chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: patient came to office for second Gardasil injection on 9/25/07 at 11:00 am. The injection was administered to the patient IM Left deltoid without difficulty by Registered Medical Assistant. Patient was advised to wait 10 minutes in the waiting area after the injection as per protocal after receiving the gardasil injection. Five minutes later triage nurses were paged to the front desk by office staff, patient was found on the floor awake but slightly disoriented, diaphoretic and stating that she felt lightheaded. Front desk staff reports that patient was in the process of checking out and asked for orange juice because she felt a bit dizzy but then immediately passed out, fell forward onto front desk and then fell to the floor. At which time front desk staff called nurses for help. Nurses and Medical Assistants immediately used ammonia salts to help awaken patient and monitored vital signs, which were stable at BP-100/70 P-80 office staff  also immediately called 911. Ems arrived less than 10 minutes later and patient was transported to the ER. Information has been received from a Registered nurse concerning a 23 year old female student who on 24-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #654539/0742U, with no reaction noted. On 25-SEP-2007 at 11:00 a.m. she was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #654539/0742U). The nurse reported that the patient fainted after receiving the second injection, passed out about 5 minutes after the vaccination, and hit her head on the wall. Treatment included administration of "smelling salt". She was sent to an emergency room for evaluation for a head injury. Follow up information indicated that the patient was "awake, oriented, anicteric and conversational," with mo photophobia. The treating physician noted that the patient "needs something to eat. She had a vasovagal epidode." and added that there was no indication for laboratory tests or studies. Vital signs were as follows: temperature 97.8, pulse 93, respirations 20, blood pressure 131/67 mmHg. an electrocardiagram was ordered (results not provided). At the time of this report, the patient had recovered from the events (duration not specified). Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness, No reaction on previous exposure to drug, Syncope
Clinical narrative: patient came to office for second Gardasil injection on 9/25/07 at 11:00 am. The injection was administered to the patient IM Left deltoid without difficulty by Registered Medical Assistant. Patient was advised to wait 10 minutes in the waiting area after the injection as per protocal after receiving the gardasil injection. Five minutes later triage nurses were paged to the front desk by office staff, patient was found on the floor awake but slightly disoriented, diaphoretic and stating that she felt lightheaded. Front desk staff reports that patient was in the process of checking out and asked for orange juice because she felt a bit dizzy but then immediately passed out, fell forward onto front desk and then fell to the floor. At which time front desk staff called nurses for help. Nurses and Medical Assistants immediately used ammonia salts to help awaken patient and monitored vital signs, which were stable at BP-100/70 P-80 office staff  also immediately called 911. Ems arrived less than 10 minutes later and patient was transported to the ER. Information has been received from a Registered nurse concerning a 23 year old female student who on 24-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #654539/0742U, with no reaction noted. On 25-SEP-2007 at 11:00 a.m. she was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #654539/0742U). The nurse reported that the patient fainted after receiving the second injection, passed out about 5 minutes after the vaccination, and hit her head on the wall. Treatment included administration of "smelling salt". She was sent to an emergency room for evaluation for a head injury. Follow up information indicated that the patient was "awake, oriented, anicteric and conversational," with mo photophobia. The treating physician noted that the patient "needs something to eat. She had a vasovagal epidode." and added that there was no indication for laboratory tests or studies. Vital signs were as follows: temperature 97.8, pulse 93, respirations 20, blood pressure 131/67 mmHg. an electrocardiagram was ordered (results not provided). At the time of this report, the patient had recovered from the events (duration not specified). Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Ataxia, Crying, Vomiting
Clinical narrative: Patient came into the office with complaint of loss of balance when crawling (ataxia) since administration of immunizations approx 1 week ago. waking at night more often crying. emesis x1 last PM.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Decreased appetite, Screaming, Speech disorder, Vomiting
Clinical narrative: Patient came into the office with complaint of loss of balance when crawling (ataxia) since administration of immunizations approx 1 week ago. waking at night more often crying. emesis x1 last PM.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Erythema, Pain, Pruritus, Rash vesicular
Clinical narrative: Intense itch and exaserbation of scar tissue from poison oak contracted in 2004 on the right forearm, distal from the vaccin,  arm heavy and small fluid filled blisters are noteed on the arm, some have been broken due to scratching.  Also generalized aching, some tachycardia  up to 24 + hours after injection.  Skin on arm is red and there is also generalized itching,  No respriatory symptoms.  Applied cortizone otc cream 12 hours after injection, upon waking with the intense itching.  This reactin is similar to a reaction seen on this patient upon recieving PPD injection...the skin gets red but not endurated.  Also, pt took 50 mg of benadryl at hs the night of the injection (Approx. 7 hours after).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Tachycardia
Clinical narrative: Intense itch and exaserbation of scar tissue from poison oak contracted in 2004 on the right forearm, distal from the vaccin,  arm heavy and small fluid filled blisters are noteed on the arm, some have been broken due to scratching.  Also generalized aching, some tachycardia  up to 24 + hours after injection.  Skin on arm is red and there is also generalized itching,  No respriatory symptoms.  Applied cortizone otc cream 12 hours after injection, upon waking with the intense itching.  This reactin is similar to a reaction seen on this patient upon recieving PPD injection...the skin gets red but not endurated.  Also, pt took 50 mg of benadryl at hs the night of the injection (Approx. 7 hours after).
Age: 4.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Varicella
Clinical narrative: PT. HAD 2 VARICELLA VACCINES IN HER LIFE TIME AND WAS DIAGNOSED WITH VARICELLA 9/27/07
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient had a reaction to the vaccination resulting in a 7X5 cm red area around the sithe of injection. Was also vesicular appearing (blisters). Patient was also unsure if he had the chickenpocks before durring child hood.
Sex: U
Vaccine: TD
Symptoms: Medication error
Clinical narrative: illegal drugs were entered on 3 separate occasions by false pretense of novocain - the vials were heated , there were three separate injecetions for one tooth a red yellow and other vial that produced antihypertensive or psychotropic side effects. the victim does not take pharmaceuticals, alcohol drugs or anything else the conduct is covert illegal and violates religous rights. office contracts with us government medicare
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Enema administration, Intussusception, Vomiting
Clinical narrative: Intussusception, admitted to hospital on 09/20/2007 with vomiting, dehydration.  Reduced by air enema.  Discharged in good health.  9/28/07 Received pcp medical records & vax records which confirms RO dose & lot # as reported. 10/30/07 Reviewed hospital medical records which reveal patient experienced abdominal tenderness, vomiting & reduced oral intake x 5 days.  Admitted 9/20-9/21/07 for observation s/p barium enema reduction of IS.  Progressed well & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Nausea, Vomiting
Clinical narrative: Patient had a recent hx of intestinal N/V, no fever, and was better.  She received the Flu shot at 8:45 a.m.  She was fine then around 10:00 she had some nausea, then vomited, and then started to shiver.  she is also diabetic and her blood sugar was 68.  She drank some "Coke" and rechecked blood sugar and it was 91, her Temp was 100.2 and continuing to shiver.  Adminstered Acetaminophen 325 mg 2 tabs and gave her some saltine crackers to eat to raise her blod sugar.  Her temp reached 101.3.  By 11:00 the shivering had stopped, her temp was 99.2, and her blood sugar was 159.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: Tenderness to R deltoid, headache.  Bilateral tenderness of medial thighs.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling hot, Oxygen saturation normal, Pruritus
Clinical narrative: 15 minutes post injection c/o feeling "hot", itching to trunk and hands, tightness in chest area
Age: 50.0
Sex: F
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: Arthralgia, Blister, Hypoaesthesia, Pharyngeal oedema
Clinical narrative: On Thursday, Sept. 6,2007, client awoke to numbness of bil arms, legs, feet, hands. Symptoms continued and patient developed  blister on right side of inner cheek, slight swelling of throat. MD was seen who ruled out Guillain [[name]] Syndrome, neurologist was consulted who suspected symptoms were vaccination-caused; suggested LP puncture to dx which patient declined.  Client was seen on 9/27/07 and reported her symptoms of numbness are lessening and are intermittent, symptoms in her throat/mouth have disappeared, and the most prominient symptom is joint aching. 10/4/07-notes received from PCP-9/12/07-C/O numbness up to knees, arms and hands cold and tingling and right side of mouth and tongue has feeling of burning and blistering only on right side. Disccusion with neurologist feels Buillain [[name]] is unlikely. Assessment: other specified idiopathic peripheral neuropathy.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site red,  large area swollen, hot - treated with antibiotic with relief
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: large baseball size, red and hard area at varicella injection site
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Anorexia, Body temperature increased, Chills, Fatigue
Clinical narrative: temp 102, chills, no apetite, very tired,
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Profuse watery diarrhea lasting 10 days following the third dose of Rotateq. Remained well hydrated throughout.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anorexia, Fatigue, Pyrexia
Clinical narrative: fever approximetly 102, no apetite, very tired
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Headache, Injection site swelling, Irritability
Clinical narrative: Severe Headaches, severe swelling at injection site, body chills, extreme irritability, stomach ache...all symptoms have been constant for 3 days now starting from the first day of the vaccination. Before hospitalization, I gave her 10mg doses of vitamin c, as well as Tylenol for the body and headache pain.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever, tired
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anorexia, Pain, Pyrexia
Clinical narrative: high fever, whole body ache, loss of apetite
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Blood cholesterol increased, Headache, Hearing impaired, Sleep disorder
Clinical narrative: STRESS, HIGH CHOLESTEROL, HEARING AND VISUAL DISORDERS, HEADACHE, HAIR LOSS, SLEEPING PROBLEM.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Stress, Visual disturbance
Clinical narrative: STRESS, HIGH CHOLESTEROL, HEARING AND VISUAL DISORDERS, HEADACHE, HAIR LOSS, SLEEPING PROBLEM.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Abnormal behaviour, Amnesia, Anxiety, Apathy
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Balance disorder, Confusional state, Coordination abnormal, Depression
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Disturbance in attention, Dry eye, Fatigue, Headache, Increased upper airway secretion
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Insomnia, Learning disability, Loss of libido, Lymphadenopathy, Mood altered
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle twitching, Myalgia, Ocular hyperaemia, Oral herpes, Pain
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Pharyngolaryngeal pain, Restlessness, Sensorimotor disorder, Tendon disorder, Tendonitis
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus, Weight decreased
Clinical narrative: Syptoms started about 4 years ago and become more and more noticeable and more prevelant over time.  Syptoms are unlike patient has acted or felt normally.  Muscular twitching, dry red eyes, joint soreness, tendonitis, extended muscle soreness, tendons pop throughout the body at joints, confusion, major short term memory loss, lost sense of direction (physically), no motivation/lack of creativity, chronic fatugue, difficulty concentrating, difficulty learning new things, depression for no reason, anxiety (social and physical), restlessness, insomnia, destructive behavior (excessive drinking, fighting), moodiness, loss of libido, abdominal pains, pain underneath skin, cold sores, mucus build up in throat (constant for years), sore throat, swollen lymph nodes in neck and arm pits, bad headaches, weight loss (varying 10-20 lbs), ringing in ears, loss of balance, among other symptoms, these are all constant.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a hospital staff member concerning a patient who was vaccinated with the second dose of ROTATEQ vaccine(Lot number was not provided) at four months of age.  Subsequently the patient was vaccinated with the third dose four days later by mistake.  No adverse event was reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information is expected. This is in follow-up to report (s) previously submitted on 9/17/2007.  Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning a 6 year old male patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Lot#656394/0162U) instead of VARIVAX. No adverse symptoms were noted. No further information was provided. There was no product quality complaint involved. This is one of several reports from the same reporter.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning a 6 year old male patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Lot#656394/0162U) instead of VARIVAX. No adverse symptoms were noted. No further information was provided. There was no product quality complaint involved. This is one of several reports from the same reporter.
Age: 11.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning an 11 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose ZOSTAVAX (Lot#656394/0162U) instead of VARIVAX. No adverse symptoms were noted. No further information was provided. There was no product quality complaint involved. This is one of several reports from the same source. This is in follow-up to report (s) previously submittedon 9/24/2007.
Age: 8.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning an 8 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656394/0162U) instead of Varivax (Oka/Merck) (MSD).  No adverse symptoms were noted.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience (WAES#0708USA04532).  This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a physician, an office manager and a medical assistant concerning an 8 year old female patient with no known allergies or pertinent medical history who on 16-AUG-2007 at 11:00 was vaccinated SC in the right thigh with a dose of ZOSTAVAX (Merck) (Lot # 656394/0162U) instead of VARIVAX (Merck) (MSD).  No adverse symptoms were noted.  There was no illness at the time of vaccination.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience (WAES#0708USA04532).  This is one of several reports from the same source.
Age: 8.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning an 8 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656394/0162U) instead of Varivax (Oka/Merck) (MSD).  No adverse symptoms were noted.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience (WAES#0708USA04532).  This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a physician, an office manager and a medical assistant concerning an 8 year old female patient with no known allergies or pertinent medical history who on 16-AUG-2007 at 11:00 was vaccinated SC in the right thigh with a dose of ZOSTAVAX (Merck) (Lot # 656394/0162U) instead of VARIVAX (Merck) (MSD).  No adverse symptoms were noted.  There was no illness at the time of vaccination.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience (WAES#0708USA04532).  This is one of several reports from the same source.
Age: 13.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning a 13 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656394/0162U) instead of Varivax (Oka/Merck) (MSD).  No adverse symptoms were noted.  No further information was provided.  There was no product quality complaint involved.  This is one of several reports from the same source. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician and an office manager concerning a 13 year old female patient with no known allergies or pertinent medical history who on 15-AUG-2007 at 11:30 was vaccinated SC in the left arm with a dose of ZOSTAVAX (Oka/Merck) (Lot#656394/0162U) instead of VARIVAX (Oka/Merck) (MSD). Concomitant vaccination included an IM in the right arm first dose of VAQTA (MSD) (Lot#658172/0800U). There was no illness at the time of vaccination. No adverse symptoms were noted. No further information was provided. There was no product quality complaint involved. This is one of several reports from the same source.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 47 year old female with no medical history and/or drug/allergic reactions who on 18-APR-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  No symptoms were noted.  No diagnostic laboratory tests were performed.  There was no product quality complaint.  Additional information has been received which stated that there was no adverse reaction and the vaccine was administered in error instead of a dose of Varivax (MSD).  Additional information has been received from the licensed practical nurse who stated that the patient's zoster IgG test showed no immunity.  A new nurse in the office showed the negative results to the physician and asked if she could vaccinate the patient.  The physician said yes in reference to vaccinating the patient with a dose of Varivax (MSD).  The new nurse was unfamiliar with both vaccines assumed the vaccine to be given was Zostavax (MSD).  So the patient was vaccinated with a dose of Zostavax (MSD).  It was reported that the patient was doing "fine".  No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female with no known drug reactions who on 30-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 01-JUN-2007 the patient experienced soreness, erythema, swelling, pruritus and warmth around the site of injection.  The area measured 2 cm by 2.5 cm.  Unspecified medical attention was sought.  The patient did not have a temperature and her vitals were normal. No labs were performed.  As of 01-JUN-2007 the patient was not recovered.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old male with no medical history who on 10-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 22-MAY-2007, the patient developed shingles and went to the emergency room and was released with a prescription for seven days of FAMVIR therapy.  On 30-MAY-2007, the went to the physician's office and was given an unknown antiviral medication.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Flushing
Clinical narrative: Information has been received from a physician concerning a 66 year old male with no allergies and a history of hernia surgery who on 30-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 656606/0033U).  There was no concomitant medication.  On 31-MAY-2007, the area under his eyes was puffy and swollen and his face was very flushed.  Unspecified medical attention was sought and he was treated with antihistamines.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 01-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  On 01-JUN-2007 the patient experienced received Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) due to human error.  The patient had no symptoms.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no known medical history who on 21-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot # 656859/0357U).  There was no concomitant medication.  On 21-MAY-2007 the patient developed local redness and swelling at the injection site.  On 01-JUN-2007 the patient developed shingles and the rash was mostly on her forehead and temple.  She went to a different clinic to see a physician who prescribed pain medication and antiviral medication.  At the time of the report the patient had not recovered.  No laboratory tests were performed.  There was no product quality complaint involved.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 75 year old female with no pertinent medical history who on 14-MAY-2007 was vaccinated with Zostavax (Oka/Merck) SQ.  Concomitant therapy included unspecified concomitant medications (physician could not provide list).  On 15-MAY-2007 the patient went to the emergency room and presented with shingles on same side as the vaccine (right side).  The patient did not have a rash of greater than 50 lesions and the patient was not admitted to the hospital.  As of 04-JUN-2007 the patient was recovering from the shingles.  Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 69 year old male with atrial fibrillation and gout who on 01-FEB-2007 at 09:31 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck) (lot # 652947/1212F).  On 27-MAY-2007 the patient developed typical shingles over his left shoulder, neck in C7-8 dermatome.  The patient had no prodome pain and it was a mild case.  No additional information was provided.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female "over 60 years" old who in February 2007, was vaccinated with Zostavax (Oka/Merck).  No information was provided with regard to the patient's medical history and concomitant therapy.  "Within a few weeks", in approximately March 2007, the patient developed shingles on the thoracic line.  The patient was treated with an unspecified antiviral medication.  The patient outcome was not reported.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a health professional concerning his 62 year old wife with allergies to minocycline, erythromycin and Keflex who on 01-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included an unspecified over the counter antacid.  On 02-JUN-2007 the patient experienced a moderate to severe injection site reaction.  The area affected was 6 to 7 inches long and 4 to 5 inches wide.  It was oval shaped and had progressed toward the elbow.  It was pale pink and indurated.  At the upper end of the oval there was a dark red circle that was approximately 3cm in diameter.  The reporter noted that the entire injection site area looked like a distorted bulls eye.  the patient has mild to moderate pain in the area.  The patient was afebrile and taking Aleve for the reaction.  There were no labs performed.  The patient tried to call her physician but they were unavailable.  As of 04-JUN-2007, she had not recovered.  Additional information has been requested. This is in follow-up to previously submitted on 9/24/2007. Information has been received from a physician concerning a 62 year old female with allergic reaction to minocycline, erythromycin, and KELFEX, colonic polyp, rhinitis allergic, obstructive sleep apnoea syndrome, glaucoma, lipids increased. DEMEROL allergy who on 01-JUN-2007 was vaccinated SC with Zostavax (Merck) (lot #657559/0462U). Concomitant therapy included an unspecified over the counter antacid. On 03-JUN-2007 the patient experienced a moderate to severe injection site reaction. The area affected was a 10-15 cm patch. It was oval shaped and had progressed toward the elbow. It was pruritic, pale pink and indurated. At the upper end of the oval there was a dark red circle that was approximately 3cm in diameter. The reporter noted that the entire injection site area looked like a distorted bulls eye. The patient had mild to moderate pain in the area. The patient was afebrile and taking Aleve for the reaction. There were no labs performed. The patient tried to call her physicians but they were unavailabe. As of 05-JUN-2007. She had not recovered. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a 76 year old female who on 06-MAR-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included PLAVIX, ZOLOFT, aspirin, NEXIUM, furosemide and lovastatin (manufacturer unknown).  Subsequently in 2007, the patient developed sores or blisters on her chin and lip.  The patient did not seek medical attention.  Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Influenza like illness
Clinical narrative: Information has been received from an 81 year old male who on 01-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  The patient reported that in June 2007, he experienced "pain in my bones on the shoulder" and flu like symptoms.  The patient questioned if this was a reaction to the vaccine.  The patient's pain in my bones on the shoulder persisted.  As of 03-JUN-2007 the patient had not sought medical attention.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Petechiae, Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a registered nurse (also reported as a medical assistant) and a nurse practioner respectively concerning a 73 year old white male with a penicillin allergy who on an 22-MAY-2007  was vaccinated in the left arm with a first dose of Zostavax (Oka/Merck) (Lot #657625/06180).  Two days later he had a red rash all over his body.  The rash consisted of erythematous petchea at his left upper extremity, back, and bilateral lower extremeties.  He returned to the office and they did made the determination it "may be" due to the Zostavax.  No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient who on 23-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  She reported that on 28-MAY-2007, she developed shingles.  A product quality complaint was not involved.  No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Pain
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 19-JAN-2007 was vaccinated IM with a first dose of Zostavax (Oka/Merck) (lot # 654603/1405F).  On approximately 19-MAR-2007, 2 months after vaccination the patient developed shingles.  The physician reported that there was sciatic nerve involvement, but it was a mild case.  The patient was treated with VALTREX.  At the time of report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that patient experienced shingles outbreak along sciatic nerve to post knee from buttock approximately 4 months after vaccination (also reported as 2 months).  The patient experienced mild symptoms of pain and it was improving at the time of report.  There was no severe neuropathy.  The patient recovered in one week.  No further information is expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: Information has been received from a physician concerning a 73 year old female with high blood pressure, history of cancer and no allergies who on 30-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot # 657558/0461U).  Concomitant therapy included lisinopril, metoprolol and hydrochlorothiazide.  On 02-JUN-2007 the patient developed shingles like rash.  It was reported that rash was mostly on her chin but was spreading to her cheeks and was very itchy and sometime it burned.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report, the patient was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a receptionist concerning an over 65 year old female patient with no pertinent medical history who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck). There was no concomitant medication. It was reported that the patient developed "a couple of spots" within 3 weeks of administration in unknown locations. The spots went away in 4 days. A few weeks later. The patient developed shingles around her hip and other unspecified areas. After few weeks it cleared. At the time of the report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient with no medical history or allergies who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). It was reported that the patient developed fever after receiving the vaccine. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Information has been received from a woman at a physician's office concerning a 67 year old female with a sulfa allergy and a history of uterine dilation and curettage x 6, fracture right leg, tubal ligation, increased lipids, high density lipoprotein increased, oestrogen replacement therapy, gastrooesophageal reflux disease, sciatica, spinal stenosis, carpal tunnel syndrome, PPD skin test positive, benign paroxysmal positional vertigo, knee pain, colonic tubular adenoma, hand osteoarthritis, oesophagogastroduodenoscopy (February 2007) and arthroscopy left knee (November 2003) who on 09-MAY-2007 was vaccinated SC on the left with a first dose of Zostavax (Oka/Merck) (lot # 656859/0357U).  On 09-MAY-2007, the night of having the vaccine, the patient experienced throbbing pain in her knees, shoulders, wrists, back of legs and heels all at once.  Then in the AM on 10-MAY-2007 the pain was gone, but then the patient had a horrible wave of nausea and fatigue.  No additional information was provided.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from an 84 year old female who on approximately 21-MAY-2007 (reported as "2 1/2 weeks ago") was vaccinated with a dose of Zostavax (Oka/Merck). The patient reported that she developed a "few scattered little bumps" under her breast and on arms after receiving the vaccination. The patient could not recall specific dates and did not seek medical attention. At the time of the report, the patient had not recovered. There was no product quality complaint. No further information is available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 82 year old female with no known allergies, hypertension, type II diabetes mellitus, rhinitis allergic and supraventricular tachycardia who on 29-MAY-2007 was vaccinated SC "in the right deltoid muscle" with a single dose of Zostavax (Oka/Merck) (lot # 652965/0622F).  Concomitant therapy included cyanocobalamin, CARDIZEM CD, LANOXIN, GLUCOPHAGE, ALLEGRA, calcium (unspecified), aspirin and FLONASE.  On 30-MAY-2007, the day after the administration of Zostavax (Oka/Merck) (lot # 652965/0622F), the patient developed "flu-like symptoms" including a low-grade fever and widespread body aches.  Unspecified medical attention was sought.  No labs were performed.  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: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female with a history of shingles who on 07-MAR-2007 was vaccinated with Zostavax (Oka/Merck) (lot # 656609/0015U).  On 19-MAR-2007, just over 1 week post vaccination with Zostavax (Oka/Merck), the patient developed a very mild case of shingles.  Subsequently, the patient recovered.  In follow-up information, the registered nurse reported that the 77 year old female patient was vaccinated on 07-MAR-2007 with the first dose of Zostavax (Oka/Merck) (lot # 656609/0015U) (also reported as "00154"), intramuscularly in the left arm.  It was reported that on 14-MAR-2007 (also reported as one week after Zostavax).  The stated "However, in retrospect had symptoms of shingles one week prior to Zostavax".  It was reported that the patient recovered.  Date of recovery reported as 14-APR-2007.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Information has been received from a physician concerning a female patient in her sixties who on 05-JUL-2007, a few hours after vaccination, the patient developed redness and itching involving "almost the whole arm." The physician examined the patient on 06-JUN-2007 and diagnosed her with an allergic C-type reaction. The physician prescribed topical steroid cream and oral antihistamines. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a male (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy not reported.  Subsequently, within a couple of days post vaccination the patient developed an annular area of redness and vesicular bumps around the injection site, and along the arm there were linear erythema with small vesicles.  The patient experienced a little burning and itching.  Outcome of the patient was not reported.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a male (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy not reported.  Subsequently, within a couple of days post vaccination the patient developed an annular area of redness and vesicular bumps around the injection site, and along the arm there were linear erythema with small vesicles.  The patient experienced a little burning and itching.  Outcome of the patient was not reported.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) who in approximately April 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In approximately April 2007, the patient experienced patient came down with shingles after receiving Zostavax (Oka/Merck).  Unspecified medial attention was sought.  No product quality complaint.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Mass, Skin warm, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning his 72 year old wife who on 05-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR, DIAZIDE and INDERAL.  It was reported that on 05-JUN-2007 the patient developed a little bump which was described as 4x1 inches.  Bump was red in color warm to touch and tender.  The patient also had headache for which she took TYLENOL.  The patient had been applying ice and steroid cream to injection site.  No medical attention was sought.  At the time of report the patient was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient's spouse developed a "shingles like rash."  Subsequently, the patient's spouse recovered from the shingles like rash.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 76 year old female consumer who on 11-JAN-2007 was vaccinated with Zostavax (Oka/Merck).  Three months after getting the vaccine in first week of April 2007, the patient developed shingles.  Medical attention was sought.  The patient's shingles persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 04-JUN-2007 was vaccinated with Zostavax (Oka/Merck) (lot# 657675/0618U).  Concomitant therapy included EVISTA and omega-3 marine triglycerides.  On 04-JUN-2007 the patient's balance was off when walking after the vaccination.  As of 08-JUN-2007 the outcome was unknown.  Additional information has been requested.