chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of chills in a 63-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included VITAMIN B COMPLEX, Pyridoxine hydrochloride (B6), CALCIUM, L-LYSINE, Selenium, SOYA LECITHIN, VITAMIN C, ALLEGRA and NEXIUM. On 17 May 2010 at 12:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, left arm). On the night of 17 May 2010, less than one day after vaccination with BOOSTRIX, the subject experienced chills, fever (over 100 degrees) and headache. The subject consulted the physician's office on 19 May 2010. At the time of reporting the fever had improved, and the chills and headache were unresolved. The healthcare professional reported that the physician considered the events were probably related to vaccination with BOOSTRIX.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a physician, via GSK representative, and described the occurrence of tenderness around injection site in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included 6 weeks post-partum. On 25 May 2010 the subject received 1st dose of BOOSTRIX (unknown route, unknown arm). On 26 May 2010, 1 day after vaccination with BOOSTRIX, the subject experienced tenderness around injection site, injection site induration and injection site redness. The subject was treated with non-steroidal anti-inflammatory and warm compress. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. The subject was seen at the physician's practice on 08 May 2010 and reported that she had developed a large red, tender, indurated area (approximately 8 cm) at the site of vaccination approximately 24 hours after the vaccine was administered. The subject reported that the size had decreased since it first appeared.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, via GSK representative, and described the occurrence of injection site redness in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) post-partum. Concurrent medical conditions included allergies, asthma, 6 weeks post-partum and rosacea. Concurrent medications included ZYRTEC and MAXAIR. On 8 June 2010 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 10 June 2010, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness and raised area injection site. The raised red area was 3-4 centimeters. The subject did not have fever. The subject was treated with cold compress. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Sex: U
Vaccine: TDAP
Symptoms: Bordetella infection, Bordetella test positive, Pertussis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Bordetella pertussis test positive in a subject of unspecified age and gender who was vaccinated with DTPa (manufacturer unspecified). On an unspecified date the subject received unspecified dose of DTPa (unknown). At an unspecified time after vaccination with DTPa, the subject experienced Bordetella pertussis test positive. At the time of reporting the outcome of the event was unspecified. The healthcare professional had no further information at the time of reporting.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX. On an unspecified date the subject received unspecified dose of BOOSTRIX. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness and raised area injection site. At the time of reporting the outcome of the events was unspecified. Per the sales representative, there were two reports of injection site redness and raised area injection site. Please see A0865132A for an additional report of injection site redness and raised area injection site.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Chorioamnionitis, Delivery, Drug exposure during pregnancy, Live birth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 15-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) while pregnant. Concurrent medications included Prenatal vitamins. On 18 November 2008 at 10:15 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. This was considered to be a case of vaccine exposure during pregnancy. The subjects due date was reported as 20 March 2009. No adverse events were reported. Follow-up information was received on 22 December 2008, via healthcare professional who reported the subject possesses the sickle cell trait. She also received an Influenza vaccine on 05 November 2008. The subject's last menstrual period occurred on 13 June 2008. Follow-up received on 26 May 2009: On 06 March 2009, the subject gave birth to a healthy male neonate of 38 weeks gestation via normal vaginal delivery. The neonate had weight of 3280 grams and Apgar score of 8 at 1 minute and 9 at 5 minutes. Follow-up information was received on 10 August 2009 from the reporting nurse midwife. Date of birth of the baby was reported as 07 March 2009. The fetal/neonatal status was reported as normal. The infant was reported to be healthy. The method of delivery was spontaneous vaginal. Chorioamnionitis was reported. Please see A0758632B for the baby case.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Rash papular
Clinical narrative: This case was reported by a physician and described the occurrence of red raised skin on arms in a 12-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 29 July 2009 the subject received unspecified dose of BOOSTRIX in an unknown arm. The subject went back to the office on 31 July 2009 and a red raised area about 3 to 4 inches in diameter was noted at the injection site. The official onset date was not known. At the time of reporting the outcome of the event was unspecified.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On an unknown date the subject received unspecified dose of BOOSTRIX. An unspecified amount of time after administration with BOOSTRIX, the subject experienced injection site redness about 2 inches from the injection site. The subject was watched and then was allowed to leave. At the time of reporting the outcome of the event was unspecified.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen eyes in a 18-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concomitant medications and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included TB skin test. On 6 August 2009 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, right arm). On 6 August 2009, 5 minutes after vaccination with BOOSTRIX, the subject experienced swollen eyes. At the time of reporting the event was resolved.
Age: 4.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Vomiting, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a 4-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included IPV (Sanofi) given on 10 August 2009. Concurrent medications included ZYRTEC given over 24 hours prior to this report. On 10 August 2009 at 18:00 the subject received unspecified dose of BOOSTRIX in the left thigh. This was the wrong vaccine for administration. BOOSTRIX is not indicated for use in children under the age of 10 years. The child was to have received her 5th dose of her DTaP series. Three days following vaccination with BOOSTRIX, the child experienced vomiting. At the time of reporting the vomiting was unresolved. The reporter did not know if the event was related to the maladministration.
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Hypotension, Vomiting
Clinical narrative: This case was reported by a healthcare professional via sales representatives and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In August 2009 (date believed to be 14 August 2009), the subject received unspecified dose of BOOSTRIX in the left deltoid. On the same day of vaccination, the subject developed diarrhea, vomiting and low blood pressure. The events were resolved at the time of reporting. Relationship of these reported events to BOOSTRIX was unknown.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: This case was reported by a physician and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In September 2009 the subject received unspecified dose of BOOSTRIX (unknown arm). On 29 September 2009, 8 days after vaccination with BOOSTRIX, the subject experienced swelling in her arm. The physician did not have any information about the subject only that she was vaccinated 9 days ago; and yesterday, 8 days after vaccination, the subject had swelling in her arm. The physician reported that today the subject's arm was less swollen than the day before. No further information from the physician was provided. At the time of reporting the arm swelling was improved. The physician also reported a case of injection site pain, see A0810008A.
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Flatulence, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of upset stomach in a 4 hour-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 17 September 2009 at 15:45 the subject inadvertently received a dose of BOOSTRIX at 0.5 ml in the right thigh.  On 17 September 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced upset stomach and gassiness.  This was also a maladministration (asymptomatic/child too young).  At the time of reporting the events of upset stomach and gassiness were unresolved.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itchy rash in a 46-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Concurrent medical conditions included high cholesterol.  Concurrent medications included Multivitamins (Vitamins).  On 22 February 2010 at 14:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left deltoid).  On 24 February 2010, 2 days after vaccination with BOOSTRIX, the subject experienced itchy rash.  The healthcare professional reported the subject has been experiencing an itchy rash off and on since receiving BOOSTRIX.  At the time of reporting the itchy rash was unresolved.  Follow-up information was received on 20 April 2010, via healthcare professional who indicated the itchy rash started on 10 March 2010 as opposed to the previously reported 23 February 2010.  The itchy rash had improved.  The subject had no adverse following previous vaccinations.
Age: 66.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Burning sensation, Injection site reaction, Nerve injury, Paraesthesia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of nerve hit during vaccine injection in a 67-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; left arm given on 18 January 2010.  Concurrent medications included Blood pressure medication (Unknown blood pressure medication).  On 18 January 2010 at 11:45 the subject received booster dose of BOOSTRIX (unknown, right deltoid).  At an unspecified time after vaccination with BOOSTRIX, the subject experienced nerve hit during vaccine injection, possible hematoma, tingling sensation, burning sensation and nerve irritation.  On an unspecified date the subject returned to the physician office reporting tingling and burning sensations around the front part of the arm in which the BOOSTRIX was given.  The physician suggested that the subject might have a small hematoma or general nerve irritation from the BOOSTRIX needle.  The subject also received HAVRIX the same day, but in the left arm.  The subject has since sought the medical advice of a neurologist who suggested that the person who administered the vaccine may have hit a nerve; however, "the medical assistant stated that she did not aspirate blood, which one would expect if a nerve had been hit".  At the time of reporting the outcome of the nerve hit during vaccine injection, possible hematoma, tingling sensation, burning sensation and nerve irritation was unspecified.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline.  Concurrent medications included Olmesartan medoxomil.  On 31 March 2010 at 10:55 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm.  On 2 April 2010, after vaccination with BOOSTRIX, the subject experienced injection site pruritus, injection site tenderness (level 1) and injection site redness.  It was also noted that when examining the subject's injection site, the site was 1/2 cm in size with induration.  At the time of reporting the events were improved.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent medical conditions included allergy to amoxicillin.  There were no concurrent medications.  On 5 April 2010 at 08:15 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm.  On 5 April 2010, less than one day after vaccination with BOOSTRIX, the subject experienced injection site redness and injection site pruritus.  The subject was treated with Benadryl.  At the time of reporting the events were improved.
Age: 29.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of raised welts in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), TWINRIX.  Concurrent medications included Yasmin.  On 21 April 2010 the subject received unspecified dose of BOOSTRIX (unknown, unknown arm), 1st dose of TWINRIX (unknown, unknown arm).  On 22 April 2010, 24 hours after vaccination with BOOSTRIX, at an unspecified time after vaccination with TWINRIX, the subject experienced raised welts.  The physician reported the subject received both a BOOSTRIX and TWINRIX vaccines on 21 April 2010.  The actual sites of the injections were not documented.  The physician discussed this with a sales representative and believed BOOSTRIX was more likely to be "wheel" area on arm.  Tylenol and cold compress were prescribed as treatment.  At the time of reporting the event was unresolved.  The physician considered the event was probably related to vaccination with BOOSTRIX and TWINRIX.
Age: 23.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Acne, Feeling hot, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pimply bumps in a 23-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), MMR II (non-gsk) and RECOMBIVAX.  On 19 April 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm), 3rd dose of MMR II (Non-GSK) (unknown, right arm), 1st dose of RECOMBIVAX (unknown, right arm).  On 19 April 2010, less than one day after vaccination with BOOSTRIX, MMR II (Non-GSK) and RECOMBIVAX, the subject experienced "raised pimple like bumps on arm and shoulder" and "warmth in area".  The subject had raised red pimples and sensation of warmth after receiving MMR II, BOOSTRIX and RECOMBIVAX in his right arm on 19 April 2010.  On 23 April 2010 the subject sought medical care and was treated with Benadryl.  On 28 April 2010 the subject returned to the medical office and he no longer had the symptoms.  The subject was treated with TYLENOL.  On 28 April 2010, the pimply bumps and feeling of warmth were resolved.  The healthcare professional considered the events were probably related to vaccination with BOOSTRIX, MMR II (Non-GSK) and RECOMBIVAX.
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (also the subject), via a GSK representative and described the occurrence of injection site redness in an adult female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  No information was available regarding concomitant medications, medical history or any adverse events following previous vaccinations.  Concurrent vaccination included TWINRIX, (GlaxoSmithKline) given in August 2009.  On either 24 August 2009 or 25 August 2009 the subject received one and only dose of BOOSTRIX (unknown route, left arm).  In August 2009, less than one week after vaccination with BOOSTRIX, the subject experienced injection site redness and swelling injection site.  It was described as a "fairly large" diameter around the injection site.  At the time of reporting the outcome of the events were was unspecified.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood pressure normal, Dyspnoea, Feeling hot, Heart rate increased, Hyperventilation
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Immediate post-injection reaction, Movement disorder, Palpitations
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Panic attack, Panic reaction, Paraesthesia, Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood pressure normal, Chest discomfort, Dyspnoea, Electrocardiogram ambulatory, Feeling hot
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Hyperventilation, Hypoaesthesia, Hypoaesthesia facial, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Panic attack, Panic disorder, Paraesthesia, Paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. This was reported by a consumer and described the occurrence of heat waves in a 35-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report. Concurrent medications included ZOLOFT, AMITRIPTYLINE HCl and TYLENOL. On 5 May 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm). On 5 May 2010, immediately after vaccination with BOOSTRIX, the subject experienced heat waves, shortness of breath, chest tightness, tingling of extremity, numbness of extremities, increased heart rate, hyperventilating panic attack and paralysis. Immediately after vaccination the subject's entire body felt as if it was on fire, starting in stomach (also described as hot waves going through body), shortness of breath, tightness in chest, hands, feet, fingers face were tingly and numb (tingling of extremity and numbness of extremities) and heart reate increased to 140. The subject was still at physician's office, she laid down and vitals were taken; blood pressure was normal. She was also hyperventilating. It was reported that the physician indicated BOOSTRIX brought on a panic attack. Approximately 20 to 30 minutes later she tried to leave physician office and the same thing happened; 20 to 30 minutes later she was able to leave and go home. The symptoms returned when the subject got home. She called her physician who advised her to call 911. The subject couldn't move arms or legs, she was laying down and her, entire body paralyzed for 30 to 45 minutes. Paramedics administered oxygen, her blood pressure was normal, heart rate was fast and it took about 30 minutes to get her stabilized. Since then the subject stated she has emergency room (ER) visits about three to four times a week. The subject indicated this has turned into a panic disorder. When she goes to the ER she is treated with oxygen, an electrocardiogram (EKG) monitors her heart. She is observed and released with no overnight hospital stays. When the subject feels an attack coming on she treats it with VALIUM and was scheduled for a mental health appointment. This case was assessed as medically serious by GSK. The subject was treated with oxygen and VALIUM. At the time of reporting the events were unresolved.
Age: 56.0
Sex: F
Vaccine: PER
Symptoms: Bordetella test, Cough, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat, stuffy nose cough, chest congestion. Lasted 2-3 weeks better for 2 weeks then another onset on September 20 with same symptoms but more severity.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure inadequately controlled, Blood test, Burning sensation, Fatigue
Clinical narrative: Bottom of feet and hands were burning; tingling.  Muscle twitching in legs and arms.  Developed into joint pain and muscle soreness later.  Hands swell and arms are asleep many mornings.  Bottom of feet still burn. Easily tire out. Blood pressure became more difficult to control.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching, Myalgia, Neurological examination abnormal, Oedema peripheral, Paraesthesia
Clinical narrative: Bottom of feet and hands were burning; tingling.  Muscle twitching in legs and arms.  Developed into joint pain and muscle soreness later.  Hands swell and arms are asleep many mornings.  Bottom of feet still burn. Easily tire out. Blood pressure became more difficult to control.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, Urine analysis, X-ray
Clinical narrative: Bottom of feet and hands were burning; tingling.  Muscle twitching in legs and arms.  Developed into joint pain and muscle soreness later.  Hands swell and arms are asleep many mornings.  Bottom of feet still burn. Easily tire out. Blood pressure became more difficult to control.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Shaking chills, 102 temp, myalgias. Treated with Tylenol and ASA. Lasted about 24 hrs with fatigue lasting 48 hrs. Pneumocoocal vaccine received at same time with site pain persisting 3 days.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: Shaking chills, 102 temp, myalgias. Treated with Tylenol and ASA. Lasted about 24 hrs with fatigue lasting 48 hrs. Pneumocoocal vaccine received at same time with site pain persisting 3 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Skin infection
Clinical narrative: 9-6-10 at 1530 called triage & spoke to nurse regarding pain, redness and swelling at site of DTAP. Adv ER 9-6-10 at 1821 went to hospital ER  (L) thigh 6 cm x 5 cm upper lateral portion of erythema. Induration 2 cm x 2 cm. Dx: skin infection, localized reaction to vaccine. Put on cephalexin 250mg 9/9 called office to update 9/17 pt well.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Pt. developed herpes zoster after receiving 1st dose of varicella.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Mobility decreased, Pain, Pyrexia, Swelling
Clinical narrative: Soreness & swelling. Fever of 101 & chills, unable to lift arm. Rx was TYLENOL ES two po prn.
Age: 53.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Malaise, Pain, Pain in extremity
Clinical narrative: Had a slight sore throat prior to vaccination did not report it (felt it was insignificant per patient). Notes general malaise & achy all over. Right arm still sore and extends to fingers on Rt hand. Reported chest heaviness no SOB or difficulty breathing. Seeing 0B/GYN Wed 9/29 will f/u then.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dysstasia
Clinical narrative: Feeling of extreme weakness about 6 hrs. after injection, needed help to stand. Symptoms improved over the next 12 hrs. No treatment needed, was feeling much better 30 hrs after injection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Flushing, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Vaccine administered 9-27-10 1:21 PM (1321) approx. 15 mins. later had numbness tingling of lips & tongue, which progressed to flushed feeling, nausea & headache. She had flushing upper chest. No itching, swelling or trouble breathing. To E.R. 3:15PM. T 100 F. O2 saturation 99 room air. IV BENADRYL 25 mg, IV SOLU-MEDROL 125mg. Discharged home 5:50PM - Improved.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation normal, Paraesthesia oral
Clinical narrative: Vaccine administered 9-27-10 1:21 PM (1321) approx. 15 mins. later had numbness tingling of lips & tongue, which progressed to flushed feeling, nausea & headache. She had flushing upper chest. No itching, swelling or trouble breathing. To E.R. 3:15PM. T 100 F. O2 saturation 99 room air. IV BENADRYL 25 mg, IV SOLU-MEDROL 125mg. Discharged home 5:50PM - Improved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Eye pruritus, Lacrimation increased
Clinical narrative: Patient developed sore throat, itchy and watery eyes, coughing within ~ 2 hours of vaccine injection. Patient also reports chills and difficulty breathing and (had to use inhaler).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Patient developed sore throat, itchy and watery eyes, coughing within ~ 2 hours of vaccine injection. Patient also reports chills and difficulty breathing and (had to use inhaler).
Age: 1.32
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Convulsion, Gaze palsy, Pyrexia, Respiratory arrest
Clinical narrative: Pt with generalized convulsions and eyes rolling back for 45 seconds. Stopped breathing for 30 sec. Had fever at time of event.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site pain
Clinical narrative: pain in R. upper arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Injection site pain
Clinical narrative: Aching pain in Left Deltoid and aching and burning across left anterior chest.  Headache.  Symptoms persisting today still.
Age: 1.07
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Irritability, Rash, Sleep disorder
Clinical narrative: Rash on entire torso increasing daily. Now on chin & cheeks. Slight alteration in sleep, slightly irritable and slight decrease appetite. Afebrile.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Dyspnoea, Flushing, Swollen tongue
Clinical narrative: Patient experienced a flushed face, tongue swelled and difficulty breathing approximately 1 hour after vaccine administered. Patient diagnosed with anaphylactoid reaction.  Received diphenhydramine 50 mg IVP, famotidine 20 mg IV push, and methylprednisolone 125 mg IVP.  Symptoms improved and patient discharged to home from ED.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: sudden fever and constant vomiting
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient came to Employee Health with compliants of Lethergy, aches, swollen, painful left arm.  Sent to Occupational Health given Septra DS and Medrol Dose pack.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Patient noticed rash on abdomen, upper left thigh, and left arm, four days after receiving second dose of Varivax in the office. First dose was given 01/20/03.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: PATIENT HAD MMR AND VARICELLA ON 09/01/10. CHILD RAN LOW GRADE FEVER FOR THREE DAYS PRIOR TO BREAKING OUT WITH A RASH ON 9/17/2010. WAS GIVEN BENADRYL LIQUID BY GRANDPARENTS. PATIENT'S MOTHER DELIVERED A BABY ON 9/14/2010. PATIENT WAS OUT RIDING ON 4 WHEELER. NOT REAL SURE IF SHOTS CAUSED REACTION SINCE IT WAS 16 DAYS AFTER SHOTS THAT THE RASH OCCURED. CHILD WAS NOT AROUND NEWBORN WHEN SHE HAD FEVER. CHILD IS OKAY NOW.
Age: 50.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram, Headache, Heart rate irregular, Nausea, Pyrexia
Clinical narrative: Irregular heart beat Saturday night through all of Sunday. Headache Sunday to present day, nausea, low fever. Some irregular heart beats all days to present 9/29/2010 and continuing.
Age: 50.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood test, Cardiac monitoring, Cardiac stress test, Feeling abnormal, Headache
Clinical narrative: Irregular heart beat Saturday night through all of Sunday. Headache Sunday to present day, nausea, low fever. Some irregular heart beats all days to present 9/29/2010 and continuing.
Age: 50.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Palpitations
Clinical narrative: Irregular heart beat Saturday night through all of Sunday. Headache Sunday to present day, nausea, low fever. Some irregular heart beats all days to present 9/29/2010 and continuing.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Soreness, redness, swelling, fever > 102.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Depressed mood, Tremor
Clinical narrative: Pt not happy. About 2-3 hours after getting vaccination started to shake all over but did not have temp. lasted 3/4 night then felt hot until morning, stomach was also upset.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb immobilisation, Oedema peripheral, Pain in extremity
Clinical narrative: Patient called and said arm where Pneumococcal vaccine given was very sore, swelling & pain. Could hardly use arm for 3 days. Then was ok.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Sinus congestion
Clinical narrative: Injection 6:30pm nose/sinuses congested, headache, nausea reaction (9/22/10) 9:00pm was light. Started to recede about noon next day (9/23/10).
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, C-reactive protein increased, Chest X-ray normal, Dizziness, Electrocardiogram abnormal
Clinical narrative: Developed mild fever and headache on Friday afternoon (day of vaccine receipt). Increase in temp to 101 on Saturday (9/18) with increased heart rate; also awakened early Sat a.m. with N/V followed by mild abdominal discomfort and lightheadedness. On Sunday (9/19), pt's temp increased to 103 and she was taken to the ER by her mother who is an LPN. Pt was admitted to Medical Center after noted increased WBC, ESR and CRP. Received IV hydration and TYLENOL overnight and felt better the next a.m (9/20), but now, PNEUMOVAX site with increased redness, swelling, warmth and tenderness - See photos. Seen on 9/24/2010 and all symptoms resolved except affected area still tender to palpation. No fever since discharge without TYLENOL. Will have repeat CBC next week.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed mild fever and headache on Friday afternoon (day of vaccine receipt). Increase in temp to 101 on Saturday (9/18) with increased heart rate; also awakened early Sat a.m. with N/V followed by mild abdominal discomfort and lightheadedness. On Sunday (9/19), pt's temp increased to 103 and she was taken to the ER by her mother who is an LPN. Pt was admitted to Medical Center after noted increased WBC, ESR and CRP. Received IV hydration and TYLENOL overnight and felt better the next a.m (9/20), but now, PNEUMOVAX site with increased redness, swelling, warmth and tenderness - See photos. Seen on 9/24/2010 and all symptoms resolved except affected area still tender to palpation. No fever since discharge without TYLENOL. Will have repeat CBC next week.