chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fibula fracture, Gait disturbance, Herpes zoster, Hypoaesthesia, Insomnia
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nerve injury, Pain, Pain in extremity, Scab, Skin lesion
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tibia fracture
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Arthropathy, Back pain, Bone operation
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depression, Fall, Fibula fracture, Frustration, Gait disturbance
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Joint swelling, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tibia fracture, Weight bearing difficulty
Clinical narrative: This letter is in regard to my case 1-281-768-0126 that I have on file with your company. I am writing this letter to summarize this issues that contracting shingles has caused, post shingles vaccine (12/09). Contracting shingles has turned my life upside down. I first got them at the beginning of November and initially was evaluated for  a back problem due the numbness in my lower left leg and pain in my lower back and down my left leg. The MRI's were negative. There had been no suspicion of shingles as I had the vaccine 1 months prior! Finally I was diagnosed. The lesions spread from my back, down my outer thigh, to BOTH sides of my left calf! The pain was excruciating. After 2 trips to the ER for the intense pain, I was diagnosed and put on acyclovir.  I was also given pain medication. Eventually, due to the severity of the pain, I was given LYRICA. On December 6th, knowing that my lower calf was numb, I had also developed weakness in my left knee. My knee gave out and I crumbled, causing 3 fractures to the tibia/fibula. I had surgery to both bones with screws and plates to put the ankle back together. As of today, I still have full time care ad cannot out any weight on my foot/ankle. It has been so humiliating to have to have to ask for help with everything from using the commode to helping me get dressed. Most of my holiday was spent in bed and in deep depression over this.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Abasia, Antinuclear antibody positive, Body temperature increased, Juvenile arthritis, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Rheumatoid arthritis
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Abasia, Antinuclear antibody positive, Arthralgia, C-reactive protein increased, Hypokinesia
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Joint swelling, Juvenile arthritis, Myalgia, Neutrophil count, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Rash macular, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 12 year old female patient with a medical history of tonsillectomy and no known allergies and no pre-existing illness, on 18-FEB-2008 was vaccinated with the second dose of GARDASIL (lot# 658554/0928U). Concomitant therapy included MENACTRA (lot# U2382BA) and BOOSTRIX (lot# AC52B019AA) on the same day. On 28-JUN-2008, the patient's body temperature went up to 104 and she could not walk. She experienced a lot of pain and was admitted to the hospital. It was reported that hospital discharge summary, history and physical examination (H&P), consults and diagnostics for date of service (DOS) were from 28-JUN-2008 to 02-JUL-2008 and emergency room (ER) record for DOS was on 13-SEP-2008. The final diagnosis (Dx) was reported as juvenile rheumatoid arthritis. The patient presented with complaints of (c/o) high fever and severe joint pains. Upon presentation, the patient's temperature was 100.4 F and patient had severe joint and muscle pain and would not move her limbs, unless asked. It was reported that symptoms started ten days earlier with development of a rash, which subsequently resolved after treatment with prednisone and BENADRYL. One day after the rash resolved, the patient then developed fever, and ankle/knee joint pain. The patient was admitted and while hospitalized, spiked fevers and was started on ROCEPHIN. Rheumatology was consulted. Consult exam noted that the patient experienced salmon-colored macular rash on arms and legs. The exam noted swelling of wrist, interphalangeal joints and ankles. There was palpable tenderness to the patient's toes. The patient was treated with prednisone and subsequently pain and fever resolved. The rashes persisted. The patient was discharged home (Plan: refer to medication). According to ER record of 13-SEP-2008, it noted that patient had been seen at outside medical center and had received a prescription which the local pharmacy was not able to fill (a prescription for leucovorin). The patient was seen and received leucovorin. The impression symptom was reported as juvenile rheumatoid arthritis. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The events were considered to be serious and permanent disabling and life-threatening. The original reporting source was not provided. The VAERS ID # is 414486. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; left thigh given on 7 March 2011. There were no concurrent medications. The subject had no relevant medical history. The subject had no adverse events following previous vaccinations. On 7 March 2011 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). On 8 March 2011, 1 day after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb. The physician reported that the subject's right thigh swelled to three times the size. The physician considered the event was life threatening. At the time of reporting the event was worse. After the next vaccination with KINRIX the event recurred. The physician considered the event was probably related to vaccination with KINRIX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; left thigh given on 7 March 2011. There were no concurrent medications. The subject had no relevant medical history. The subject had no adverse events following previous vaccinations. On 7 March 2011 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). On 8 March 2011, 1 day after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb. The physician reported that the subject's right thigh swelled to three times the size. The physician considered the event was life threatening. At the time of reporting the event was worse. After the next vaccination with KINRIX the event recurred. The physician considered the event was probably related to vaccination with KINRIX.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Blood creatine phosphokinase normal, Chest discomfort, Electrocardiogram normal, Flushing
Clinical narrative: Information has been received from a licensed practical nurse concerning an 89 year old female patient with mitral regurgitation, osteoporosis, chronic kidney disease, gastrooesophageal reflux disease, polymyalgia, drug hypersensitivity to LAMISIL and BACTRIM, and a history of tachycardia who on 23-MAR-2011 was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular in her left deltoid muscle. (Lot number 667914/1067Z). Concomitant therapy included prednisone (manufacturer unknown) and alendronate sodium (MSD). The nurse reported that the patient who was vaccinated on 23-MAR-2011 with PNEUMOVAX 23, within 2 minutes of receiving the vaccine, developed redness in the face and body, the patient complained of feeling warm, chest pain, low back pain and low back spasms. The patient was given oxygen, an EKG was performed and she was transported to the emergency room. At the time of the report, the patient's outcome was unknown. Redness in the face and body, feeling warm, chest pain, low back pain and low back spasms were considered to be disabling and immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Chest pain, Electrocardiogram, Erythema, Feeling hot
Clinical narrative: Information has been received from a licensed practical nurse concerning an 89 year old female patient with mitral regurgitation, osteoporosis, chronic kidney disease, gastrooesophageal reflux disease, polymyalgia, drug hypersensitivity to LAMISIL and BACTRIM, and a history of tachycardia who on 23-MAR-2011 was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular in her left deltoid muscle. (Lot number 667914/1067Z). Concomitant therapy included prednisone (manufacturer unknown) and alendronate sodium (MSD). The nurse reported that the patient who was vaccinated on 23-MAR-2011 with PNEUMOVAX 23, within 2 minutes of receiving the vaccine, developed redness in the face and body, the patient complained of feeling warm, chest pain, low back pain and low back spasms. The patient was given oxygen, an EKG was performed and she was transported to the emergency room. At the time of the report, the patient's outcome was unknown. Redness in the face and body, feeling warm, chest pain, low back pain and low back spasms were considered to be disabling and immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Generalised erythema, Muscle spasms
Clinical narrative: Information has been received from a licensed practical nurse concerning an 89 year old female patient with mitral regurgitation, osteoporosis, chronic kidney disease, gastrooesophageal reflux disease, polymyalgia, drug hypersensitivity to LAMISIL and BACTRIM, and a history of tachycardia who on 23-MAR-2011 was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular in her left deltoid muscle. (Lot number 667914/1067Z). Concomitant therapy included prednisone (manufacturer unknown) and alendronate sodium (MSD). The nurse reported that the patient who was vaccinated on 23-MAR-2011 with PNEUMOVAX 23, within 2 minutes of receiving the vaccine, developed redness in the face and body, the patient complained of feeling warm, chest pain, low back pain and low back spasms. The patient was given oxygen, an EKG was performed and she was transported to the emergency room. At the time of the report, the patient's outcome was unknown. Redness in the face and body, feeling warm, chest pain, low back pain and low back spasms were considered to be disabling and immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Disorientation, Headache, Injection site pain, Injection site rash
Clinical narrative: rash at injection point, back pain, sore at injection point, tingling hot feeling at injection point, headache, disoreintation
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia, Skin warm
Clinical narrative: rash at injection point, back pain, sore at injection point, tingling hot feeling at injection point, headache, disoreintation
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Immediate post-injection reaction, Movement disorder, Syncope
Clinical narrative: Information has been received from a certified nurse practitioner (C.N.P.) concerning an 18 year old female with asthma who on 21-OCT-2009 was intramuscularly vaccinated with the second dose of 0.5 ml GARDASIL (lot # 0702X/ exp. 08-SEP-2010) in left deltoid.  Concomitant therapy included albuterol.  The patient received the first dose and the second dose at the university where the patient was a student.  No other vaccine was given at the time of the second dose on 21-OCT-2009.  ADACEL was to be administered, but it was not given due to the patient's events immediately following the GARDASIL dosing.  The reporter stated that the patient experienced syncope and tonic-clonic like seizure activity after receiving her second dose of GARDASIL on 21-OCT-2009 (date of dose 1 was unspecified).  The patient reported that she remained in the provider's (unspecified) office until she recovered from her adverse effects.  On 21-OCT-2009, the patient had recovered from syncope and tonic-clonic like seizure activity.  Upon internal review, tonic-clonic like seizure activity was determined to be an other important medical event.  No further information is available.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Redness and blistering at site of injection approx. 2 to 3 day after administration of vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Vaccine administered Feb. 9, 11. Reaction Feb.22-27. Quarter sized raised welt at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash macular, Skin warm
Clinical narrative: Woke up with "red blotches" on face and neck, warm to touch, mild itching. Reports no trouble breathing, no dizziness or other symptoms noted.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt. fainted 5 minutes post injection. Vitals stable, MD notified. Pt didn't eat breakfast. Gatorade and OJ given. Pt lying flat, symptoms improved.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal pain upper, Colonoscopy, Diarrhoea, Endoscopy gastrointestinal, Endoscopy upper gastrointestinal tract
Clinical narrative: Belly pain, vomiting, diarrhea, fever & mass on intestines.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Intestinal mass, Pyrexia, Ultrasound scan, Vomiting, X-ray
Clinical narrative: Belly pain, vomiting, diarrhea, fever & mass on intestines.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3-28-11 11:30 am: about 5 x 5 1/2 in. pink, raised, warm area of erythema to left lateral thigh, tx with diphenhydramine p.o. & hcz crm topically. 3-30-11 9:00 am: swelling has decreased per pt's mom.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt to Emp. Health 3/30/11 with c/o left upper arm pain in general deltoid region with initial redness soreness, sl swelling resolved after a couple of days. Sore to sleep on L arm x 2 wks now with continued soreness "ache" of (L) deltoid, no lump, no redness or swelling, no burning, no w/n/t, no joint pain, increased pain with movement of (L) arm - pain moves around deltoid region only no specific point tenderness. Pain is 6/10 at worst decreased with NSAID.
Age: 10.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local swelling
Clinical narrative: Localized redness, swelling and some induration of left deltoid area where HPV and Flu shots were administered 03/28/2011. Manufacturer for Flu Shot is Sanofi Pasteur.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Muscle spasms, Pain in extremity
Clinical narrative: Red, warm at injection site started immediately and lasted 7 days. Only treatment was cool compresses. approximately 2" x 2 1/2". Painful leg cramps x 2 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC, VARCEL
Symptoms: Autism spectrum disorder, Decreased eye contact, Gait disturbance, Stereotypy
Clinical narrative: Patient lost eye contact and would not look us in the eyes.  He started walking in circles.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: Weakness, dizziness, shortness of breath,  and brief moments of loss of consciousness.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: My daughter had afebrile seizure from MMR vaccine. This happened on the 9th day after the vaccination.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion, Crying, Laboratory test normal, Loss of consciousness
Clinical narrative: My daughter had afebrile seizure from MMR vaccine. This happened on the 9th day after the vaccination.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Contusion, Injection site pain, Oedema peripheral, Swelling
Clinical narrative: Minor pain at injection site which spread to upper arm over the course of a few days. Swelling and bruising was notice after 5 days. Swelling moved from upper arm to lower arm and fingers. Medication & follow up care provided by clients primary care provider.
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram, Dyskinesia, Electroencephalogram, Eye movement disorder
Clinical narrative: This is an initial spontaneous report from a contactable reporter.  A reporter reported for (age and race unknown) her son, who started to receive PREVNAR 13 (unknown date).  His concomitant medications were not provided.  His medical history included the first dose of PREVNAR 13 at approximately 2 years and 11 months of age.  His physician recommended 2 other doses after that.  His second dose was given approximately 3 months later.  After that dose he experienced an acute reaction, clarified as his eyes were fluttering and jerking but it resolved within approximately 3 days.  He has had several tests including an EEG and a CT.  They have not provided a diagnosis yet but they are considering seizures or epilepsy.  The reporter states the physicians do not feel the events are related to PREVNAR 13.  Physician's Contact: refused.
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram, Electroencephalogram, Eye movement disorder, Gaze palsy, Vaccine positive rechallenge
Clinical narrative: This is an initial spontaneous report from a contactable reporter.  This female consumer reported that her son received the third injection of PREVNAR 13 on 09MAR2011.  His concomitant medications were not provided.  His medical history includes the first dose PREVNAR 13 at the age of 35 months and a second dose at age 38 months.  The patient experienced an acute reaction, clarified as his eyes were fluttering and jerking after the second dose but it resolved within approximately 3 days.  Within hours after his third dose, he experienced eye jerking, fluttering and rolling into the back of his head.  These events continue.  He has had several tests including an EEG and a CT.  They have not provided a diagnosis yet but they are considering seizures or epilepsy.  The reporter states the physicians do not feel the events are related to PREVNAR 13.  Physician's Contact: refused.  Follow-up (21Mar2011): This is a follow-up spontaneous report from a contactable consumer included product details and event details.  No follow-up attempts needed.  No further information expected.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case is a cluster of 7 unidentified patients' who experienced similar events following vaccination with ADACEL.  Initial case was retrieved from the scientific literature in a foreign country on 22 March 2011.  The article reported 7 cases of anaphylactic reactions in children.  A group of seven unidentified children, with milk-allergies, received an injection (route and site not reported) of ADACEL, same lot (not reported) between September 2007 and March 2010.  "Seven milk-allergic children in one practice developed anaphylactic reactions to DTAP over a two and a half-year period.  They all received (ADACEL) from the lot between September 2007 and March 2010.  Although vials from the suspect lot was not available for testing, researchers at the Food Allergy Institute tested two other lots and found milk protein in one (30 ng/ml).  The outcomes were not reported.  Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP, TDAP
Symptoms: Allergy to vaccine, Anaphylactic reaction, Angioedema, Blood immunoglobulin E increased, Cough
Clinical narrative: This case is a cluster of 7 unidentified patients' who experienced similar events following vaccination with ADACEL.  Initial case was retrieved from the scientific literature in a foreign country on 22 March 2011.  The article reported 7 cases of anaphylactic reactions in children.  A group of seven unidentified children, with milk-allergies, received an injection (route and site not reported) of ADACEL, same lot (not reported) between September 2007 and March 2010.  "Seven milk-allergic children in one practice developed anaphylactic reactions to DTAP over a two and a half-year period.  They all received (ADACEL) from the lot between September 2007 and March 2010.  Although vials from the suspect lot was not available for testing, researchers at the Food Allergy Institute tested two other lots and found milk protein in one (30 ng/ml).  The outcomes were not reported.  Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP, TDAP
Symptoms: Nasal congestion, Sneezing, Urticaria, Wheezing
Clinical narrative: This case is a cluster of 7 unidentified patients' who experienced similar events following vaccination with ADACEL.  Initial case was retrieved from the scientific literature in a foreign country on 22 March 2011.  The article reported 7 cases of anaphylactic reactions in children.  A group of seven unidentified children, with milk-allergies, received an injection (route and site not reported) of ADACEL, same lot (not reported) between September 2007 and March 2010.  "Seven milk-allergic children in one practice developed anaphylactic reactions to DTAP over a two and a half-year period.  They all received (ADACEL) from the lot between September 2007 and March 2010.  Although vials from the suspect lot was not available for testing, researchers at the Food Allergy Institute tested two other lots and found milk protein in one (30 ng/ml).  The outcomes were not reported.  Documents held by sender: None.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Balance disorder, Computerised tomogram head, Computerised tomogram normal, Cyanosis, Tremor
Clinical narrative: Started with some balance issues (walked into furniture), then arms started shaking, followed by full-body shaking and temporary blueish color on lips.
Age: 1.32
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Papule, Scab, Skin lesion
Clinical narrative: The patient presented to my office on 3/30/11 with two days of a rash. The rash was papules, pustuled and crusted lesions in dermatomal distribution consistent with herper zoster.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Decreased appetite, Nausea
Clinical narrative: 3/8/11 Given first influenza vaccination. 3/17/11 Experienced stomach pain and nausea; took Peptobismal without relief. 3/18/11 at 1115 AM Reported to work with complaints of: stomach upset, loss of appetite; chills. Sent home to recover. Follow-up with physician/care clinic. 3/23/11 Seen at Urgent Care Clinic. Prescribed PRILOSEC. 3/24/11 Presented to hospital ED for evaluation. Hospitalized 2 days. Given IV fluids and PRILOSEC. Released from hospital 3/26/11. Continues on PRILOSEC - slow steady recovery. Diagnosed with pancreatitis during hospitalization.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Pancreatitis
Clinical narrative: 3/8/11 Given first influenza vaccination. 3/17/11 Experienced stomach pain and nausea; took Peptobismal without relief. 3/18/11 at 1115 AM Reported to work with complaints of: stomach upset, loss of appetite; chills. Sent home to recover. Follow-up with physician/care clinic. 3/23/11 Seen at Urgent Care Clinic. Prescribed PRILOSEC. 3/24/11 Presented to hospital ED for evaluation. Hospitalized 2 days. Given IV fluids and PRILOSEC. Released from hospital 3/26/11. Continues on PRILOSEC - slow steady recovery. Diagnosed with pancreatitis during hospitalization.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Pain in arm from injection site down to just above the elbow. It's a constant throbbing and aching feeling that varies intensity from 2-7 on a 10-chart. Not able to sleep on that arm.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm was swollen, warm to touch, and painful 2 days following Tdap vaccine
Age: 37.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TYP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Right arm (Injection site): redness, swelling, tender to touch, inability to move arm due to swelling, fever.