chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and eye redness who on 04-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659437/1266U) intramuscularly. On 20-MAR-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U) intramuscularly and on 24-JUL-2008 the patient received the third dose of GARDASIL (Lot # 660620/0571X) intramuscularly. It was reported that approximately two months after receiving the third dose of GARDASIL the patient experienced a delayed anaphylactic allergic reaction. The reaction was described as being severe but there were no specific symptoms provided. It was reported that the anaphylactic reaction has been concurrent. The number of recurrent anaphylactic episodes was unspecified. The patient was seen at the emergency room following each episode and received intravenous fluids and epinephrine. The reporting physician considered the delayed anaphylactic allergic reaction to be other important medical event, life threatening and significantly disabling. A standard lot check investigation was performed for the Lot # 660387/1967U. 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. A standard lot check investigation was performed for the Lot # 660620/0571X. 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. A standard lot check investigation was performed for the Lot # 659437/1266U. 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. Follow-up information was received from the licensed practical nurse via phone call indicating that the patient's mother had called the office on 25-FEB-2009. The patient's mother reported that approximately two months after her daughter's last GARDASIL injection; she began having seizures and had an anaphylactic reaction. The mother told the office that the patient was being seen by an allergist. The licensed practical nurse had no other information to provide as they had not been following/treating the patient. It was also believed that the patient may have moved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Convulsion
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and eye redness who on 04-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659437/1266U) intramuscularly. On 20-MAR-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U) intramuscularly and on 24-JUL-2008 the patient received the third dose of GARDASIL (Lot # 660620/0571X) intramuscularly. It was reported that approximately two months after receiving the third dose of GARDASIL the patient experienced a delayed anaphylactic allergic reaction. The reaction was described as being severe but there were no specific symptoms provided. It was reported that the anaphylactic reaction has been concurrent. The number of recurrent anaphylactic episodes was unspecified. The patient was seen at the emergency room following each episode and received intravenous fluids and epinephrine. The reporting physician considered the delayed anaphylactic allergic reaction to be other important medical event, life threatening and significantly disabling. A standard lot check investigation was performed for the Lot # 660387/1967U. 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. A standard lot check investigation was performed for the Lot # 660620/0571X. 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. A standard lot check investigation was performed for the Lot # 659437/1266U. 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. Follow-up information was received from the licensed practical nurse via phone call indicating that the patient's mother had called the office on 25-FEB-2009. The patient's mother reported that approximately two months after her daughter's last GARDASIL injection; she began having seizures and had an anaphylactic reaction. The mother told the office that the patient was being seen by an allergist. The licensed practical nurse had no other information to provide as they had not been following/treating the patient. It was also believed that the patient may have moved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematology test, Hypersensitivity, Lip swelling, Oedema peripheral, Pruritus generalised
Clinical narrative: Hives head to toe, swollen feet, hands, lips on 2/18/09 went to Dr/shot and prescription. 2/22/09 worse breakout took to ER, shot and meds 2/23/09. Dr sent to hospital 24 hr observation IV Breathing treatments and injections 2/27/09 Dr follow up 3/13/09.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria, Urticaria
Clinical narrative: Hives head to toe, swollen feet, hands, lips on 2/18/09 went to Dr/shot and prescription. 2/22/09 worse breakout took to ER, shot and meds 2/23/09. Dr sent to hospital 24 hr observation IV Breathing treatments and injections 2/27/09 Dr follow up 3/13/09.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Lip swelling, Oedema peripheral, Urticaria
Clinical narrative: Hives head to toe, swollen feet, hands, lips on 2/18/09 went to Dr/shot and prescription. 2/22/09 worse breakout took to ER, shot and meds 2/23/09. Dr sent to hospital 24 hr observation IV Breathing treatments and injections 2/27/09 Dr follow up 3/13/09.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Epistaxis, Injection site pain, Injection site reaction, Oedema
Clinical narrative: Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX 23 (lot# 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that the patient was a 71 year old female with hypertension, overweight, hypothyroidism and no known allergies who on 10-FEB-2009 received a dose of PNEUMOVAX 23 (lot# 662599/1076X) into deltoid. On 10-FEB-2009, the patient experienced edema, epistaxis and pain at site of injection. The patient was treated with BENADRYL. The patient did not use steroid pack treatment. It took a week for the adverse events to clear. Subsequently, the patient recovered. It was reported the patient had no illness at time of vaccination and it was given at a new patient office visit. The reporter considered the edema, epistaxis and pain at site of injection to be other important medical events. This is one of several reports from the same source. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pyrexia, Rash erythematous, Rash vesicular, Tongue disorder
Clinical narrative: Information has been received from a physician concerning an approximately 12 month old (reported as "1 year") male who within the last few weeks was vaccinated subcutaneously with a first dose of VARIVAX (Merck) 0.5 mL (lot# 662464/1738X). 7 days after the vaccination the patient developed diffuse red rash which looked like chicken pox, a fever, swelling of the hands and feet and a ruby red tongue and was hospitalized. On unspecified date, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Herpes simplex, Wound dehiscence
Clinical narrative: Information has been received from a health professional through the Merck pregnancy registry concerning a 17 year old female who on 22-JAN-2008 was vaccinated with the first dose of GARDASIL (lot# 657868/0523U). On 26-MAR-2008 the patient came to the physician's office for the second dose and told the nurse that she was "3 to 4 months pregnant" (LMP = 31-DEC-2007). The patient did not receive the second dose. No adverse reactions were reported and no other information was available. Follow up information has been received from the nurse practitioner who indicated that the baby was born on 02-SEP-2008 at 39 weeks of gestation by cesarean-section was performed because the baby failed to descend the birth canal. The mother remained in the hospital for an extended 6 days total because her cesarean-section wound dehisced. The mom had also experienced "out break of HSV" two weeks prior to delivery on approximately 19-AUG-2008, and was treated with Valtrex. The date the baby was developmentally normal, "cheerful" and "thriving". She reported that were not known birth defects, the baby is normal. She also mentioned that the baby was seen in the office on 19-MAR-2009 for some nasal congestion "like a any child in a day care". The mother of the baby was in school and shared care with the foster mother. Upon internal review, C-section performed because the baby failed to descend was determine to be an other important medical event. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blighted ovum, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female who was vaccinated with the first or second dose of GARDASIL 0.5ml (Lot# not reported). Couple days later, the patient called the office and informed that she think she was pregnant. The patient had a home pregnancy test, the result was not reported. The outcome of adverse event was unknown. It was reported that the patient sought unspecified medical attention. Follow-up information was received from the registered nurse who reported that the patient on 26-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 26-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot# not reported) 0.5ml. The registered nurse reported the patient was not pregnant when she received GARDASIL. The patient's LMP Was unknown. On an unspecified date, the patient miscarried. An ultrasound on 16-MAR-2009 showed "blighted ovum and no gestational sack". Upon internal review, the miscarried and blighted ovum were determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blindness, Cyanosis, Deafness, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with no allergies who on 12-NOV-2008 was vaccinated with the first dose of GARDASIL.  On 12-MAR-2009 the patient was vaccinated with the second dose of GARDASIL.  Concomitant therapy included MENACTRA on 12-MAR-2009 into opposite arm, LEXAPRO and RECLIPSEN.  On 13-MAR-2009, almost exactly 24 hours after administration, she experienced blacking out, legs feeling like "dead weight", her lips turned blue, she had an ashen color to her skin, and she could not see or hear.  She visited the physician assistant who admitted her to the hospital.  She was given saline and was monitored on telemetry for cardiac function.  She also had a CT scan (results not reported).  She was discharged after 24 hours.  Her blood pressure was 94/54.  The patient recovered on an unspecified date.  The patient's mother also told the physician assistant that after the first dose similar symptoms occurred but no black-outs.  The symptoms occurred 24 hours after receiving first dose but the patient did not seek medical attention and had recovered.  The events occurring 13-MAR-2009 were considered to be disabling.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Sensation of heaviness, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with no allergies who on 12-NOV-2008 was vaccinated with the first dose of GARDASIL.  On 12-MAR-2009 the patient was vaccinated with the second dose of GARDASIL.  Concomitant therapy included MENACTRA on 12-MAR-2009 into opposite arm, LEXAPRO and RECLIPSEN.  On 13-MAR-2009, almost exactly 24 hours after administration, she experienced blacking out, legs feeling like "dead weight", her lips turned blue, she had an ashen color to her skin, and she could not see or hear.  She visited the physician assistant who admitted her to the hospital.  She was given saline and was monitored on telemetry for cardiac function.  She also had a CT scan (results not reported).  She was discharged after 24 hours.  Her blood pressure was 94/54.  The patient recovered on an unspecified date.  The patient's mother also told the physician assistant that after the first dose similar symptoms occurred but no black-outs.  The symptoms occurred 24 hours after receiving first dose but the patient did not seek medical attention and had recovered.  The events occurring 13-MAR-2009 were considered to be disabling.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 24 year old female patient with no known drug allergies, who on 26-APR-2008 was vaccinated with her first dose of GARDASIL (lot# 654272/0073X). There was no concomitant medication. On 08-APR-2008 the patient had her LMP and in MAY-2008 (6 weeks from her LMP), the patient had an elective termination. At the time of reporting the outcome of the patient was unknown. Subsequently, the patient again experienced vaccine exposure during pregnancy and an elective termination of pregnancy while on therapy with GARDASIL (MSD, WAES_0903USA04267). Upon internal review elective termination was considered as an Other Important Medical Event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 25 year old female patient with no known drug allergies, who on 26-APR-2008 was vaccinated with her first dose of GARDASIL (lot# 654272/0073X), on 30-JUN-2008 with the second dose of GARDASIL (lot# 0250X) and on 30-OCT-2008 with the third dose of GARDASIL (lot# 660620/0571X). There was no concomitant medication. On 05-OCT-2008, the patient had her LMP and had an elective termination of pregnancy in December 2008. At the time of reporting the outcome of the patient was unknown. The patient experienced an elective termination in May 2008 after the first vaccination with GARDASIL (MSD, WAES: 0903USA03061). Upon internal review elective termination was considered as an Other Important Medical Event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a children patient who on an unspecified date was vaccinated with the third dose of ROTATEQ (Lot # and date of administration were not reported). It was reported that the patient became infected with rotavirus after receiving all three doses of ROTATEQ. It was reported that the patient was hospitalized but then went home within 14-24 hours. It was reported that the patient received intravenous fluids. It was reported that the patient had recovered at the time of the report. The reporting physician considered that the patient received intravenous fluids to be other important medical event. This is one of several cases from the same source. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a child who on an unspecified date was vaccinated with the third dose of ROTATEQ (Lot # and date of administration were not reported). It was reported that the patient became infected with rotavirus after receiving all three doses of ROTATEQ. It was reported that the patient was examined in the emergency room and then sent home. It was reported that the patient received intravenous fluids. It was reported that the patient had recovered at the time of the report. The reporting physician considered that the patient received intravenous fluids to be other important medical event. This is one of several cases from the same source. No further information is available.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Pertussis, Post-tussive vomiting
Clinical narrative: This case was received via an author of a newspaper article on 19 March 2009.  It is part of a cluster involving one identified eight-year-old male patient, and 16 other children, who were diagnosed with pertussis in the same county.  An eight-year-old male patient, with no reported medical history, received five doses of DTaP vaccine (manufacturer, date of administration, route, and sites not reported).  In January 2009, the patient experienced cough and post-tussive vomiting, and was diagnosed with pertussis.  In addition, 16 other cases of pertussis were reported in children in that county (first through fifth grade) who had been previously vaccinated with DTaP.  No additional information was provided.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Headache, Intensive care, Intraventricular haemorrhage, Vomiting
Clinical narrative: Headache, vomiting approximately 36 hrs after vaccine administration. Admitted to SICU on 3/21/09 for observation and close monitoring for Intraventricular hemorrhage. 4/8/09-records received-DC DX Left ventricular hemorrhage. Presented on 3/21/09 with C/O severe headache since Thursday with vomiting and nausea occasional.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Computerised tomogram, Headache, Intensive care, Intraventricular haemorrhage, Nuclear magnetic resonance imaging
Clinical narrative: Headache, vomiting approximately 36 hrs after vaccine administration. Admitted to SICU on 3/21/09 for observation and close monitoring for Intraventricular hemorrhage. 4/8/09-records received-DC DX Left ventricular hemorrhage. Presented on 3/21/09 with C/O severe headache since Thursday with vomiting and nausea occasional.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Vomiting
Clinical narrative: Headache, vomiting approximately 36 hrs after vaccine administration. Admitted to SICU on 3/21/09 for observation and close monitoring for Intraventricular hemorrhage. 4/8/09-records received-DC DX Left ventricular hemorrhage. Presented on 3/21/09 with C/O severe headache since Thursday with vomiting and nausea occasional.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Activities of daily living impaired, Asthenia, Atrophy, Blood test, Computerised tomogram
Clinical narrative: Severe pain - whole body - muscles stiff - jaw muscles sore sore throat - needed assistance dressing - getting out of bed - etc. Used wheel chair and cane - legs weak- muscle spasms. Various places each day = shoulders, neck- trapezius muscles all stiff and aching - shot given 2-3-09 - Severe symptoms appeared 2-5-09 pain meds. 4/6/09 Received PCP medical records of FINAL DX: none provided Records reveal patient experienced usual state of health when seen 2/3 for routine PE & Td updated. Last Td 5/99.  T/C to clinic 2/5/09 w/increase in joint pain over past several weeks.  Requested referral to rheumatology. Follow-up: Contractions, cramps - sore throat - all over body pain - weakness - sore joint muscles -needed assistance bathing- dressing -getting out of bed - upper arms wasted away- weight loss - stiffness - pain and muscle problems moved place to place day by day. At the last visit with my civilian doctor PCP we discussed the vaccine amount given to me - He handed me a syringe and asked me to show him how much was in the syringe just before I got the shot- I showed him what I saw and he explained that the normal adult dose age is .5cc and in his opinion the nurse gave me 5 cc which would have been 10 times the normal dosage which is a massive over dose. Before the nurse gave me the shot during the regular visit that day she asked if I was taking any new meds. I told her I had just finished 2 MEDROL packs. I now am also on LYRICA - 75mg in A.M. and 150mg P.M. and Doxycycline 100mg. twice daily.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Glycosylated haemoglobin increased, Incorrect dose administered, Lumbar puncture, Muscle contractions involuntary, Muscle spasms
Clinical narrative: Severe pain - whole body - muscles stiff - jaw muscles sore sore throat - needed assistance dressing - getting out of bed - etc. Used wheel chair and cane - legs weak- muscle spasms. Various places each day = shoulders, neck- trapezius muscles all stiff and aching - shot given 2-3-09 - Severe symptoms appeared 2-5-09 pain meds. 4/6/09 Received PCP medical records of FINAL DX: none provided Records reveal patient experienced usual state of health when seen 2/3 for routine PE & Td updated. Last Td 5/99.  T/C to clinic 2/5/09 w/increase in joint pain over past several weeks.  Requested referral to rheumatology. Follow-up: Contractions, cramps - sore throat - all over body pain - weakness - sore joint muscles -needed assistance bathing- dressing -getting out of bed - upper arms wasted away- weight loss - stiffness - pain and muscle problems moved place to place day by day. At the last visit with my civilian doctor PCP we discussed the vaccine amount given to me - He handed me a syringe and asked me to show him how much was in the syringe just before I got the shot- I showed him what I saw and he explained that the normal adult dose age is .5cc and in his opinion the nurse gave me 5 cc which would have been 10 times the normal dosage which is a massive over dose. Before the nurse gave me the shot during the regular visit that day she asked if I was taking any new meds. I told her I had just finished 2 MEDROL packs. I now am also on LYRICA - 75mg in A.M. and 150mg P.M. and Doxycycline 100mg. twice daily.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Myalgia, Myalgia
Clinical narrative: Severe pain - whole body - muscles stiff - jaw muscles sore sore throat - needed assistance dressing - getting out of bed - etc. Used wheel chair and cane - legs weak- muscle spasms. Various places each day = shoulders, neck- trapezius muscles all stiff and aching - shot given 2-3-09 - Severe symptoms appeared 2-5-09 pain meds. 4/6/09 Received PCP medical records of FINAL DX: none provided Records reveal patient experienced usual state of health when seen 2/3 for routine PE & Td updated. Last Td 5/99.  T/C to clinic 2/5/09 w/increase in joint pain over past several weeks.  Requested referral to rheumatology. Follow-up: Contractions, cramps - sore throat - all over body pain - weakness - sore joint muscles -needed assistance bathing- dressing -getting out of bed - upper arms wasted away- weight loss - stiffness - pain and muscle problems moved place to place day by day. At the last visit with my civilian doctor PCP we discussed the vaccine amount given to me - He handed me a syringe and asked me to show him how much was in the syringe just before I got the shot- I showed him what I saw and he explained that the normal adult dose age is .5cc and in his opinion the nurse gave me 5 cc which would have been 10 times the normal dosage which is a massive over dose. Before the nurse gave me the shot during the regular visit that day she asked if I was taking any new meds. I told her I had just finished 2 MEDROL packs. I now am also on LYRICA - 75mg in A.M. and 150mg P.M. and Doxycycline 100mg. twice daily.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain, Walking aid user, Weight decreased
Clinical narrative: Severe pain - whole body - muscles stiff - jaw muscles sore sore throat - needed assistance dressing - getting out of bed - etc. Used wheel chair and cane - legs weak- muscle spasms. Various places each day = shoulders, neck- trapezius muscles all stiff and aching - shot given 2-3-09 - Severe symptoms appeared 2-5-09 pain meds. 4/6/09 Received PCP medical records of FINAL DX: none provided Records reveal patient experienced usual state of health when seen 2/3 for routine PE & Td updated. Last Td 5/99.  T/C to clinic 2/5/09 w/increase in joint pain over past several weeks.  Requested referral to rheumatology. Follow-up: Contractions, cramps - sore throat - all over body pain - weakness - sore joint muscles -needed assistance bathing- dressing -getting out of bed - upper arms wasted away- weight loss - stiffness - pain and muscle problems moved place to place day by day. At the last visit with my civilian doctor PCP we discussed the vaccine amount given to me - He handed me a syringe and asked me to show him how much was in the syringe just before I got the shot- I showed him what I saw and he explained that the normal adult dose age is .5cc and in his opinion the nurse gave me 5 cc which would have been 10 times the normal dosage which is a massive over dose. Before the nurse gave me the shot during the regular visit that day she asked if I was taking any new meds. I told her I had just finished 2 MEDROL packs. I now am also on LYRICA - 75mg in A.M. and 150mg P.M. and Doxycycline 100mg. twice daily.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Wheelchair user, X-ray
Clinical narrative: Severe pain - whole body - muscles stiff - jaw muscles sore sore throat - needed assistance dressing - getting out of bed - etc. Used wheel chair and cane - legs weak- muscle spasms. Various places each day = shoulders, neck- trapezius muscles all stiff and aching - shot given 2-3-09 - Severe symptoms appeared 2-5-09 pain meds. 4/6/09 Received PCP medical records of FINAL DX: none provided Records reveal patient experienced usual state of health when seen 2/3 for routine PE & Td updated. Last Td 5/99.  T/C to clinic 2/5/09 w/increase in joint pain over past several weeks.  Requested referral to rheumatology. Follow-up: Contractions, cramps - sore throat - all over body pain - weakness - sore joint muscles -needed assistance bathing- dressing -getting out of bed - upper arms wasted away- weight loss - stiffness - pain and muscle problems moved place to place day by day. At the last visit with my civilian doctor PCP we discussed the vaccine amount given to me - He handed me a syringe and asked me to show him how much was in the syringe just before I got the shot- I showed him what I saw and he explained that the normal adult dose age is .5cc and in his opinion the nurse gave me 5 cc which would have been 10 times the normal dosage which is a massive over dose. Before the nurse gave me the shot during the regular visit that day she asked if I was taking any new meds. I told her I had just finished 2 MEDROL packs. I now am also on LYRICA - 75mg in A.M. and 150mg P.M. and Doxycycline 100mg. twice daily.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Convulsion, Electroencephalogram normal, Full blood count normal
Clinical narrative: Pt administered PENTACEL, PREVNAR and ROTATEQ 3/16/09. Pt had 5 generalized seizures on 3/17/09. Temp 100.1 rectally.  4/2/09 MR received for DOS 3/17-19/2009 with DX:  New onset seizures. Pt found by parent in bed with shaking arms and legs and eye deviation. Pt appeared to not be breathing and was limp and unresponsive.  Initially thought to be choking, so when pt recovered in ~ 2 minutes, no tx was sought. Similar event later in the day where pt was taken via EMS to ER where pt had 2 more witnessed generalized tonic-clonic activity. Transferred to current facility for tx. PE WNL on arrival.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Urine analysis normal
Clinical narrative: Pt administered PENTACEL, PREVNAR and ROTATEQ 3/16/09. Pt had 5 generalized seizures on 3/17/09. Temp 100.1 rectally.  4/2/09 MR received for DOS 3/17-19/2009 with DX:  New onset seizures. Pt found by parent in bed with shaking arms and legs and eye deviation. Pt appeared to not be breathing and was limp and unresponsive.  Initially thought to be choking, so when pt recovered in ~ 2 minutes, no tx was sought. Similar event later in the day where pt was taken via EMS to ER where pt had 2 more witnessed generalized tonic-clonic activity. Transferred to current facility for tx. PE WNL on arrival.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Scab, Skin lesion
Clinical narrative: MENACTRA given left upper arm 3/18. Increased redness and swelling around site 3/20. 7"x7" warm, firm with vesicular lesions in center, with crusting.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: MENACTRA given left upper arm 3/18. Increased redness and swelling around site 3/20. 7"x7" warm, firm with vesicular lesions in center, with crusting.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Drug hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Had some significant pain in arm at injection site.  Had some redness around site the next day as well as some joint discomfort in wrist/hand.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Rash papular, Varicella
Clinical narrative: rash - scattered papules -> Probable chickenpox *Child rec'd 2 doses of VARIVAX dose #1 age 12 mos. dose #2 age 6 yr.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Reaction to food additive
Clinical narrative: 1) Swollen, red circle about 4" in diameter at injection site. Sore to touch. 2) Slight headache and same feeling I get if I eat food with MSG, surprised to see one of inactive ingredients is MSG, should be noted since so many people have a sensitivity to MSG. # 1 lasted for several days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Erythema, Headache, Oedema peripheral
Clinical narrative: Given 11 yr old immunizations on 3/18 noted swelling & redness on right arm 3/19.  Also c/o fainting feeling with h/a 3/19 for several hrs that subsided.  Return to office on 3/20 & 3/21.  2 cm erythemic patches on both arms, 4 inch oval area on right arm with swelling & erythema BENADRYL q6 x recheck 3/21 - Better, less swelling & redness noted ? allergy to band aid
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Rash pruritic
Clinical narrative: Swelling, Red rash size, 2 " in diameter started Sat. AM some soreness. 2 days later still bright red, rash itching. No swelling. Dx localized reaction. Patient advised to use OTC cortisone.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Fatigue, Induration, Pyrexia, Urticaria
Clinical narrative: Polio vaccine given March 12 3:00 pm March 16 low grade fever, tired, March 18 broke out in hives. March 16 - 18 low grade fever March 18 bad hives complain since March 12 about leg Hurting.
Age: 1.93
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL, HEP, PNC
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site noted after administration of vaccine. 1 tsp BENADRYL given start: 2 doses of steroid for HS and next day AM.
Age: 1.93
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL, HEP, PNC
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site noted after administration of vaccine. 1 tsp BENADRYL given STAT 2 doses with steroids for HS and in AM.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure-no treatment
Age: 29.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Activities of daily living impaired, Arthralgia, Chronic fatigue syndrome, Fatigue, Headache
Clinical narrative: A 31 year old male subject presented to the Healthcare Center for evaluation of a progressively disabling fatigue-like syndrome that he believed was due to receipt of the anthrax vaccinations. The symptom complex became increasingly disabling over a 4 year period and ultimately required his removal from Special Forces training and assignment to administrative duties. A detailed investigation uncovered a past medical history of a prolonged diarrheal illness while abroad to a foreign country in 2001 that required almost daily IV fluid replacement for ~6 weeks. Following resolution of the initial illness, the service member developed progressively disabling fatigue and multiple systemic symptoms such as myalgias, arthralgias and headaches that interfered with physical performance. There was no well defined temporal association or exacerbation of symptoms following ANTHRAX vaccine doses. Came to the HC with a diagnosis of Chronic fatigue syndrome.
Age: 29.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Laboratory test normal, Myalgia
Clinical narrative: A 31 year old male subject presented to the Healthcare Center for evaluation of a progressively disabling fatigue-like syndrome that he believed was due to receipt of the anthrax vaccinations. The symptom complex became increasingly disabling over a 4 year period and ultimately required his removal from Special Forces training and assignment to administrative duties. A detailed investigation uncovered a past medical history of a prolonged diarrheal illness while abroad to a foreign country in 2001 that required almost daily IV fluid replacement for ~6 weeks. Following resolution of the initial illness, the service member developed progressively disabling fatigue and multiple systemic symptoms such as myalgias, arthralgias and headaches that interfered with physical performance. There was no well defined temporal association or exacerbation of symptoms following ANTHRAX vaccine doses. Came to the HC with a diagnosis of Chronic fatigue syndrome.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Upper respiratory tract infection
Clinical narrative: Patient received varicella vaccine at ages 19 months and 10 years -on 5/12/08-.  The vaccine was administered in the left arm at 10 years of age, location of injection at 19 months not available in current medical record.  On 2/23/09, patient presents with URI and rash.  The rash is described as papulovesicular lesions and clusters to left back, side and abdomen- appears to follow T-10 or T-11 dermatome.  Treated with CAPSAICIN cream.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: 4 days after vaccine, he ran a fever of 100-102 degrees F on and off for 6 days.  On the 7th day after vaccine, he broke out in severe full-body hives which continued for 5 days.  Treated with BENADRYL.  Decided not to treat with doctor - Recommended steroids.  Also received treatment from Holistic doctor in form of chiropractic adjustment, homeopathic allergy remedy and supplements, and that day he looked much better.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Chicken pox #2 given on 3/17/09 and came back on 3/19/09 with (R) arm posterior redness and swelling. Tx: Ice daily to affected area for 20 mins and apply triple abx ointment bid x 7 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Received immunization on 3/12/09. Parent of child noticed pain, swelling on 3/19/09 came into clinic on 3/20 with area of redness, swelling and pain increasing in size. CEPHALEXIN, BENADRYL, sling given on 3/20. PREDNISONE RX written on 3/21 after another office visit.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Redness, itching, swelling, fever at injection site and rash extending from deltoid to elbow on (R) arm.
Sex: U
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pyrexia, Rash
Clinical narrative: Redness, itching, swelling and fever at injection site and rash extending from deltoid to elbow on left arm.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Ultrasound scan normal
Clinical narrative: Information has been received from a 22 year old female consumer (medical assistant), for the pregnancy registry for GARDASIL, who on 11-APR-2008 was vaccinated IM with the second 0.5 ml dose of GARDASIL.  On the same day she received her second dose she found out she was pregnant.  It was unknown whether medical attention was sought.  Patient outcome was unknown.  No product quality complaint was involved.  Follow-up information was received which reported that on 28-JUL-2008, an ultrasound was performed (second trimester) and the results were normal.  It was reported that there were no previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortions (miscarriages), elective terminations or fetal deaths (stillbirths).  Follow up information has been received from the consumer with no concurrent medical conditions, who reported that on 23-NOV-2008 she delivered a normal and healthy female baby weighing 6 lb and 7 oz and length 19 in.  There was complications or abnormalities, she reported an erratic heart rate and breathing difficulties of the baby who born at 36 weeks.  No complications during the pregnancy and labor/delivery, no congenital anomalies and no diagnostic test during the pregnancy was performed.  The patient had group B strep during her pregnancy.  Additional information is not available. 05/28/2009: Follow-up information has been received from medical records and from a medical assistant who reported on behalf of the physician. It was reported that the female baby had a small umbilical hernia ("an outie") which the physician felt was normal, not a congenital anomaly and would resolve on its own. At the time of reporting, the small umbilical hernia had not resolved and the causality was not reported. Additional information is not expected. All available medical records will be provided upon request.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood calcium decreased, Drug exposure during pregnancy, Gonorrhoea, Laboratory test normal, Nausea
Clinical narrative: Information has been received through the Merck Pregnancy Registry via a physician concerning a 19 year old female with a history of tobacco abuse and cannabis abuse who on 20-Feb-2008 was vaccinated with the first dose of GARDASIL 0.5ml, IM, (lot #, not reported). Concomitant therapy included prenatal vitamins (manufacturer unknown). On 21-Apr-2008 the patient was given the second dose of GARDASIL 0.5ml, IM to the left deltoid, (lot # 659655/14860). After the patient received her second dose, she later reported her pregnancy. Unspecified medical attention was sought and routine prenatal tests (data and names unspecified) were performed with results not reported. Therapy has been discontinued as of 07-May-2008. Patients last menstrual cycle was reported on 20-Feb-2008, her due date was calculated to be 26-Nov-2008. No adverse events were reported. No product quality complaint was involved. Follow-up information has been received from a physician concerning a female patient with nicotine dependence, THC use during pregnancy and a history of abnormal Papanicolaou smear and no previous pregnancies. It was reported that on 4-Apr-2008, on 22-Jul-2008 and on 10-Sep-2008 routine screening test were performed, all of them within normal results. On 26-Nov-2008, 39+ 0 weeks from the last menstrual period, the patient delivered a normal healthy female baby weighing 5 pounds 5 ounces. The baby's length was 19 inches, her APGAR score 9/9 and her head circumference was 11 1/2 inches. It was reported that during the pregnancy the patient developed a meticillin resistant staphylococcus aureus (MRSA) abscess which was treated with Clindamycin (Unspecified) 150mg, QID during 7 days. Also the patient was taking calcium + vitamin D (unspecified) , 500/200 mg, BID for the treatment of poor calcium mass, fish oil (unspecified) , 500 mg daily for nutrition and metoclopramide (unspecified), 5mg, QID/ PRN for the treatment of nausea. It was also reported that on an unspecified date the patient had gonorrhea infection.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Staphylococcal infection
Clinical narrative: Information has been received through the Merck Pregnancy Registry via a physician concerning a 19 year old female with a history of tobacco abuse and cannabis abuse who on 20-Feb-2008 was vaccinated with the first dose of GARDASIL 0.5ml, IM, (lot #, not reported). Concomitant therapy included prenatal vitamins (manufacturer unknown). On 21-Apr-2008 the patient was given the second dose of GARDASIL 0.5ml, IM to the left deltoid, (lot # 659655/14860). After the patient received her second dose, she later reported her pregnancy. Unspecified medical attention was sought and routine prenatal tests (data and names unspecified) were performed with results not reported. Therapy has been discontinued as of 07-May-2008. Patients last menstrual cycle was reported on 20-Feb-2008, her due date was calculated to be 26-Nov-2008. No adverse events were reported. No product quality complaint was involved. Follow-up information has been received from a physician concerning a female patient with nicotine dependence, THC use during pregnancy and a history of abnormal Papanicolaou smear and no previous pregnancies. It was reported that on 4-Apr-2008, on 22-Jul-2008 and on 10-Sep-2008 routine screening test were performed, all of them within normal results. On 26-Nov-2008, 39+ 0 weeks from the last menstrual period, the patient delivered a normal healthy female baby weighing 5 pounds 5 ounces. The baby's length was 19 inches, her APGAR score 9/9 and her head circumference was 11 1/2 inches. It was reported that during the pregnancy the patient developed a meticillin resistant staphylococcus aureus (MRSA) abscess which was treated with Clindamycin (Unspecified) 150mg, QID during 7 days. Also the patient was taking calcium + vitamin D (unspecified) , 500/200 mg, BID for the treatment of poor calcium mass, fish oil (unspecified) , 500 mg daily for nutrition and metoclopramide (unspecified), 5mg, QID/ PRN for the treatment of nausea. It was also reported that on an unspecified date the patient had gonorrhea infection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Dyspepsia, Laboratory test normal, Nausea, Ultrasound scan normal
Clinical narrative: Information has been received from through the Merck Pregnancy Registry via a nurse, concerning a 19 year old female with a history of asthma, and no reported concomitant medications or allergies, who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL 0.5ml, IM (Lot # 653736/0868F).  The second dose of GARDASIL (Lot # 658563/1063U) was administered on 09-JAN-2008.  It was reported that the patient was eight months pregnant and had sought medical attention on an unspecified date.  Unspecified pregnancy lab work has been completed through the obstetrician.  The expected date of delivery was calculated to be 12-JUN-2008.  No outcome information has been provided.  No product quality complaint was involved.  Follow-up information has been received from the nurse practitioner concerning the patient.  She stated that the patient has not been seen in the office since June 2008.  Follow-up information has been received from a nurse practitioner concerning the patient.  It was reported that she had a normal, vaginal delivery at 39 +3/7 weeks on 21-JUN-2008.  The baby who's gender was not specified, weighted 6 lb and 1 oz, and had APGAR scores of 9 and 9.  The baby appeared normal on exam and on her postpartum exam the patient stated that everything was fine for her and her baby.  However, the patient is not bringing her baby to the pediatric clinic that she went to, so there is no newborn exam notes on the baby.  The nurse also reported prenatal information.  The patient's LMP was 15-SEP-2007 and her estimated delivery date was 25-JUN-2008.  On 17-Oct-2007, early in the first trimester, the patient was treated with BACTRIM for a urinary tract infection.  She had routine prenatal screening test, a QUAD screen and MID-trimester anatomy survey ultrasound, which were both within limits.  She was prescribed several other medications for use during her pregnancy.  On 07-NOV-2007 she was orally treated with PHENERGAN, 25 mg, as needed every 6 hours for the treatment of nausea until DECEMBER 2007.  From 04-JAN-2008 to February 2008 she was treated for heartburn with PRILOSEC (dose and frequency not reported).  In February 2008 she was also orally treated for a bacterial vaginosis with an unspecified medication, 500 mg, twice a day for 7 days.  Additional information has been requested.