chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 11/7/08 around 9:00am patient leaned against doorway and felt pain in right upper arm. Patient felt the area warm and observed that it was red. Erythema measures 45 cm by 25cm, feels warm and swollen. Patient states "It's feeling less sore and warm".
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Fever within 24hrs, up to 103.7.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Patient began uncontrollable crying. Patient could not be consoled at any measures parents took. Crying spell was reported to last about 3 hours.
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Rhinalgia, Scab
Clinical narrative: 4th year getting FLUMIST and patient states this has happened every year, sore start to develop in both nostrils and then scab over. They bleed when nose is blown. Pain scale 0-10 (10 being highest) , patient rates at a 6-7. They last for 2/1/2 months and are painful the entire time.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Rash macular, Sensation of heaviness
Clinical narrative: Sore and swelling at injection site started on the second day. The sore and swelling became more sever on the third day, the effected arm became heavy to pick up, swelling down to elbow, and red blotch on the skin. Family doctor prescribed oral BENADRYL and Ice pack to the site. The symptoms improved in a day after the treatment.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after injection (2nd of series). Presents with swelling, erythema, warmth and itching at injection site. Treatment: BENADRYL, KEFLEX. Rechecked 12/19 with now complete resolution of symptoms.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient experienced redness at site of injection. Doctor saw patient and advised patient to give BENADRLY once at home.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Area of injection erythema, induration and tenderness.
Age: 0.8
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Culture throat negative, Culture urine positive, Irritability, Otitis media, Pharyngitis
Clinical narrative: 12-18-2008 Follow up from ER visit for ear infection- vaccines given. 12-19-08 fever-very fussy-diagnosis of otitis media, pharyngitis, pneumonia. ROCEPHIN given 12-20-08 + urine culture done 12-19-08, 12-22-08 doing good.
Age: 0.8
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: 12-18-2008 Follow up from ER visit for ear infection- vaccines given. 12-19-08 fever-very fussy-diagnosis of otitis media, pharyngitis, pneumonia. ROCEPHIN given 12-20-08 + urine culture done 12-19-08, 12-22-08 doing good.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Oedema peripheral, Swollen tongue
Clinical narrative: Swollen tongue, swollen right arm. Rash right arm at injection site.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Local reaction, Pruritus generalised, Urticaria
Clinical narrative: Patient reports having reaction 1.5 hrs after receiving vaccination. Described reaction as localized hives on right upper arm and shoulder and generalized itching. Patient reported to PH and was advised to go to ER. patient went to ER 3/19/08 pm and received BENADRYL shot.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza serology positive, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of influenza in a 54-year-old female subject who was vaccinated with Influenza vaccine, manufacturer unspecified. In October 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced influenza and vaccination failure. A physician reported that his wife, the subject, received a flu vaccine from an unknown manufacturer approximately two months ago, in October 2008. On 24 December 2008, the physician inquired about using RELENZA in the subject and noted the subject was immunized and still got the flu. The physician did say that the subject's throat was swabbed and it was identified as a B strain. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Antibody test negative, Blister, Herpes simplex, Malaise, Oral mucosal eruption
Clinical narrative: pt rec'd a flu shot at his job.  the next day he felt very ill. He was noted to have a diffuse rash on posterior palate with individual white vesicles/comedones on erythematous bases.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Rash, Rash erythematous
Clinical narrative: pt rec'd a flu shot at his job.  the next day he felt very ill. He was noted to have a diffuse rash on posterior palate with individual white vesicles/comedones on erythematous bases.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right arm red,swollen,warm to touch from shoulder to Right elbow. Vet states the pain kept him up all night.  Instructed vet to use warm compresses to arm 15 min QID, take Motrin 400 mg po q6h prn, take Benadryl 50 mg po as soon as he gets home, then Q6H prn. Written and verbal instructions given to vet.  Allergy to Pneumovax charted in CPRS. Instructed vet he can no longer get  Pneumovax injections. Instructed to call Green Team in 1 week if no improvement.  Vet verbalizes understanding of instructions.  Patient did not contact the clinic again regarding this issue.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Client fainted immediately post vaccine administration and regained consciousness within moments. Her last meal was breakfast & vaccine administration occured in the mid PM. Mother called me today (12/29/08)reporting the client ate upon returning home the day of vaccine administration, slept the rest of the day, and had no further problems. Mother verbalizes the client had never experienced this problem post vaccine administration in the past.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Ear infection, Somnolence
Clinical narrative: 12-16-08 mom presents with note of child low grad tem 100 degree F, then increased to 101 - until this am 103.8 am to pm hospital ER - noted treating tem with infant Tylenol .04 ml - ER gave appropriate dose of Tylenol 1.2 ml and sponge bath - tem at present 97.8 - voices concerns with recent vaccines and excessive sleeping - child difficult to arrouse - dx otitis by ER - RX antibiotic - this RN advice - continue observation temp for 4-6 hours - appropriate dose Tylenol every 4-6 hours and RX antibiotic - 12/17-08 TC to mom - states child cont sleeping - temp subnormal - 94.8 12-18-08 attempted TC no answer 12-22-08 TC to mom child behavior and tem returned to normal 12-20 temp 98
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Hives after 4 month set of imms..  Parents took patient to ER.  ER instructed to tx with Benedryl x 5 days.  No other s/s.
Age: 0.58
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Hives-within 1/2 of giving immunization.  Tx with benedryl and kenalog.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Patient had hives after immunizations and increased redness at one injection site.
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Pain in the arm, swollen, I was unable to raise my arm. Severe symptoms occured on 5th day after vaccination.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Left facial droop 1 week after recieving flu vaccine
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Patient received an injection while in the supine position. Following 12 minutes lying down, patient sat up for about 5 minutes on the exam table. Public Health Nurses then went on to assist her to a chair and allowed her to sit for an additional 5 minutes. The patient then fainted and fell off the chair. The entire time the patient never complained of feeling faint, she had little warning it was going to happen. After the patient fainted, nurses assisted her to a supine position and kept her that way for about a half hour when she felt much better. Patient was only out for about 30 seconds. She came back to and an ice pack was placed behind the patients neck. She was pale throughout the course until she started felling better at which time she began to get her pink color back.  She was assisted to the car by wheelchair and transported home per parent.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: 3 1/2 year old grandson developed herpes zoster skin lesions two days after exposure to patient getting Zostavax vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Culture negative, Eye disorder, Lumbar puncture normal, Somnolence, Unresponsive to stimuli
Clinical narrative: Child on 9/13/08 went to local Emerency room with a CC of vomiting x 2 and was sleeper and had an episode of eye deviation and unable to respond to to simple questions.  Tehre was no fever LOC SOB  Chold left the ER awake and well responding well.  Lumbar puncture was completed and child did well. On f/u exam 9/15/08 child well in office and 9/16/08 was seen at another ER with fever Judged to have a viral illness and did well.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Viral infection, Vomiting
Clinical narrative: Child on 9/13/08 went to local Emerency room with a CC of vomiting x 2 and was sleeper and had an episode of eye deviation and unable to respond to to simple questions.  Tehre was no fever LOC SOB  Chold left the ER awake and well responding well.  Lumbar puncture was completed and child did well. On f/u exam 9/15/08 child well in office and 9/16/08 was seen at another ER with fever Judged to have a viral illness and did well.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: CSF culture positive, Meningitis meningococcal
Clinical narrative: Patient vaccinated 4/4/06 with Menactra.  Culture confirmed meningococcal disease on 2/5/07.  CSF culture was positive for Neisseria meningitidis serogroup Y. 12/29/09 DC Summary, Hospital records (2/05-2/11/07) and PCP records received for DOS 1/19/07-4/24/07.   Pt. presented to PCP with headache, congestion, sore throat and bodyaches.  Diagnosed with viral syndrome.  Presented next day to ED with more severe headache, nausea and vomiting, photophobia, fever, chills, stiff neck, and weakness.  Admitted to PICU.  ID consult obtained and treated with antibiotics. Pt discharged stable. and f/u visit to PCP on 2/13/07 indicates symptoms improved.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme, Pain, Pruritus, Rash
Clinical narrative: Patient had smallpox vaccine 5 DEC, then developed rash 23 DEC. It is itchy and painful and is clinically consistent with erythema multiforme. The lesions are mainly on elbows and knees and hands, symmetrically
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Localized reaction at injection site; red, slightly swollen and slightly hard. Icepack applied, with instructions for patient to continue applying ice at home; to be seen at the health center primary care provider for reassessment of injection site. Size of localized reaction measured for baseline.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Localized reaction at injection site; red, slightly swollen and slightly hard. Icepack applied, with instructions for patient to continue applying ice at home; to be seen at the health center primary care provider for reassessment of injection site. Size of localized reaction measured for baseline.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Lymphadenopathy, Myalgia
Clinical narrative: Severe Swelling of Lymph nodes under arm, (left). Persistent, chronic pain in muscles and joints
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Anaphylactic reaction, Asthma, Cough, Diarrhoea, Injection site swelling
Clinical narrative: had anaphylaxis after receiving prevnar and infanrix. suspect infanrix as cause (because of left sided hives on leg and bovine protein in vax). swelling and hives at injection site on left leg. asthma-like coughing, runny nose. fever of 102.  diarrhea 48 hours past injection.  treatment was triminic thin strips every 6 hours for 4 days - prednisone for 3 days and silapap elixir. not recovered yet.  1/12/09 MR received from PCP. Pt in for WCC and imms 12/27/08. That pm developed swelling and urticaria around injection site as well as fever, cough and runny nose.  PE (+) for tachypnea at 40/min. Tx with albuterol with no effect on tachypnea, as well as prednisone and diphenhydramine. Epipen as needed.  Follow-up: Patient has significant beef allergy.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site urticaria, Injection site urticaria, Pyrexia, Rhinorrhoea
Clinical narrative: had anaphylaxis after receiving prevnar and infanrix. suspect infanrix as cause (because of left sided hives on leg and bovine protein in vax). swelling and hives at injection site on left leg. asthma-like coughing, runny nose. fever of 102.  diarrhea 48 hours past injection.  treatment was triminic thin strips every 6 hours for 4 days - prednisone for 3 days and silapap elixir. not recovered yet.  1/12/09 MR received from PCP. Pt in for WCC and imms 12/27/08. That pm developed swelling and urticaria around injection site as well as fever, cough and runny nose.  PE (+) for tachypnea at 40/min. Tx with albuterol with no effect on tachypnea, as well as prednisone and diphenhydramine. Epipen as needed.  Follow-up: Patient has significant beef allergy.
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Patient had 2 1/2x 1 1/2 in red, swollen area with lump to right arm
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Antiacetylcholine receptor antibody positive, Antinuclear antibody increased, Autoimmune disorder, Myasthenia gravis
Clinical narrative: Diagnosed with Myasthenia Gravis (autoimmune disease)  5/13/09 hospital records received DOS 11/25/08 to 11/27/08. FINAL DIAGNOSIS: Myasthenia gravis, viral meningitis Post vaccination droopy left eyelid, difficulty running, weak grip, mouth and jaw fatigue, diplopia, dizziness. Admitted for IVIG treatment. Headache, increased ptosis, upper and lower extremity weakness. Nausea, vomiting  5/14/09 Received Neuro medical records of 11/24/2008. FINAL DX: myasthenia gravis Records reveal patient experienced weakness x 2 mo starting w/left eyelid droop, then mouth weakness, arm heaviness, grip strength decreased, leg stiffness, difficulty arising from sitting position, diplopia, intermittent left lazy eye, mouth/jaw fatigue, tiredness, slurred speech, DOE, heartburn, difficulty chewing & swallowing, loss of balance, loss of memory, urinary frequency esp at night.  Sent to hospital for CT, IVIG x 2 days, steroids.  5/18/09 Received PCP medical records of 10/21/08-2/25/2009. Records reveal patient experienced fatigue, dizziness, blurred vision, gen weakness, difficulty concentrating & memory retention difficulties x approx 1 mo when seen 10/21.  Referred to Rheum.  No further visits until 2/25/09 s/p myasthenia gravis.    5/18/09 Received medical records from Rheum but was only labs of 11/19/2008.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Ileus, Intestinal resection, Intussusception, Nausea
Clinical narrative: Pt had acute onset of intestinal ileus after a procedure of 3-4 days of nausea and diarrhea, becoming frank rectal bleeding. Pt diagnosed with intussusception requiring a 6 inch resection at caecum and small bowel.  1/23/09 Reviewed hospital medical records of 09/17-09/23/2008. FINAL DX: Ileocolic & colocolonic intussusception; colectomy w/resection of terminal ileum & primary ileocolonic anastomosis. Records reveal patient experienced lethargy, vomiting, dehydration, abdominal distention x 24 hr.  Air enema resulted in bowel perforation & pneumoperitoneum.  To OR & PICU.  Tx w/TPN.  Diet advanced, tol well & d/c to home.  1/12/09 Reviewed hospital medical records of 9/14-9/17/2008. FINAL DX: acute ileus, possible IS vs volvulus; dehydration, resolved; viral enteritis; bilsteral supprative OM. Records reveal patient experienced bilateral supprative OM, vomiting, lethargy, red cheeks, low grade fever .  Developed bloody stool.  Transferred to higher level of care.  1/14/09 Reviewed PCP medical records of 8/7-12/29/2008. Records reveal patient experienced regurgitation, gas, arching back, crying during feeding on 8/7/08.  Formula changed to soy.  RTC 8/12 w/Acute URI & rhinnitis.  RTC 10/1/08 doing well post op.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rectal haemorrhage
Clinical narrative: Pt had acute onset of intestinal ileus after a procedure of 3-4 days of nausea and diarrhea, becoming frank rectal bleeding. Pt diagnosed with intussusception requiring a 6 inch resection at caecum and small bowel.  1/23/09 Reviewed hospital medical records of 09/17-09/23/2008. FINAL DX: Ileocolic & colocolonic intussusception; colectomy w/resection of terminal ileum & primary ileocolonic anastomosis. Records reveal patient experienced lethargy, vomiting, dehydration, abdominal distention x 24 hr.  Air enema resulted in bowel perforation & pneumoperitoneum.  To OR & PICU.  Tx w/TPN.  Diet advanced, tol well & d/c to home.  1/12/09 Reviewed hospital medical records of 9/14-9/17/2008. FINAL DX: acute ileus, possible IS vs volvulus; dehydration, resolved; viral enteritis; bilsteral supprative OM. Records reveal patient experienced bilateral supprative OM, vomiting, lethargy, red cheeks, low grade fever .  Developed bloody stool.  Transferred to higher level of care.  1/14/09 Reviewed PCP medical records of 8/7-12/29/2008. Records reveal patient experienced regurgitation, gas, arching back, crying during feeding on 8/7/08.  Formula changed to soy.  RTC 8/12 w/Acute URI & rhinnitis.  RTC 10/1/08 doing well post op.
Age: 68.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Body temperature increased, Erythema, Skin warm
Clinical narrative: Above mentioned patient was given ZASTOVOX (shingles vaccine) on 12/26/2008 in left deltoid area.  Subq. Large reddened area with small amt. of warmth noted.  Stated temp increased 101.3 for 2 days post injection.  T 98.3 today on 12/29/2008.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count normal, Grand mal convulsion, Laboratory test normal, Scan brain
Clinical narrative: Patient had grand mal seizure(1st ever)within few hours of receiving vaccines.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Flushing, Pruritus
Clinical narrative: Pt described itching ears and had slight flushing of skin on chest area. Benadryl given and symptoms resolved. Symptoms developed 33 mins after vaccine given. Symptoms resolved within 30 minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Deltoid area site of Dtap vaccine, slightly swollen, mild erythema, client afebrile today. Area not hot to touch N/C of pain upon palpation. Advised mother if client complains of pain if condition worsened seek advise of PCP.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Flushing
Clinical narrative: Developed several red areas on chest & neck.  0 hives, 0 sob, 0 coughing, 0 wheezing.  Pt states she has routine undiagnosed allergies & not unusual for her to develop frusney when nervous also.  Refused BENADRYL.  Pt states she's allergic, but did not list as allergy on screening.  Refused epinephrine.  Areas resolved within 30 minutes. 0 further signs/symptoms.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Rt deltoid area red, swollen-hot to touch- 12/26/08. Swelling gone 12/29/08. Pain gone 12/29/08.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Borrelia burgdorferi serology negative, HLA marker study, Influenza like illness, Partial seizures
Clinical narrative: HC received call from someone with desire for anthrax vaccine exemption because of previous "polyarthralgias" after his receipt of AVA # 3.  Symptoms: Rash, focal, Joint Pain, multiple joints, Flu-like symptoms < 96 hours.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Parvovirus B19 serology negative, Rash, Rheumatoid factor negative
Clinical narrative: HC received call from someone with desire for anthrax vaccine exemption because of previous "polyarthralgias" after his receipt of AVA # 3.  Symptoms: Rash, focal, Joint Pain, multiple joints, Flu-like symptoms < 96 hours.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Rash papular, Swelling face
Clinical narrative: Mild facial swelling maulpapule. No rest. Lasted for about 6-7 days. Remedy Prelone.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a Registered pharmacist concerning an 80 year old female with no  pertinent medical history and no drug reactions or allergies, who on 28-SEP-2007 was vaccinated with ZOSTAVAX (Oka/MERCK) (lot # not reported), via subcutaneously. The patient experienced an out break of shingles. The patient sought an unspecified medical attention. No further information is available at this time. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008.  Information has been received from a registered pharmacist concerning a female with allergies to AVELOX  and it was also reported that the patient was "allergic to everything", who on 03-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 663195/1416X, route, dose not reported).  The patient experienced a large red rash at the injection site where ZOSTAVAX (Merck) was given.  The patient states the area is "really red".  The patient sought unspecified medical attention.  No lab was reported.  The patient's large red rash was not recovered.  Follow up information was received which reported:  The 62 year old female with no illness at the time of vaccination on 03-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 663195/1416X) via subcutaneous at 3:00pm.  The pharmacist reported that on 04-NOV-2008 the site of the injection was real red about double quarter size next to each other.  There was no pustule present, just real red and itchy.  No lab tests or diagnosis were performed.  On an unspecified date, the patient recovered from the events.  Follow-up information received from the pharmacist indicated that the patient was a banker.  the patient recovered on 10-NOV-2008.  No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster
Clinical narrative: Information has been received from a 62 year old female with no pertinent medical history and no drug reactions or allergies, who in February 2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659672/0294X, dose, route not reported).  There was no concomitant medication.  In June 2008, the patient experienced an outbreak of shingles mostly on her face.  The most recent case of shingles was in October 2008 and she was still experiencing it.  The patient's eyes are almost swollen shut.  The patient never had shingles before getting the vaccine.  The patient sought unspecified medical attention.  No lab diagnostics studies performed.  The events were not recovered.  No further information provided.  Additional information is not expected.    This is in follow-up to report (s) previously submitted on 12/23/2008.  Follow up information has been received from the consumer.  She stated that she had been diagnosed with dermatitis and not shingles.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute febrile neutrophilic dermatosis
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female with hypertension who on 02-JUL-2008 was vaccinated with ZOSTAVAX (Merck) subcutaneously.  Concomitant therapy included ACUPRIL, ACTONEL, vitamins (unspecified) and calcium (unspecified).  On 15-JUL-2008 the patient experienced Sweet's syndrome.  The patient was treated by an unspecified dermatologist with CELEBREX and TYLENOL.  On 30-SEP-2008, the patient completely recovered from sweet's syndrome.  The patient sought medical attention.  Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 45 year old female who on 05-NOV-2008 was vaccinated with ZOSTAVAX 0.65mL (Lot # not provided). After getting ZOSTAVAX on 05-NOV-2008, the patient experienced bitter taste. The patient's bitter taste persisted. The patient also reported that she was vaccinated at the age of 45 year old. The patient did not seek medical attention. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received concerning an approximately 75 year old male patient who in "early summer 2008" (in June 2008), was vaccinated with ZOSTAVAX (Lot # not available) and subsequently the patient broke out with shingles along his back and shoulders shortly afterward. The patient's persisted. The patient sought medical attention. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old female with drug reaction/allergy to Tiazac, Ultram, Diflunisal (MSD) (WAES # 0811USA01605), Cymbalta, Enablex, Lyrica, Mobic, Coreg, Topamax and Keppra who in approximately 2007 (reported as "approximately one year ago") was vaccinated with ZOSTAVAX. Concomitant therapy included Cardene, MSD, Vagifem, Atrovent, MSD, Astelin, Nasonex, Celebrex, Restasis, Cafergot, Midrin, Reglan, Lamictal, Lidoderm, vitamin A, vitamin D (unspecified), glucosamine, fish oil, folic acid, omeprazole and guaifenesin. The physician reported that on approximately 23-OCT-2008 (reported as "2 weeks ago") the patient was experiencing a mild case of shingles. At the time of reporting the patient had not recovered. No labs/diagnostic tests were performed. The patient sought medical attention: was seen by the physician. There was no product quality complaint. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female who in 2006 was vaccinated with ZOSTAVAX (Merck), 0.65 ml and had a case of shingles just recently in November 2008.  Follow-up information was received from a pharmacist which reported that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Merck vaccine VZV strain.  The date of vaccination was on 17-APR-2007, dose 0.5ml, in the right upper arm (lot# 656394/0162U).  Concomitant therapy included ATENOL, Calcium (unspecified), TYLENOL, CADUET, COMBIVENT and vitamins (unspecified).  The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination.  The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination.  The patient had multiple lesions in her head, right arm including shoulder.  There was pain in the lesions.  There was no recent exposure to chickenpox or shingles.  At time of reporting, the patient was recovered.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in jaw
Clinical narrative: Information has been received from a registered pharmacist concerning a female who on approximately 05-NOV-2008 was vaccinated with ZOSTAVAX (LOT # was not reported). On approximately 05-NOV-2008 the patient experienced rash around the injection site after receiving ZOSTAVAX but it was no itchy or warm. She also experienced lower jay pain. The patient's rash around the injection site and lower jaw pain persisted. It was reported the patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male with history of about 6 cases of shingles, and no drug reactions or allergies, who in May 2006, was vaccinated with ZOSTAVAX, 0.65 ml injection (lot # not reported). Concomitant therapy included Valtrex. In September 2008 two years went by, the patient developed another case of the shingles. The patient sought unspecified medical attention. Routine labs were performed. The patient's shingles was not recovered. No further information was provided. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Laboratory test
Clinical narrative: Information has been received from a 66 year old female with arthritis and no drug allergies who on 05-NOV-2008 was vaccinated with ZOSTAVAX (Merck) 0.65ml, (lot # not provided).  Concomitant therapy included MOBIC.  A few days after vaccination, on 07-NOV-2008 the patient experienced a headache.  "Routine labs" tests were performed (results not provided).  The patient's headache persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dyspepsia, Electrocardiogram normal, Panic attack, Sleep disorder
Clinical narrative: Information has been received from a 78 year old female consumer, who was also the patient, with a history of platelet and red blood cell disorder. The consumer mentioned that she had been taking Prednisone daily since April 2008. Her dose of Prednisone started at 40 mg daily and had been decreased over the past several months. At the end of June 2008, the patient was vaccinated with a dose of ZOSTAVAX. Route was reported as oral. At that time her Prednisone dose was 20-40 mg. Beginning in July 2008, the patient developed sleep disturbance, panic attacks, heartburn and anxiety. Electrocardiogram was performed that was negative. The consumer reported that the symptoms had continued and had increased in intensity. The patient sought unspecified medical attention at office. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 61 year old female patient who on 05-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 653197/1418X).  On 06-NOV-2008 the patient experienced intense pain, redness and swelling from the shoulder ot the elbow. On approximately 08-NOV-2008 the patient recovered.  This is one of two reports received from the same source.  Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Lower extremity mass, Pain in extremity
Clinical narrative: Information has been received from a 64 year old male patient with no known drug reaction/allergies and lymphangioma which causes him to have a large mass on his thigh.  Who on 08-NOV-2008 was vaccinated with a dose of ZOSTER (Oka/Merck).  There was no concomitant medication.  On 09-NOV-2008 the patient reported that the mass on his thigh became "very achy and he could hardly walk".  The patient also mentioned that he got the "chills".  There were no lab diagnostics studies performed.  The patient did not seek medical attention.  At the time of the report, the patient has not recovered.  No further information is available.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Incorrect route of drug administration, Injection site mass
Clinical narrative: Information has been received from a registered pharmacist and female consumer concerning a 76 year old female patient with high cholesterol, hypertension and allergy to CODEINE who on 06-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663195/1416X).  Concomitant therapy unspecified medications for cholesterol and blood pressure lowering.  It was noted that the patient was "possibly" given the influenza virus vaccine (unspecified) on 06-NOV-2008.  The pharmacist reported that the patient developed a lump at the injection site.  The patient's daughter also called the pharmacist and feel it that the patient received the dose of ZOSTAVAX (Merck) intramuscularly because of the injection site reaction.  The pharmacist could not confirm that the dose of ZOSTAVAX was given intramuscularly.  The patient sought unspecific medical attention by calling the pharmacy.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral disorder, Oropharyngeal pain, Rash
Clinical narrative: Information has been received from a physician concerning an 81 year old female patient who in approximately 2007 was vaccinated with a dose of ZOSTAVAX. On 23-OCT-2008 the patient experienced sore throat and went to an urgent care facility then the ER the next day. The patient then developed shingles. She had a rash on her face (cheek) and lesions in her mouth, exactly on half the mouth. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 58 year old female patient who in approximately 2007 was vaccinated with a dose of ZOSTER (Oka/Merck).  In approximately 2007, almost immediately, the patient experienced a local injection site reaction, after receiving the ZOSTER (Oka/Merck).  It was reported that the patient is fine now.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Headache, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient, with tetracycline allergy and a medical history  of chicken pox, mumps and measles, who on 13-Feb-2008 was vaccinated with ZOSTAVAX (lot#659323/01613U) in the left arm deltoid. Concomitant therapy included PRILOSEC 20mg (2 capsules, once daily), atenolol, and amitriptyline  hydrochloride. The pharmacist reported that the patient received the vaccine and developed PHN. The timing was not known. Two days after vaccination, on 15-Feb-2008, the patient experienced rash at the site of vaccination (3 inches diameter, raised red area, hard and hot with no pustules. The patient did not have fever. There was no recent exposure to chickenpox or shingles noted. In mid April 2008, the patient experienced daily left sided headaches and in mid June, the patient experienced daily left sided headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the report, headaches and eye sensation and visual distortion continue and were diminishing. The patient was seen in the physician's office. A specimen was not collected for PCR. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Metamorphopsia, Post herpetic neuralgia
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient, with tetracycline allergy and a medical history  of chicken pox, mumps and measles, who on 13-Feb-2008 was vaccinated with ZOSTAVAX (lot#659323/01613U) in the left arm deltoid. Concomitant therapy included PRILOSEC 20mg (2 capsules, once daily), atenolol, and amitriptyline  hydrochloride. The pharmacist reported that the patient received the vaccine and developed PHN. The timing was not known. Two days after vaccination, on 15-Feb-2008, the patient experienced rash at the site of vaccination (3 inches diameter, raised red area, hard and hot with no pustules. The patient did not have fever. There was no recent exposure to chickenpox or shingles noted. In mid April 2008, the patient experienced daily left sided headaches and in mid June, the patient experienced daily left sided headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the report, headaches and eye sensation and visual distortion continue and were diminishing. The patient was seen in the physician's office. A specimen was not collected for PCR. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a doctor of pharmacist concerning a patient who a few years ago was vaccinated with a dose of ZOSTER (Oka/Merck).  The patient developed swelling and redness.  The reaction progressed to swelling from the injection site (shoulder) to the elbow.  Subsequently, the patient recovered.  This is one of the two reports received from the same source.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Erythema, Flatulence, Hypertension, Insomnia
Clinical narrative: Information has been received from a 72 year old male patient with allergic to sulfa drugs and an unspecified beta blocker and no other medical history who on 10-NOV-2008 was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included FROTONIX, and AVAPRO.  On 11-NOV-2008, at 03:00, the patient experienced stomach pains and gas, he also noted that his face "was warm and red" but he confirmed that it was not a rash.  The patient also developed high blood pressure, trouble sleeping and his left arm occasionally twitches.  No lab diagnostics studies were performed.  Therapy with ZOSTER (Oka/Merck) was discontinued.  Subsequently the patient recovered from stomach pains and stomach gas after stopping therapy, but he was still experiencing the other symptoms to a lesser degree.  The patient did not seek medical attention.  The patient also reported that he experienced stomach pains, gas and high blood pressure after receiving an unspecified corticosteroid (manufacturer unknown).  No further information is available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle twitching, Skin warm
Clinical narrative: Information has been received from a 72 year old male patient with allergic to sulfa drugs and an unspecified beta blocker and no other medical history who on 10-NOV-2008 was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included FROTONIX, and AVAPRO.  On 11-NOV-2008, at 03:00, the patient experienced stomach pains and gas, he also noted that his face "was warm and red" but he confirmed that it was not a rash.  The patient also developed high blood pressure, trouble sleeping and his left arm occasionally twitches.  No lab diagnostics studies were performed.  Therapy with ZOSTER (Oka/Merck) was discontinued.  Subsequently the patient recovered from stomach pains and stomach gas after stopping therapy, but he was still experiencing the other symptoms to a lesser degree.  The patient did not seek medical attention.  The patient also reported that he experienced stomach pains, gas and high blood pressure after receiving an unspecified corticosteroid (manufacturer unknown).  No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Information has been received from a 71 year old female with allergic to Codeine , History of allergic to dust and many other things, who on 04-Nov-2008 was vaccinated with ZOSTERVAX. Concomitant therapy included NEXIUM, ALLEGRA, NASONEX and unspecified thyroid medication. On 04-Nov-2008 the patient experienced tingling sensation on the top of her head shortly after receiving ZOSTERVAX. The next day it became a burning and stinging pain. The patient went to the emergency room and they felt that it could be shingles out break but were unsure because there was no rash along with the pain. Many unspecified tests were performed. The events have not been recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (lot @ not provided). 3 months after the vaccination, the patient experienced shingles. The patient saw the physician. At the time of the report, on 11-NOV-2008, the outcome of the patient was unknown. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 92 year old female who "a year and a half ago" in approximately May 2007, was vaccinated with ZOSTER (Oka/Merck).  On 11-NOV-2008 the patient experienced shingles.  The patient had sought medical attention from the physician.  At the time of reporting, the outcome of the shingles was unknown.  No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received from a Pharm. D. student concerning a 66 year old male patient with hypertension, gout, arthritis and prostate cancer, who on 24-JUN-2008 was vaccinated  with a dose of ZOSTAVAX (Merck) (lot# not provided) 0.65ml subcutaneously.  Concomitant therapy included LABETALOL HCL, MSD, NORVASC, NEXIUM, MONOPRIL, CELEBREX, COLCHICINE injection, ULTRAM and LOMOTIL.  In September 2008, the patient experienced post herpetic neuralgia.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male patient with no drug reactions/allergies, who on 06-NOV-2008 was vaccinated subcutaneously with a 0.5 mL dose of ZOSTAVAX (Merck) (Lot #663197/1418X).  There was no concomitant medication.  On 10-NOV-2008 the patient developed an "itchy rash on the back of his neck".  The patient was seen by the physician and the rash encompassed the right side of the neck and scalp.  The physician did not wish to culture the rash.  At the time of reporting, the patient was recovering.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/23/2008. Follow up information received from a physician on 05-JAN-2008. It was reported that concomitant therapy included COLESTID, ACCUPRIL, aspirin, METAMUCIL, folic acid, ezetimibe (+) simvastatin and ascorbic acid. On 11-NOV-2008 the patient noted a vesicular rash on the right side neck and post scalp with minor discomfort. Patient was treated with FAVIA and then the patient recovered. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a male who on 12-Nov-2008 was vaccinated subcutaneously with a dose of ZOSTER (Oka/Merck) at the pharmacy.  On 13-NOV-2008 the patient developed facial swelling and tenderness of the left cheek.  On 13-NOV-2008 the patient consulted the pharmacist and was suggested to take BENADRYL.  No laboratory or diagnostics tests were performed.  At the time of this report, 13-NOV-2008. the events persisted.  Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow up information received from the pharmacist indicated that the 63 year old male patient received the first dose of ZOSTAVAX (Oka/Merck) (lot# 663196/1417X) SQ on 12-NOV-2008. On 13-NOV-2008, the patient developed left facial cheeck swollen for 3 days. On day 3, the patient developed rash at injection site. At the time of the report, on 08-JAN-2009, the result of the adverse events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with ZOSTER (Oka/Merck).  Within 24 hours of vaccination, the patient experienced varicella like rash.  Subsequently, the patient recovered from varicella like rash.  The patient called the physician.   Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with no known drug allergies who on 10-NOV-2008 was vaccinated with one dose of ZOSTAVAX (Merck) (lot number not provided).  There was no concomitant medication.  On approximately 10-NOV-2008 the patient developed soreness, redness, swelling and pain at the injection area.  At the time of reporting, the patient did not recover.  The patient sought medical attention by consulting pharmacist.  Additional information has been requested.