chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). Concurrent vaccination included Hib (manufacturer unspecified) and DTaP (manufacturer unspecified) both given on 9 October 1998. On 9 October 1998 the infant subject received the final dose to complete the Hep B vaccination series. Years later, at the age of 13, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941134A, A0941136A and A0941137A.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a 14-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). On 20 November 1997 the infant subject received the final dose to complete the Hep B vaccination series. Years later, at the age of 14, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941135A, A0941136A and A0941137A.
Sex: U
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site bleeding in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ENGERIX B (1 ml, unknown route). On 27 July 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site bleeding. On 28 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported 3 incidences of subjects experiencing bleeding at the injection site with ENGERIX B. This is case 3 of 3 (see case IDs A0939441A and A0939443A for details of the other reports). Follow-up information received on 22 September 2011 indicated that no further information was available for this adverse event.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: This case was reported by a consumer and described the occurrence of calf twitches in a 31-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 9 November 2010 at 14:00 the subject received unspecified dose of ENGERIX B  (unknown, left arm). On 16 November 2010, 7 days after vaccination with ENGERIX B, the subject experienced twitching in calf and numbness in left hand. At the time of reporting the calf twitches and numbness in hand were unresolved.
Sex: U
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site bleeding in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ENGERIX B (1 ml, unknown route). On 27 July 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site bleeding. On 28 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported 3 incidences of subjects experiencing bleeding at the injection site with ENGERIX B. This is case 2 of 3 (see case IDs A0939441A and A0939444A for details of the other reports). Follow-up information received on 22 September 2011 indicated that no further information was available for this adverse event.
Age: 46.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 47-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tdap (non-gsk); non-GSK manufacturer given on 19 January 2010. On 19 January 2010, 22 February 2010 and 19 July 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 30 August 2010, 42 days after the 3rd vaccination with ENGERIX B, 6 months after the 2nd vaccination with ENGERIX B, and 7 months after the 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject's titers were drawn on 30 August 2010 and were negative. The vaccination series was repeated. On 4 October 2010, 5 November 2010 and 7 April 2011 the subject received 4th dose, 5th dose and 6th dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 21 May 2011, 44 days after the 6th vaccination with ENGERIX B, 6 months after the 5th vaccination with ENGERIX B, and 8 months after the 4th vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject's titers were drawn on 21 May 2011 and were 1.8 (units not provided). This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following Hep B vaccination. This is case 1 of 7 (see case IDs A0947239A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 30 August 2010, the subject's hepatitis B surface antibody was 0.24 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). On 19 May 2011 (after the 2nd series of ENGERIX B), 42 days after the 6th vaccination with ENGERIX B, 6 months after the 5th vaccination with ENGERIX B, and 7 months after the 4th vaccination with ENGERIX B, the subject's hepatitis B surface antibody was 1.89 mIU/mL. All 6 doses of ENGERIX B were administered intramuscularly in the left deltoid.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subjects from different hospital facilities. Linked cases include A0942894A, A0942899A and A0942900A.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subject from different hospital facilities. Linked cases include A0942898A, A0942899A and A0942900A.
Age: 15.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of decreased therapeutic response in a 15-year-old subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (infant series). At the age of 15, the subject was tested for antibodies to hepatitis B and the subject did not have detectable levels. This was considered to be decreased therapeutic response. The physician reported to the sales representative that this event occurred in about 15 to 20 percent of 15 year olds checked for hepatitis B antibodies.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a 6-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). Concurrent vaccination included PEDIARIX (GlaxoSmithKline) and PREVNAR (manufacturer unspecified) both given on 7 February 2006. On 7 February 2006 the infant subject received the final dose to complete the Hep B vaccination series at 0.5 ml in an unknown leg. Years later, at the age of 6, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941134A, A0941135A and A0941136A.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Pain in extremity, X-ray limb normal
Clinical narrative: This case was reported by a physician and described the occurrence of lump injection site in a 45-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On 8 February 2011 the subject received 3rd dose of ENGERIX B adult (unknown route, left arm). On 8 February 2011, less than one day after vaccination with ENGERIX B adult, the subject experienced lump injection site, injection site pain and limited range of motion. The subject complained of pain in her arm by phone call to physician's office in April 2011 and again in July 2011 in person at her physical appointment. The subject was referred for physical therapy and an x-ray of the site with unremarkable results. At the time of reporting the injection site pain was unresolved. The limited range of motion improved on an unspecified date. The lump at injection site resolved on an unknown date in February 2011. The physician considered the events were probably related to vaccination with ENGERIX B adult. Follow-up information was received on 27 September 2011 via a physician. It was reported that the events of lump injection site, injection site pain and limited range of motion occurred the same day of vaccination with ENGERIX B, 08 February 2011. The events were unresolved and were considered probably attributable to vaccination with ENGERIX B. The subject was considered to be healthy with no relevant medical history or concurrent illness. There was no history of alcohol or tobacco use. This vaccination with ENGERIX B was confirmed to be the last of 3. No concurrent medications were reported. A diagnostic test of AP and Lateral views of the left humerus was performed on 26 July 2011. Findings were: No fracture. The bones were in anatomic alignment. Impression: There was no fracture.
Age: 0.01
Sex: U
Vaccine: HEP
Symptoms: Convulsion, Hepatic enzyme increased
Clinical narrative: This case was reported by a consumer (the subject's parent) and described the occurrence of seizure in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 7 August 2011 the subject received unspecified dose of ENGERIX B (details unknown). On an unspecified date in 2011, less than one month after vaccination with ENGERIX B, the subject experienced seizure and elevated liver enzymes. The consumer reported that the subject was born on 05 August 2011 and received ENGERIX B vaccine on 07 August 2011, and "since then" the subject had experienced seizures and elevated liver enzymes. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The consumer refused to provide any further information.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Injection site irritation, Injection site pruritus, Injection site pustule, Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site blisters in a 25-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis and sinusitis. On 23 August 2011 the subject received 1st dose of ENGERIX B (1 ml, unknown route, right arm). On either 23 or 24 August 2011, within 24 hours after vaccination with ENGERIX B, the subject experienced injection site blisters, injection site pruritus and injection site irritation. The subject had a raised blister with pus at the injection site, which was the size of a pencil eraser. The healthcare professional reported that it itched and caused some irritation. At the time of reporting the events were improved.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subjects from different hospital facilities. Linked cases include A0942894A, A0942898A and A0942899A.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subjects from different hospital facilities. Linked cases include A0942894A, A0942898A and A0942900A.
Sex: U
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site bleeding in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ENGERIX B (1 ml, unknown route). On 27 July 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site bleeding. On 28 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported 3 incidences of subjects experiencing bleeding at the injection site with ENGERIX B. This is case 1 of 3 (see case IDs A0939443A and A0939444A for details of the other reports). Follow-up information received on 22 September 2011 indicated that no further information was available for this adverse event.
Age: 1.55
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, MMR, VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of  not responding to therapy in a 11-year-old male subject who was vaccinated with Hep B (manufacturer unspecified). Concurrent vaccination included Hib (manufacturer unspecified), PEDIARIX (GlaxoSmithKline), MMR (manufacturer unspecified) and VARIVAX (Merck) all given on 14 February 2002. On 14 February 2002 the infant subject received the final dose to complete the Hep B vaccination series at 0.5 ml in an unknown leg. Years later, at the age of 11, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941134A, A0941135A and A0941137A.
Age: 7.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Autopsy, Death
Clinical narrative: Headache, fever, body ache, throwing up.
Age: 7.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Death, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Headache, fever, body ache, throwing up.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Hot flush, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Hot flashes.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Hot flush, Laboratory test normal
Clinical narrative: Hot flashes.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test normal, Diplopia, Headache, Hot flush
Clinical narrative: Hot flashes.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Hot flush, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: SHE HAD AN EPISODE OF HOT FLASHES SOME TIMES ASSOCIATED WITH HEAD ACHE AND DOUBLE OR TRIPLE VISION.  ALL HER BLOOD WORK AND OTHRE REPORT COME NEGATIVE.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Hot flush, Laboratory test normal
Clinical narrative: SHE HAD AN EPISODE OF HOT FLASHES SOME TIMES ASSOCIATED WITH HEAD ACHE AND DOUBLE OR TRIPLE VISION.  ALL HER BLOOD WORK AND OTHRE REPORT COME NEGATIVE.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test normal, Diplopia, Headache, Hot flush
Clinical narrative: SHE HAD AN EPISODE OF HOT FLASHES SOME TIMES ASSOCIATED WITH HEAD ACHE AND DOUBLE OR TRIPLE VISION.  ALL HER BLOOD WORK AND OTHRE REPORT COME NEGATIVE.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Nodule
Clinical narrative: 7 cm in diameter - erythematous (ear with local nodule (2 cm in diameter).
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Nausea, Vomiting
Clinical narrative: Extreme pain at injection site. Nausea & vomiting. Redness at injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Eye swelling, Feeling hot, Paraesthesia oral, Swelling
Clinical narrative: Swelling, redness, warmth, swollen eyes, tingling lips.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Insomnia, Lacrimation increased, Ocular hyperaemia, Pyrexia
Clinical narrative: Patient had MMR, Chicken Pox, and Hepatitis A on 1/17/12 at about 3:45 pm.  He received Tylenol at 4:15 pm and again at 8:30 pm.  He woke up once in the middle of the night around 1:30 am and I gave him Tylenol and some milk. He was feverish on 1/18/12 as usual after vaccines and we alternated giving him Tylenol and Ibuprofen regularly. On 1/18/12 at about 6:00 pm hives were evident on his lower body.  Each thigh had one enormous hive that spread from the knee to the hip covering the entire top of the thigh, with jagged edges, raised, red, darker red on the edges, and hot to the touch.  He had other hives on the back of his legs and butt as well.  His left eye was red and watering.  As the night went on the hives on his thighs got better but more hives developed on his lower legs.  His face was puffy, but there were no hives.  He was restless all night and feverish, sleeping for only 2 hours and then crying for 20-30 minutes followed by playing for 1-2 hours and then sleeping for 2 hours. By 1/19/12 the hives on his thighs were gone other than the outline of the largest ones.  I continued to give him Tylenol regularly because he was still feverish.  We went to the doctor at 10:30 am at which time all but three small mosquito bite sized hives on his left calf were gone.  The nurse practitioner stated that he had an adverse reaction to one of the shots, but that there was no way to determine which shot it was because all three shots that he received were new and because the reaction was the same on both legs where the shots were administered.  She stated that he was fine now and advised on the amount of Benadryl and Tylenol allowed at his current weight for reference.  After leaving the doctor's office by around 12pm one hive the size of a quarter developed on his right upper arm.  He ate lunch and then took a nap.  When he woke up from his nap at 3:45 pm both arms had developed large patches like he had on his thighs the previous day.  We administered 6mL of 12.5 strength Benadryl and once it set in the hives went away by approximately 6-6:30 pm.  He woke up at 1:30 am and drank a few ounces of milk and went back to sleep until the morning. 1/20/12 he seemed normal other than he was still somewhat feverish.  He woke up from a nap at 4:00 PM where hives were evident on his butt.  We gave him 6 mL of Benadryl and the hives went away within 2 hours.  He has been okay since.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Restlessness, Swelling face, Urticaria, Vaccination complication
Clinical narrative: Patient had MMR, Chicken Pox, and Hepatitis A on 1/17/12 at about 3:45 pm.  He received Tylenol at 4:15 pm and again at 8:30 pm.  He woke up once in the middle of the night around 1:30 am and I gave him Tylenol and some milk. He was feverish on 1/18/12 as usual after vaccines and we alternated giving him Tylenol and Ibuprofen regularly. On 1/18/12 at about 6:00 pm hives were evident on his lower body.  Each thigh had one enormous hive that spread from the knee to the hip covering the entire top of the thigh, with jagged edges, raised, red, darker red on the edges, and hot to the touch.  He had other hives on the back of his legs and butt as well.  His left eye was red and watering.  As the night went on the hives on his thighs got better but more hives developed on his lower legs.  His face was puffy, but there were no hives.  He was restless all night and feverish, sleeping for only 2 hours and then crying for 20-30 minutes followed by playing for 1-2 hours and then sleeping for 2 hours. By 1/19/12 the hives on his thighs were gone other than the outline of the largest ones.  I continued to give him Tylenol regularly because he was still feverish.  We went to the doctor at 10:30 am at which time all but three small mosquito bite sized hives on his left calf were gone.  The nurse practitioner stated that he had an adverse reaction to one of the shots, but that there was no way to determine which shot it was because all three shots that he received were new and because the reaction was the same on both legs where the shots were administered.  She stated that he was fine now and advised on the amount of Benadryl and Tylenol allowed at his current weight for reference.  After leaving the doctor's office by around 12pm one hive the size of a quarter developed on his right upper arm.  He ate lunch and then took a nap.  When he woke up from his nap at 3:45 pm both arms had developed large patches like he had on his thighs the previous day.  We administered 6mL of 12.5 strength Benadryl and once it set in the hives went away by approximately 6-6:30 pm.  He woke up at 1:30 am and drank a few ounces of milk and went back to sleep until the morning. 1/20/12 he seemed normal other than he was still somewhat feverish.  He woke up from a nap at 4:00 PM where hives were evident on his butt.  We gave him 6 mL of Benadryl and the hives went away within 2 hours.  He has been okay since.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Large red rash at injection site.  Very hot skin.  Itchy and painful to touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Throat irritation
Clinical narrative: 1-2 hrs following vaccination noticed red bumps, face itchy - transient and periodic itching scalp, scratchy throat. BENADRYL 25 at 3 PM.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who on unknown date, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not reported). On an unknown date, the patient developed intussusception. The patient was hospitalized. The physician considered intussusception to be immediately life-threatening and an other important medical event. At the time of the report the outcome of the patient was unknown. The physician indicated that the intussusception had been previously reported to VAERS. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning a patient who on unknown date, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not reported). On an unknown date, the patient developed intussusception. The patient was hospitalized. The physician considered intussusception to be immediately life-threatening and an other important medical event. At the time of the report the outcome of the patient was unknown. The physician indicated that the intussusception had been previously reported to VAERS. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chronic obstructive pulmonary disease, Condition aggravated, Heart rate increased, Injection site erythema
Clinical narrative: Initial non-serious report received from a healthcare professional on 21 September 2011 under the local reference number 11-0601. A 74-year-old female patient who had many medications for years and allergies to PLAVIX and Sulfa had received a "lasted" intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AC) in the left deltoid on 20 September 2011. The patient had no illness at time of vaccination. The patient had no other vaccination within 4 weeks prior to 20 September 2011. On 21 September 2011 in the afternoon, the patient was seen by the physician for local redness on left arm with injection site "larger than a half dollar" with a rash over entire body, BP increased 170/100, pulse increased 120, and pulse oximeter reading of 90%. The patient required a doctor visit. At the time of the report, the patient had not recovered. Follow-up information received on 17 January 2012. Due to the following information, the case was upgraded from non-serious to serious: Concomitant medications included Baby ASA, LANOXIN, DIOVAN, ATIVAN and LASIX. The reporter clarified that the rash was from head to toe with terrible itching. The duration site was approximately 4 x 6 inches of erythema (adverse event coding updated to reflect size of vaccination reaction). The patient had recovered after treatment with steroids (one week later, the rash improved). Seventeen days after vaccination (which was on 17 October 2011), the patient was hospitalized due to COPD exacerbation. The reporter was not sure if this was aggravated by her reaction to the FLUZONE vaccine. Diagnostic tests/laboratory data or treatments for the COPD were not reported. Hospital discharge date not reported. At the time of this report, the patient had recovered (date not reported).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Initial non-serious report received from a healthcare professional on 21 September 2011 under the local reference number 11-0601. A 74-year-old female patient who had many medications for years and allergies to PLAVIX and Sulfa had received a "lasted" intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AC) in the left deltoid on 20 September 2011. The patient had no illness at time of vaccination. The patient had no other vaccination within 4 weeks prior to 20 September 2011. On 21 September 2011 in the afternoon, the patient was seen by the physician for local redness on left arm with injection site "larger than a half dollar" with a rash over entire body, BP increased 170/100, pulse increased 120, and pulse oximeter reading of 90%. The patient required a doctor visit. At the time of the report, the patient had not recovered. Follow-up information received on 17 January 2012. Due to the following information, the case was upgraded from non-serious to serious: Concomitant medications included Baby ASA, LANOXIN, DIOVAN, ATIVAN and LASIX. The reporter clarified that the rash was from head to toe with terrible itching. The duration site was approximately 4 x 6 inches of erythema (adverse event coding updated to reflect size of vaccination reaction). The patient had recovered after treatment with steroids (one week later, the rash improved). Seventeen days after vaccination (which was on 17 October 2011), the patient was hospitalized due to COPD exacerbation. The reporter was not sure if this was aggravated by her reaction to the FLUZONE vaccine. Diagnostic tests/laboratory data or treatments for the COPD were not reported. Hospital discharge date not reported. At the time of this report, the patient had recovered (date not reported).
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a consumer for VARIVAX (Merck), a Pregnancy Registry Product, concerning his 30 year old wife with a history of chicken pox "as a child" and no drug allergies or reaction who on 01-MAR-2011 was vaccinated with a 0.5 ml dose of VARIVAX (Merck). There was no concomitant medication. On 17-MAY-2011 the patient found out she was pregnant. There was no AE reported. The patient was seeing her OB/GYN on Tuesday. The patient sought unspecified medical attention and the patient's pregnancy had been confirmed by pregnancy test. Her last LMP was on 08-MAR-2011. Expected date of delivery was 13-DEC-2011. Follow up information was received from the consumer in regards to his wife's pregnancy outcome. He reported that his wife, the patient, gave birth to a healthy baby boy on 09-DEC-2011 that was full term. The baby weighed 8 lbs, 2 oz.; length was 22 inches. He stated his son had no difficulties or anomalies. He reported the delivery was a C-section. When asked why his wife had a C-section, he stated that he did not really know. His wife and baby suffered no complications of the cesarean birth. He verified that his wife only had one dose of VARIVAX (Merck) and that she did have chickenpox as a child. He did not know if VARIVAX (Merck) titers were done on his wife. Upon internal review, cesarean section delivery was determined to be an other important medical event. No further information is available.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood pressure increased, Dizziness, Dry throat
Clinical narrative: Pt felt dizzy, dry throat following flu vaccine. Continued to feel dizzy, weak, lightheaded, and dyspneic on exertion at work.  Sought medical care 3 weeks later and was started on Avlelox on 10/27/11 and saw her PCM on 11/7/11 and was also started on Advair. Told at that time she had a "lung" infection and elevated BP.  Continued to work until 11/18/11 until she sought emergency care for increasing SOB.  Was hospitalized x 5 days at that time.  Is continuing care and treatment with a cardiologist.  Returned to work full time on 3 January with a limited duty profile to not walk more than 50 feet at a time.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Dyspnoea exertional, Impaired work ability, Lung infection
Clinical narrative: Pt felt dizzy, dry throat following flu vaccine. Continued to feel dizzy, weak, lightheaded, and dyspneic on exertion at work.  Sought medical care 3 weeks later and was started on Avlelox on 10/27/11 and saw her PCM on 11/7/11 and was also started on Advair. Told at that time she had a "lung" infection and elevated BP.  Continued to work until 11/18/11 until she sought emergency care for increasing SOB.  Was hospitalized x 5 days at that time.  Is continuing care and treatment with a cardiologist.  Returned to work full time on 3 January with a limited duty profile to not walk more than 50 feet at a time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Chills, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: Began with a fever at 4pm-ish.  Woke up at 12:00 AM shaking with chills and fever of 101.  Vomited once.  Leg hurt. Fever spiked to 103.4 at 12:15AM.  12:30AM fever at 104.0. Motrin given at 12:30 so we waited to see if it came down.  Fever at 103 at 1:00AM. Fever at 101.3 at 1:30 AM.  Put him to bed.  He maintained a low grade 100 degree fever which lowered slowly over the next few days.  Visited the doctor to check him out with fever on 12/14 or 12/15/2011.  They said to watch him and come back if fever worsened.  His fever went  away the next day and we have had no further issues.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at the injection site.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule, Injection site streaking, Laboratory test
Clinical narrative: The mother reported "on right upper leg there was a red streak going outward from the shot site and a noduale under the skin.  The child was seen by Dr. and given Bactroban and Cefzil medicine.  The Doctors office confirmed this information and said there was lab work done and improvement seen by 12/19/11 at follow up.
Age: 1.15
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Generalized rash, fever.
Age: 68.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Swelling, erythema and itching noted to left arm. Patient treated with 10 days of Cefprozil 500mg.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Vaccination site inflammation
Clinical narrative: Parents note left hip inflamed @ vaccine site.  Received both Kinrix and MMR in that upper leg.  NO c/o pain.  Ambulation and all movement without a problem. Cold compress at home, ibuprofen if needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 8x7cm redness with induration and some trailing to left axilla and mild tenderness under left axilla. No lymphadenopathy. Treated with Cephalexin 250mg TID x 10 days.
Age: 5.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling/redness to elbow. Mildly warm. Treated with Augmentin 600mg BID x 10 days.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test negative, Loop electrosurgical excision procedure
Clinical narrative: PAP smear after series of vaccines testepositive for CIN III. I had to have a leep procedure to remove.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Loop electrosurgical excision procedure, Mass
Clinical narrative: PAP smear after series of vaccines testepositive for CIN III. I had to have a leep procedure to remove.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: PAP smear after series of vaccines testepositive for CIN III. I had to have a leep procedure to remove.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pruritus, Vaccination site pain
Clinical narrative: A painful and very tender knot at the vaccination site, woke me up when I rolled onto it on my arm.  Also became very itchy.  Site was red and hot to touch thru 1/24/2012 where today it is finally not so hot and tneder, but knot is still there, still itchy and still painful to touch.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Autism, Convulsion
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 16 January 2012. A male patient (age at time of vaccination not reported) received an injection of DTP and Hib vaccines (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced seizures. In addition, the patient has been experiencing autism-like symptoms (unspecified) ever since vaccination. Currently the patient is 18-years-old and "has not been the same". No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Aphasia, Chest discomfort, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: At 1400, was given vaccines Hep A and TdaP. Several seconds later, noted left arm swelling (both vaccines given in the same arm), numbness. Subsequently difficulty breathing, light headed, throat closing, "couldn't talk". Also lightheaded. Tongue was not swollen, but had difficulty swallowing. No itchiness. No hives or swelling anywhere else. No N/V/D. Did not have any redness noted that the site of injections. Was given epinephrine 0.5 mg x2, albuterol, BENADRYL IV, SOLUMEDROL IV and subsequently transported to hospital for further observation x 2 nights. She was given another dose of epinephrine the morning after admission for chest tightness again.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hypoaesthesia, Oedema peripheral, Throat tightness
Clinical narrative: At 1400, was given vaccines Hep A and TdaP. Several seconds later, noted left arm swelling (both vaccines given in the same arm), numbness. Subsequently difficulty breathing, light headed, throat closing, "couldn't talk". Also lightheaded. Tongue was not swollen, but had difficulty swallowing. No itchiness. No hives or swelling anywhere else. No N/V/D. Did not have any redness noted that the site of injections. Was given epinephrine 0.5 mg x2, albuterol, BENADRYL IV, SOLUMEDROL IV and subsequently transported to hospital for further observation x 2 nights. She was given another dose of epinephrine the morning after admission for chest tightness again.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blister, Chills, Dizziness, Hyperhidrosis
Clinical narrative: 1) Persistent dizziness. 2) Ongoing transient rash - foot burning blisters. 3) Chills/sweat/aches. 4) Anxiety.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: 1) Persistent dizziness. 2) Ongoing transient rash - foot burning blisters. 3) Chills/sweat/aches. 4) Anxiety.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Depression, Tremor
Clinical narrative: 1) Severe depression & anxiety. 2) Trembling in right arm - worsened.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Appendicectomy, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal operation
Clinical narrative: Child received ROTATEQ at 6 mo visit - third vaccine 1/17/12 - next day - 1/18 (7:39 pm) bout with vomiting & 1/19 bloody stools. To hospital ER with US -> showing possible intussusception. Transferred to another hospital. Had reduction of intussusception & appendectomy noted dr.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Platelet count normal, Ultrasound scan abnormal, Vomiting, White blood cell count increased
Clinical narrative: Child received ROTATEQ at 6 mo visit - third vaccine 1/17/12 - next day - 1/18 (7:39 pm) bout with vomiting & 1/19 bloody stools. To hospital ER with US -> showing possible intussusception. Transferred to another hospital. Had reduction of intussusception & appendectomy noted dr.
Age: 48.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Injection site discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymphadenopathy noted transiently for approximately 48 hours total. Mild tender right axillary node enlargement with no other symptoms or fever. Mild injection site discomfort noted.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash on ears, neck and chest.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: Fever/faint.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Blood test normal, Condition aggravated, Diarrhoea, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), Flu vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included back injury, high blood pressure, high cholesterol, migraine headache and sleep disorder. Concurrent medications included VICODIN, AMBIEN, COZAAR and LIPITOR. On an unspecified date several years ago, the subject reacted to an unspecified flu vaccine, but the reaction was not described (adverse reaction). Later, on 6 December 2011 at 13:30 the subject received booster dose of BOOSTRIX in the right arm. The subject instantly had diarrhea, which was reported to be controlled (improved) at the time of reporting. Events that occurred on the same day of vaccination with BOOSTRIX (06 December 2011) included dizziness and vomiting. Other dates that vomiting occurred were 08 December 2011, sometime between 24 December 2011 and 30 December 2011 and 05 January 2012. The day after receiving BOOSTRIX (07 December 2011) the subject experienced fatigue, which was improved at the time of reporting and she could not move which improved. Three days after vaccination with BOOSTRIX (09 December 2011), the subject experienced migraine headache which was worsening. The subject reported a history of migraine headaches that occurred about once a month prior to receiving BOOSTRIX. Some time during the weeks following vaccination with BOOSTRIX (between 06 December 2011 to the time of reporting 20 January 2012), the subject felt wired (unspecified), experienced memory loss, had hot flashes (unresolved), developed insomnia which was improving, bruised easily and a wart appeared under the subject's left nostril. Some of the subject's treatments included LOMOTIL, PROVIGIL and HALCION. Others were not provided.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Hot flush, Immediate post-injection reaction, Increased tendency to bruise
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), Flu vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included back injury, high blood pressure, high cholesterol, migraine headache and sleep disorder. Concurrent medications included VICODIN, AMBIEN, COZAAR and LIPITOR. On an unspecified date several years ago, the subject reacted to an unspecified flu vaccine, but the reaction was not described (adverse reaction). Later, on 6 December 2011 at 13:30 the subject received booster dose of BOOSTRIX in the right arm. The subject instantly had diarrhea, which was reported to be controlled (improved) at the time of reporting. Events that occurred on the same day of vaccination with BOOSTRIX (06 December 2011) included dizziness and vomiting. Other dates that vomiting occurred were 08 December 2011, sometime between 24 December 2011 and 30 December 2011 and 05 January 2012. The day after receiving BOOSTRIX (07 December 2011) the subject experienced fatigue, which was improved at the time of reporting and she could not move which improved. Three days after vaccination with BOOSTRIX (09 December 2011), the subject experienced migraine headache which was worsening. The subject reported a history of migraine headaches that occurred about once a month prior to receiving BOOSTRIX. Some time during the weeks following vaccination with BOOSTRIX (between 06 December 2011 to the time of reporting 20 January 2012), the subject felt wired (unspecified), experienced memory loss, had hot flashes (unresolved), developed insomnia which was improving, bruised easily and a wart appeared under the subject's left nostril. Some of the subject's treatments included LOMOTIL, PROVIGIL and HALCION. Others were not provided.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Migraine, Nuclear magnetic resonance imaging, Skin papilloma, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), Flu vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included back injury, high blood pressure, high cholesterol, migraine headache and sleep disorder. Concurrent medications included VICODIN, AMBIEN, COZAAR and LIPITOR. On an unspecified date several years ago, the subject reacted to an unspecified flu vaccine, but the reaction was not described (adverse reaction). Later, on 6 December 2011 at 13:30 the subject received booster dose of BOOSTRIX in the right arm. The subject instantly had diarrhea, which was reported to be controlled (improved) at the time of reporting. Events that occurred on the same day of vaccination with BOOSTRIX (06 December 2011) included dizziness and vomiting. Other dates that vomiting occurred were 08 December 2011, sometime between 24 December 2011 and 30 December 2011 and 05 January 2012. The day after receiving BOOSTRIX (07 December 2011) the subject experienced fatigue, which was improved at the time of reporting and she could not move which improved. Three days after vaccination with BOOSTRIX (09 December 2011), the subject experienced migraine headache which was worsening. The subject reported a history of migraine headaches that occurred about once a month prior to receiving BOOSTRIX. Some time during the weeks following vaccination with BOOSTRIX (between 06 December 2011 to the time of reporting 20 January 2012), the subject felt wired (unspecified), experienced memory loss, had hot flashes (unresolved), developed insomnia which was improving, bruised easily and a wart appeared under the subject's left nostril. Some of the subject's treatments included LOMOTIL, PROVIGIL and HALCION. Others were not provided.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Pain in extremity, Skin discolouration, Upper extremity mass
Clinical narrative: Arm was sore, black and blue and had a lump. Lump lasted for a couple weeks -> she got vaccine 12/2 and reported this on 1/24 -> she did not show us her arm during the time when she it was bothering her - arm's better now.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Very red rash developed on 11-10-11 within 48-72 hours if receiving the vaccines. The rash was from head to toe. We sent her on to a dermatologist the same day. He felt it certainly possible from vaccines. Only treatment needed was BENADRYL at HS. Rash was gone by 11-22-11. Mother stated her stomach feels not as smooth no marks.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site joint pain
Clinical narrative: 2 wks after MMR was given, patient complained of arthralgia in shoulders, hands, ankles - atypical for her, although she was recently doing physical work around her house at same time, lasted 3 wks with no further complaints, completely resolved.
Age: 14.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Axillary mass
Clinical narrative: Pt. was given Flu injection on 1/19/12. Came to office 1/23/12 with lump under left axillary area. Treatment to monitor, hot-cold compress, anti inflammatories.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Pt had febrile seizure on 01/22/12.