chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Hypoaesthesia facial, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with no drug allergies and with a history of influenza immunisation on 22-SEP-2007 who on 28-AUG-2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (Lot # 658556/1060U). "A few days after vaccination", the patient developed joint pain, headache, numbness in face and malaise. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of Gardasil. Subsequently, the patient presented with a welt at the injection site. At the time of this report, the patient's outcome was unknown. This is one of 2 reports from the same source. Additional information has been requested.  Additional infromation is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from the mother concerning her 18 year old daughter who on 21-DEC-2006, was vaccinated with the first dose of Gardasil, the second dose of Gardasil, the second dose on 27-FEB-2007, and the third dose on 19-JUL-2007. On 21-AUG-2007, the patient inadvertently received a fourth dose of Gardasil. After receiving the fourth dose, the patient developed acne on her face. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Follow up information states that she has only had her menstrual cycle for two days and it was very light. The mother reported that her daughter never had irregular periods prior to the vaccination. As of 28-SEP-2007, the patient had not recovered. No product quality complaint was involved. The patient's twin sister also received 4 doses of Gardasil and developed acne on her face (WAES 0710USA00171). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant, via a company representative, concerning a patient (age and gender not specified), who on an unspecified date was vaccinated with a dose of Gardasil (lot # not specified), and fainted. No further information was available. This is one of two reports received from the same source (WAES#0710USA00040). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Muscle tightness
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning patients who on an unspecified date were vaccinated by injection with the second dose of Gardasil. The nurse reported that after the patients received the second dose, the patients had experienced burning and muscle tightness. The burning and muscle tightness lasted for about five minutes and then it went away. There was no redness or swelling. The nurse said that they used a different arm from the first injection of Gardasil. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. In follow up it was reported by the LPN that at least 10 patients have experienced his muscle tightening and burning for 5 minutes with the second dose. These patients were mostly 18 years of age or older. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female was vaccinated IM with a first dose of Gardasil. The physician mentioned that the patient fainted after the injection without any complication. Patient decided not to continue with the series. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pigmentation disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown), who on three unspecified dates was vaccinated with a dose of Gardasil. Subsequently, after each dose the patient developed deep pigmentation. At the time of the report, the patient's outcome was unknown. This report is 1 of 2 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil. It was reported that the patient developed a sore throat. At this reporting time the patient's outcome is unknown.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Sensory loss
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested.  12/18/07-records received for DOS 9/10-9/28/07- DC DX:  Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk.  PE: reflexes absent in both lower and upper extremities.  This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008.  Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007.  On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported.  On 14/SEP/2007, the patient was given  a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered.  It was unknown if the prescriptions wore taken by the patient.  On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed.  She presented to the emergency room, with Guillain Barre syndrome where she was examined.  On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome.  The patient had a magnetic resonance imaging performed that was being evaluated.  At the time of reporting, the patient had not recovered and was in the intensive care unit.  The reporting physician felt that the event was serious (Other Important Medical  Event) immediately life-threatening, required hospitalization, and was disabling.  A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil. It was reported that the patient developed an upper respiratory tract infection. At this reporting time the patient's outcome is unknown. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 05-SEP-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658558/1061U. The nurse reported that post vaccination patient went to the waiting room and fainted. She got cold compress and they took her blood pressure which was normal. She was monitored in the waiting room for 15 to 20 minutes. The patient recovered. This report is one of the two reports from the same reporter. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy who on 05-SEP-2007 in the AM was vaccinated IM into the right arm with a first dose of GARDASIL lot #658558/1061U. The nurse reported that post vaccination patient went to the waiting room and fainted. In follow up it was reported that the patient walked out to the waiting room with her father and then experienced syncope episode while sitting in the waiting room after injection. She got cold compress and they took her blood pressure which was normal. She was monitored in the waiting room for 15 to 20 minutes. The patient recovered. This report is one of the two reports from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the past 3 month with a dose of Gardasil. Subsequently the patient experienced fainted. Medical attention was sought. The patient's outcome was unknown. Follow up information indicated there were 6 patients who after vaccination with a dose of Gardasil fainted and none of them needed resuscitation. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the past 3 months with a dose of Gardasil. Subsequently the patient experienced fainted. Medical attention was sought. The patient's outcome was unknown. Follow up information indicated there were 6 patients who after vaccination with a dose of Gardasil fainted and none of them needed resuscitation. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a nurse concerning several (3-4) female patients who on an unspecified date were vaccinated in the first dose of Gardasil (Lot # not reported). The nurse reported that a few minutes after receiving the vaccination the patients had "near fainting episodes". The patients had recovered from the events. She stated that she works in a large clinic and they have now made it a policy to observe the patients for 20 to 30 post vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil (Lot #not reported). Subsequently post vaccination the patient fainted. Subsequently, the patient recovered after about 20 minutes. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil (Lot # not reported). Subsequently post vaccination the patient fainted. Subsequently, the patient recovered after about 20 minutes. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: hives, itching skin, fatigue
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: hives, fatigue, pruritis
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HIBV, PPV
Symptoms: Hypotonia, Joint stiffness, Pyrexia, Respiratory arrest
Clinical narrative: Fever started the evening of the shots.  The next day went limp, fell back, jaw clenched, not breathing.  Mom gave rescue breaths and EMS came.  After being cooled by EMR, the rectal temp at ER was 102.
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Feeling cold, Hyperhidrosis, Vomiting
Clinical narrative: Three hours after administration of Fluarix Dr de Delva had profuse sweating, felt cold and clammy and vomited.  This lasted approximately two hours.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Seen on 10/12/07 in our office for nurse only visit for Dtap & Ipol.  Mom called 10/13/07 with arm red, tight and swollen.  Refferd to ED (after hours) Diagnosed with cellulitis.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Food allergy, Headache, Mass, Urticaria
Clinical narrative: About an hour after receiving flu vaccine large, painful pimple-like hives started appearing all over my face and neck.  I also had a rather large, painful bump in the muscle just above the elbow in my right upper forearm. This bump persisted for approximately 18 hours.  Before taking the vaccine I did ask if having taken my allergy medications, Singular and Hydroxyzine (Atarax), beforehand would be a problem and was told that it would not be.  Some of the hives on my neck disappeared after taking 3 hyrdoxyzine (anti-hive medication) later in the day, but as of 10/16/07 at 9:27AM I still have lots of large, red, soar bumps all over my cheeks and neck. I also have a backache and headache.  The bump in upper forearm had disappeared overnight.  Could all of this be a reaction between the Singulair and the influenza vaccine? Singulair is an asthma medication as well as an allergy medication.  Needless to say, I will never take the flu vaccine again.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Flushing, Urticaria, Wheezing
Clinical narrative: Patient developed wheezing, hives, and flushing within 10 minutes of vaccine administration.  He was treated with epinephrine, Albuterol aerosol, and Prednisone.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Crying, Discomfort, Furuncle, Oedema peripheral, Pruritus
Clinical narrative: While receiving the flu shot on the right arm on Thursday October 11, 2007, patient was poked with the needle three to four times before the nurse was able to get the shot in.  The morning of Friday October 12th is when we first noticed patient's right arm starting to swell.  When we removed the band aid at 7:50 pm Friday October 12th, there were three visible little holes, in addition to a scratch that was probably caused when the needle was pulled away, as well as three little boils that were not there prior to the shot that was 15mm down from the three holes.  Saturday October 13th the boils were no longer there but instead a little open wound that is 5mm in length and 1mm in width.  Sunday October 14th the wound began to form a scab around the outer edge.  Saturday October 13th patient's arm continued to swell and it started to become very warm.  Patient complained of a lot of itching. Sunday October 14th patient's arm was swollen a past the elbow.  We called the Nurse the morning of Sunday October 14th.  She told us that based on his symptoms, it is protocol to bring him in especially considering the open wound.  Patient saw Dr. at the office for an 11:00 appointment Sunday October 14th.  Dr. said that she noticed the three places where the needle was and asked if he had other shots.  When we told her that it was only one shot, the flu shot, she said that next time patient needs to come with reinforcements to help hold him down.  She also noticed the place where the little wound was and said to put Neosporin or Bacitracin on it but, she preferred Bacitracin. Dr. said she did not believe that his arm was infected because patient did not change expressions when she touched it twice and he was able to pull and push with both arms and he was able to rotate the arm.  Dr. wrote a prescription for Augmentin to fill only if he started to not be able to move his arm.  Monday October 15th patient stayed home from school.  Patient's arm was still very swollen.  The swelling is now 200 mm from the site of the shot.   The bottom portion of the inner arm looks like a red blotch that is 90mm in length and 70mm wide.   This then increased to include the upper portion of the arm later Monday night.  Patient was experiencing extreme itching and discomfort the night of Monday October 15th.  He was restless and whining about how much it itched.  Also Monday night he started to get areas of large bumps on the lower arm.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Rash, Restlessness, Scab, Scratch, Skin warm
Clinical narrative: While receiving the flu shot on the right arm on Thursday October 11, 2007, patient was poked with the needle three to four times before the nurse was able to get the shot in.  The morning of Friday October 12th is when we first noticed patient's right arm starting to swell.  When we removed the band aid at 7:50 pm Friday October 12th, there were three visible little holes, in addition to a scratch that was probably caused when the needle was pulled away, as well as three little boils that were not there prior to the shot that was 15mm down from the three holes.  Saturday October 13th the boils were no longer there but instead a little open wound that is 5mm in length and 1mm in width.  Sunday October 14th the wound began to form a scab around the outer edge.  Saturday October 13th patient's arm continued to swell and it started to become very warm.  Patient complained of a lot of itching. Sunday October 14th patient's arm was swollen a past the elbow.  We called the Nurse the morning of Sunday October 14th.  She told us that based on his symptoms, it is protocol to bring him in especially considering the open wound.  Patient saw Dr. at the office for an 11:00 appointment Sunday October 14th.  Dr. said that she noticed the three places where the needle was and asked if he had other shots.  When we told her that it was only one shot, the flu shot, she said that next time patient needs to come with reinforcements to help hold him down.  She also noticed the place where the little wound was and said to put Neosporin or Bacitracin on it but, she preferred Bacitracin. Dr. said she did not believe that his arm was infected because patient did not change expressions when she touched it twice and he was able to pull and push with both arms and he was able to rotate the arm.  Dr. wrote a prescription for Augmentin to fill only if he started to not be able to move his arm.  Monday October 15th patient stayed home from school.  Patient's arm was still very swollen.  The swelling is now 200 mm from the site of the shot.   The bottom portion of the inner arm looks like a red blotch that is 90mm in length and 70mm wide.   This then increased to include the upper portion of the arm later Monday night.  Patient was experiencing extreme itching and discomfort the night of Monday October 15th.  He was restless and whining about how much it itched.  Also Monday night he started to get areas of large bumps on the lower arm.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Wound
Clinical narrative: While receiving the flu shot on the right arm on Thursday October 11, 2007, patient was poked with the needle three to four times before the nurse was able to get the shot in.  The morning of Friday October 12th is when we first noticed patient's right arm starting to swell.  When we removed the band aid at 7:50 pm Friday October 12th, there were three visible little holes, in addition to a scratch that was probably caused when the needle was pulled away, as well as three little boils that were not there prior to the shot that was 15mm down from the three holes.  Saturday October 13th the boils were no longer there but instead a little open wound that is 5mm in length and 1mm in width.  Sunday October 14th the wound began to form a scab around the outer edge.  Saturday October 13th patient's arm continued to swell and it started to become very warm.  Patient complained of a lot of itching. Sunday October 14th patient's arm was swollen a past the elbow.  We called the Nurse the morning of Sunday October 14th.  She told us that based on his symptoms, it is protocol to bring him in especially considering the open wound.  Patient saw Dr. at the office for an 11:00 appointment Sunday October 14th.  Dr. said that she noticed the three places where the needle was and asked if he had other shots.  When we told her that it was only one shot, the flu shot, she said that next time patient needs to come with reinforcements to help hold him down.  She also noticed the place where the little wound was and said to put Neosporin or Bacitracin on it but, she preferred Bacitracin. Dr. said she did not believe that his arm was infected because patient did not change expressions when she touched it twice and he was able to pull and push with both arms and he was able to rotate the arm.  Dr. wrote a prescription for Augmentin to fill only if he started to not be able to move his arm.  Monday October 15th patient stayed home from school.  Patient's arm was still very swollen.  The swelling is now 200 mm from the site of the shot.   The bottom portion of the inner arm looks like a red blotch that is 90mm in length and 70mm wide.   This then increased to include the upper portion of the arm later Monday night.  Patient was experiencing extreme itching and discomfort the night of Monday October 15th.  He was restless and whining about how much it itched.  Also Monday night he started to get areas of large bumps on the lower arm.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swollen lips about 2 hours after shot.  Hives at armpits, groin, waste, and head in about same period.  Took Benedryl about 7 hours after the shot.  This seemed to knock down the hives.  Swollen lips persist into second day. ***No airway problems***.  I do not have a history of allergies or reactions to this shot.
Age: 23.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Body temperature increased, Chills, Convulsion, Liver function test abnormal, Pyrexia
Clinical narrative: Chills and felt feverish one day after receiving Hep. A and yellow fever vaccines.  One week later, pt. started oral typhoid and was still experiencing chills.  No temp. measurement done up to this time. After 3rd oral typhoid, pt. experienced "convulsions." One week later her temp. was measured at 103.9 and she had inc. LFT's. She was hospitalized for 5 days in Chicago.  As of 7/20/2007, LFT's have returned to normal according to pt. 11/26/07-records received for DOS 5/24-5/27/07- DC DX: fever of unknown origin, abnormal liver transaminases, adenopathy. Seen for acute febrile illness of unknown etiology. Two week HX of fevers chills and rigors.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Pain and swelling near left ear beginning 1 day after vaccine administration                  area is somewhat hot         patient took antihistine which seemed to help
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: reddening/soreness of injection site, followed by severe headache, wheezing for about an hour, dizziness, diarrhea. Benadryl, tylenol,imodium.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: reddening/soreness of injection site, followed by severe headache, wheezing for about an hour, dizziness, diarrhea. Benadryl, tylenol,imodium.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: rt. posterior Arm had golf ball size red, swollen, and itchy area
Age: 1.08
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt presented on 10/13/07 with a vesicular dermatomal rash on R leg which was clinically significant with Zoster.  Pt never had chicken pox, but did have the Varicella vaccine on 11/8/06
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Anorexia, Feeling jittery, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: I received my pnenmonia vaccination on Friday, October 11, 2007.  On Saturday, about 24 hours after my vaccination, my heart started racing, nausea, sweaty palms, jittery feeling.  That went away in about 30 minutes.  A few hours later, I took 800mg of Motrin for the stabbing pain at the injection sight.  That helped a little.  By the time evening came, I was just about in tears the pain was so bad.  The pain was traveling up and down my arm.  I had some vicadin from previous tooth ache.  I ended out taking 3 Vicadin on Saturday, 4 on Sunday, 3 on Monday and 1 today.  The pain is no longer stabbing.  That ended on Monday.  But on Sunday and Monday, I have had nausea, stomach cramping, no appatite, hot and cold feeling and an aching feeling all over my body.  Through this whole time the injection sight has been red, swollen and a burning sensation.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Nausea
Clinical narrative: I received my pnenmonia vaccination on Friday, October 11, 2007.  On Saturday, about 24 hours after my vaccination, my heart started racing, nausea, sweaty palms, jittery feeling.  That went away in about 30 minutes.  A few hours later, I took 800mg of Motrin for the stabbing pain at the injection sight.  That helped a little.  By the time evening came, I was just about in tears the pain was so bad.  The pain was traveling up and down my arm.  I had some vicadin from previous tooth ache.  I ended out taking 3 Vicadin on Saturday, 4 on Sunday, 3 on Monday and 1 today.  The pain is no longer stabbing.  That ended on Monday.  But on Sunday and Monday, I have had nausea, stomach cramping, no appatite, hot and cold feeling and an aching feeling all over my body.  Through this whole time the injection sight has been red, swollen and a burning sensation.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Palpitations
Clinical narrative: I received my pnenmonia vaccination on Friday, October 11, 2007.  On Saturday, about 24 hours after my vaccination, my heart started racing, nausea, sweaty palms, jittery feeling.  That went away in about 30 minutes.  A few hours later, I took 800mg of Motrin for the stabbing pain at the injection sight.  That helped a little.  By the time evening came, I was just about in tears the pain was so bad.  The pain was traveling up and down my arm.  I had some vicadin from previous tooth ache.  I ended out taking 3 Vicadin on Saturday, 4 on Sunday, 3 on Monday and 1 today.  The pain is no longer stabbing.  That ended on Monday.  But on Sunday and Monday, I have had nausea, stomach cramping, no appatite, hot and cold feeling and an aching feeling all over my body.  Through this whole time the injection sight has been red, swollen and a burning sensation.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Uterine dilation and curettage
Clinical narrative: Information has been received for pregnancy Registry for Gardasil from a Certified Medical Assistant (C.M.A) concerning a 33 year old female patient who on 29-MAR-2007 was vaccinated with a first dose of Gardasil and on 26-APR-2007, received her second dose of Gardasil. The patient was discovered to be pregnant in July (date unspecified). In August there was no fetal heartbeat detected (date unspecified). The patient had a Dialation and curettage (D & C) on 18-SEP-2007 and post D & C visit on 04-OCT-2007. It was unclear if any fetal tissue was recovered and what the cause of the termination of pregnancy. No other information to report. On 04-OCT-2007 patient recovered. Upon internal review, miscarriage was determined other medical event (OME) category. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Myelitis, Pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 63 year old healthy female with hyperlipidaemia and hypertension who on 23-SEP-2007 was vaccinated subcutaneously with Zostavax. Concomitant therapy included unspecified medications for hyperlipidaemia and hypertension. The patient came into the office presenting a very severe shingles reaction. She started having symptoms on 04-OCT-2007 and it became very serious by 06-OCT-2007. The patient experienced excruciating pain and the physician identified a shingles rash in her genital area, buttocks and leg. She had vesicular lesions on the right side of her labia and buttocks and had electric shock sensations down her right leg. The physician reported that this was the worst case of shingles she had ever seen, and mentioned myelitis. According to the physician, it seemed like a systemic reaction and did not fit the typical presentation. The patient also experienced knife-like pain in her right eye and was referred to an ophthalmologist. No facial lesions were noted. No lab/diagnostic studies were performed. Treatment included valacyclovir hydrochloride (VALTREX) and gabapentin (NEURONTIN). As of 09-OCT-2007, the patient had not recovered. The physician considered the very severe shingles reaction to be disabling due to the significant pain. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 63 year old healthy female with hyperlipidaemia and hypertension who on 23-SEP-2007 was vaccinated subcutaneously with Zostavax. Concomitant therapy included unspecified medications for hyperlipidaemia and hypertension. The patient came into the office presenting a very severe shingles reaction. She started having symptoms on 04-OCT-2007 and it became very serious by 06-OCT-2007. The patient experienced excruciating pain and the physician identified a shingles rash in her genital area, buttocks and leg. She had vesicular lesions on the right side of her labia and buttocks and had electric shock sensations down her right leg. The physician reported that this was the worst case of shingles she had ever seen, and mentioned myelitis. According to the physician, it seemed like a systemic reaction and did not fit the typical presentation. The patient also experienced knife-like pain in her right eye and was referred to an ophthalmologist. No facial lesions were noted. No lab/diagnostic studies were performed. Treatment included valacyclovir hydrochloride (VALTREX) and gabapentin (NEURONTIN). As of 09-OCT-2007, the patient had not recovered. The physician considered the very severe shingles reaction to be disabling due to the significant pain. Additional information has been requested.
Sex: M
Vaccine: FLUX, TTOX, VARZOS
Symptoms: Haemoglobin decreased
Clinical narrative: Information has been received from a physician concerning a male who, on an unspecified date, was vaccinated with a single dose of Zostavax (Oka/Merck). Vaccinations received on the same day included tetanus toxoid (manufacturer unknown) and influenza virus vaccine (unspecified) (manufacturer unknown). The physician reported that after receiving the vaccinations the patient's hemoglobin levels dropped. The patient was sent to the hospital and admitted. There was no product quality complaint. Hemoglobin levels dropped was considered to be disabling. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a physician concerning a 51 year old female nurse with sulfonamide allergy who on 19-SEP-2007 at 02:30 PM was vaccinated in the arm with a first dose of Pneumovax 23 lot #658075/0962U. Concomitant therapy included alprazolam (XANAX) and escitalopram oxalate (LEXAPRO). The physician reported that on 19-SEP-2007 the patient experienced "bad injection-site reaction which included pain, warmth, redness and welts/hives surrounding the injection site". In follow up it was reported that on 20-SEP-2007 at 06:00 PM patient developed several scattered areas of redness and swelling with tenderness in her left upper arm. She was prescribed oral steroids (unspecified) and over the counter (OTC) antihistamines and compresses to treat symptoms. Patient recovered on 22-SEP-2007. The reporter felt that getting oral steroids (unspecified), over the counter (OTC) antihistamine and compresses to treat symptoms was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a physician concerning a 51 year old female nurse with sulfonamide allergy who on 19-SEP-2007 at 02:30 PM was vaccinated in the arm with a first dose of Pneumovax 23 lot #658075/0962U. Concomitant therapy included alprazolam (XANAX) and escitalopram oxalate (LEXAPRO). The physician reported that on 19-SEP-2007 the patient experienced "bad injection-site reaction which included pain, warmth, redness and welts/hives surrounding the injection site". In follow up it was reported that on 20-SEP-2007 at 06:00 PM patient developed several scattered areas of redness and swelling with tenderness in her left upper arm. She was prescribed oral steroids (unspecified) and over the counter (OTC) antihistamines and compresses to treat symptoms. Patient recovered on 22-SEP-2007. The reporter felt that getting oral steroids (unspecified), over the counter (OTC) antihistamine and compresses to treat symptoms was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Cough, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician concerning a 56 year old male sales person with low back pain and no known allergies who on 05-SEP-2007 at 02:00 PM was vaccinated into the arm (not specified) with a first dose of Pneumovax 23 lot#658075/0962U (Previously reported as lot #658075/0962U). Concomitant therapy included "TALECRIS", exetimibe (+) simvastatin (MSD), pantoprazole sodium (PROTONIX) and tetanus toxoid. The physician reported that the patient called the office two weeks later to report that he was experiencing "fever, sweating and non productive cough". He reported that the patient also complained of injection site reactions which included pain, swelling and redness. In follow up it was reported that on 06-SEP-2007 at PM patient developed painful red swelling at injection site. This was in arm that received the Pneumovax 23. In addition he developed cough, congestion and fever. In follow up information it was also reported that on 18-SEP-2007 chest xray was done and it showed active disease. Patient was prescribed oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat the fever, sweating and non-productive cough. On 25-SEP-2007 patient recovered. The reporter felt that getting oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat fever, sweating and non-productive cough was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial and follow up information has been received from a physician concerning a 56 year old male sales person with low back pain and no known allergies who on 05-SEP-2007 at 02:00 PM was vaccinated into the arm (not specified) with a first dose of Pneumovax 23 lot#658075/0962U (Previously reported as lot #658075/0962U). Concomitant therapy included "TALECRIS", exetimibe (+) simvastatin (MSD), pantoprazole sodium (PROTONIX) and tetanus toxoid. The physician reported that the patient called the office two weeks later to report that he was experiencing "fever, sweating and non productive cough". He reported that the patient also complained of injection site reactions which included pain, swelling and redness. In follow up it was reported that on 06-SEP-2007 at PM patient developed painful red swelling at injection site. This was in arm that received the Pneumovax 23. In addition he developed cough, congestion and fever. In follow up information it was also reported that on 18-SEP-2007 chest xray was done and it showed active disease. Patient was prescribed oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat the fever, sweating and non-productive cough. On 25-SEP-2007 patient recovered. The reporter felt that getting oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat fever, sweating and non-productive cough was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a male who on 11-SEP-2007 was vaccinated with a second oral dose of Rotateq. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) for an ear infection. Subsequently the patient experienced intussusception. The patient was taken to the emergency room and was treated with an air enema reduction. It was reported that the patient recovered. The patient's intussusception was considered to be immediately life-threatening by the reporter. Additional information has been requested.  10/18/2007 Vax record recieved and info updated in VAERS database. 10/30/2007 MR received for hospital DOS 9/27-30/2007 for D/C DX of Reduced Intussusception on air enema.  Infant presented to the ER with intractable vomiting and dark, bloody bowel movements as well as excessive sleep.  PE (+) for lack of bowel sounds, lethargy, and depressed fontenelle. (+) Currant jelly stool in ER.  Barium enema successfuly reduced IS.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic shock, Blood pressure decreased, Bradycardia, Dyspnoea, Hypotension
Clinical narrative: Information has been received from a physician concerning a 4-year-old female with allergy to nuts who on 10-SEP-2007 was vaccinated subcutaneous in her left arm with a second dose of Varivax at 16:00 hours (Lot # 658413/1025U). Concomitant vaccine included a second dose of MMR II (Lot# 6554200279U) administered on 10-SEP-2007 at 16:00 hours, subcutaneous in the right arm. There was no illness/adverse events at the time of vaccination or following prior vaccinations. On 10-SEP-2007 at 16:05 the patient experienced anaphylactic reaction 5 minutes after vaccination that included the following symptoms: scratchy throat, hives, vomiting, difficulty breathing (decreased O2 saturation, bradycardia, hypotension and greater than five second capillary refill. On the same day the patient developed left arm edematous. Patient sought medical attention via an office exam and hospitalization. The patient was treated with dexamethasone (MSD) 10 mg intramuscularly once, diphenhydramine oral (BENADRYL) 25 mg PO once and epinephrine injection (EPIPEN JR) administered intramuscularly once. On 11-SEP-2007 the patient recovered from all adverse events. A product quality complaint was not involved. Anaphylactic reaction and left arm edematous were considered immediately life-threatening, required one day hospitalization, and was an other important medical event. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Oedema peripheral, Oxygen saturation decreased, Throat irritation, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4-year-old female with allergy to nuts who on 10-SEP-2007 was vaccinated subcutaneous in her left arm with a second dose of Varivax at 16:00 hours (Lot # 658413/1025U). Concomitant vaccine included a second dose of MMR II (Lot# 6554200279U) administered on 10-SEP-2007 at 16:00 hours, subcutaneous in the right arm. There was no illness/adverse events at the time of vaccination or following prior vaccinations. On 10-SEP-2007 at 16:05 the patient experienced anaphylactic reaction 5 minutes after vaccination that included the following symptoms: scratchy throat, hives, vomiting, difficulty breathing (decreased O2 saturation, bradycardia, hypotension and greater than five second capillary refill. On the same day the patient developed left arm edematous. Patient sought medical attention via an office exam and hospitalization. The patient was treated with dexamethasone (MSD) 10 mg intramuscularly once, diphenhydramine oral (BENADRYL) 25 mg PO once and epinephrine injection (EPIPEN JR) administered intramuscularly once. On 11-SEP-2007 the patient recovered from all adverse events. A product quality complaint was not involved. Anaphylactic reaction and left arm edematous were considered immediately life-threatening, required one day hospitalization, and was an other important medical event. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Haematochezia, Ileus, Irritability, Ultrasound scan normal
Clinical narrative: Patient received immunizations on 9/18/07. 9/18/07 in evening has increase fussiness/emesis, 9/19/07 - was stooling normally with, intermittent emesis. Stool at 9/20/07, then no stool x 24 hours, then smell heme +, not grossly bloody stools. Admitted 9/21/07 with ileus, NBNB emesis, (see attached).  10/17/07-discharge summary included with report for DOS 9/21-9/23/07- DC DX: Possible viral GI infection.  Two day history of poor po intake and vomiting as well as 1 day history of decreased stooling. Premature 27 weeks. Stool positive for trace occult blood. Previous hospitalization 9/14/07 with DX ALTE related to choking on medication. Mutlichannel study showed mild immature respiratory pattern with periodic breathing.  10/17/07-vac rec received no changes required.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Patient received immunizations on 9/18/07. 9/18/07 in evening has increase fussiness/emesis, 9/19/07 - was stooling normally with, intermittent emesis. Stool at 9/20/07, then no stool x 24 hours, then smell heme +, not grossly bloody stools. Admitted 9/21/07 with ileus, NBNB emesis, (see attached).  10/17/07-discharge summary included with report for DOS 9/21-9/23/07- DC DX: Possible viral GI infection.  Two day history of poor po intake and vomiting as well as 1 day history of decreased stooling. Premature 27 weeks. Stool positive for trace occult blood. Previous hospitalization 9/14/07 with DX ALTE related to choking on medication. Mutlichannel study showed mild immature respiratory pattern with periodic breathing.  10/17/07-vac rec received no changes required.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Tachycardia
Clinical narrative: Patient was administered Pneumovax and immediately after receiving vaccine he became diaphoretic and tachycardic. Patient was transported via ambulance to the ER for evaluation. Symptoms: 1. Tachycardia (2) diaphoresis.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: CSF test abnormal, Convulsion, Encephalitis, Herpes simplex, Lethargy
Clinical narrative: 15 month PE 8-2-04. 8-8-04 lethargic. Diagnosis encephalitis 8-11-04. CSF PCR + HSV - mid August 2004 10/18/07-records received for DOS-8/8-8/9/04-DC DX: Acute viral illness. Presented with fever and history of not acting right. Seen in clinic day before, lethargic, some vomiting and runny nose. DX: otitis media. Temp on admission 102.3. Admitted for observation. Per 60 day follow up: On set of illness around same time as vaccination. Patient has seizures and developemental delay. Dx with herpes encephelitis as likely cause of seizures & delay.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Polymerase chain reaction
Clinical narrative: 15 month PE 8-2-04. 8-8-04 lethargic. Diagnosis encephalitis 8-11-04. CSF PCR + HSV - mid August 2004 10/18/07-records received for DOS-8/8-8/9/04-DC DX: Acute viral illness. Presented with fever and history of not acting right. Seen in clinic day before, lethargic, some vomiting and runny nose. DX: otitis media. Temp on admission 102.3. Admitted for observation. Per 60 day follow up: On set of illness around same time as vaccination. Patient has seizures and developemental delay. Dx with herpes encephelitis as likely cause of seizures & delay.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Lumbar puncture, Myalgia, Pain
Clinical narrative: 10-8-07 sore, scratchy throat. 10-9-07 3:00 pm fever 103, chills, myalgia, confusion.  11/26/2007 MR received for DOS 10/09-11/2007 with D/C DX Adverse reaction to influenza vaccine.  Pt presented to ER on 10/9/07 with fever and mental status changes/delirium, numbness of feet.  Txd with abx with resolution of fever.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pyrexia, Throat irritation
Clinical narrative: 10-8-07 sore, scratchy throat. 10-9-07 3:00 pm fever 103, chills, myalgia, confusion.  11/26/2007 MR received for DOS 10/09-11/2007 with D/C DX Adverse reaction to influenza vaccine.  Pt presented to ER on 10/9/07 with fever and mental status changes/delirium, numbness of feet.  Txd with abx with resolution of fever.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Back pain, Dizziness, Injection site nodule, Macroangiopathy
Clinical narrative: Syncope episodes.  10/25/2007 MR received for DOS 10/08-12/2007 for D/C DX: Syncopal episodes thought to be likely 2' to HPV vaccine administration. Orthostasis (contributing factor to syncopal episodes). Acute on chronic headache.  Chronic low back pain. Chronic pain syndrome.  Depression.  Nodule infiltrate on lingula per CT scan.  Pt presented to ER with c/o multiple syncopal episodes.  Pt developed nausea and H/A ~ 15 minutes after HPV vax.  Within 30" she had 1st syncopal episode where pt fell and hit her head. MD recommended increased po fluids and Benadryl, however pt had another episode that pm. En route to ER pt lost consciouness for few seconds. Pt was discharged from ER (10/3/07) but had 5 more syncopal episodes over the next several days. Also c/o generalized weakness, decreased appetite, and tiredness. Pt had cardiac and neuro consults.  Pt was found to be orthostatic and several medications were d/cd as they may havbe been contributing. Last syncopal episode was 10/9/07 Per 60 day follow up: Patient with residual dizziness & fainting spells, currently being evaluated by neurology and cardiology.