chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Drug ineffective, Herpes zoster, Rash, Skin lesion
Clinical narrative: Information has been received from a 73 year old female consumer with a degenerative disc and allergies to LEVAQUIN, OXYCONTIN, and "Otrast" and "Otram" and a history of chicken pox who on 12-NOV-2007 who received a single dose series injection in the left arm of ZOSTAVAX (lot# "1088U".) Concomitant therapy included MOBIC, triamterene, aspirin, alendronate sodium (MSD), DYAZIDE, and Valium. On 18-NOV-2007, she developed a few red spots on the back of her neck. She reported that the day (19-NOV-2007); there were a few more spots. On 21-NOV-2007, she was seen by her physician who diagnosed her with shingles. At the time of this report, the consumer reported that she was recovering. A product quality complaint was no reported. 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 (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information from a physician reported that six days (18-NOV-2007) post vaccination, she developed classic herpes zoster in the left C5-C6 dermatone area. He described the lesions as herpetic vesicles numbering 12-15 lesions. Current patient status was not reported. Follow up information reported that the varicella zoster vaccine identification specimens were obtained on 18-NOV-2007, and 27-NOV-2007 from a vesicle from an unspecified site. The PCR results for the specimen from the vesicle identified the presence of WT. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Information has been received from a 73 year old female consumer with a degenerative disc and allergies to LEVAQUIN, OXYCONTIN, and "Otrast" and "Otram" and a history of chicken pox who on 12-NOV-2007 who received a single dose series injection in the left arm of ZOSTAVAX (lot# "1088U".) Concomitant therapy included MOBIC, triamterene, aspirin, alendronate sodium (MSD), DYAZIDE, and Valium. On 18-NOV-2007, she developed a few red spots on the back of her neck. She reported that the day (19-NOV-2007); there were a few more spots. On 21-NOV-2007, she was seen by her physician who diagnosed her with shingles. At the time of this report, the consumer reported that she was recovering. A product quality complaint was no reported. 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 (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information from a physician reported that six days (18-NOV-2007) post vaccination, she developed classic herpes zoster in the left C5-C6 dermatone area. He described the lesions as herpetic vesicles numbering 12-15 lesions. Current patient status was not reported. Follow up information reported that the varicella zoster vaccine identification specimens were obtained on 18-NOV-2007, and 27-NOV-2007 from a vesicle from an unspecified site. The PCR results for the specimen from the vesicle identified the presence of WT. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an immunizing pharmacist that developed shingles. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that the vaccination was a while ago and that there still was a round circle at the site of the injection. It was unspecified if the patient sought medical attention. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Culture urine positive, Escherichia infection, Pyrexia, Urinary tract infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 65-year-old male with no pertinent medical history or allergies, who on 21-NOV-2007 was vaccinated subcutaneously with a "single dose" of zoster vaccine live (Oka/Merck) (lot# 658602/1080U). There was no concomitant medication. One day after receiving the vaccination, on 22-NOV-2007, the patient developed an elevated temperature of 102F. The fever was controlled with TYLENOL. The patient was examined in the office on 23-Nov-2007 and the oral temperature was 98.3F. A urine culture revealed a urinary tract infection and the patient was prescribed SEPTRA. The outcome is unknown. No product quality complaint was involved. Follow-up information has been received from the certified medical assistant concerning a white male. A urine culture on 23-Nov-2007 was positive for E coli. The patient got better in 3 to 4 days. It was reported that "all of this may have been his urinary tract infection". Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 78-year-old female with no allergies or pertinent medical history who on 21-NOV-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 23-NOV-2007 the patient developed "significant headaches that were generalized". The patient contacted the physician for medical attention. No laboratory tests or diagnostic studies were performed. The outcome was reported as recovering, " the headaches got less severe but are not completely resolved". No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pharmacy technician concerning a patient who on 23-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck). It was reported that after receiving the vaccination the patient developed erythema at the injection site that spread to a 9 1/2 cm by 13 1/4 cm area with central in duration. The patient was examined by the physician who diagnosed the patient with cellulitis. It was reported that the physician prescribed BACTRIM DS and BENADRYL. It was reported that as of 27-NOV-2007, the patient was doing "OK". A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a 66 year old 120 lb. 64.5 in. white retired female with no allergies and no pertinent medical history who on 20-NOV-2007 at 14:30 hours received a subcutaneous single dose in the right deltoid of ZOSTAVAX (lot# 656395/0290U, or lot# 0657766/0620U).  Concomitant therapy included venlafaxine hydrochloride (EFFEXOR).  It was reported that one day after the vaccination (21-NOV-2007); she developed itchy, red splotches, and deep aching under her right breast extending around to the right mid back.  The patient called the physicians office and was advised to take diphenhydramine (BENADRYL).  On 23-OCT-2007, she was examined in the office by the physician who diagnosed her with Herpes Zoster.  The Herpes Zoster reportedly affected the T7 to T8 dermatone area.  Treatment included administration of kertolac (TORADOL) 60 mg. intramuscular in the office.  She was written prescriptions for kertolac (TORADOL), 10 mg tablets, one tablet twice a day, oxycodone (+) actaminophen (PEROCET).  She was also prescribed methylprednisolone, hydrocodone, and valacyclovir (VALTREX).  The patient was last seen by the physician on 12-DEC-2007, and current patient status was reported as unknown by the physician.  A product quality complaint was not reported.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Pt. seen Wed. 4-2-08, given Pneumovax inj., by Thurs. night her arm was fiery red, red rash, warm to the touch, and sore.  No tx.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, No therapeutic response
Clinical narrative: Information has been received from a physician concerning an approximately 75 year old male who on 18-DEC-2006 received a single dose injection of Zostavax (Oka/Merck). There were no concomitant vaccinations. It was reported that after he had received the vaccination, he developed on 07-DEC-2007, a severe case of shingles. It was reported that he sought unspecified medical attention. Current patient status was not reported. It was reported that the patient had picked up the vaccine from a pharmacy and transported it himself to the physician's office. Follow up information indicated that patient developed shingles in December 2007. The reporter felt that the patient did not get immunity from the vaccine and was not an adverse reaction. Current patient status was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Vaccine reaction on (L) arm 3 1/2 in. x 3 1/2 in. Advised parent to use cold water, Tylenol
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Activities of daily living impaired, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Fever-current 99.3-has had chills/sweats today.  Sore throat-predated immunization.  Fatigue-all day today.  Skipped class.  Headache-all day today.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test normal, Pyrexia, Streptococcal identification test
Clinical narrative: Fever-current 99.3-has had chills/sweats today.  Sore throat-predated immunization.  Fatigue-all day today.  Skipped class.  Headache-all day today.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Injection site vesicles, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 66 year old female who on 13-SEP-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (Lot # 65820/0883U). There was no concomitant medication. On 01-OCT-2007 the patient developed a large edematous welt with a central blister at the injection site. One week later, on approximately 08 OCT 2007, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint; Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures (two in 24 hours) after DTaP, Hib, Hepatitis B
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L deltoid red, bruised, warm, little bit swollen.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Weakness, chills, fever, malaise. Reaction at site- 5 cc swelling
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: Weakness, chills, fever, malaise. Reaction at site- 5 cc swelling
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: thigh had erythema and swelling from groin to knee, complete circumference of this (L) leg
Age: 21.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: (L) arm deltoid pain and shoulder pain x 2 days starting 14 days after injection. No erythema, no ecchymosis, no induration, no warmth at injection site. Tx -warm packs, ROM exercises, Tylenol/Aleve.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning an approximately 55 year old male with a history of shingles thirty years ago who on 19-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot # 658361/1090U). The physician stated that "the patient's post herpetic neuralgia has gotten 50% better since the vaccine was administered". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a 71-year-old female with Hodgkin's lymphoma (left upper neck below ear), fibromyalgia, irritable bowel syndrome (IBS) and allergies to Sulfa drugs, codeine and aspirin who on 26-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  The patient noted that she was in remission from the Hodgkin's lymphoma but it had returned prior to receiving ZOSTAVAX.  Illness at the time of vaccination included swollen lymph nodes.  Concomitant therapy included estradiol (CLIMARA), dicyclomine HC1 omeprazole (PRILOSEC), amitriptyline HC1 (ELAVIL), vitamin D (unspecified), calcium (unspecified) and lutein (xanthophyll).  The patient reported that on 26-NOV-2007, she experienced bone pain in hips and thighs 3-4 hours after being vaccinated.  The patient also reported that she experienced a stiff neck, pain on the left and mild pain on the right side.  The patient subsequently called her physician.  No laboratory/diagnostic tests were performed.  The patient indicated that as of 28-NOV-2007 she had no pain and considered herself to be recovering.  No further information is available.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Dysphonia, Herpes zoster, Lethargy, Oropharyngeal blistering
Clinical narrative: Information has been received from a consumer concerning her 73-year-old husband who had no medical history or allergies who on 06-NOV-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included LIPITOR. On 23-NOV-2007, the patient developed blisters in his mouth, a low-grade fever, was lethargic and developed some lesions on his gums. On 24-NOV-2007, the lesions had spread to the back of his tongue and the inside of his cheek. All of the lesions were noted to be on one side of his mouth except for on the upper part of his tongue which had lesions on both sides. The patient was experienced severe pain, burning, soreness and hoarseness. On 26-NOV-2007, the patient was examined by a physician who was not sure what was causing the patient's symptoms. He was prescribed VALTREX. On 27-NOV-2007, the patient was examined by a Periodonist who diagnosed him with shingles. On 28-NOV-2007, the patient was examined by an ENT physician who diagnosed him with stomatitis. No laboratory/diagnostic tests were performed. As of 28-NOV-2007, the patient was still taking VALTREX and for the first time since onset had some improvement. The patient was noted to be recovering. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Stomatitis, Tongue ulceration
Clinical narrative: Information has been received from a consumer concerning her 73-year-old husband who had no medical history or allergies who on 06-NOV-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included LIPITOR. On 23-NOV-2007, the patient developed blisters in his mouth, a low-grade fever, was lethargic and developed some lesions on his gums. On 24-NOV-2007, the lesions had spread to the back of his tongue and the inside of his cheek. All of the lesions were noted to be on one side of his mouth except for on the upper part of his tongue which had lesions on both sides. The patient was experienced severe pain, burning, soreness and hoarseness. On 26-NOV-2007, the patient was examined by a physician who was not sure what was causing the patient's symptoms. He was prescribed VALTREX. On 27-NOV-2007, the patient was examined by a Periodonist who diagnosed him with shingles. On 28-NOV-2007, the patient was examined by an ENT physician who diagnosed him with stomatitis. No laboratory/diagnostic tests were performed. As of 28-NOV-2007, the patient was still taking VALTREX and for the first time since onset had some improvement. The patient was noted to be recovering. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Vaccine omitted, check wasn't clear.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin warm
Clinical narrative: Left hip was red and hot, measured 3 1/2 in x 5 1/2 in after receiving all shots.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Injection site vesicles, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old female with codeine, ASA and morphine allergy who on 20-NOV-2007 at 10:30 AM was vaccinated with a first 0.6 ml dose of ZOSTAVAX (Lot # 658397/1820U).  On 21-NOV-2007 the patient developed blistering around injection site which did spread along dermatome.  On 27-NOV-2007 the physician diagnosed it as mild to moderate case of shingles.  Additional information has been received from the physician who stated that the patient on 21-NOV-2007 in morning developed zoster like eruption starting at injection site.  It was reported that the eruption occurred within 24 hours of vaccination.  On an unspecified date the patient recovered.  No further information is expected.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain (L) deltoid to elbow.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 48 post-vaccination was noted to have a 4.5 x 6 cm area of erythema and induration at injection site. No fever, area tender to touch. Tx's with ice to area and Tylenol every 4-6 prn. Call back
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6" x 4" redness, 4" x 4" swelling left upper thigh.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Dtap vaccine given instead of Tdap at 11 years old.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a 72 year old male pharmacist with no medical history or allergies who on 28-AUG-2007 was vaccinated IM with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant therapy. The pharmacist reported that on 28-AUG-2007, he experienced pain that shot up his arm (unspecified), up the shoulder and down which lasted approximately 90 seconds. The pharmacist indicated that he was a little sore the rest of the day, but recovered the same day. No laboratory/diagnostic tests were performed as medical attention was not sought. This is one several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: Patient arrived at clinic with parents-for well child check and establishment with healthcare provider-Questions and concerns relating to vaccines discussed- Mom requested that Hep B be administered to patient.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R arm red, warm and swollen.  Motrin, Benadryl, dexamethasone, warm compresses.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Information has been received from a 67 year old female who "sometime last year" in approximately 2006 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included cholesterol medicine and hormone pills. Two to three hours post vaccination the patient reported feeling sleepy. She reported lying down for a little while after which she was fine. At the time of report the patient recovered. No medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Follow up information was received from a registered nurse who reported that the patient, a 67 year old female was vaccinated subcutaneously with a first dose of ZOSTAVAX (Oka/Merck) (lot # "00154") on 05 MAR 2007. It was also noted that the patient had not called the doctor's office with any reports of any adverse effects. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Client's left thigh became red and swollen, twice the size of her other thigh.  Client had pain and itching of her left thigh.  On 4/5/08 in A.M., she had a fever of 101.  On 4/6/08, leg was worse - mom took to ER - was told it was cellulitis and put on Keflex 250mg TID.  Mom also used cold compresses and Motrin.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Client's left thigh became red and swollen, twice the size of her other thigh.  Client had pain and itching of her left thigh.  On 4/5/08 in A.M., she had a fever of 101.  On 4/6/08, leg was worse - mom took to ER - was told it was cellulitis and put on Keflex 250mg TID.  Mom also used cold compresses and Motrin.
Age: 51.0
Sex: M
Vaccine: RAB
Symptoms: Hyperhidrosis, Nausea, Skin warm
Clinical narrative: Stated on 4-3-08 approx 1 1/2 mo after leaving medical center-states felt "nausea, hot, sweaty" for "20 min- 30 min". It disapated and went about my business". Reported to center on 4-8-08.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Viral skin infection
Clinical narrative: Information has been received from a 69 year old female patient with no medical history, who on 09-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  On approximately 25-NOV-2007 the patient experienced a blotchy rash at injection site and on different parts of her body.  She spoke with her doctor's physician assistant who told her that the one at the injection site was an injection site reaction and the rest were a viral type rash.  She did not say if it was shingles or if it was related to the virus in the vaccine.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient has a swollen area the size of an egg on the (L) arm. It is red, swollen, and itching. Came home from school.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: 4 1/2 x 2 3/4 redness with some itching Parent gave Tylenol and Benadry prior to bringing in for eval. of reaction
Age: 4.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain, Skin lesion, Swelling, Upper respiratory tract infection
Clinical narrative: Pt had had approx 1 wk of URIs x (rhinorrhea and cough) prior to onset of rxn, (URI sx began the night later vaccines given). Mother described "hive-like" rash on legs, regressed somewhat and Benadryl. Pt slept well. She awoke with more florid eruption on thighs, legs, back, arms. Swellin gof feet was painful and presented swelling. In office rash on back had faded, but mod to dark pink MP erythema iwth irregular border and sore lesions.
Age: 4.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt had had approx 1 wk of URIs x (rhinorrhea and cough) prior to onset of rxn, (URI sx began the night later vaccines given). Mother described "hive-like" rash on legs, regressed somewhat and Benadryl. Pt slept well. She awoke with more florid eruption on thighs, legs, back, arms. Swellin gof feet was painful and presented swelling. In office rash on back had faded, but mod to dark pink MP erythema iwth irregular border and sore lesions.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injected limb mobility decreased, Injection site induration, Pain in extremity, Skin warm
Clinical narrative: Arm pain with redness, warmth, induration at injection site.  Decreased limb mobility secondary to pain.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Rash vesicular
Clinical narrative: After two doses pt. developed rash which involved several fluid-filled lesions in axilla and face with no other symptoms. No fever, no itching or flu-like symptoms. (photos attached)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: "None"
Age: 42.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed redness and swelling at and distal to injection site on L upper arm - started within one day of injection.  He had a hx of delayed reaction one month ago that occurred 6 days after the injection.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Facial palsy
Clinical narrative: Varicella and Hep A given 3/18/08. Facial symptom 4/14/08. Seen 4/15/08 diagnosed with (L) Facial Bell's Palsy. Treated with steroids and Acyclovir.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) lateral and post thigh, 3 cm firm induration with slight eyrthema. Not tender.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 77-year-old female who on 21-DEC-2006 was vaccinated subcutaneous with a single dose of ZOSTAVAX.  On 19-NOV-2007 the patient developed a mild case of shingles on one side of her body.  On 26-NOV-2007 the patient developed another mild case of shingles on the opposite side of her body.  The patient was treated with famciclovir (FAMVIR) antiviral medication.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a couple that came into the office and one of them in 2007 (a few months ago) was vaccinated with a dose of Zostavax (Oka/Merck) and one did not, "afterwards the couple kissed in the mouth" and the next day the spouse that did not receive the vaccine presented with shingles on their face. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. A product quality complaint was not involved. No further information is available.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 68-year-old male with no allergies and hypercholesterolaemia and diverticulitis who on 29-NOV-2007 was vaccinated with a SC dose of ZOSTAVAX.  There was no concomitant therapy.  The LPN reported that on 29-NOV-2007, within 15 minutes of being vaccinated, the patient developed a 3 cm area of redness around injection site.  No other symptoms were reported.  The patient was seen in the physician's office.  At the time of this report, the patient's injection site redness persisted.  Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a patient who in October or November 2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Oka/Merck). Subsequently, the patient developed an itch that lasted for 2 days. Medical attention was sought at the pharmacy. On an unspecified date the patient recovered from the itch. No product quality complaint was involved. Follow-up has been received from the pharmacist who stated that a 76-year-old male patient was vaccinated at 2 PM on 26-Oct-2007, intramuscularly in the deltoid with a first dose of ZOSTAVAX (Oka/Merck) (lot#658395/0966U). No medical attention was sought. This is one of several reports from the same reporter. 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 a dose of ZOSTAVAX (lot# not available) and subsequently developed shingles "6 months after receiving the vaccine."  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain.  Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Herpes simplex, Rash generalised, Swelling face
Clinical narrative: Information has been received from a physician's office staff concerning a 92 year old female who on 01-NOV-2007 was vaccinated with a dose of ZOSTAVAX (no lot# provided).  On approximately 01-NOV-2007 the patient called the physician's office "within 24 hours" after vaccination because the patient's face was swollen and she developed a rash all over her body.  Per office staff, the patient was brought to the emergency room on 16-NOV-2007 and because of the rash all over her body.  On approximately 16-NOV-2007 a culture of the rash was performed which showed the patient was positive for "herpes cytopathic."  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a 70 year old male with gastrooesophageal reflux disease and allergy to antibiotics who on 16-NOV-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX.  Concomitant therapy included rabeprazole sodium (ACIPHEX) and flecainide acetate.  On 20-NOV-2007 the patient developed shingles.  It was reported that the patient had no history of shingles.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the patient who stated that he had no previous history of shingles.  The patient broke out into a dozen hive-like eruptions on his upper left thigh which he thought were bug bites.  The eruptions did not clear up and developed into blisters.  The patient was seen by his physician who confirmed it as shingles.  The patient at the time of report had rash for which the patient's dermatologist stated that it might take 6 months to fade.  Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Information has been received from an 89 year old male with no pertinent medical history or drug allergies who on approximately 19-OCT-2007 "6 weeks ago," was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) (no lot# provided) by the physician while he had shingles. There was no concomitant medication. The shingles went away but after 4 days on approximately 23-OCT-2007 the shingles "came back." The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information from a physician indicated that the 89 year old retired male who on 02-NOV-2007 at 11:00 was vaccinated SC with a 0.5 ml dose of Zostavax (Oka/Merck) (lot# 658395/0966U) in the right arm. The patient stated that he had shingles on the "down deep inside of his body at the time of vaccination." Follow-up with the physician never had an actual diagnosis of shingles at any time. A screening form also indicated that there was no illness at the time of vaccination or contraindications to therapy. Additional follow-up information from a physician indicated that the patient did not receive Zostavax (Oka/Merck) (lot# 658395/0966U) during a shingles episode and that the patient never had shingles. The physician does not have any additional information. No further information is available. This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information received from the consumer stating that the physician prescribed him codeine for his pain-which had not helped. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a received a 61 year old female registered nurse with hypertension and a drug allergy to DEMEROL who on 02-NOV-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Oka/Merck) in the right deltoid. Concomitant drug therapy included lisinopril. On 03-NOV-2007 the patient developed injection site pain, redness and warmth at the right deltoid. The patient contacted the physician's office by phone. No labs or diagnostic studies were performed. The patient's injection site reaction resolved in 10 days on 13-NOV-2007 without requiring treatment. There was no product quality complaint. No further information is available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Pruritus, Rash, Thermal burn
Clinical narrative: Information has been received from an 81 year old female, with no medical history and no allergies, who on 13-NOV-2007 was vaccinated with a first dose of ZOSTAVAX (Merck). Concomitant therapy included blood pressure pills, osteoporosis pills, and a pill for acid reflux. On 27-NOV-2007 the patient experienced little red rashes around elbow and on legs.  The reporter indicated that the rash felt like wintry itch.  She noted that she usually has a little break out during the winter time.  The patient was applying cortisol cream on it and it was getting better.  There were no laboratory or diagnostic tests performed.  Medical attention was not sought.  No product quality complaint was involved.  No other information was provided.  Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information has been received from the physician that the 73 year old female patient with high blood pressure on 17-NOV-2007 was vaccinated with an unknown dose of ZOSTAVAX (Merck) in the right arm. The patient's relevant concomitant medications and past drug history included verapamil 240 mg, lisinopril/hctz 10/12.5 mg, EVISTA, omeprazole 20 mg and diazepam. On 29-JAN-2009 the patient thought that she was having a back pain, so she slept on a heating pad. On 30-JAN-2009 when she woke up, she thought that she had a burn from the heating paid, so she went to see her doctor. The doctor told her that she had shingles on her right side, from her shoulder and wrapping around to the upper part of her back. It was unknown if any laboratory tests were performed. As of 31-JAN-2009, the patient continued to have the shingles which was being treated with 500 mg of VALTREX three times a day. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a consumer concerning his 74 year old wife with drug "allergies to cholestyramine (QUESTRAN) and etodolac" and no other pertinent medical history who on 26-NOV-2007 was vaccinated with a dose of ZOSTAVAX (lot# not available).  Concomitant drug therapy included "atorvastatin calcium (LIPITOR)".  On 27-NOV-2007 the patient developed a "red itchy circle around injection site surrounding the injection site about 2-3 inches around."  The patient did not seek medical attention.  No labs or diagnostic studies performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female with no pertinent medical history or drug allergies who on 14-NOV-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On 23-NOV-2007 the patient developed shingles. The patient was seen by the physician for medical attention. No labs or diagnostic studies were performed. The patient was treated with acyclovir. The patient was recovering. There was no prodcut quality complaint.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site swelling, Lymphadenopathy, Nerve conduction studies normal
Clinical narrative: Information has been received from a pharmacy student concerning a 74 year old female patient who on 24-NOV-2007 was vaccinated with Zostavax (Oka/Merck), SQ, 0.65 ml (lot number 658361/1090U). On 25-NOV-2007 the patient developed swelling on the crease of her elbow and numbness from the injection area down to the lower arm. It was reported the patient contacted the pharmacy and physician for medical attention. At the time of reporting, the patient's swelling at crease of elbow and numbness from injection area down to lower arm persisted. There was no product quality complaint. Additional information has been requested. Follow-up information from the pharmacist indicated that in the am on 25-NOV-2007 the patient had numbness on the injection arm especially in the lower arm and thumb. The patient saw the physician on 28-NOV-2007 for enlarged gland in elbow cease. As reported the enlarged gland wasn't bad enough for any medications and her numbness had gotten better. Doctor did not think vaccination hit a nerve, thought maybe susceptible to the vaccine. The doctor was asked about Bell's Palsy, but he did not think this was involved. The patient saw the doctor about the rash (spots) broken out on her chest and upper arms. No medication/ antivirals were prescribed. The pharmacist indicated on 08-JAN-2008 the patient saw a neurologist who ran "nerve testing", all reults were normal. The patient reported the spots on her chest had resolved on their own.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin test
Clinical narrative: Information has been received from a 75 year old male with an aspirin allergy and adverse drug reaction to blood thinners who on 26-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Concomitant drug therapy included a small dose of losartan potassium (MSD), COUMADIN, FLOMAX, vitamin D (unspecified), calcium (unspecified) and supplements.  On 30-NOV-2007 the patient was diagnosed with shingles.  The patient sought unspecified medical attention.  Lab diagnostic studies included a skin test.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a consumer concerning his 68-year-old wife on on Friday, 30-NOV-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). On approximately 30-NOV-2007 the patient developed pain and redness at the injection site. No outcome was reported. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 7-year-old female who on 10-OCT-2007 was vaccinated inadvertently with a dose of ZOSTAVAX (Oka/Merck). No adverse symptoms were reported. No outcomes were reported. No product quality complaint involved. Additional information has been received on 06-FEB-2008 via a telephone call with R.N. She explained the reason for product confusion was that they had not received a varicella virus vaccine live (Oka/Merck) shipment but received a ZOSTAVAX (Oka/Merck) shipment instead. The nurse said she did not know that ZOSTAVAX (Oka/Merck) had been ordered and read "varicella zoster" on the vial label and thought it was for chicken pox and administered it to the child. The R.N. explained that it would have helped if the sales rep had done a phone conference prior to them receiving the ZOSTAVAX (Oka/Merck) so that she would have been aware that it was for shingles. She also reported that it "would have helped if the ZOSTAVAX (Oka/Merck) vial indicated shingles. The child is fine and had no adverse experience." Additional information has been requested. Additional information was received from the registered nurse concerning a 7-year-old Female stundent with no pre-existing allergies, birth defects or medical conditions who on 10-OCT-2007 at 07:27 am was vaccinated subcutaneously in the right arm with a first dose of ZOSTAVAX (Merck) (lot# reported as 04560) instead of VARIVAX (Merck). No adverse reactions occurred and no relevant diagnostic tests were performed. No additional information was reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning a 72 year old female with increased lipids who on 13-NOV-2007, in the AM was vaccinated subcutaneously with a first dose of Zostavax (Oka/Merck). There was no illness at the time of vaccination. It was reported that on 14 NOV 2007 the patient's right deltoid was red, warm, painful, bumpy, and hard. Subsequently, the patient recovered on an undisclosed date. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Oral herpes, Pain
Clinical narrative: Information has been received from a female consumer with no pertinent medical history and an iodine allergy who on 12-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included MAALOX.  On 01-JUL-207 the patient reported experiencing a stabbing, sharp pain throughout her body.  At the time of reporting the sharp pain had recently subsided, but the patient was still experiencing some mild pain and itching in an area of a past shingles episode.  The patient also reported that in November 2007, she developed cold sores on her lips and inside of her mouth that at the time of reporting had not yet healed.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information was received from a physician who reported that the patient with an allergy to PERCOCET, DARVON, iodine, DEMEROL, PLAVIX, and CIPRO was vaccinated on 12-JUN-2007 subcutaneously into the right arm with a first dose of Zostavax (Oka/Merck) (Lot# "02904").  It was reported that "the patient developed right sided chest pain after the vaccine".  It was unknown if the patient had any illness at the time of vaccination.  There were no lab diagnostic studies performed.  The patient's status was unknown at the time of reporting.  No further information is expected.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARZOS
Symptoms: Body temperature increased, Irritability, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female with no pertinent medical history, drug reactions or allergies who on 03-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658603/1081U) instead of varicella virus vaccine live (Oka/Merck). The nurse noted the medication error occurred due to the fact that the two vaccines were in the same freezer in side by side labeled bins. It was further noted that the vaccine bins have since been moved apart and the bins have been labeled clearly with different colors. Vaccine therapy that same day included MMR II (Lot # "0413U"), Hib conj vaccine (unspecified carrier) (ACTHIB) (Sanofi) (Lot# UF196AA), TRIPEDIA (Sanofi) (Lot # C2651AA), PREVNAR (Lot # B08702A), and HAVRIX (GSK) (Lot # AHAVB181AA). On 05-DEC-2007 the patient developed a temperature of 100-101F, which lasted one day. It was also noted that ( post vaccination) the patient was "fussy" more than usual for a period of three weeks, which resolved on 24 DEC 2007. There was no reported illness at the time of vaccinations. There were no reported adverse events following prior vaccinations. There were no concomitant medications. Medical attention was not sought. There was no product quality complaint. There were no lab diagnostic studies performed. No further information is expected.
Age: 15.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of a dose of varicella virus live (Oka/Merck) (MSD). The incident was due to human error and not product confusion. It was unspecified if medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 59 or 60 year old female who in approximately November 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). "Nine days after vaccination, in November 2007", the physician confirmed that the patient had shingles. Shingles were present around the torso on one side. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 70-year-old female who in October 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In October 2007 (post vaccination), the patient experienced injection site redness, swelling and pain.  The patient sought medical attention via a conversation with the administering pharmacist.  No diagnostic labs were performed.  In October 2007, "about one week after the injection", the patient recovered.  A product quality complaint was not involved.  This is one of two reports received from the same source.  No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchial disorder, Nasopharyngitis
Clinical narrative: Information has been received from a 70 year old consumer with an unspecified blood pressure and thyroid disorder, and an allergy to monosodium glutamate who on 03-DEC-2007, received a 0.65 ml, intramuscular dose of Zostavax (Oka/Merck).  Concomitant therapy included unspecified medication for "blood pressure", and an unspecified medication for "thyroid".  She indicated that on an unspecified date since receiving the vaccine, she developed a cold, and unspecified bronchial problems.  Current patient status was not reported.  A product quality complaint was not reported.  This is one of two of two from the same source.  Follow up information has been requested.