chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 39-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to given it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006660; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006659; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year old male.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the vaccine program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670;  MEDI-0006671;  MEDI-0006672;  MEDI-0006673;  MEDI-0006674;  MEDI-0006675;  MEDI-0006676;  MEDI-0006659;  MEDI-0006678;  MEDI-0006679;  MEDI-0006680;  MEDI-0006681;  MEDI-0006682;  MEDI-0006683;  MEDI-0006684.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse in the USA concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-000662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006659; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 14-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter:  MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006659; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 28-month-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006659; MEDI-0006684.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither medical history nor concomitant medications were provided.  The patient received FLUMIST on 17-Mar-2008.  The FLUMIST had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FLUMIST from the Vaccines for Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FLUMIST was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006659.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information was obtained on request by the Company from the FDA via the Freedom of Information Act concerning a 12 year old female who on 12-JUN-2007 was vaccinated IM in the left arm with the first dose of GARDASIL (lot # 656372/0243U). Concomitant therapy included the second SC dose in the right leg of VARIVAX (lot # 656819/0172U) and the first IM dose in the right arm of BOOSTRIX (lot # AC52B015AA). On 13-JUN-2007 the patient developed a 2" x 1 1/2" red warm large area at the injection site. The patient's outcome was not reported. The original reporting source was not reported. The VAERS ID # is 281915. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Bursitis, Cellulitis, Full blood count, Infection, Laboratory test
Clinical narrative: Information has been received from a physician concerning a female with diabetes, hyperlipidaemia, seasonal allergy and anemia secondary to a history of small intestine arteriovenous malformation (20 SEP 2007) who on 20-SEP-2007 was vaccinated subcutaneously into the left upper arm with ZOSTAVAX (Oka/Merck) (lot # 658208/0886U). Concomitant therapy included influenza virus vaccine (unspecified), metformin, PAXIL, LIPITOR, RYTHMOL, diltiazem hydrochloride, aspirin, hydrochlorothiazide, estrogens, PREMARIN and vitamins (unspecified). On 20 SEP 2007 the patient developed a 'vascular rash" following the vaccination with ZOSTAVAX (Oka/Merck). The patient was seen in the office on 12 OCT 2007 for a rash that the patient report had started "a couple of weeks ago". The rash was generalized itchy rash with lesions, some with crusted covering the whole body (limbs, trunk, front and back). The patient developed a secondary infecting on 29 OCT 2007 that was described as olecranon bursitis and or cellulitis on her left elbow, which resolved with antibiotic treatment. The patient was referred to a dermatologist who felt that the rash was related to ZOSTAVAX (Oka/Merck), and not pre-existing eczema. It was reported that "the rash gets better and almost disappears and then breaks out with new lesions and itching". The patient was last examined on 06 FEB 2008, at which time there were intact vesicles. Lab diagnostic studies were performed, of which the results were not reported. At the time of reporting the patient had not yet recovered. There was no product quality complaint; Additional information has been requested. Additional information is not available. Follow up information was received from a physician who reported that the patient was seen on follow up on 7 FEB 2008 at which time the patient was still getting vesicles on her body, except they were now smaller than previously. The physician described them as "teeny tiny" varicella like diseminated blisters. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash generalised, Rash pruritic, Rash vesicular, Scab, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female with diabetes, hyperlipidaemia, seasonal allergy and anemia secondary to a history of small intestine arteriovenous malformation (20 SEP 2007) who on 20-SEP-2007 was vaccinated subcutaneously into the left upper arm with ZOSTAVAX (Oka/Merck) (lot # 658208/0886U). Concomitant therapy included influenza virus vaccine (unspecified), metformin, PAXIL, LIPITOR, RYTHMOL, diltiazem hydrochloride, aspirin, hydrochlorothiazide, estrogens, PREMARIN and vitamins (unspecified). On 20 SEP 2007 the patient developed a 'vascular rash" following the vaccination with ZOSTAVAX (Oka/Merck). The patient was seen in the office on 12 OCT 2007 for a rash that the patient report had started "a couple of weeks ago". The rash was generalized itchy rash with lesions, some with crusted covering the whole body (limbs, trunk, front and back). The patient developed a secondary infecting on 29 OCT 2007 that was described as olecranon bursitis and or cellulitis on her left elbow, which resolved with antibiotic treatment. The patient was referred to a dermatologist who felt that the rash was related to ZOSTAVAX (Oka/Merck), and not pre-existing eczema. It was reported that "the rash gets better and almost disappears and then breaks out with new lesions and itching". The patient was last examined on 06 FEB 2008, at which time there were intact vesicles. Lab diagnostic studies were performed, of which the results were not reported. At the time of reporting the patient had not yet recovered. There was no product quality complaint; Additional information has been requested. Additional information is not available. Follow up information was received from a physician who reported that the patient was seen on follow up on 7 FEB 2008 at which time the patient was still getting vesicles on her body, except they were now smaller than previously. The physician described them as "teeny tiny" varicella like diseminated blisters. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site irritation, Myalgia, Pruritus, Swelling
Clinical narrative: Information has been received from an 81 year old female allergic to "NYOCIN", nicotanic acid, nitrofurantoin (MACROBID), sulfa, all arthritic prescriptions, celecoxib (CELEBREX), rofecoxib (MSD), cyclosporine (RESTASIS), lisinopril, "BENECAR", cisapride (CIPRIL) and lovastatin (MSD) who on 24-OCT-2007 was vaccinated with a single dose of ZOSTAVAX.  Concomitant therapy included aspirin.  In October 2007, few days after vaccination the patient experienced itching, redness and swelling from her shoulder down to her elbow that lasted for approximately 2 weeks.  The patient also experienced difficulty with her eyes and muscle pain.  The patient was still experiencing the muscle pain.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Follow-up information from a physician indicated that the 81 year old retired female was vaccinated on 24-OCT-2007 at 10:15 with a dose of ZOSTAVAX (lot# 656609/0015U) in the left deltoid (site unspecified).  On 02-NOV-2007 the patient developed local skin irritation at the injection site.  No medical attention was sought.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Information has been received from an 81 year old female allergic to "NYOCIN", nicotanic acid, nitrofurantoin (MACROBID), sulfa, all arthritic prescriptions, celecoxib (CELEBREX), rofecoxib (MSD), cyclosporine (RESTASIS), lisinopril, "BENECAR", cisapride (CIPRIL) and lovastatin (MSD) who on 24-OCT-2007 was vaccinated with a single dose of ZOSTAVAX.  Concomitant therapy included aspirin.  In October 2007, few days after vaccination the patient experienced itching, redness and swelling from her shoulder down to her elbow that lasted for approximately 2 weeks.  The patient also experienced difficulty with her eyes and muscle pain.  The patient was still experiencing the muscle pain.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Follow-up information from a physician indicated that the 81 year old retired female was vaccinated on 24-OCT-2007 at 10:15 with a dose of ZOSTAVAX (lot# 656609/0015U) in the left deltoid (site unspecified).  On 02-NOV-2007 the patient developed local skin irritation at the injection site.  No medical attention was sought.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 27-DEC-2007 was vaccinated with a third dose of GARDASIL.  On approximately 10-JAN-2008 the patient came into the office with arm pain and swelling.  It was noted that the patient complained of other symptoms and was referred to see a rheumatologist.  The patient was diagnosed with lupus.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Oedema peripheral, Pain in extremity, Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 27-DEC-2007 was vaccinated with a third dose of GARDASIL.  On approximately 10-JAN-2008 the patient came into the office with arm pain and swelling.  It was noted that the patient complained of other symptoms and was referred to see a rheumatologist.  The patient was diagnosed with lupus.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Exposure to communicable disease, Herpes zoster, Pain of skin
Clinical narrative: Information has been received from a medical assistant concerning a 70-year-old male with no known allergies, who on 07-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 12-NOV-2007 the patient developed shingles. He had blisters on his right chest area. The patient sought medical attention at the office. The outcome was reported as recovering, as some blisters are still present. It is reported that the physician is interested in the VZV Analysis by PCR. No product quality complaint was involved. Follow up information has been received from the physician who indicated that the patient was vaccinated in the upper right arm with a subcutaneous dose of 0.65 milliliters of ZOSTAVAX (Oka/Merck) (lot # unknown). The patient has had no history of chickenpox, or a recent exposure to chickenpox. On 04-Nov-2007, the patient was exposed to shingles. On 13-Nov-2007, previously reported as 12-Novc-2007, the patient developed a rash that spread on the right chest wall. There were no other systemic symptoms. The physician stated that he was not sure if the patient would be willing to come back to the office for a specimen for the VZVIP program. He reported that the patient was very upset that he developed shingles. On approximately 27-Nov-2007, the physician spoke with the patient who said that his vesicles were recovering and starting to scab over but still had some pain. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blood test, Burning sensation, Erythema, Furuncle
Clinical narrative: A few days after receiving the Shingles vaccine, itchy spots appeared on my upper body, forming into what looked like small fluid-containing boils. Saw family physician, who thought it might be shingles caused by the vaccine.  A week after the vaccination, an itchy rash broke out on the lower part of my body, not like the upper, but more of red patches, with a burning type itch.  Saw a dermatologist who wasn't sure of what it was.  Saw a second dermatologist who thought the lower patches might be eczema.  Had a biopsy of the upper lesions - which was inconclusive.  Also had blood test, also inconclusive.  Saw an allergist, who was baffled but prescribed a four day regimen of prednisone, plus Zyrtec for the itch.  No improvement.  I also contacted Merck, the supplier of the vaccine, who said they had not had any adverse reports at that time.    It has been nearly six months without any significant relief. I contacted Merck again today, and they said they would file a report.  What I want is a diagnosis and an effective treatment. Merck case # is 1-1732765594.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic, Skin lesion
Clinical narrative: A few days after receiving the Shingles vaccine, itchy spots appeared on my upper body, forming into what looked like small fluid-containing boils. Saw family physician, who thought it might be shingles caused by the vaccine.  A week after the vaccination, an itchy rash broke out on the lower part of my body, not like the upper, but more of red patches, with a burning type itch.  Saw a dermatologist who wasn't sure of what it was.  Saw a second dermatologist who thought the lower patches might be eczema.  Had a biopsy of the upper lesions - which was inconclusive.  Also had blood test, also inconclusive.  Saw an allergist, who was baffled but prescribed a four day regimen of prednisone, plus Zyrtec for the itch.  No improvement.  I also contacted Merck, the supplier of the vaccine, who said they had not had any adverse reports at that time.    It has been nearly six months without any significant relief. I contacted Merck again today, and they said they would file a report.  What I want is a diagnosis and an effective treatment. Merck case # is 1-1732765594.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Inappropriate schedule of drug administration, Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a 54 year old female registered nurse with allergies to sedatives and antidepressants who on 20-JAN-2008 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Concomitant therapy included calcium (unspecified) and ascorbic acid.  The patient noted that she requested the vaccine since she was exposed to shingles.  She stated that the physician did not give her complete information regarding the vaccine prior to administration (recommended for patients 60 years or older). On approximately 22-JAN-2008 the patient developed sickness in the stomach and tiredness which she attributed to her calcium (unspecified) (3 tablets) and ascorbic acid (3 tablets) that she took all at once on 22-JAN-2008.  Unspecified medical attention was sought, it was noted that the discharge notes were not legible nor explained properly.  No further information is available.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Exposure to communicable disease, Fatigue, Inappropriate schedule of drug administration, Stomach discomfort
Clinical narrative: Information has been received from a 54 year old female registered nurse with allergies to sedatives and antidepressants who on 20-JAN-2008 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Concomitant therapy included calcium (unspecified) and ascorbic acid.  The patient noted that she requested the vaccine since she was exposed to shingles.  She stated that the physician did not give her complete information regarding the vaccine prior to administration (recommended for patients 60 years or older). On approximately 22-JAN-2008 the patient developed sickness in the stomach and tiredness which she attributed to her calcium (unspecified) (3 tablets) and ascorbic acid (3 tablets) that she took all at once on 22-JAN-2008.  Unspecified medical attention was sought, it was noted that the discharge notes were not legible nor explained properly.  No further information is available.
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her son who on 25-JAN-2008 was accidentally vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck).  No AE was reported.  It was unspecified if medical attention was sought.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 64-year-old female with no pertinent medical history or allergies, who on 25-JAN-2008 was vaccinated subcutaneously in the back of her arm above the elbow with one dose of 0.65 ml of ZOSTAVAX (lot# 659325/1823U).  Subsequently, the patient experienced an injection site reaction.  The patient did not notice any symptoms until the day after the administration, 26-Jan-2008, when she pulled the band aid from the injection site.  The area was red, swollen, warm, itchy and affected an area of 3 to 4 inches down to her elbow.  An ice pack seemed to comfort the area.  The patient showed the pharmacist her arm who directed her to the emergency room.  At the E.R., the patient was given an antibiotic and was told to take diphenhydramine hydrochloride (BENADRYL).  The pharmacist spoke to the patient on 28-Jan-2008 who said the swelling has now gone below the elbow and to the front side of her arm.  The area is still itchy.  The pharmacist also vaccinated the patient's husband that same day and he has not experienced any symptoms.  No product quality complaint was involved.  Follow up information was received from the pharmacist concerning a white female who was vaccinated on 25-Jan-2008, at 3:45 PM subcutaneously in the left arm with a dose of ZOSTAVAX (lot# 659325/1823U).  On 26-Jan-2008 at 8:00 AM the patient experienced a severe local reaction at the injection site.  Her arm was swollen, warm, red and itching.  Diphenhydramine hydrochloride (BENADRYL) did not alleviate her symptoms.  She went to the ER and was told to follow up with her regular physician if her conditions worsened.  The physician prescribed or administered steroids to clear up the condition.  The patient recovered on 31-Jan-2008.  The reporter considered severe injection site pruritis, injection site erythema, injection site warmth and injection site swelling to be other important medical events.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a 64-year-old female with no pertinent medical history or allergies, who on 25-JAN-2008 was vaccinated subcutaneously in the back of her arm above the elbow with one dose of 0.65 ml of ZOSTAVAX (lot# 659325/1823U).  Subsequently, the patient experienced an injection site reaction.  The patient did not notice any symptoms until the day after the administration, 26-Jan-2008, when she pulled the band aid from the injection site.  The area was red, swollen, warm, itchy and affected an area of 3 to 4 inches down to her elbow.  An ice pack seemed to comfort the area.  The patient showed the pharmacist her arm who directed her to the emergency room.  At the E.R., the patient was given an antibiotic and was told to take diphenhydramine hydrochloride (BENADRYL).  The pharmacist spoke to the patient on 28-Jan-2008 who said the swelling has now gone below the elbow and to the front side of her arm.  The area is still itchy.  The pharmacist also vaccinated the patient's husband that same day and he has not experienced any symptoms.  No product quality complaint was involved.  Follow up information was received from the pharmacist concerning a white female who was vaccinated on 25-Jan-2008, at 3:45 PM subcutaneously in the left arm with a dose of ZOSTAVAX (lot# 659325/1823U).  On 26-Jan-2008 at 8:00 AM the patient experienced a severe local reaction at the injection site.  Her arm was swollen, warm, red and itching.  Diphenhydramine hydrochloride (BENADRYL) did not alleviate her symptoms.  She went to the ER and was told to follow up with her regular physician if her conditions worsened.  The physician prescribed or administered steroids to clear up the condition.  The patient recovered on 31-Jan-2008.  The reporter considered severe injection site pruritis, injection site erythema, injection site warmth and injection site swelling to be other important medical events.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 64-year-old female with no pertinent medical history or allergies, who on 25-JAN-2008 was vaccinated subcutaneously in the back of her arm above the elbow with one dose of 0.65 ml of ZOSTAVAX (lot# 659325/1823U).  Subsequently, the patient experienced an injection site reaction.  The patient did not notice any symptoms until the day after the administration, 26-Jan-2008, when she pulled the band aid from the injection site.  The area was red, swollen, warm, itchy and affected an area of 3 to 4 inches down to her elbow.  An ice pack seemed to comfort the area.  The patient showed the pharmacist her arm who directed her to the emergency room.  At the E.R., the patient was given an antibiotic and was told to take diphenhydramine hydrochloride (BENADRYL).  The pharmacist spoke to the patient on 28-Jan-2008 who said the swelling has now gone below the elbow and to the front side of her arm.  The area is still itchy.  The pharmacist also vaccinated the patient's husband that same day and he has not experienced any symptoms.  No product quality complaint was involved.  Follow up information was received from the pharmacist concerning a white female who was vaccinated on 25-Jan-2008, at 3:45 PM subcutaneously in the left arm with a dose of ZOSTAVAX (lot# 659325/1823U).  On 26-Jan-2008 at 8:00 AM the patient experienced a severe local reaction at the injection site.  Her arm was swollen, warm, red and itching.  Diphenhydramine hydrochloride (BENADRYL) did not alleviate her symptoms.  She went to the ER and was told to follow up with her regular physician if her conditions worsened.  The physician prescribed or administered steroids to clear up the condition.  The patient recovered on 31-Jan-2008.  The reporter considered severe injection site pruritis, injection site erythema, injection site warmth and injection site swelling to be other important medical events.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old female patient who on 18-FEB-2008 at "12:05" was vaccinated IM into left arm with a third dose of Gardasil (lot # 658563/1063U).  The reporter reported that at "12:20" on the day of vaccination the patient had syncopal episode after vaccine was administered.  She recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 18-FEB-2008 at 10:45 was vaccinated IM in the left arm with a third dose of Gardasil (Lot# 658556/1060U).  There were no illnesses at the time of the vaccination.  There was no concomitant medication.  On 18-FEB-2008 at 10:50 the patient experienced a syncopal episode, fell to the ground, and striked her head.  A head computed axial tomography was performed and was negative.  The patient recovered on an unspecified date.  This is one of two reports from the same source.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a 60 year old female with no medical history or allergies who in fall 2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included MOBIC, NEXIUM, losartan potassium-HCTZ (MSD) and diabetic medications (unspecified).  In 2007, about 3 weeks after vaccination the patient experienced itching from middle of back to abdomen for about 10 days.  The patient also stated that her husband had shingles in the past and took rofecoxib (MSD) which cured the shingles.  No diagnostic laboratory tests were under taken.  At the time of report the patient had recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 60 year old female with no medical history or allergies who in fall 2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included MOBIC, NEXIUM, losartan potassium-HCTZ (MSD) and diabetic medications (unspecified).  In 2007, about 3 weeks after vaccination the patient experienced itching from middle of back to abdomen for about 10 days.  The patient also stated that her husband had shingles in the past and took rofecoxib (MSD) which cured the shingles.  No diagnostic laboratory tests were under taken.  At the time of report the patient had recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Facial palsy, Headache
Clinical narrative: Information has been received from a 75 year old female with type 2 diabetes mellitus and irregular heart rhythm and no allergies who in February 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included metformin, atenolol and lovastatin. On 02-FEB-2008 the patient developed a headache that lasted for 5 days.  On 06-FEB-2008 the patient began to developed numbness and paralysis on the left side of her face.  The patient called her physician's office and they advised her to go to the emergency room, where a diagnosis if stroke was ruled out and the patient was discharged.  The patient was diagnosed with Bell's palsy.  Unspecified blood diagnostic tests were undertaken with CT scan of head.  At the time of report the patient had not recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Follow-up information has been received from a physician indicated that the patient was confirmed to have Bell's palsy on her left and was recently exposed to her husband (WAES # 0802USA02681) who also developed Bell's palsy.  Both patients were vaccinated on 12-FEB-2008 with a dose of Zostavax (Oka/Merck) (lot# 656608/0032U).  The physician noted that the patient was not seen for an office visit but she was seen in the ER and had an appointment with the physician on 14-FEB-2008.  It was mentioned that the patient was in pretty good health otherwise.  Additional information has been requested.  This is one of several reports received from the same source.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Facial palsy, Headache, Hypoaesthesia facial, Laboratory test
Clinical narrative: Information has been received from a 75 year old female with type 2 diabetes mellitus and irregular heart rhythm and no allergies who in February 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included metformin, atenolol and lovastatin. On 02-FEB-2008 the patient developed a headache that lasted for 5 days.  On 06-FEB-2008 the patient began to developed numbness and paralysis on the left side of her face.  The patient called her physician's office and they advised her to go to the emergency room, where a diagnosis if stroke was ruled out and the patient was discharged.  The patient was diagnosed with Bell's palsy.  Unspecified blood diagnostic tests were undertaken with CT scan of head.  At the time of report the patient had not recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Follow-up information has been received from a physician indicated that the patient was confirmed to have Bell's palsy on her left and was recently exposed to her husband (WAES # 0802USA02681) who also developed Bell's palsy.  Both patients were vaccinated on 12-FEB-2008 with a dose of Zostavax (Oka/Merck) (lot# 656608/0032U).  The physician noted that the patient was not seen for an office visit but she was seen in the ER and had an appointment with the physician on 14-FEB-2008.  It was mentioned that the patient was in pretty good health otherwise.  Additional information has been requested.  This is one of several reports received from the same source.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has bee received from a nurse midwife concerning a 20 year old female who on 17-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 24-MAR-2008 the patient visited a tanning salon and then experienced a rash on her chest. The patient called the physician's office and was recovering from the rash on her chest. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 18-APR-2008 from the physician. The information was not same as the information in the NSC call. A call was placed to obtain more information.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has bee received from a nurse midwife concerning a 20 year old female who on 17-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 24-MAR-2008 the patient visited a tanning salon and then experienced a rash on her chest. The patient called the physician's office and was recovering from the rash on her chest. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 18-APR-2008 from the physician. The information was not same as the information in the NSC call. A call was placed to obtain more information.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Laboratory test normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 23-NOV-2007 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 06-FEB-2008 the patient experienced tingly pins and needles on both legs and weakness in legs. The patient sought unspecified medical treatment. The patient had an MRI performed on an unspecified date. No additional information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 23-NOV-2007 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 06-FEB-2008 the patient experienced tingly pins and needles on both legs and weakness in legs. The patient sought unspecified medical treatment. The patient had an MRI performed on an unspecified date. No additional information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 23-NOV-2007 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 06-FEB-2008 the patient experienced tingly pins and needles on both legs and weakness in legs. The patient sought unspecified medical treatment. The patient had an MRI performed on an unspecified date. No additional information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein, Full blood count, Headache
Clinical narrative: Information has been received from a physician concerning a 22 year old female with migraine and penicillin allergy who on 25-FEB-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 658100/0525U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in the right arm.  On 26-FEB-2008 the patient experienced severe joint pain, sore throat, high fever and chest congestion.  The patient had difficulty walking due to the severe joint pain.  She was examined at the healthcare center on 26-FEB-2008.  Complete blood count and influenza test were negative.  The physician's office called the patient on 28-FEB-2008 and she was feeling much better.  Subsequently, the patient recovered from severe joint pain, sore throat, high fever and chest congestion.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 20-MAY-2008. The patient has not returned for a follow up appointment. The office has made several attempts to contact her for her second GARDASIL injection but no response.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Laboratory test, Myalgia, Pyrexia, Red blood cell sedimentation rate, Throat tightness
Clinical narrative: Information has been received from a physician concerning a 22 year old female with migraine and penicillin allergy who on 25-FEB-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 658100/0525U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in the right arm.  On 26-FEB-2008 the patient experienced severe joint pain, sore throat, high fever and chest congestion.  The patient had difficulty walking due to the severe joint pain.  She was examined at the healthcare center on 26-FEB-2008.  Complete blood count and influenza test were negative.  The physician's office called the patient on 28-FEB-2008 and she was feeling much better.  Subsequently, the patient recovered from severe joint pain, sore throat, high fever and chest congestion.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 20-MAY-2008. The patient has not returned for a follow up appointment. The office has made several attempts to contact her for her second GARDASIL injection but no response.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Urine analysis
Clinical narrative: Information has been received from a physician concerning a 22 year old female with migraine and penicillin allergy who on 25-FEB-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 658100/0525U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in the right arm.  On 26-FEB-2008 the patient experienced severe joint pain, sore throat, high fever and chest congestion.  The patient had difficulty walking due to the severe joint pain.  She was examined at the healthcare center on 26-FEB-2008.  Complete blood count and influenza test were negative.  The physician's office called the patient on 28-FEB-2008 and she was feeling much better.  Subsequently, the patient recovered from severe joint pain, sore throat, high fever and chest congestion.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 20-MAY-2008. The patient has not returned for a follow up appointment. The office has made several attempts to contact her for her second GARDASIL injection but no response.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Arthralgia, Full blood count normal, Gait disturbance, Influenza serology negative, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 22 year old female with migraine and penicillin allergy who on 25-FEB-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 658100/0525U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in the right arm.  On 26-FEB-2008 the patient experienced severe joint pain, sore throat, high fever and chest congestion.  The patient had difficulty walking due to the severe joint pain.  She was examined at the healthcare center on 26-FEB-2008.  Complete blood count and influenza test were negative.  The physician's office called the patient on 28-FEB-2008 and she was feeling much better.  Subsequently, the patient recovered from severe joint pain, sore throat, high fever and chest congestion.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 20-MAY-2008. The patient has not returned for a follow up appointment. The office has made several attempts to contact her for her second GARDASIL injection but no response.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pharyngolaryngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Information has been received from a physician concerning a 22 year old female with migraine and penicillin allergy who on 25-FEB-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 658100/0525U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA) and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in the right arm.  On 26-FEB-2008 the patient experienced severe joint pain, sore throat, high fever and chest congestion.  The patient had difficulty walking due to the severe joint pain.  She was examined at the healthcare center on 26-FEB-2008.  Complete blood count and influenza test were negative.  The physician's office called the patient on 28-FEB-2008 and she was feeling much better.  Subsequently, the patient recovered from severe joint pain, sore throat, high fever and chest congestion.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information was received on 20-MAY-2008. The patient has not returned for a follow up appointment. The office has made several attempts to contact her for her second GARDASIL injection but no response.