chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Blood test normal, Epidural injection, Fall
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a currently 20 years old female patient, with the medical history of injured back during volleyball season (in 2009), had back surgery on herniated disc. The patient also stated that the surgery worked, but she still had a little bit of existing pain, which was common anytime person had spinal surgery. A few years later, on an unknown date the patient finished series of GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported), and her health went downhill from there. She stated that her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. She has been in pain for years. On unspecified date she was visiting multiple doctors, who gave her pain remedy that did not work. One of the doctors stated that he did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. She could not walk, she could not sleep, she could barely have friends. The patient started the strict diet and vitamin regimen to cleanse her body. She believed that the diet and vitamins would help her to walk again, but would not get rid of all of the pain. She stated that GARDASIL caused a build-up of metals because it has a lot of aluminium in it and it caused a lot of toxins to build up, which caused her intense stomach pain. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that these symptoms have taken years from her life. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Loss of consciousness, Loss of control of legs, Muscle spasms, Muscular weakness
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a currently 20 years old female patient, with the medical history of injured back during volleyball season (in 2009), had back surgery on herniated disc. The patient also stated that the surgery worked, but she still had a little bit of existing pain, which was common anytime person had spinal surgery. A few years later, on an unknown date the patient finished series of GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported), and her health went downhill from there. She stated that her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. She has been in pain for years. On unspecified date she was visiting multiple doctors, who gave her pain remedy that did not work. One of the doctors stated that he did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. She could not walk, she could not sleep, she could barely have friends. The patient started the strict diet and vitamin regimen to cleanse her body. She believed that the diet and vitamins would help her to walk again, but would not get rid of all of the pain. She stated that GARDASIL caused a build-up of metals because it has a lot of aluminium in it and it caused a lot of toxins to build up, which caused her intense stomach pain. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that these symptoms have taken years from her life. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Nerve block, Spinal nerve stimulator implantation
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a currently 20 years old female patient, with the medical history of injured back during volleyball season (in 2009), had back surgery on herniated disc. The patient also stated that the surgery worked, but she still had a little bit of existing pain, which was common anytime person had spinal surgery. A few years later, on an unknown date the patient finished series of GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported), and her health went downhill from there. She stated that her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. She has been in pain for years. On unspecified date she was visiting multiple doctors, who gave her pain remedy that did not work. One of the doctors stated that he did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. She could not walk, she could not sleep, she could barely have friends. The patient started the strict diet and vitamin regimen to cleanse her body. She believed that the diet and vitamins would help her to walk again, but would not get rid of all of the pain. She stated that GARDASIL caused a build-up of metals because it has a lot of aluminium in it and it caused a lot of toxins to build up, which caused her intense stomach pain. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that these symptoms have taken years from her life. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Abdominal pain upper, Antisocial behaviour, Back pain, Condition aggravated
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a currently 20 years old female patient, with the medical history of injured back during volleyball season (in 2009), had back surgery on herniated disc. The patient also stated that the surgery worked, but she still had a little bit of existing pain, which was common anytime person had spinal surgery. A few years later, on an unknown date the patient finished series of GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported), and her health went downhill from there. She stated that her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. She has been in pain for years. On unspecified date she was visiting multiple doctors, who gave her pain remedy that did not work. One of the doctors stated that he did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. She could not walk, she could not sleep, she could barely have friends. The patient started the strict diet and vitamin regimen to cleanse her body. She believed that the diet and vitamins would help her to walk again, but would not get rid of all of the pain. She stated that GARDASIL caused a build-up of metals because it has a lot of aluminium in it and it caused a lot of toxins to build up, which caused her intense stomach pain. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that these symptoms have taken years from her life. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: General physical health deterioration, Insomnia, Pain, Pain in extremity
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a currently 20 years old female patient, with the medical history of injured back during volleyball season (in 2009), had back surgery on herniated disc. The patient also stated that the surgery worked, but she still had a little bit of existing pain, which was common anytime person had spinal surgery. A few years later, on an unknown date the patient finished series of GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported), and her health went downhill from there. She stated that her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. She has been in pain for years. On unspecified date she was visiting multiple doctors, who gave her pain remedy that did not work. One of the doctors stated that he did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. She could not walk, she could not sleep, she could barely have friends. The patient started the strict diet and vitamin regimen to cleanse her body. She believed that the diet and vitamins would help her to walk again, but would not get rid of all of the pain. She stated that GARDASIL caused a build-up of metals because it has a lot of aluminium in it and it caused a lot of toxins to build up, which caused her intense stomach pain. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that these symptoms have taken years from her life. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Drug administered at inappropriate site, Erythema multiforme
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Blood potassium increased, Blood sodium normal, Blood urea normal, C-reactive protein increased
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Dermatitis allergic, Dermatitis contact, Drug administered at inappropriate site, Erythema
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Haematocrit decreased, Haemoglobin decreased, Lumbar puncture abnormal, Neutrophil count increased
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pharyngeal oedema, Platelet count normal, Pyrexia, Rash, Skin lesion
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Urticaria, White blood cell count normal
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count increased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Culture urine, Dermatitis contact, Erythema, Erythema multiforme
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematocrit decreased, Haemoglobin normal, Lumbar puncture, Neutrophil count increased, Pharyngeal oedema
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count normal, Pyrexia, Rash, Skin lesion, Urine analysis
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: Initial report was received on 17 January 2014 from another manufacturer (manufacturer report number A1056364A), who received the case from a health care professional. A 10 week-old male patient with a history of premature birth (born at 27 weeks gestation) had received the following vaccines on 17 August 2013: Poliomyelitis vaccine inactivated (manufacturer, lot number, route and site of administration not reported), haemophilius influenza type b (manufacturer, lot number, route and site of administration not reported), a thigh administration of DTAP (GlaxoSmithKline lot number, route and site of administration not reported), oral ROTARIX (manufacturer, lot number and site of administration not reported), and hepatitis B (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same date 17 August 2013, experienced anaphylactic reaction, urticaria, pharyngeal oedema and pyrexia. The patient was hospitalized (dates not reported). The events were considered by the reporter to be disabling, life threatening and clinically significant. Immunization series with DTAP was delayed. The patient had no known allergies, was taking no concomitant medications and had no adverse events after prior vaccinations. According to the reporter, the events were probably related to vaccination with DTAP, hepatitis B, ROTARIX, haemophilus influenza type b, PREVNAR and poliomyelitis inactivated. The patient outcome was recovered. Documents held by sender: None. Addendum on 30-JAN-2014: Upon internal review, significant correction was made to add a suspect product poliomyelitis (inactivated) with manufacturer name unknown.
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: None.
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 18 year old female patient with allergy for cantaloupe. On 03-JAN-2014 the patient was vaccinated with GARDASIL first dose, lot # J008423, intramuscular. Concomitant medication was not provided. 19 days after administration of GARDASIL the patient called and stated that she was pregnant and may have been pregnant at the time of the administration. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis infection in right upper arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Syncope, Tremor
Clinical narrative: Pt experienced weakness, trembling, syncopal episode.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Cardiac function test, Concussion, Disorientation, Dizziness, Fatigue
Clinical narrative: Patient passed out after exiting the exam room. Hit head on floor. Decreased LOC for 10-20 seconds. Disoriented to person and place. Monitored patient in office for 2 1/2 hrs. 3 episodes of vomiting, tiredness, and dizziness. Pt was sent to hospital for further exam. Received IV fluids and cardiac testing at ER. Sent home from ER with Dx of concussion.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Head injury, Loss of consciousness, Vomiting
Clinical narrative: Patient passed out after exiting the exam room. Hit head on floor. Decreased LOC for 10-20 seconds. Disoriented to person and place. Monitored patient in office for 2 1/2 hrs. 3 episodes of vomiting, tiredness, and dizziness. Pt was sent to hospital for further exam. Received IV fluids and cardiac testing at ER. Sent home from ER with Dx of concussion.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: 01/20/14 pt presents with reaction on (L) thigh red upraised, itchy welt. It is in the same place as where she got Dtap on 01/17/14 during her 18 month check-up (4 cm diameter upraised pink round lesion on (L) UT.
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: 01/20/14 pt presents with reaction on (L) thigh red upraised, itchy welt. It is in the same place as where she got Dtap on 01/17/14 during her 18 month check-up (4 cm diameter upraised pink round lesion on (L) UT.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Asthenia, Limb operation, Lung neoplasm malignant, Malaise
Clinical narrative: This spontaneous report as received from a currently 77 year old female consumer. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot, dose and route not reported). Possible concomitant therapies included atenolol (manufacturer unknown), multi-vit (manufacturer unknown), biotin (manufacturer unknown), vitamin D (manufacturer unknown), aspirin (manufacturer unknown), COLACE, MIRALAX, LEVAQUIN and sulfanilamide (manufacturer unknown). On an unknown date, the reporter mentioned that the patient experienced sick and weak after vaccination with PNEUMOVAX23. On an unknown date, the patient experienced lung cancer, leg surgery. The patient's medical history included leg problems and leg surgery as reaction of LEVAQUIN, rash as reaction to sulfas (manufacturer unknown). The outcome of the events was not reported. Upon internal review lung cancer and leg surgery were considered to be medically significant. The patient also experienced an adverse event while on therapy with MIRALAX (MARRS 1401USA013767). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Rash
Clinical narrative: This spontaneous report was received from a 70 year old female patient with diabetes, high blood pressure, high cholesterol and erythromycin allergy who was reporting on herself. On 12-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX injection (route, strength, lot number and expiration date not provided). Concomitant therapies included ATIVAN, ACTOS, BENICAR, CRESTOR, LEXAPRO and LANTUS. On 30-DEC-2013 the patient developed a rash and pain after receiving the ZOSTAVAX vaccine. The patient reported that this rash developed on her neck, right shoulder, right arm and all the way down to her right hand and thumb. The patient then reported that on 30-DEC-2013 she has lost almost all of the mobility in her right hand and right arm. The patient reported that she can't lift any thing with her right arm. The patient saw the doctor. The outcome of events was not reported. The relatedness between vaccination with ZOSTAVAX and events was not reported. Upon internal review the event of patient's decreased mobility was considered to be disabling. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: This spontaneous report was received from a company representative via a physician refers to a 83 year old female patient. No pertinent medical history and drug reactions or allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 dose 1 (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. On an unknown date, approximately one month after receiving the PNEUMOVAX23 the patient was diagnosed with bacteremic pneumococcal disease (hospitalization). The patient was hospitalized on an unspecified date, where she recovered after an unspecified period of time. Sought medical attention was reported as no (though patient was hospitalized). There was no PQC involved. The outcome of bacteremic pneumococcal disease was reported as recovered/resolved. The causality of the event in relation to therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune disorder, Blood test, Hypersensitivity
Clinical narrative: This spontaneous report as received from a physician refers to herself: an approximately 33 year old female patient. Medical history was not provided. In the summer of 1986, the patient was vaccinated with hepatitis B vaccine (V232) dose 3. After about one month (unspecified date in 1986) the patient experienced sub-acute allergic reaction (medically significant). The patient received the hepatitis B vaccine (V232) that was released on 01-JUN-1982, the other one was only released on 01-MAY-1986. The sub-acute allergic reaction lasted 9 months. The worst of it had stopped in the Spring of 1987; however patient had still some "auto immune reaction" (dates not provided). The outcome of sub-acute allergic reaction was reported as recovered. Sub-acute allergic reaction was determined medically significant upon internal review. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Angiogram, Body temperature increased, Erythema, Limb discomfort, Local swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 68 year old female patient. Patients medical history was unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date, dose and route of administration unknown, reported as 'as directed by physician') after an angiogram was performed. Concomitant medication included a lot of unspecified medications. It was reported that the patient experienced redness and swelling in the arm and developed a temperature of 100F. It was reported that there was pain and discomfort in the arm (disability). The patient sought medical attention and visited physicians office. She was told to take BENADRYL, TYLENOL and use cold compress on the arm. There was no intervention to prevent pain and discomfort to the arm. The outcome of redness and swelling in the arm, developed a temperature of 100F and redness and swelling of the arm was reported as recovering. The causality of the event with suspect product was unknown. There was no product quality complaint. Additional information has been requested.