chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: U
Vaccine: DTAP, MMR, PNC, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 17 month old patient who on 15-APR-2009 was subcutaneously vaccinated with one dose of ZOSTAVAX (Merck) (lot #663175/1553X) instead of VARIVAX (Merck) inadvertently. It was unknown if it was a product confusion or not. The vaccines were next to each other and the wrong one was selected. The patient was at the office for medical attention. Additional information has been requested.
Age: 1.4
Sex: U
Vaccine: DTAP, MMR, PNC, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 17 month old patient who on 15-APR-2009 was subcutaneously vaccinated with one dose of ZOSTAVAX (Merck) (lot #663175/1553X) instead of VARIVAX (Merck) inadvertently. It was unknown if it was a product confusion or not. The vaccines were next to each other and the wrong one was selected. The patient was at the office for medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMR, PPV, TDAP, VARCEL, VARZOS, VARCEL, VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with codeine and cortisone shot allergy and no pertinent medical history reported, who on 22-APR-2009, was vaccinated with ZOSTAVAX (Merck) (Lot # 663202/1730X) 0.65ml, SQ in the morning for shingles and VARIVAX (Merck) (Lot # 664360/0551Y valid for MMR II) in the afternoon for travel at 2 different locations. There was no concomitant medication. On 26-APR-2009, the patient developed wheals on the left side of her abdomen. It was itchy, 4 inches in diameter and painful (pain scale of 2-3). Her rash spread to 12 inches in diameter and localized to the left side of the abdomen. Patient was referred to her primary care physician. The patient is recovering from adverse events. No laboratories were performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMR, PPV, TDAP, VARCEL, VARZOS, VARCEL, VARZOS
Symptoms: Pain of skin, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with codeine and cortisone shot allergy and no pertinent medical history reported, who on 22-APR-2009, was vaccinated with ZOSTAVAX (Merck) (Lot # 663202/1730X) 0.65ml, SQ in the morning for shingles and VARIVAX (Merck) (Lot # 664360/0551Y valid for MMR II) in the afternoon for travel at 2 different locations. There was no concomitant medication. On 26-APR-2009, the patient developed wheals on the left side of her abdomen. It was itchy, 4 inches in diameter and painful (pain scale of 2-3). Her rash spread to 12 inches in diameter and localized to the left side of the abdomen. Patient was referred to her primary care physician. The patient is recovering from adverse events. No laboratories were performed. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Drug hypersensitivity, Gait disturbance, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a 76 year old female with allergies to penicillin, bee sting, B-Blockers, COUMADIN, who on 30-APR-2009 was vaccinated into the left upper arm with 0.65ml dose of ZOSTAVAX (Merck) in (route unspecified, lot number:663884/0131Y). Concomitant therapy included PREMARIN and vitamins. The nurse stated, the patient developed inflammation at the injection site two days after vaccination (on 2-MAY-2009) also reported on 7-MAY-2009 (8 days after the vaccination), she developed shingles and 3 days after vaccination experienced rash (also reported as 1-MAY-2009) with 11 lesions in her left scapular (C7-C8) and other symptoms: sweats, headache, severe stomach pain, fatigue, her left arm felt numb and weakness at her legs. Also the patient was not exposure to chickenpox but was exposed to shingles when she was in contact with her husband (in APR-2009). The patient was treated with antivirals. Also, the patient stated did not understand how she could get shingles after being vaccinated. She explained that she initially developed a painful rash on her left hip area within several days post-vaccination, which progressed and was subsequently diagnosed as shingles 8 days post-vaccination. She was treated with VALTREX, and the shingles resolved; however, within several days of discontinuing the VALTREX, she experienced a recurrence of the shingles on the opposite arm (i.e. right upper arm). She said she never developed vesicles or scabs during either episode of shingles or with the rash on her left hip. She reported the lesions for all the rashes shingles were like "red welts". She also stated her doctor had collected a sample from one of the upper arm lesions for identification of Varicella Zoster. The patient was enrolled in the Varicella Zoster 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. The sample of the lesion was collected on 12-MAY-2009. The sample was taken from a papule and the site of specimen was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Musculoskeletal pain, Rash
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a 76 year old female with allergies to penicillin, bee sting, B-Blockers, COUMADIN, who on 30-APR-2009 was vaccinated into the left upper arm with 0.65ml dose of ZOSTAVAX (Merck) in (route unspecified, lot number:663884/0131Y). Concomitant therapy included PREMARIN and vitamins. The nurse stated, the patient developed inflammation at the injection site two days after vaccination (on 2-MAY-2009) also reported on 7-MAY-2009 (8 days after the vaccination), she developed shingles and 3 days after vaccination experienced rash (also reported as 1-MAY-2009) with 11 lesions in her left scapular (C7-C8) and other symptoms: sweats, headache, severe stomach pain, fatigue, her left arm felt numb and weakness at her legs. Also the patient was not exposure to chickenpox but was exposed to shingles when she was in contact with her husband (in APR-2009). The patient was treated with antivirals. Also, the patient stated did not understand how she could get shingles after being vaccinated. She explained that she initially developed a painful rash on her left hip area within several days post-vaccination, which progressed and was subsequently diagnosed as shingles 8 days post-vaccination. She was treated with VALTREX, and the shingles resolved; however, within several days of discontinuing the VALTREX, she experienced a recurrence of the shingles on the opposite arm (i.e. right upper arm). She said she never developed vesicles or scabs during either episode of shingles or with the rash on her left hip. She reported the lesions for all the rashes shingles were like "red welts". She also stated her doctor had collected a sample from one of the upper arm lesions for identification of Varicella Zoster. The patient was enrolled in the Varicella Zoster 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. The sample of the lesion was collected on 12-MAY-2009. The sample was taken from a papule and the site of specimen was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Herpes zoster, Hyperhidrosis
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a 76 year old female with allergies to penicillin, bee sting, B-Blockers, COUMADIN, who on 30-APR-2009 was vaccinated into the left upper arm with 0.65ml dose of ZOSTAVAX (Merck) in (route unspecified, lot number:663884/0131Y). Concomitant therapy included PREMARIN and vitamins. The nurse stated, the patient developed inflammation at the injection site two days after vaccination (on 2-MAY-2009) also reported on 7-MAY-2009 (8 days after the vaccination), she developed shingles and 3 days after vaccination experienced rash (also reported as 1-MAY-2009) with 11 lesions in her left scapular (C7-C8) and other symptoms: sweats, headache, severe stomach pain, fatigue, her left arm felt numb and weakness at her legs. Also the patient was not exposure to chickenpox but was exposed to shingles when she was in contact with her husband (in APR-2009). The patient was treated with antivirals. Also, the patient stated did not understand how she could get shingles after being vaccinated. She explained that she initially developed a painful rash on her left hip area within several days post-vaccination, which progressed and was subsequently diagnosed as shingles 8 days post-vaccination. She was treated with VALTREX, and the shingles resolved; however, within several days of discontinuing the VALTREX, she experienced a recurrence of the shingles on the opposite arm (i.e. right upper arm). She said she never developed vesicles or scabs during either episode of shingles or with the rash on her left hip. She reported the lesions for all the rashes shingles were like "red welts". She also stated her doctor had collected a sample from one of the upper arm lesions for identification of Varicella Zoster. The patient was enrolled in the Varicella Zoster 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. The sample of the lesion was collected on 12-MAY-2009. The sample was taken from a papule and the site of specimen was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site inflammation, Laboratory test, Muscular weakness, Rash
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a 76 year old female with allergies to penicillin, bee sting, B-Blockers, COUMADIN, who on 30-APR-2009 was vaccinated into the left upper arm with 0.65ml dose of ZOSTAVAX (Merck) in (route unspecified, lot number:663884/0131Y). Concomitant therapy included PREMARIN and vitamins. The nurse stated, the patient developed inflammation at the injection site two days after vaccination (on 2-MAY-2009) also reported on 7-MAY-2009 (8 days after the vaccination), she developed shingles and 3 days after vaccination experienced rash (also reported as 1-MAY-2009) with 11 lesions in her left scapular (C7-C8) and other symptoms: sweats, headache, severe stomach pain, fatigue, her left arm felt numb and weakness at her legs. Also the patient was not exposure to chickenpox but was exposed to shingles when she was in contact with her husband (in APR-2009). The patient was treated with antivirals. Also, the patient stated did not understand how she could get shingles after being vaccinated. She explained that she initially developed a painful rash on her left hip area within several days post-vaccination, which progressed and was subsequently diagnosed as shingles 8 days post-vaccination. She was treated with VALTREX, and the shingles resolved; however, within several days of discontinuing the VALTREX, she experienced a recurrence of the shingles on the opposite arm (i.e. right upper arm). She said she never developed vesicles or scabs during either episode of shingles or with the rash on her left hip. She reported the lesions for all the rashes shingles were like "red welts". She also stated her doctor had collected a sample from one of the upper arm lesions for identification of Varicella Zoster. The patient was enrolled in the Varicella Zoster 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. The sample of the lesion was collected on 12-MAY-2009. The sample was taken from a papule and the site of specimen was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a 76 year old female with allergies to penicillin, bee sting, B-Blockers, COUMADIN, who on 30-APR-2009 was vaccinated into the left upper arm with 0.65ml dose of ZOSTAVAX (Merck) in (route unspecified, lot number:663884/0131Y). Concomitant therapy included PREMARIN and vitamins. The nurse stated, the patient developed inflammation at the injection site two days after vaccination (on 2-MAY-2009) also reported on 7-MAY-2009 (8 days after the vaccination), she developed shingles and 3 days after vaccination experienced rash (also reported as 1-MAY-2009) with 11 lesions in her left scapular (C7-C8) and other symptoms: sweats, headache, severe stomach pain, fatigue, her left arm felt numb and weakness at her legs. Also the patient was not exposure to chickenpox but was exposed to shingles when she was in contact with her husband (in APR-2009). The patient was treated with antivirals. Also, the patient stated did not understand how she could get shingles after being vaccinated. She explained that she initially developed a painful rash on her left hip area within several days post-vaccination, which progressed and was subsequently diagnosed as shingles 8 days post-vaccination. She was treated with VALTREX, and the shingles resolved; however, within several days of discontinuing the VALTREX, she experienced a recurrence of the shingles on the opposite arm (i.e. right upper arm). She said she never developed vesicles or scabs during either episode of shingles or with the rash on her left hip. She reported the lesions for all the rashes shingles were like "red welts". She also stated her doctor had collected a sample from one of the upper arm lesions for identification of Varicella Zoster. The patient was enrolled in the Varicella Zoster 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. The sample of the lesion was collected on 12-MAY-2009. The sample was taken from a papule and the site of specimen was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old patient who on 11-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) instead of the first dose of VARIVAX (Merck). No symptom was reported. Follow up information was received concerning a 24 month old (previous reported as 36 month) female patient who was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) (lot #663198/1419X) into the left thigh. The patient had no medical history of drug allergy. There was no illness at time of vaccination. The patient's mother stated that the patient had no redness, rash or fever. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old patient who on 11-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) instead of the first dose of VARIVAX (Merck). No symptom was reported. Follow up information was received concerning a 24 month old (previous reported as 36 month) female patient who was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) (lot #663198/1419X) into the left thigh. The patient had no medical history of drug allergy. There was no illness at time of vaccination. The patient's mother stated that the patient had no redness, rash or fever. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Activities of daily living impaired, Apnoea, Back pain, Confusional state, Crying
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling drunk, Feeling hot
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Headache, Hyperacusis, Hyperhidrosis, Incoherent, Migraine
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Panic reaction
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Phonophobia, Photophobia, Somnolence
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Abasia, Back pain, Fatigue, Gait disturbance, Headache
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Muscular weakness, Paraesthesia, Syncope, Wheelchair user
Clinical narrative: Symptoms continued, exhausted, problems walking. Had to wake her to eat, drink, bathe and make her attempt to walk very small distance. Admitted to Hospital from 5/15-5/17 severe back and head pain. Doctor refused to administer plasmaresis all test came back negative. Had to advocate for wheelchair because she could not walk. 5/16 good sign alert and attentive.  Home 5/17-5/18. Finished last 2 1/2 weeks of school in a wheel chair. Had problems with walking, would collaspe, tingling and feet/legs. Weak upper and lower extremeties.  Slowly started back walking conti collapsing, tingling feet/legs back pain. Unable to get a referral to a neurologist, they would not see her. In wheelchair for about a month. Started Physical therapy 6/26.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 68 year old female patient with hypothyroidism and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663333/1555X) subcutaneously into her left arm. It was reported that on 04-MAY-2009 the patient experienced pain at the injection site during the injection. It was reported that the injection became itchy and a red track that was 3 inches by 6 inches went down her arm beginning at the injection site. There was a "bumpy line in the redness". It was also reported that on 06-MAY-2009 at 01:00 am the patient woke with fever, shaking and chills and by 03:00 am the injection was a magenta color and hard. It was reported that on 07-MAY-2009 the redness was a lighter color and improving. On 08-MAY-2009 the patient was seen in doctor's office and cephalexin was prescribed. It was reported that the physician told the patient that the "immunizer did not clean the site well enough". It was reported by the pharmacist that the patient did not have a rash. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 68 year old female patient with hypothyroidism and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663333/1555X) subcutaneously into her left arm. It was reported that on 04-MAY-2009 the patient experienced pain at the injection site during the injection. It was reported that the injection became itchy and a red track that was 3 inches by 6 inches went down her arm beginning at the injection site. There was a "bumpy line in the redness". It was also reported that on 06-MAY-2009 at 01:00 am the patient woke with fever, shaking and chills and by 03:00 am the injection was a magenta color and hard. It was reported that on 07-MAY-2009 the redness was a lighter color and improving. On 08-MAY-2009 the patient was seen in doctor's office and cephalexin was prescribed. It was reported that the physician told the patient that the "immunizer did not clean the site well enough". It was reported by the pharmacist that the patient did not have a rash. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 68 year old female patient with hypothyroidism and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663333/1555X) subcutaneously into her left arm. It was reported that on 04-MAY-2009 the patient experienced pain at the injection site during the injection. It was reported that the injection became itchy and a red track that was 3 inches by 6 inches went down her arm beginning at the injection site. There was a "bumpy line in the redness". It was also reported that on 06-MAY-2009 at 01:00 am the patient woke with fever, shaking and chills and by 03:00 am the injection was a magenta color and hard. It was reported that on 07-MAY-2009 the redness was a lighter color and improving. On 08-MAY-2009 the patient was seen in doctor's office and cephalexin was prescribed. It was reported that the physician told the patient that the "immunizer did not clean the site well enough". It was reported by the pharmacist that the patient did not have a rash. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Pyrexia, Tremor
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 68 year old female patient with hypothyroidism and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663333/1555X) subcutaneously into her left arm. It was reported that on 04-MAY-2009 the patient experienced pain at the injection site during the injection. It was reported that the injection became itchy and a red track that was 3 inches by 6 inches went down her arm beginning at the injection site. There was a "bumpy line in the redness". It was also reported that on 06-MAY-2009 at 01:00 am the patient woke with fever, shaking and chills and by 03:00 am the injection was a magenta color and hard. It was reported that on 07-MAY-2009 the redness was a lighter color and improving. On 08-MAY-2009 the patient was seen in doctor's office and cephalexin was prescribed. It was reported that the physician told the patient that the "immunizer did not clean the site well enough". It was reported by the pharmacist that the patient did not have a rash. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female with no medical history or allergy who on 18-MAY-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot # 663779/1791X). There was no concomitant medication. The patient developed an injection site reaction 12 to 24 hours after the vaccination. The swelling was 2 inch in radius which was red and warm to the touch. The patient sought medical attention by seeing the pharmacist. The patient was recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female with no medical history or allergy who on 18-MAY-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot # 663779/1791X). There was no concomitant medication. The patient developed an injection site reaction 12 to 24 hours after the vaccination. The swelling was 2 inch in radius which was red and warm to the touch. The patient sought medical attention by seeing the pharmacist. The patient was recovering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female with an unspecified joint disorder, who on 18-MAY-2009 was vaccinated SQ with 0.65 ml of ZOSTAVAX (Merck) (lot number:663199/1557X). Concomitant therapy included propranolol HCl (manufacturer unknown), PROTONIX, primidone, corticosteroid injection and potassium (unspecified). The pharmacist reported that on 19-MAY-2009, the patient received an intra-articular corticosteroid injection for a medical condition that occurred prior to administration of the vaccine. Subsequently on 20-MAY-2009, the patient developed "fire red hot" facial cheeks after administration of the vaccine. The outcome of the patient was not recovered. The patient sought medical attention by call to the pharmacist. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female with an unspecified joint disorder, who on 18-MAY-2009 was vaccinated SQ with 0.65 ml of ZOSTAVAX (Merck) (lot number:663199/1557X). Concomitant therapy included propranolol HCl (manufacturer unknown), PROTONIX, primidone, corticosteroid injection and potassium (unspecified). The pharmacist reported that on 19-MAY-2009, the patient received an intra-articular corticosteroid injection for a medical condition that occurred prior to administration of the vaccine. Subsequently on 20-MAY-2009, the patient developed "fire red hot" facial cheeks after administration of the vaccine. The outcome of the patient was not recovered. The patient sought medical attention by call to the pharmacist. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain
Clinical narrative: Information has been received from a 74 year old male patient with penicillin and sulfonamide allergy and a history of heart attack 2 years ago who on 28-MAR-2009 was vaccinated with with a dose of ZOSTAVAX (Merck) after his son came down with shingles on 19-MAR-2009 and his grandson had chicken pox. It was reported that after "a couple of days" of receiving the ZOSTAVAX the patient's arm started to sore. He developed a rash and blisters on his elbow area, and then 4 little bumps started appearing. They were very itchy and sore and they started to show in his buttocks and then at the back of both of his legs which had 3 or 4 blister spots. It was reported that around 09-APR-2009 the rest of his son's family (5 of them in total) started contracting chicken pox and since the patient was around them after receiving the ZOSTAVAX he did not know whether they got the chicken pox from him or from his son who had shingles around that time (WAES # 0905USA02780). The patient did not seek medical attention. At the time of reporting the patient was recovering and  his lesions were starting to dry. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Rash, Skin lesion
Clinical narrative: Information has been received from a 74 year old male patient with penicillin and sulfonamide allergy and a history of heart attack 2 years ago who on 28-MAR-2009 was vaccinated with with a dose of ZOSTAVAX (Merck) after his son came down with shingles on 19-MAR-2009 and his grandson had chicken pox. It was reported that after "a couple of days" of receiving the ZOSTAVAX the patient's arm started to sore. He developed a rash and blisters on his elbow area, and then 4 little bumps started appearing. They were very itchy and sore and they started to show in his buttocks and then at the back of both of his legs which had 3 or 4 blister spots. It was reported that around 09-APR-2009 the rest of his son's family (5 of them in total) started contracting chicken pox and since the patient was around them after receiving the ZOSTAVAX he did not know whether they got the chicken pox from him or from his son who had shingles around that time (WAES # 0905USA02780). The patient did not seek medical attention. At the time of reporting the patient was recovering and  his lesions were starting to dry. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Abdominal pain, Computerised tomogram normal, Dizziness, Dyspnoea, Headache
Clinical narrative: Initial report received on 08 July 2009 from a health care professional. A 19-year-old female patient, who had no concurrent illnesses or allergies, received a first left arm (route not reported) dose of TYPHIM VI (lot number D0251-2), and a first right arm (route not reported) dose of "HEP A" vaccine (Trade name not reported, manufacturer name GlaxoSmithKline, lot number AHAVB343CA) on 07 July 2009 at 13:30 pm. Use of concomitant medications was unknown; and the patient had not received any other vaccinations within four weeks. Approximately 90 minutes after receiving the TYPHIM VI and HEP A vaccine which was around 15:00 pm on 07 July 2009, the patient reported being dizzy, having a headache and nausea, and abdominal pain and short of breath. The patient was directed to the hospital emergency room for treatment; however, treatments received were not reported. While in the emergency room, the patient reported that she had a CAT scan and other tests completed, but did not know what all tests were done, or what the results were. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Laboratory test, Nausea
Clinical narrative: Initial report received on 08 July 2009 from a health care professional. A 19-year-old female patient, who had no concurrent illnesses or allergies, received a first left arm (route not reported) dose of TYPHIM VI (lot number D0251-2), and a first right arm (route not reported) dose of "HEP A" vaccine (Trade name not reported, manufacturer name GlaxoSmithKline, lot number AHAVB343CA) on 07 July 2009 at 13:30 pm. Use of concomitant medications was unknown; and the patient had not received any other vaccinations within four weeks. Approximately 90 minutes after receiving the TYPHIM VI and HEP A vaccine which was around 15:00 pm on 07 July 2009, the patient reported being dizzy, having a headache and nausea, and abdominal pain and short of breath. The patient was directed to the hospital emergency room for treatment; however, treatments received were not reported. While in the emergency room, the patient reported that she had a CAT scan and other tests completed, but did not know what all tests were done, or what the results were. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Abdominal pain, Computerised tomogram, Dizziness, Dyspnoea, Headache
Clinical narrative: Initial report received on 08 July 2009 from a health care professional. A 19-year-old female patient, who had no concurrent illnesses or allergies, received a first left arm (route not reported) dose of TYPHIM VI (lot number D0251-2), and a first right arm (route not reported) dose of "HEP A" vaccine (Trade name not reported, manufacturer name GlaxoSmithKline, lot number AHAVB343CA) on 07 July 2009 at 13:30 pm. Use of concomitant medications was unknown; and the patient had not received any other vaccinations within four weeks. Approximately 90 minutes after receiving the TYPHIM VI and HEP A vaccine which was around 15:00 pm on 07 July 2009, the patient reported being dizzy, having a headache and nausea, and abdominal pain and short of breath. The patient was directed to the hospital emergency room for treatment; however, treatments received were not reported. While in the emergency room, the patient reported that she had a CAT scan and other tests completed, but did not know what all tests were done, or what the results were. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Nausea
Clinical narrative: Initial report received on 08 July 2009 from a health care professional. A 19-year-old female patient, who had no concurrent illnesses or allergies, received a first left arm (route not reported) dose of TYPHIM VI (lot number D0251-2), and a first right arm (route not reported) dose of "HEP A" vaccine (Trade name not reported, manufacturer name GlaxoSmithKline, lot number AHAVB343CA) on 07 July 2009 at 13:30 pm. Use of concomitant medications was unknown; and the patient had not received any other vaccinations within four weeks. Approximately 90 minutes after receiving the TYPHIM VI and HEP A vaccine which was around 15:00 pm on 07 July 2009, the patient reported being dizzy, having a headache and nausea, and abdominal pain and short of breath. The patient was directed to the hospital emergency room for treatment; however, treatments received were not reported. While in the emergency room, the patient reported that she had a CAT scan and other tests completed, but did not know what all tests were done, or what the results were. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Breast tenderness, Cellulitis, Erythema, Nausea, Vomiting
Clinical narrative: Patient complained of n/v and left breast tenderness following immunization with TDAP. N/V subsided but breast redness and tenderness worsened resulting in hospitalization and IV antibiotic therapy for cellulitis.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Breast tenderness, Cellulitis, Erythema, Nausea, Nervousness
Clinical narrative: Patient complained of n/v and left breast tenderness following immunization with TDAP. N/V subsided but breast redness and tenderness worsened resulting in hospitalization and IV antibiotic therapy for cellulitis.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vomiting
Clinical narrative: Patient complained of n/v and left breast tenderness following immunization with TDAP. N/V subsided but breast redness and tenderness worsened resulting in hospitalization and IV antibiotic therapy for cellulitis.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Endoscopy
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who in approximately October 2008, was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) intramuscularly. In December 2008 she received second dose of GARDASIL (lot # not reported) intramuscularly. In the same visit in December 2008, she received a dose of VAQTA (manufacturer unknown). There was no concomitant medication. In December 2008" right after the dose" of GARDASIL vaccine the patient developed chronic fatigue, fainting spells. The patient slept 20 hours a day and had not been attending school. The patient sought medical attention was at office. At the time on the report on 06-JUL-2009 the patient had not recovered. On unspecified date psychiatrist evaluation was performed (results not reported). The patient did not experience any adverse effects after the first dose of GARDASIL. The physician mentioned that he did not feel that the symptoms were related to GARDASIL. Chronic fatigue, fainting spells, slept 20 hours were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Fatigue, Hypersomnia, Nuclear magnetic resonance imaging, Ophthalmological examination, Pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who in approximately October 2008, was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) intramuscularly. In December 2008 she received second dose of GARDASIL (lot # not reported) intramuscularly. In the same visit in December 2008, she received a dose of VAQTA (manufacturer unknown). There was no concomitant medication. In December 2008" right after the dose" of GARDASIL vaccine the patient developed chronic fatigue, fainting spells. The patient slept 20 hours a day and had not been attending school. The patient sought medical attention was at office. At the time on the report on 06-JUL-2009 the patient had not recovered. On unspecified date psychiatrist evaluation was performed (results not reported). The patient did not experience any adverse effects after the first dose of GARDASIL. The physician mentioned that he did not feel that the symptoms were related to GARDASIL. Chronic fatigue, fainting spells, slept 20 hours were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope, Ultrasound scan, Visual impairment, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who in approximately October 2008, was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) intramuscularly. In December 2008 she received second dose of GARDASIL (lot # not reported) intramuscularly. In the same visit in December 2008, she received a dose of VAQTA (manufacturer unknown). There was no concomitant medication. In December 2008" right after the dose" of GARDASIL vaccine the patient developed chronic fatigue, fainting spells. The patient slept 20 hours a day and had not been attending school. The patient sought medical attention was at office. At the time on the report on 06-JUL-2009 the patient had not recovered. On unspecified date psychiatrist evaluation was performed (results not reported). The patient did not experience any adverse effects after the first dose of GARDASIL. The physician mentioned that he did not feel that the symptoms were related to GARDASIL. Chronic fatigue, fainting spells, slept 20 hours were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Activities of daily living impaired, Fatigue, Hypersomnia, Immediate post-injection reaction, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who in approximately October 2008, was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) intramuscularly. In December 2008 she received second dose of GARDASIL (lot # not reported) intramuscularly. In the same visit in December 2008, she received a dose of VAQTA (manufacturer unknown). There was no concomitant medication. In December 2008" right after the dose" of GARDASIL vaccine the patient developed chronic fatigue, fainting spells. The patient slept 20 hours a day and had not been attending school. The patient sought medical attention was at office. At the time on the report on 06-JUL-2009 the patient had not recovered. On unspecified date psychiatrist evaluation was performed (results not reported). The patient did not experience any adverse effects after the first dose of GARDASIL. The physician mentioned that he did not feel that the symptoms were related to GARDASIL. Chronic fatigue, fainting spells, slept 20 hours were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who in approximately October 2008, was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) intramuscularly. In December 2008 she received second dose of GARDASIL (lot # not reported) intramuscularly. In the same visit in December 2008, she received a dose of VAQTA (manufacturer unknown). There was no concomitant medication. In December 2008" right after the dose" of GARDASIL vaccine the patient developed chronic fatigue, fainting spells. The patient slept 20 hours a day and had not been attending school. The patient sought medical attention was at office. At the time on the report on 06-JUL-2009 the patient had not recovered. On unspecified date psychiatrist evaluation was performed (results not reported). The patient did not experience any adverse effects after the first dose of GARDASIL. The physician mentioned that he did not feel that the symptoms were related to GARDASIL. Chronic fatigue, fainting spells, slept 20 hours were considered to be disabling. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a 63 year old female with no known drug allergies and who was first diagnosed with herpes zoster ophthalmic in 2005 who on 20-FEB-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose reported as 0.6mg, lot number 663895/0135Y). Concomitant therapy included simvastatin (manufacturer unknown), VALTREX and aspirin. The physician reported that when the patient was vaccinated, her current medication VALTREX was withheld for two weeks post vaccination. A week after being vaccinated (on 27-FEB-2009) the patient experienced a flare-up of herpes zoster ophthalmicus of her right eye. She was treated with "two courses" of VALTREX for 14 to 20 days with no improvement noted. The physician was consulting an ophthalmologist. No lab studies were performed. At the time of reporting the patient had not recovered from flare-up of herpes zoster ophthalmicus. Flare-up of herpes zoster ophthalmicus was considered to be disabling by the reporting physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The registered nurse reported "somebody that works within the community health center's child received the dose of GARDASIL, at another office (which was not specified) and experienced a serious adverse event where she could not walk among other things which were unspecified". The registered nurse reported that the patient was hospitalized and the length of stay was unspecified. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.