drug ineffective, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 16 week old patient who was vaccinated with the first dose of Rotateq (human bovine). Unspecified medical attention was sought and no symptoms were noted. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with a first 2ml oral dose of Rotateq (human bovine). Concomitant vaccinations included "other vaccines". It was reported that one week after the patient experienced diarrhea. It was noted that the physician did not feel the event was due to Rotateq (human bovine). 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: Drug ineffective, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who, at 2 months of age, was vaccinated with a first oral dose of Rotateq (human bovine). On 29 Nov 2006, at 6 months of age, the patient was vaccinated with a second oral dose of Rotateq (human bovine). It was reported that no adverse experience was related to the event. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of Rotateq (human bovine). The nurse reported that the patient subsequently developed diarrhea and fever. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed visiting nurse concerning a greater than 12 week old patient who on 29 Nov 2006 was vaccinated with a first oral dose of Rotateq (human bovine) (Lot#654663/0942F). It was noted that the patient was not experiencing any known symptoms. 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: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning two patients who were vaccinated with a first 2.0mL PO dose of Rotateq (human bovine). Subsequently the patients developed vomiting and diarrhea. The patient's outcome was not reported. It was unknown if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 66 year old male who on 26 Oct 2006 was vaccainted with a 0.65ml dose of varicella zoster virus vaccine (lot #0621). On 27 Oct 2006 the patient developed lesions. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint was involved. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 86 year old healthy male retired physician with no known allergies who on 20 Oct 2006 was vaccinated in the right deltoid with a dose of Zostavax. The patient was not receiving any immunosuppressive agents. On 01 Nov 2006, eleven days after vaccination, the patient developed 3 small red papules and 1 early lesion which were clustered in an area approximately 3 cm in diameter on the right buttocks. It was noted that the patient had pain which was rated as 3 (scale of 0-10). The physician suspected herpes zoster and has prescribed VALTREX. Unspecified medical attention was sought. Subsequently the patient recovered. It was reported that the patient had a history of childhood chickenpox. No recent exposure to chickenpox or shingles was noted. There was no product quality complaint involved. Additional information has been requested.
Age: 1.74
Sex: M
Vaccine: VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information has been received from a physician and medical assistant concerning a 20 month old male who on 24 Oct 2004 was inadvertently vaccinated with a dose of varicella zoster virus vaccine (lot #652936/0981F) instead of varicella virus vaccine live. The medical assistant did not know there were two varicella vaccines and both vaccines were stored in the same place in the refrigerator. She reported, "it was just a mistake." Unspecified medical attention was sought and no adverse event was reported. As of 07 Nov 2006, the patient was doing fine. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: Information has been received from a nurse concerning a female patient who on approximately 27 Oct 2006 was vaccinated with a dose of varicella zoster virus vaccine live. On approximately 27 Oct 2006, the patient experienced a headache and flu-like symptoms. Unspecified medical attention was sought and the patient recovered after one day. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a registered nurse concerning a female patient who on approximately 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (Merck).  On approximately 27-OCT-2006, the patient experienced a headache and flu-like symptoms.  Unspecified medical attention was sought and the patient recovered after one day.  A product quality complaint was not involved.  Additional information has been received from the nurse who reported that she was "clear as th whom this is referring to."  Additional information was received from the registered nurse who reported that the patient stated that she never expected to feel head achy and "like she was coming down with the flu."  In a follow-up telephone call with the patient months later, she reported no ill effects and hardly remembered the previous conversation.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 31 Oct 2006 was vaccinated with a 0.65ml dose of varicella zoster virus vaccine live. On 03 Nov 2006, the patient developed a rash and blisters that follow the dermatone and also experienced pain. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster, Infection transmission via personal contact, Oral mucosal blistering, Pain
Clinical narrative: Information has been received from a 53 year old female licensed practical nurse with allergies to CECLOR, morphine, DEMEROL, codeine, and TEQUIN who on 19 Oct 2006 vaccinated a patient with a dose of VARIVAX (Merck). The next day, the nurse developed a large blister like rash in her mouth which was subsequently diagnosed by an oral surgeon as herpes zoster in the roof of her mouth. This was the very first dose of vaccine the nurse ever administered to a patient. The nurse's rash has improved but her present status was unknown. A product quality complaint was not involved. Additional information has been received from the nurse who reported that on 19 Oct 2006 she administered a dose of varicella zoster virus vaccine live to a patient. The next day, on 20 Oct 2006, her front teeth began to hurt. The day after that, on 21 Oct 2006, shingles lesions erupted on the right side of the roof of her mouth. She was also exposed to an active shingles patient on 18 Oct 2006. She was placed on FAMVIR 150 mg for eight days and pain medications. The patient recovered after nine days, on 29 Oct 2006. Follow up information: It was also reported that the patient experienced an adverse experience following vaccination of VARIVAX (Oka/Merck) (WAES# 0709USA00291). Additional information is expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Secondary transmission, Viral infection
Clinical narrative: Information has been received from a 53 year old female licensed practical nurse with allergies to CECLOR, morphine, DEMEROL, codeine, and TEQUIN who on 19 Oct 2006 vaccinated a patient with a dose of VARIVAX (Merck). The next day, the nurse developed a large blister like rash in her mouth which was subsequently diagnosed by an oral surgeon as herpes zoster in the roof of her mouth. This was the very first dose of vaccine the nurse ever administered to a patient. The nurse's rash has improved but her present status was unknown. A product quality complaint was not involved. Additional information has been received from the nurse who reported that on 19 Oct 2006 she administered a dose of varicella zoster virus vaccine live to a patient. The next day, on 20 Oct 2006, her front teeth began to hurt. The day after that, on 21 Oct 2006, shingles lesions erupted on the right side of the roof of her mouth. She was also exposed to an active shingles patient on 18 Oct 2006. She was placed on FAMVIR 150 mg for eight days and pain medications. The patient recovered after nine days, on 29 Oct 2006. Follow up information: It was also reported that the patient experienced an adverse experience following vaccination of VARIVAX (Oka/Merck) (WAES# 0709USA00291). Additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Viral infection
Clinical narrative: Information has been received from a health professional concerning a female patient who on an unspecified date was vaccinated with a dose of varicella zoster virus vaccine live. Within one week of vaccination, the patient developed shingles in her eye. Unspecified medical attention was sought. The reporter had no other information as it was only mentioned to her and was not one of her patients. A product quality complaint was not involved. Additional information had been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a health professional concerning a 62 year old male with an erythromycin allergy an no other medical history who on 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (lot # 652936/0981F). On 30-OCT-2006, the patient developed a red rash on his right flank and right lateral ribs. The physician diagnosed this as a possible drug allergy and prescribed prednisone as treatment. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning a female patient who on 01 Nov 2006 was vaccinated with a 0.65ml dose of varicella zoster virus vaccine live (lot #652936/0981F). On approximately 01 Nov 2006, the patient developed an injection site reaction that was described as red, swollen, hot, and itchy. Unspecified medical attention was sought. The patient was told to take antihistamines and to use a cold compress. As of 06 Nov 2006, the reaction was less severe, but had not resolved. A product quality was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 63 year old female who on 31 Oct 2006 was vaccainted SC with a 0.65 ml dose of varicella zoster virus vaccine live. On approximately 31 Oct 2006, the patient developed a red area that was pretty painful at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information had been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 67 year old male with neuropathy, no known drug reaction or allergies and a history of chemotherapy and lung cancer who on 24 Oct 2006 was vaccainted with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant therapy included many cancer drugs, the consumer had been on for awhile. It was reported that the patient suffered from neuropathy in his hands and feet as a result of his chemotherapy which was completed in September 2006. On 25 Oct 2006, the next day after vaccination, the patient's neuropathy greatly improved and has remained so. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 73 year old male with Hepatitis C, hypertension, asthma, osteoarthritis, hyperglycaemia, hematospermia, no known allergies and a history of chickenpox who on 01 Nov 2006 was vaccinated SC in left arm with a 0.65ml dose of varicella zoster virus vaccine live (lot 652925/0621F). Concomitant therapy included lisinopril (ZESTRIL), Felodipine, and sildenafil citrate (VIAGRA) as needed. Subsequently on 01 Nov 2006 the patient experienced a sore arm and joints, which lasted for three days. The patient also developed a fever and chills and also had discomfort. Fever was reported as 101.8 F (the duration of this temperature was unknown). There was no anaphylaxis, no edema and no rash. The patient's fever and chills lasted for 5 days, broke on the morning of 06 Nov 2006 and the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up report(s) previously submitted on 12/14/2006:  3/23/2007.  Information has been received from a health professional concerning a 73 year old male with Hepatitis C, hypertension, asthma, osteoarthritis, hyperglycaemia, hematospermia, no known allergies and a history of chickenpox who on 01-NOV-2006 at 10:11 was vaccinated SC in left arm with a 0.65 ml first dose of ZOSTAVAX (Merck) (lot # 652925/0621F).  Concomitant therapy included ZESTRIL, Felodipine (MSD) and VIAGRA as needed.  Subsequently on 01-NOV-2006 the patient experienced a sore arm and joints, which lasted for three days.  The patient also developed a fever and chills and also had discomfort.  Fever was reported as 101.8 F (the duration of this temperature was unknown).  There was no analphylaxis, no edema and no rash.  The patient's fever and chills lasted for 5 days, broke on the morning of 06-NOV-2006 and the patient recovered.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information from the physician indicated that the patient is a retired orthopedist who reported three days of fever and joint pain after injection.  The patient was not seen and subsequently recovered.  The patient has a history of interferon treatment for hepatitis C many years ago, no treatment within the past three years.  The patient was not immunocompromised.  No laboratory tests were performed.  Follow up information received from a physician reported that on an unspecified date the patient had some type of blood serum poisoning after he received the vaccine.  No further information was provided.  No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Medication error, Skin burning sensation
Clinical narrative: Information has been received from a medical assistant and a physician concerning a female patient who on 06 Nov 2006 was vaccinated SC with a 0.65ml dose of varicella zoster virus vaccine live. The medical assistant reported that he had administered the varicella zoster virus vaccine live diluent without the vaccine to the patient. However, when confronted by the doctor, the medical assistant reported that the vaccine had been reconstituted before it had been given. The patient also experienced a burning sensation at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the patient experienced localized swelling, redness and pain at the injection site. Unspecified medical attention was sought. The patient was given and antibiotic and it helped with the pain and swelling. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 72 year old female consumer with Non Hodgkin's Lymphoma, allergy to antibiotics and a history of herpes zoster breakouts who on 07 Oct 2006 was vaccainted SC with one dose of varicella zoster virus vaccine live. Concomitant therapy included PROCRIT, DETROL, NEXIUM, and RESTUSGAN. On 07 Oct 2006 the patient reported that she was itchy all over. She reported that she has a compromised immune system due to cancer treatments. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning a female patient who on 01 Nov 2006 was vaccinated with a 0.65ml dose of varicella zoster virus vaccine live (lot #652936/0981F). On approximately 01 Nov 2006, the patient developed an injection site reaction that was described as red, swollen, hot, and itchy. Unspecified medical attention was sought. The patient was told to take antihistamines and to use a cold compress. As of 06 Nov 2006, the reaction was less severe, but had not resolved. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of varicella zoster virus vaccine live. Three days after vaccination, the patient had manifestations of herpes labialis and herpes genitalis. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Haemorrhage, Infection transmission via personal contact, Ocular hyperaemia
Clinical narrative: Information has been received from a nurse practitioner concerning a female nurse who on 08 Nov 2006 was splashed in the eye with a dose of varicella zoster virus vaccine live. The patient experienced hemorrhaging in the eye immediately following exposure to the vaccine. It was also reported that she was experiencing redness in her eye. The patient went to an eye doctor who said that the  incident should resolve without complication. As of 09 Nov 2006, no other symptoms were reported since the incident. A product quality complaint was not involved. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Occipital neuralgia, Sensory disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old male with no allergies and diverticulitis, back pain, hypergonadism, gastroesophageal reflux disease, and hyperlipidaemia, who on 01 Nov 2006 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live (lot 652946/102F). Concomitant therapy included ANDROGEL, aspirin, FLOMAX, VIAGRA, and CELEBREX. On 02 Nov 2006, within 24 hours of vaccinations, the patient experienced an increased sensitivity in the top of his head. He called the physician's office on 06 Nov 2006 to report the event. Unspecified medical attention was sought and the physician did not feel it was related to the vaccine and was possibly occipital neuralgia. The patient currently had less sensitivity in the area and at the time of the report, was recovering. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. 6/17/10 Additional information indicated that the patient complained of a brief episode of occiptal neuraliga on 05-NOV-2006 (also reported as 02-NOV-2006). The physician felt it was totally unrelated to his vaccination 4 days prior to the symptoms. This occiptal neuralgia resolved on 05-NOV-2006 without incident or treatment. No office visit was necessary. No further information is available.
Age: 56.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a 56 year old female licensed practical nurse with sarcoidosis in remission who between approximately 26 Oct 2006 and 05 Nov 2006 administered 12 doses of varicella zoster virus vaccine live. It was noted that during the same time period she also administered three doses of varicella virus vaccine live. On 05 Nov 2006, the nurse contracted herpes zoster starting with pain and developing into a painful rash on the face as of 09 Nov 2006. Unspecified medical attention was sought and since 08 Nov 2006, the nurse has not been allowed to work. The nurse reported that there were no needle sticks or skin contact with the vaccine. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature decreased, Erythema, Fatigue, Headache, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 57 year old female, who is a physician, with a sulfonamide allergy who on 02-Nov-2006 was vaccinated in the left deltoid with a dose of varicella-zoster virus vaccine live (lot#652965/0622F). There was no illness at the time of vaccination. On 03-Nov-2006 the physician experienced injection site reactions of tenderness, swelling, warm, erythema, and pruritus on a 2x3 cm area. She experienced malaise, fatigue, low grade fevers and headaches for 36 hours. Unspecified medical attention was sought. Subsequently, the physician recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pruritus, Swelling
Clinical narrative: Information has been received from a health professional concerning a 57 year old female, who is a physician, with a sulfonamide allergy who on 02-Nov-2006 was vaccinated in the left deltoid with a dose of varicella-zoster virus vaccine live (lot#652965/0622F). There was no illness at the time of vaccination. On 03-Nov-2006 the physician experienced injection site reactions of tenderness, swelling, warm, erythema, and pruritus on a 2x3 cm area. She experienced malaise, fatigue, low grade fevers and headaches for 36 hours. Unspecified medical attention was sought. Subsequently, the physician recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Information has been received from a phyisican concerning a 61 year old female who on 25-Oct-2006 was vaccinated with a dose of varicella-zoster virus live (lot#652925/0621F). On approximately 07-Nov-2006, the patient developed a tingling sensation in the trunk area (or on her side) which turned into a stabbing pain and then a slight rash developed after receiving the vaccine. The physician thought the rash and the other reported symptoms was possibly shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old male who on 09-Nov-2006 was vaccinated SC with a dose of varicella-zoster virus vaccine live (lot#652925/0621F). On 09-Nov-2006, about two hours post vaccination, his scalp began to itch. Over the next few hours, he developed a maculopapular rash that involved his head, body, and extremities. 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 requested.
Age: 26.0
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a 26 year old employee who on 13-Nov-2006 was inadvertently vaccinated with a dose of varicella-zoster virus vaccine live. No symptoms were reported. The pharmacist reported that the error occurred due to three factors. There was some confusion with the name of the vaccines, even though "zoster" does appear on the varicella-zoster virus vaccine live label. The varicella-zoster virus vaccine live was kept in the same cubicle as varicella virus vaccine live was kept. They were very busy at the time and had a lot of interruptions and did not have enough time to assess the order. He also noted that the packaging of varicella-zoster virus vaccine live and varicella virus vaccine live is different, "which is good". Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on approximately 06-Nov-2006 was vaccinated SC with a 0.65 ml dose of varicella-zoster virus vaccine live (lot#652936/0981F). After vaccination, on approximately 06-Nov-2006, the patient developed an atypical shingles rash with pain. Unspecified medical attention was sought and the patient was treated with gabapentin (NEUROTIN) for the pain. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a 68-year-old female with a history of influenza immunization 'a few weeks ago" and "feeling a little achiness" following vaccination, who on 10-Nov-2006 was vaccinated with a dose of varicella-zoster virus vaccine live. There was no concomitant medication. On 12-Nov-2006 the patient experienced " a big red spot that was itchy, hot and hard after vaccination. The patient did not describe it as a rash but as a single hard area. No medical attention was sought, no laboratory or diagnostic tests were performed. At the time of this report, the patient had not recovered. No product quality complaints were involved. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner and an office manager concerning a 34 year old female who on 13-Nov-2006 was inadvertently vaccinated SC with a 0.65 ml dose of varicella-zoster virus vaccine live instead of a dose of varicella virus vaccine live. The office manger noted that the person giving the injections hadn't seen the new varicella-zoster virus vaccine live and "just reached in grabbed that one". The varicella virus vaccine live was hidden from view. Additional information was received from a consumer concerning his 35 (also reported as 34) year old wife with no allergies or medical history who on 10-Nov-2006 (also reported as 13-Nov-2006) was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. The reporter did not known why the vaccine was given in error. She also developed a red, warm injection site reaction which has resolved. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pruritus, Swelling
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning an 82-year-old female with a history of breast cancer, osteoporosis, hernia, a ruptured gallbladder and a phenobartibal allergy, who on 10-Nov-2006 was vaccinated subcutaneously with a "0.6 ml" dos of varicella-zoster virus vaccine live (lot#652925/0621F). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR), warfarin sodium (COUMADIN), multivitamins (unspecified), albuterol sulfate (PROVENTIL), montelukast sodium and atenolol (TENORMIN). On 11-Nov-2006 the patient developed an injection site reaction characterized as itchy and hot to the touch at the injection site. Unspecified medical attention was sought, no laboratory or diagnostic studies were performed. A cold compress was applied and reportedly "helped a little". She also took diphenhydramine hydrochloride (BENADRYL) in the night to help her sleep. On the morning of 13-Nov-2006, the affected area was the size of a silver dollar. A lot check of this vaccine was requested. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency.  Additional information has been requested.