chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Encephalopathy, Heart rate increased, Hepatic enzyme increased
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Intensive care, Leukocytosis, Loss of consciousness, Myocarditis, Pain
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Platelet count increased, Prothrombin time prolonged, Renal failure, Rhabdomyolysis, Thrombocytosis
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin I increased, White blood cell count increased
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injection site redness in a 3-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline) for prophylaxis. On 21 January 2013 at 16:00 the subject received 3rd dose of INFANRIX (.5 ml, unknown route, left arm). On the morning of 22 January 2013, 1 day after vaccination with INFANRIX, the subject experienced injection site redness and injection site edema. The reporter stated the subject experienced redness, erythema, and edema of the left upper arm. The reporter stated that the subject was prescribed ice to apply to the site. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 3.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injection site redness in a 3-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline) for prophylaxis. On 21 January 2013 at 16:00 the subject received 3rd dose of INFANRIX (.5 ml, unknown route, left arm). On the morning of 22 January 2013, 1 day after vaccination with INFANRIX, the subject experienced injection site redness and injection site edema. The reporter stated the subject experienced redness, erythema, and edema of the left upper arm. The reporter stated that the subject was prescribed ice to apply to the site. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 0.76
Sex: F
Vaccine: HEP, HEP
Symptoms: Crying, Hypersensitivity, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 9 month old female patient with no pertinent medical history or drug reactions/allergies. On 15-MAY-2013 the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose and rout unspecified) (lot number H020604, expired date 10-FEB-2015). There was no concomitant medications. On 15-MAY-2013, a few hours after receiving RECOMBIVAX HB the patient developed a rash that began on the back of the neck and spread to the back of the head, arms, and upper back. The patient had also begun crying when crawling after received the vaccine as if the activity had become painful. The event was talked to the doctor for medical attention. The event was treated with BENADRYL. No lab diagnostics studies performed. The possible pain during crawling had now subsided, however the rash had persisted. Additional information has been requested.
Age: 0.76
Sex: F
Vaccine: HEP, HEP
Symptoms: Crying, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 9 month old female patient with no pertinent medical history or drug reactions/allergies. On 15-MAY-2013 the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose and rout unspecified) (lot number H020604, expired date 10-FEB-2015). There was no concomitant medications. On 15-MAY-2013, a few hours after receiving RECOMBIVAX HB the patient developed a rash that began on the back of the neck and spread to the back of the head, arms, and upper back. The patient had also begun crying when crawling after received the vaccine as if the activity had become painful. The event was talked to the doctor for medical attention. The event was treated with BENADRYL. No lab diagnostics studies performed. The possible pain during crawling had now subsided, however the rash had persisted. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Respiratory tract congestion
Clinical narrative: Painful joints, stiff muscles, chills, congestion.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Soreness, swelling, itching pain at injection site. Nausea, aching of joints.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Redness at injection site as per MD it looks infected. MD prescribe BACTROBAN applying TID.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Headache, Hypoaesthesia, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed report (initial receipt 16-May-2013) concerns a 51-year-old female patient who had a relevant medical history of neck problems from a motor vehicle accident. She had no history of hypersensitivity. In 1990 she had hepatitis B injections; two years ago she received the tetanus/diphtheria shot and has not had the pneumococcal injection. She received the flu shot every year. In mid Dec-2012 the patient received influenza vaccine (manufacturer and batch number not specified) in the deltoid of the left arm and ZOSTAVAX (batch number not specified) subcutaneously in the right posterior aspect part of the arm. She received both vaccinations at the same time. Within a few days of receiving the vaccinations the patient experienced a pretty big response. She developed a large red bump that was the size of an egg, swelling, itching and a headache. Three weeks later in Jan-2013 she developed scapular pain, numbness of the right hand and excruciating pain explained as numbness in the thumb, index finger and middle finger of the right hand. She saw an orthopaedic doctor who ordered an MRI (magnetic resonance imaging). The results were not reported. She also saw a neurosurgeon. Reporters comment: The patient stated that she told her neurosurgeon that she received ZOSTAVAX and where it was injected who said it could have caused irritation.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: This medically confirmed report (initial receipt 16-May-2013) concerns a 51-year-old female patient who had a relevant medical history of neck problems from a motor vehicle accident. She had no history of hypersensitivity. In 1990 she had hepatitis B injections; two years ago she received the tetanus/diphtheria shot and has not had the pneumococcal injection. She received the flu shot every year. In mid Dec-2012 the patient received influenza vaccine (manufacturer and batch number not specified) in the deltoid of the left arm and ZOSTAVAX (batch number not specified) subcutaneously in the right posterior aspect part of the arm. She received both vaccinations at the same time. Within a few days of receiving the vaccinations the patient experienced a pretty big response. She developed a large red bump that was the size of an egg, swelling, itching and a headache. Three weeks later in Jan-2013 she developed scapular pain, numbness of the right hand and excruciating pain explained as numbness in the thumb, index finger and middle finger of the right hand. She saw an orthopaedic doctor who ordered an MRI (magnetic resonance imaging). The results were not reported. She also saw a neurosurgeon. Reporters comment: The patient stated that she told her neurosurgeon that she received ZOSTAVAX and where it was injected who said it could have caused irritation.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Amnesia, Asthenia, Dyspnoea, Hyperacusis, Hypoaesthesia
Clinical narrative: Initial report was received on 21 May 2013 from a consumer who is also the patient. A male patient had received in July or August 2007 MENACTRA (lot number, route and site of administration not reported) and ADACEL (lot number, route and site of administration not reported) and "soon after" developed swollen tonsils. Two months after vaccination the patient had mononucleosis and developed chronic migraine headaches, nerve pain, tingling and numbness of hands and feet, organ pain, experiences shortness of breath, memory loss, unrestful sleep, decreased energy and sensitivity to light and sound. According to the reporter, he had "GBS like symptoms". The patient had no known allergies and no history of medical conditions. The patient is being seen by a physician. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Infectious mononucleosis, Migraine, Neuralgia, Pain, Paraesthesia
Clinical narrative: Initial report was received on 21 May 2013 from a consumer who is also the patient. A male patient had received in July or August 2007 MENACTRA (lot number, route and site of administration not reported) and ADACEL (lot number, route and site of administration not reported) and "soon after" developed swollen tonsils. Two months after vaccination the patient had mononucleosis and developed chronic migraine headaches, nerve pain, tingling and numbness of hands and feet, organ pain, experiences shortness of breath, memory loss, unrestful sleep, decreased energy and sensitivity to light and sound. According to the reporter, he had "GBS like symptoms". The patient had no known allergies and no history of medical conditions. The patient is being seen by a physician. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Photophobia, Poor quality sleep, Tonsillitis
Clinical narrative: Initial report was received on 21 May 2013 from a consumer who is also the patient. A male patient had received in July or August 2007 MENACTRA (lot number, route and site of administration not reported) and ADACEL (lot number, route and site of administration not reported) and "soon after" developed swollen tonsils. Two months after vaccination the patient had mononucleosis and developed chronic migraine headaches, nerve pain, tingling and numbness of hands and feet, organ pain, experiences shortness of breath, memory loss, unrestful sleep, decreased energy and sensitivity to light and sound. According to the reporter, he had "GBS like symptoms". The patient had no known allergies and no history of medical conditions. The patient is being seen by a physician. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Injection site warmth, Nausea, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussive vaccine ;GlaxoSmithKline;unknown;unknown given on 3 August 2009, 7 September 2010, and 1 August 2011. Concurrent vaccination included MMR vaccine (non-gsk) ;non-GSK manufacturer;unknown;left thigh given on 26 July 2012. The subject had no reactions to her three prior INFANRIX vaccinations. On 26 July 2012 the subject received 4th dose of INFANRIX (intramuscular, right thigh). On 26, 27 or July 2012, less than one week after vaccination with INFANRIX, the subject experienced extensive swelling of vaccinated limb, injection site hot to touch and sick in stomach. The subject was experiencing swelling in her thigh from above the knee to groin, worse in the lower half of the thigh (not at the injection site) and it was hot to touch. The subject was not experiencing fever, but was sick to stomach. At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Thursday. See cases A0989437A, A0989438A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to the product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Extensive swelling of vaccinated limb, Local reaction, Nausea
Clinical narrative: This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussive vaccine ;GlaxoSmithKline;unknown;unknown given on 7 September 2010 and 1 August 2011. Concurrent vaccination included MMR vaccine (non-gsk) ;non-GSK manufacturer;unknown; left thigh given on 26 July 2012. The subject had no reactions to his two prior INFANRIX vaccinations. On 26 July 2012 the subject received 3rd dose of INFANRIX (intramuscular, right thigh). On 26, 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced extensive swelling of vaccinated limb and sick in stomach. The subject was experiencing swelling in the leg above the knee to the groin and the swelling was worse in the middle of the thigh (not at injection site). The subject was also sick to stomach. At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Thursday. See cases A0989417A, A0989438A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hives in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) and FLUARIX. Concurrent medical conditions included allergies. Concurrent medications included Allergy medication. On 3 October 2012 the subject received unspecified dose of INFANRIX (unknown, unknown arm) and unspecified dose of FLUARIX (unknown, unknown arm). On 5 October 2012, 2 days after vaccination with FLUARIX and INFANRIX, the subject experienced injection site hives, injection site redness, swelling injection site and itching. The healthcare professional is also the subject's aunt, who reported the subject experienced hives wrapped around his arm at injection site, redness at injection site, swelling at injection site and itching. It was unknown if both INFANRIX and FLUARIX were given in the same arm. The healthcare professional inquired if soy was in INFANRIX and FLUARIX; she did not suspect soy as being the cause of this reaction but believed it is just related to the subject receiving in multiple vaccinations on the same day. At the time of reporting the injection site hives, injection site redness, swelling injection site and itching were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX and FLUARIX.
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria, Injection site vesicles
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site hives in a child male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown, unknown thigh). Approximately 48 hours after vaccination with INFANRIX, the subject experienced injection site hives and injection site blisters. The subject developed hives and blisters on the injection site (thigh) 48 hours post injection. The next time the subject came into the clinic, the subject received PREVNAR (other manufacturer) and experienced the same reaction. Immunization series with INFANRIX was discontinued. At the time of reporting the outcome of the injection site hives and injection site blisters were unspecified.
Age: 0.14
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Eczema
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of eczema in a 3-month-old male subject who was vaccinated with DTaP (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included dairy allergy and dog allergy. Concurrent vaccination included Hib; manufacturer unspecified; unknown; unknown given in 2012; HepB ; manufacturer unspecified; unknown; unknown given in 2012; pneumonia vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012; IPV (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012. It was not clear which vaccines were administered with each dose of DTaP. On January 2012 and May 2012 the subject received 1st dose and 2nd dose of DTaP (unknown route, unknown thigh). In February 2012, 1 month after vaccination with 1st dose of DTaP, the subject experienced eczema and either in May 2012 or June 2012 within months of vaccination with 2nd dose of DTaP, the subject experienced eczema flare up. The subject developed eczema after the 1st dose and then the eczema flared up after the second dose. The subject was seen in the physician's office. The subject was treated with Steroid cream "which is helping the eczema". At the time of reporting the events were unresolved.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Blood immunoglobulin G increased, Bordetella test, Cough
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of "FHA IgG" increased in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (details unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced "FHA IgG" increased and cough. The nurse stated that the subject had a cough and they did a pertussis panel, "and his panel came back on the FHA IgG, it was 16, it was a little bit higher, but not a lot". The nurse asked if "FHA" was in the vaccine, which would cause the number to go up, or if it was due to exposure. At the time of reporting the outcome of the events was unspecified. Follow up received from the nurse on 31 July 2012. The nurse reported that she made an "inquiry not a report of reaction", but she did not say the events did not occur. She listed date of adverse event onset as unknown. She noted "does not apply" for concomitant medications and that it was unknown if the vaccination series was discontinued.
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of back pain in an adult female subject who was vaccinated with DTaP (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTaP vaccine (details unknown) and experienced wrong vaccine administered (DTaP is not indicated in adults). Two days after vaccination with DTaP vaccine, the subject experienced back pain. The subject's daughter called the pharmacy and stated that her mother began experiencing back pain approximately two days after receiving the vaccination. At the time of reporting, there were no further details available for this report. At the time of reporting the outcome of the event was unspecified.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of sick in stomach in a 15-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined ;GlaxoSmithKline;unknown;unknown given on 30 June 2011 and 16 December 2011; diphtheria and tetanus toxoids and acellular pertussis vaccine; GlaxoSmithKline;unknown;unknown given on 16 September 2011. The subject had no reactions to his prior INFANRIX and PEDIARIX vaccinations. On 27 July 2012 the subject received a dose of INFANRIX (intramuscular, right thigh) as the 4th dose in series. On 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced sick in stomach, brain pain, injection site redness and puffiness injection site. The subject was sick to stomach complaining that "brain hurts" (brain pain) and redness in thigh closer to injection site, about a "quarter size with a little puffiness". At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Friday. See cases A0989417A, A0989437A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Hypersensitivity, Lymphadenopathy, Pain, Pyrexia, Rash macular
Clinical narrative: Patient developed low grade fever, body aches, axillary lymphadenopathy, and a diffuse macular rash to the torso; treated with Motrin 800mg TID and Tylenol prn; reaction may be allergic in nature or may respresnet mild diffuse vaccinia; symptomatic management with close patient follow up.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: Patient developed low grade fever, body aches, axillary lymphadenopathy, and a diffuse macular rash to the torso; treated with Motrin 800mg TID and Tylenol prn; reaction may be allergic in nature or may respresnet mild diffuse vaccinia; symptomatic management with close patient follow up.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Mobility decreased, Oedema peripheral
Clinical narrative: Extreme swelling in left arm, could not move due to horrific pain, trouble breathing slight temperature, fatigue, numbness in back and chest.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme swelling in left arm, could not move due to horrific pain, trouble breathing slight temperature, fatigue, numbness in back and chest.
Age: 1.22
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Spiked a fever of 102, Gave her Tylenol but fever did not drop. Fever went as high as 104.7 (Gave her a cool bath and alternated between Tylenol and Advil. Fever did drop at that point to 102 but the fever has stayed for the past 2 days with Tylenol not having much effect.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash pruritic, Varicella post vaccine
Clinical narrative: Developed a few spots, which became "pimple like" and itchy.  Diagnosed with chicken pox, approx. 32 pox to abdomen.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal death, Umbilical cord thrombosis
Clinical narrative: Fetal demise at 37 weeks gestation. Suspected thrombosed cord.
Age: 1.13
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile convulsions NOS on 2013-05-16, clinician comment: Febrile seizures 10 days after MMR and Varicella.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Eosinophil count increased
Clinical narrative: Eosinophils on 2013-05-20, clinician comment: Patient has had intermittently elevated eosinophils.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Insomnia, Irritability, Local reaction
Clinical narrative: This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of not eating in an 18-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on 29 March 2011, 19 May 2011 and 21 July 2011. The subject had no reactions to her prior PEDIARIX vaccinations. On 27 July 2012 at approximately 16:00, the subject received a dose of INFANRIX (intramuscular, right thigh) as the 4th dose in series. On 27 July 2012, hours after vaccination with INFANRIX the subject experienced not sleeping and on 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced not eating and fussy. The subject did not have redness, but "will not eat, is fussy and wouldn't sleep last night" (27 July 2012). At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Friday. See cases A0989417A, A0989437A and A0989438A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of hive in an 18-month-old male subject who was vaccinated with Dtap (manufacturer unspecified). On an unspecified date the subject received 4th dose of Dtap (details unknown). At an unspecified time after vaccination with Dtap vaccine, the subject experienced hive. At the time of the report, the subject was 14 years old, but the healthcare professional reported that at 18 months old when the subject received the 4th dose of Dtap vaccine, he experienced hives. The manufacturer of the Dtap was unknown. At the time of reporting the outcome of the event was unspecified.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site rash, Rash
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site rash in a 16-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 2 October 2012; MMR II (non-gsk); Merck; unknown; unknown given on 2 October 2012. On 2 October 2012 at 14:03 the subject received 4th dose of INFANRIX (unknown, right thigh). On 2 October 2012, 27 minutes after vaccination with INFANRIX, the subject experienced injection site rash. The subject had a local rash 4 to 5 centimeters on right upper thigh after administration of INFANRIX. The subject was treated with BENADRYL. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the injection site rash was unresolved. The physician considered the event was probably related to vaccination with INFANRIX.
Age: 1.52
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site pain, Labyrinthitis, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 18-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Sanofi; unknown; unknown given on 17 October 2012. On 17 October 2012 at 16:15 the subject received the 4th dose of INFANRIX (.5 ml, unknown route, left arm). On 18 October 2012, 1 day after vaccination with INFANRIX, the subject experienced injection site redness (8 centimeters x 6 centimeters) and injection site tenderness. On 19 October, 2 days after vaccination with INFANRIX, the subject experienced fever and inner ear infection. At the time of reporting, it was unknown if the immunization series was delayed or discontinued. At the time of reporting the events were unresolved. The healthcare professional considered the events of injection site redness and tenderness were probably related to vaccination with INFANRIX. The healthcare professional considered the fever was possibly related to vaccination with INFANRIX. The healthcare professional considered the inner ear infection to be unrelated to vaccination with INFANRIX. Follow up was received from healthcare professional (nurse) on 6 November 2012. The diagnosis was reported as a local reaction. The healthcare professional reported that the earliest sign or symptom of the events of injection site redness, injection site tenderness, fever, inner ear infection was on 17 October 2012. All events resolved on 19 October 2012. The nurse did not consider the events to be serious. The nurse noted that the immunization series was not delayed or discontinued. It was unknown if symptoms recurred following subsequent administration since the subject had not received the next dose. The reporter stated that the subject had not experienced any adverse events following previous vaccinations. This case has been reported to a Regulatory Agency with reference number 7645703.
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist (mother of the subject) and described the occurrence of swelling injection site in a male subject aged between 0 and 9 years old who was vaccinated with DTaP vaccine (manufacturer unspecified). Concurrent medical conditions included reactive airway disease. Concurrent medications included SINGULAIR, NASONEX and ZYRTEC. On an unspecified date the subject received unspecified dose of DTaP vaccine (unknown route, unknown leg). At an unknown time after vaccination with DTaP vaccine, the subject experienced swelling injection site. The reporter stated that "the last dose of DTaP: swelling of leg where vaccine was given." The pharmacist also reported adverse experiences to another vaccine. See case A0998237A for details.
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist (mother of the subject) and described the occurrence of swelling injection site in a male subject aged between 0 and 9 years old who was vaccinated with DTaP vaccine (manufacturer unspecified). Concurrent medical conditions included reactive airway disease. Concurrent medications included SINGULAIR, NASONEX and ZYRTEC. On an unspecified date the subject received unspecified dose of DTaP vaccine (unknown route, unknown leg). At an unknown time after vaccination with DTaP vaccine, the subject experienced swelling injection site. The reporter stated that "the last dose of DTaP: swelling of leg where vaccine was given." The pharmacist also reported adverse experiences to another vaccine. See case A0998237A for details.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Pyrexia, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a 2-year-old female subject who was vaccinated with DTAP vaccine (manufacturer unspecified) for prophylaxis. Approximately in 1982 or 1983 the subject received unspecified dose of DTAP vaccine (unknown). In 1982 or 1983, at an unspecified time after vaccination with DTAP vaccine, the subject experienced allergic reaction, pertussis vaccination reaction, fever, erythema and swelling. The pharmacist, who is also the subject reported when she was about 2 to 3 years old, after receiving DTAP vaccine from an unknown manufacturer she experienced an allergic reaction with symptoms of spiking a fever of 105 degrees Fahrenheit, redness and swelling. The fever could not be reduced with TYLENOL so the subject was sent to the emergency room and packed in ice. The subject could not recall what additional treatment took place. The subject was not hospitalized overnight. The subject was diagnosed with an allergy to the pertussis component of the vaccine [pertussis vaccination reaction]. The events have since resolved. The subject, who is also a pharmacist, received a booster shot in 2004 containing Diphtheria and Tetanus and no adverse reaction was experienced. At the time of reporting the events were resolved. Immunization series with DTAP vaccine was discontinued. The pharmacist considered the events were probably related to vaccination with DTAP vaccine.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a 2-year-old female subject who was vaccinated with DTAP vaccine (manufacturer unspecified) for prophylaxis. Approximately in 1982 or 1983 the subject received unspecified dose of DTAP vaccine (unknown). In 1982 or 1983, at an unspecified time after vaccination with DTAP vaccine, the subject experienced allergic reaction, pertussis vaccination reaction, fever, erythema and swelling. The pharmacist, who is also the subject reported when she was about 2 to 3 years old, after receiving DTAP vaccine from an unknown manufacturer she experienced an allergic reaction with symptoms of spiking a fever of 105 degrees Fahrenheit, redness and swelling. The fever could not be reduced with TYLENOL so the subject was sent to the emergency room and packed in ice. The subject could not recall what additional treatment took place. The subject was not hospitalized overnight. The subject was diagnosed with an allergy to the pertussis component of the vaccine [pertussis vaccination reaction]. The events have since resolved. The subject, who is also a pharmacist, received a booster shot in 2004 containing Diphtheria and Tetanus and no adverse reaction was experienced. At the time of reporting the events were resolved. Immunization series with DTAP vaccine was discontinued. The pharmacist considered the events were probably related to vaccination with DTAP vaccine.
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: This case was reported by a consumer via another manufacturer and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with DTAP vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On 28 December 2012 the subject received a dose of DTAP vaccine (unknown details). In December 2012, within days of vaccination with DTAP vaccine, the subject experienced injection site pain ("arm hurt"). On 12 January 2013, 15 days after vaccination with DTAP vaccine, the subject experienced shingles. No further information was provided. At the time of reporting the outcome of the events were unspecified.