chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site inflammation, Injection site rash
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Pruritus, Rash generalised, Rash macular
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash pustular, Urticaria
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Culture positive, Eyelid oedema, Herpes zoster, Oedema peripheral
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Skin test positive, Skin warm
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash generalised, Rash pustular, Urticaria
Clinical narrative: My husband and I were told by the pharmacist that we might expect some redness at the sight of injection, perhaps with some slight swelling and itching. She also cautioned that taking ALEVE or TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday June 25, my arm was very puffy, hot, and red, and another red, itchy spot appeared on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It also now developed on the inside of my right thigh, and there were red blotches on my abdomen all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and on my left shoulder. Without an appointment, I went to my family physician, who diagnosed it as a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three times daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist said she thought I had shingles. By Friday June 27, my right eyelid was affected, swollen, red, and itching. The spot under my jawbone was worse, and now more blotches appeared on my chest and abdomen. I call the doctors office, who told me to see a doctor at dermatology. The doctor was out but his physician assistant said she believed it to be shingles. She took pictures of the infected areas, then scraping for cultures and studying them under a microscope, said it was shingles. She prescribed VALTREX (one tablet three times daily), and CLOBETASOL (apply topically twice daily except on face, armpits, and groin area). On July 11, the physician assistant prescribed HYDROXYZINE and SARNA anti-itch lotion. On July 16, she further prescribed LOCOID LIPOCREAM. The pharmacy told me I needed to report my reaction to CDC and ask that the necessary paperwork be sent to me for completion and return to both CDC and VAERS.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Spleen disorder
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a penicillin allergy and an unremarkable medical history, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 0469U), 0.5 mL intramuscular administration. On 20-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654540/1209U), 0.5 mL intramuscular administration. On 03-JUN-2008, she was vaccinated with the third dose of GARDASIL (lot # 0053X), 0.5 mL intramuscular administration. There was no concomitant therapy. On 20-JUN-2008, the patient was found dead in her bed. She had been dead for 48 hours. The patient had complained of fatigue prior to her death. The patient's mother contacted the physician via telephone. The autopsy performed in June 2008 was negative with evidence of inflammation around her spleen caused by a viral infection. The cause of death was inflammation of spleen caused by a virus. The physician considered the events to be life threatening. A lot check has been initiated. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a penicillin allergy and an unremarkable medical history, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 0469U), 0.5 mL intramuscular administration. On 20-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654540/1209U), 0.5 mL intramuscular administration. On 03-JUN-2008, she was vaccinated with the third dose of GARDASIL (lot # 0053X), 0.5 mL intramuscular administration. There was no concomitant therapy. On 20-JUN-2008, the patient was found dead in her bed. She had been dead for 48 hours. The patient had complained of fatigue prior to her death. The patient's mother contacted the physician via telephone. The autopsy performed in June 2008 was negative with evidence of inflammation around her spleen caused by a viral infection. The cause of death was inflammation of spleen caused by a virus. The physician considered the events to be life threatening. A lot check has been initiated. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Fatigue, Splenitis, Viral infection
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a penicillin allergy and an unremarkable medical history, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 0469U), 0.5 mL intramuscular administration. On 20-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654540/1209U), 0.5 mL intramuscular administration. On 03-JUN-2008, she was vaccinated with the third dose of GARDASIL (lot # 0053X), 0.5 mL intramuscular administration. There was no concomitant therapy. On 20-JUN-2008, the patient was found dead in her bed. She had been dead for 48 hours. The patient had complained of fatigue prior to her death. The patient's mother contacted the physician via telephone. The autopsy performed in June 2008 was negative with evidence of inflammation around her spleen caused by a viral infection. The cause of death was inflammation of spleen caused by a virus. The physician considered the events to be life threatening. A lot check has been initiated. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Autopsy, Death, Pulmonary oedema
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a penicillin allergy and an unremarkable medical history, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 0469U), 0.5 mL intramuscular administration. On 20-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654540/1209U), 0.5 mL intramuscular administration. On 03-JUN-2008, she was vaccinated with the third dose of GARDASIL (lot # 0053X), 0.5 mL intramuscular administration. There was no concomitant therapy. On 20-JUN-2008, the patient was found dead in her bed. She had been dead for 48 hours. The patient had complained of fatigue prior to her death. The patient's mother contacted the physician via telephone. The autopsy performed in June 2008 was negative with evidence of inflammation around her spleen caused by a viral infection. The cause of death was inflammation of spleen caused by a virus. The physician considered the events to be life threatening. A lot check has been initiated. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Acute respiratory distress syndrome, Blood culture negative, Chest pain, Cough, Dyspnoea
Clinical narrative: Acute respiratory distress, pulmonary edema and possible pleural effusion. 13 YOF received immunizations on 7/14/08. On 2/15/08 c/o fatigue and stomach ache. Later in the evening found to have coughing, difficulty breathing, labored breathing. on 7/17/08 found to have pulmonary edema, required bilevel pressure support upon transfer to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Oxygen supplementation, Tachypnoea, Toxicologic test normal
Clinical narrative: Acute respiratory distress, pulmonary edema and possible pleural effusion. 13 YOF received immunizations on 7/14/08. On 2/15/08 c/o fatigue and stomach ache. Later in the evening found to have coughing, difficulty breathing, labored breathing. on 7/17/08 found to have pulmonary edema, required bilevel pressure support upon transfer to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Acute respiratory distress syndrome, Blood culture negative, Chest X-ray abnormal, Cough
Clinical narrative: Acute respiratory distress, pulmonary edema and possible pleural effusion. 13 YOF received immunizations on 7/14/08. On 2/15/08 c/o fatigue and stomach ache. Later in the evening found to have coughing, difficulty breathing, labored breathing. on 7/17/08 found to have pulmonary edema, required bilevel pressure support upon transfer to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Fatigue, Full blood count abnormal, Neutrophil percentage increased, Pleural effusion
Clinical narrative: Acute respiratory distress, pulmonary edema and possible pleural effusion. 13 YOF received immunizations on 7/14/08. On 2/15/08 c/o fatigue and stomach ache. Later in the evening found to have coughing, difficulty breathing, labored breathing. on 7/17/08 found to have pulmonary edema, required bilevel pressure support upon transfer to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pregnancy test negative, Pulmonary oedema, Toxicologic test normal, White blood cell count increased
Clinical narrative: Acute respiratory distress, pulmonary edema and possible pleural effusion. 13 YOF received immunizations on 7/14/08. On 2/15/08 c/o fatigue and stomach ache. Later in the evening found to have coughing, difficulty breathing, labored breathing. on 7/17/08 found to have pulmonary edema, required bilevel pressure support upon transfer to hospital.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electromyogram normal, Erythema, Hypoaesthesia, Laboratory test normal, Pain in extremity
Clinical narrative: Patient developed left arm numbness, tingling, pain and redness from above elbow to mid-forearm. Pt says that it constantly hurts, is worse with movement. Symptoms are unchanged over past few months. No injuries. Pt saw PCP , ortho and neurologist about this. They thought she could have had cellulitis, tendinitis, carpal tunnel, blood clot, or nerve damage, but nothing determined.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed left arm numbness, tingling, pain and redness from above elbow to mid-forearm. Pt says that it constantly hurts, is worse with movement. Symptoms are unchanged over past few months. No injuries. Pt saw PCP , ortho and neurologist about this. They thought she could have had cellulitis, tendinitis, carpal tunnel, blood clot, or nerve damage, but nothing determined.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electromyogram normal, Erythema, Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: Patient developed left arm numbness, tingling, pain and redness from above elbow to mid-forearm. Pt says that it constantly hurts, is worse with movement. Symptoms are unchanged over past few months. No injuries. Pt saw PCP , ortho and neurologist about this. They thought she could have had cellulitis, tendinitis, carpal tunnel, blood clot, or nerve damage, but nothing determined.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Pyrexia
Clinical narrative: Fever, diarrhea - profuse.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Screaming
Clinical narrative: Child began screeching, crying, inconsolable at 12:30 pm on day of vaccine administered. Vaccines admin at 10 am. Continued to cry until after 4 pm. Tylenol was given at 1:30 without cessation of symptoms. Warm bath to soothe minimally effective.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Patient experienced onset of nausea at 10:00 am on 7-15-08 approx. 19 hrs after receiving vaccine in L deltoid. Nausea waxed and wanned until she ate lunch around 12:30 pm. Denies any fever, chills, vomiting, or diarrhea. She also began having frontal throbbing headaches on and off since 10:30 am which are relieved by lying down. Took tylenol at 12:15 w/o relief. Also reports same associated lightheadedness and fatigue since the onset of nausea this am. Work up with L axillary pain that has since resolved. L deltoid is tender to touch only at right of injection. No other side effects/symptoms . No treatment necessary.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: Patient experienced onset of nausea at 10:00 am on 7-15-08 approx. 19 hrs after receiving vaccine in L deltoid. Nausea waxed and wanned until she ate lunch around 12:30 pm. Denies any fever, chills, vomiting, or diarrhea. She also began having frontal throbbing headaches on and off since 10:30 am which are relieved by lying down. Took tylenol at 12:15 w/o relief. Also reports same associated lightheadedness and fatigue since the onset of nausea this am. Work up with L axillary pain that has since resolved. L deltoid is tender to touch only at right of injection. No other side effects/symptoms . No treatment necessary.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient arrived 6-26 for PPD reading. C/O left arm pain and redness from MENACTRA given 2 days prior. Seen by doctor who noted +4 cm irregular shaped erythematous, tender, warm area at injection site over left deltoid. No streaking. Diagnosis cellulitis and not a local reaction. Treated with OMNICEF 300 mg BID till gone #20. Return 2 days if no better.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Diarrhoea, Full blood count normal, Hypotonia, Metabolic function test normal
Clinical narrative: Patient began vomiting x 4 around 11:35 or noon on 7/10/2008. That evening Mom reports he was pale, limp and eyes were glazed over,, so they went to ER. Temp in ER was 38.8 degrees C rectally, started "pink up" after some tylenol and zofran. No jerking movements noticed. He was diagnosed with a seizure at the ER, then discharged home. Was fine the next day until that afternoon 7/11 he started vomiting again, vomited x 2 Saturday 7/12, once Sunday 7/13. Diarrhea started Thursday 7/11.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pallor, Staring, Vomiting
Clinical narrative: Patient began vomiting x 4 around 11:35 or noon on 7/10/2008. That evening Mom reports he was pale, limp and eyes were glazed over,, so they went to ER. Temp in ER was 38.8 degrees C rectally, started "pink up" after some tylenol and zofran. No jerking movements noticed. He was diagnosed with a seizure at the ER, then discharged home. Was fine the next day until that afternoon 7/11 he started vomiting again, vomited x 2 Saturday 7/12, once Sunday 7/13. Diarrhea started Thursday 7/11.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Redness and swelling at injection site, aches, malaise and fever. All symptoms resolved on own in 6 days.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Life support, Myocarditis, Respiratory arrest
Clinical narrative: Pt found 5-15-08 @ 2110 by mother unresponsive, not breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at local hospital where CPR was performed and pt transferred via helicopter to another hospital. Pt on life support until 5-18-08 when it was stopped and he expired. 8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary arrest, resuscitative efforts included CPR, intubation, mechanical ventilation. Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low grade fever, placed in crib on abdomen, found white, lump with face buried in cover. Drove child to hospital. PE: agonal respirations not compatible with life. Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep tendon reflexes absent.  8/11/08-records received-Findings:Myocarditis. Inflammation and necrosis, myocardium. Interstitial edema, epiglottis. Tracheobronchitis, chronic. The inflammatory lesions observed in heart are consistent with either acute viral infection or post-viral syndrome.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt found 5-15-08 @ 2110 by mother unresponsive, not breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at local hospital where CPR was performed and pt transferred via helicopter to another hospital. Pt on life support until 5-18-08 when it was stopped and he expired. 8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary arrest, resuscitative efforts included CPR, intubation, mechanical ventilation. Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low grade fever, placed in crib on abdomen, found white, lump with face buried in cover. Drove child to hospital. PE: agonal respirations not compatible with life. Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep tendon reflexes absent.  8/11/08-records received-Findings:Myocarditis. Inflammation and necrosis, myocardium. Interstitial edema, epiglottis. Tracheobronchitis, chronic. The inflammatory lesions observed in heart are consistent with either acute viral infection or post-viral syndrome.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood culture negative, Body temperature increased, Cellulitis, Full blood count, Pain
Clinical narrative: 24 hours after HPV inject - pain/swell; 48 hours after HPV inject - 102/ increased swell; 72 hours after HPV inject; admitted for suspected cellulitis; 96 hours after HPV inject - discharged PO Cephalexin. 8/12/08-records received for DOS 7/20-7/21/08-DX: cellulitis vs allergic hypersensitivity. Developed palpable lump in upper arm with fever, pain and warmth and induration. Treated with antibiotics.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: 24 hours after HPV inject - pain/swell; 48 hours after HPV inject - 102/ increased swell; 72 hours after HPV inject; admitted for suspected cellulitis; 96 hours after HPV inject - discharged PO Cephalexin. 8/12/08-records received for DOS 7/20-7/21/08-DX: cellulitis vs allergic hypersensitivity. Developed palpable lump in upper arm with fever, pain and warmth and induration. Treated with antibiotics.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Haemophilus infection, Lumbar puncture, Meningitis haemophilus
Clinical narrative: This serious case was received from a physician in the country on 16 July 2008.
Age: 61.0
Sex: F
Vaccine: DT
Symptoms: Dizziness, Dyspnoea, Erythema, Injection site bruising, Malaise
Clinical narrative: Seriousness criteria: Other-Medically Significant. Initial report was received from the patient on 16 July 2008. A 60 year-old female patient with a history of heart disease, blood pressure, hip problems, and allergies to DARVON and sulfa, received an intramuscular right deltoid injection of DECAVAC, lot number U1962AB (invalid lot number) on 10 July 2008 and 10 minutes later, she developed dizziness and her skin turned red and was described as sunburn color (the symptom "skin turning red" was also reported with an onset 45 minutes later), 30 minutes later, she had one episode of vomiting. The redness persisted four and a half hours. The patient also developed a fever of 102 degrees Fahrenheit and bruising at the injection site. On 16 July 2008, nausea still persisted and the patient reported some shortness of breath. The patient stated she had felt sick ever since. The patient received corrective treatment with PROMETHAZINE 25 mg. She had no illness at the time of vaccination and had been receiving concomitant medications which consisted of HTZ, LOPRESSOR, VICODIN, NORVASC, baby aspirin and VALIUM. The patient spoke with her physician and her physician informed her that "he didn't do anything wrong so it must be the medication". The patient also stated "there was a recall of some of the vaccine and although her lot was not recalled it makes her nervous". At the time of the report, the patient had not recovered from the event.
Age: 61.0
Sex: F
Vaccine: DT
Symptoms: Nausea, Pyrexia, Sunburn, Vomiting
Clinical narrative: Seriousness criteria: Other-Medically Significant. Initial report was received from the patient on 16 July 2008. A 60 year-old female patient with a history of heart disease, blood pressure, hip problems, and allergies to DARVON and sulfa, received an intramuscular right deltoid injection of DECAVAC, lot number U1962AB (invalid lot number) on 10 July 2008 and 10 minutes later, she developed dizziness and her skin turned red and was described as sunburn color (the symptom "skin turning red" was also reported with an onset 45 minutes later), 30 minutes later, she had one episode of vomiting. The redness persisted four and a half hours. The patient also developed a fever of 102 degrees Fahrenheit and bruising at the injection site. On 16 July 2008, nausea still persisted and the patient reported some shortness of breath. The patient stated she had felt sick ever since. The patient received corrective treatment with PROMETHAZINE 25 mg. She had no illness at the time of vaccination and had been receiving concomitant medications which consisted of HTZ, LOPRESSOR, VICODIN, NORVASC, baby aspirin and VALIUM. The patient spoke with her physician and her physician informed her that "he didn't do anything wrong so it must be the medication". The patient also stated "there was a recall of some of the vaccine and although her lot was not recalled it makes her nervous". At the time of the report, the patient had not recovered from the event.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Initial information was received on 17 July 2008 from a consumer.  A 26 year old female patient received an injection of TYPHIM VI (lot number A0923-3) on 11 July 2008 at 3:45 pm.  Two hours later, at 5:45 pm, the patient had hives and was seen in the doctor's office.  One day prior on 10 July 2008 she received an injection of Tetanus and Hepatitis A (manufacturer and lot number not provided).  On 11 July 2008 she was given epinephrine.  On 12 July 2008 she was seen in the doctor's office and given BENADRYL and ZYRTEC.  On 14 July 2008 prednisone was prescribed.  The patient resolved from the event.  No further information was provided.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a consumer concerning her son, a 6 month old male who on 10-JUL-2008 was vaccinated with his third dose of ROTATEQ (Lot # not reported).  The consumer reported that her son had received his third dose of ROTATEQ on 10-JUL-2008.  Approximately 24 hours after receiving dose, the patient experienced intussusception.  The patient was rushed to the emergency room and needed surgery.  He was hospitalized from 11-JUL-2008 to 16-JUL-2008.  ROTATEQ was not reintroduced.  The patient was considered to be not recovered.  The reported considered intussusception as an other important medical event.  There was no product quality complaint.  Additional information has been requested.8/4/08-records received for DOS 7/16-7/22/08-DC DX: Intussusception. Laparotomy, small bowel resection, incidental appendectomy. Presented with C/O oen day history of fever, abdominal pain with intermittent crying, vomiting and blood in stool. Fussiness and abdominal distension.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Joint swelling, Laboratory test
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported).  Two weeks after the vaccination the patient experienced acute arthritis pain.  The patient's knees were swollen and she was having trouble walking.  The patient was sent to see the specialist.  The patient's acute arthritis pain, swollen knees and trouble walking persisted.  According to the physician, the patient's acute arthritis pain and swollen knees and having trouble walking were considered to be disabling.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Drug exposure during pregnancy, Eclampsia, Inappropriate schedule of drug administration, Live birth
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician through the Merck Pregnancy Registry for GARDASIL concerning a 16 year old female with no previous pregnancies and no significant past medical history who on 31-Jan-2007, 03-Apr-2007 and 25-Oct-2007 was vaccinated intramuscularly with first, second and third 0.5ml doses, respectively, of GARDASIL (lot #s: 653937/0637U, 654389/0961F, 658560/1062U) while pregnant.  The patient's last menstrual period (LMP) was 15-AUG-2007 with an estimated delivery date of 15-MAY-2008.  The patient took prenatal vitamins (unspecified) one daily from October 2007 to May 2008.  On 10-JAN-2008 and 14-MAY-2008 the patient underwent routine ultrasound which were normal per patient.  On 15-MAY-2008 at 40-41 weeks from the LMP, the patient delivered a normal liveborn male, weighing 7lbs, 4 ozs., length: 21 in; head circumference: 14 in.  On approximately 15-MAY-2008, after delivery the patient experienced "eclampsia-seizure xl".  Upon internal review, the patient's "eclampsia-seizure" was considered to be an other important medical event.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician through the Merck Pregnancy Registry for GARDASIL concerning a 16 year old female with no previous pregnancies and no significant past medical history who on 31-Jan-2007, 03-Apr-2007 and 25-Oct-2007 was vaccinated intramuscularly with first, second and third 0.5ml doses, respectively, of GARDASIL (lot #s: 653937/0637U, 654389/0961F, 658560/1062U) while pregnant.  The patient's last menstrual period (LMP) was 15-AUG-2007 with an estimated delivery date of 15-MAY-2008.  The patient took prenatal vitamins (unspecified) one daily from October 2007 to May 2008.  On 10-JAN-2008 and 14-MAY-2008 the patient underwent routine ultrasound which were normal per patient.  On 15-MAY-2008 at 40-41 weeks from the LMP, the patient delivered a normal liveborn male, weighing 7lbs, 4 ozs., length: 21 in; head circumference: 14 in.  On approximately 15-MAY-2008, after delivery the patient experienced "eclampsia-seizure xl".  Upon internal review, the patient's "eclampsia-seizure" was considered to be an other important medical event.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from the mother of a 17 year old female with no known drug allergies and no pertinent medical history, who in February 2008 was vaccinated with the second dose of GARDASIL (lot # not provided), 0.5 mL intramuscularly.  There was no concomitant therapy.  The mother reported that on 14-JUL-2008, her daughter fainted and convulsed after receiving GARDASIL.  The patient sought unspecified medical attention.  No lab diagnostics studies were performed.  The patient recovered on 14-JUL-2008.  Upon internal review, convulsions was considered to be an other important medical event.  No further information is available as the mother declined to give her physician's information.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain, Back pain, Foreign body trauma, Headache, Vertigo
Clinical narrative: Information has been received from a physician concerning a 19 year old female with vertigo, headache and on 20-APR-2008, the patient swallowed ring in tongue who on 21-APR-2008, was vaccinated with GARDASIL (LOT # 659964/1978U), 0.5ml, IM.  Concomitant therapy included ORTHO TRI-CYCLEN LO) and Tdap.  On 05-MAY-2008, the patient experienced vomiting, abdominal pain and back pain.  The mother of the patient called office for medical attention.  Emergency room did blood work and Computerized Axial Tomography scans (CAT), results not reported.  On an unspecified date, the patient experienced a possible urine infection.  On 22-MAY-2008, the patient recovered from vomiting, abdominal pain and back pain.  The outcome of the possible urine infection was not reported.  The physician felt that the vomiting, abdominal pain, back pain, and urine infection were disabling and other important medical events.  The physician felt that the possible urine infection was serious (other important medical event) because the patient needed unspecified antibiotics for the possible urine infection.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female with vertigo, headache and on 20-APR-2008, the patient swallowed ring in tongue who on 21-APR-2008, was vaccinated with GARDASIL (LOT # 659964/1978U), 0.5ml, IM.  Concomitant therapy included ORTHO TRI-CYCLEN LO) and Tdap.  On 05-MAY-2008, the patient experienced vomiting, abdominal pain and back pain.  The mother of the patient called office for medical attention.  Emergency room did blood work and Computerized Axial Tomography scans (CAT), results not reported.  On an unspecified date, the patient experienced a possible urine infection.  On 22-MAY-2008, the patient recovered from vomiting, abdominal pain and back pain.  The outcome of the possible urine infection was not reported.  The physician felt that the vomiting, abdominal pain, back pain, and urine infection were disabling and other important medical events.  The physician felt that the possible urine infection was serious (other important medical event) because the patient needed unspecified antibiotics for the possible urine infection.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Echocardiogram, Foetal disorder, Pulmonary function test, Ultrasound scan
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female with morphine allergy and no relevant medical history who was vaccinated with GARDASIL during the first trimester of her pregnancy.  The vaccine was provided at another location.  Dose, route of administration and lot number were not provided.  There was no concomitant medication.  Ultrasounds, fetal echo, pulmonary function tests were performed and no results were provided.  Prenatal testing revealed that the fetus had multiple skeletal abnormalities (dysplasias) and was not expected to survive after delivery.  The patient contacted the physician to seek unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Fall, Hypoaesthesia, Loss of consciousness, Muscle fatigue
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 15 year old daughter with no pertinent medical history, drug reactions or allergies who "three months ago", on approximately 18-APR-2008 was vaccinated with a dose of GARDASIL.  There was no concomitant medication.  "Approximately two months ago", in approximately May 2008, the patient began to experience numbness and tingling in her hands.  On 16-JUL-2008 the patient experienced two episodes of syncope during which she lost consciousness and hit the floor.  On 17-JUL-2008 the patient noted that all of her muscles felt tired.  Allergy tests were performed (results not provided).  At the time of the report, the patient's event persisted.  The patient did not seek medical attention.  The reporter considered numbness and tingling in hands, syncope and muscles tired to be immediately life-threatening.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Syncope
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 15 year old daughter with no pertinent medical history, drug reactions or allergies who "three months ago", on approximately 18-APR-2008 was vaccinated with a dose of GARDASIL.  There was no concomitant medication.  "Approximately two months ago", in approximately May 2008, the patient began to experience numbness and tingling in her hands.  On 16-JUL-2008 the patient experienced two episodes of syncope during which she lost consciousness and hit the floor.  On 17-JUL-2008 the patient noted that all of her muscles felt tired.  Allergy tests were performed (results not provided).  At the time of the report, the patient's event persisted.  The patient did not seek medical attention.  The reporter considered numbness and tingling in hands, syncope and muscles tired to be immediately life-threatening.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: None occurred.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, induration, pain, and warmth over injection site. 4 X 4 1/2 cm right deltoid at 48 hours.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Some swelling 6/26/08. Increasing pain 06/27/08. ER visit 06/28/08, diagnosis cellulitis. Cephalexin 500 mg.q.6 hrs prescribed for 8 days. 7/12/08, no pain, no swelling, client reports minor bump, not palpable.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Hypermenorrhea (menstrual periods every 2 weeks) after her first dose of GARDASIL 04/01/08.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Grand mal convulsion
Clinical narrative: Approximately 12-14 hours status post HPV administration patient had grand mal seizure requiring EMS transport and ER evaluation for 6-8 hours.  7/30/08 ER rec received for DOS 7/24/08 with DX:  Seizures. Pt presented via EMS following an episode of seizure-like activity consisting of arms shaking and eyes rolling back in the head on the day of 2nd HPV4 vax.  Drowsy on exam, coarse respirations noted in upper lobes,  otherwise WNL. GCS 15.