chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: This study case was received from the investigator in the trial on 03 July 2013. A 41 year-old male subject whose past medical history included high blood pressure, elevated cholesterol, chest pain, chest pressure, abnormal ECG, dizziness/fainting spells, shortness of breath and headaches was found to have other, chest pain 16 days after the subject had received the following vaccines on 09 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI vaccine (lot number, route and site of administration not reported) and Anthrax 3 (manufacturer, lot number, route and site of administration not reported). On 25 April 2013, Troponin I was normal and the subject's ECG was abnormal. Results of an echocardiogram were not available. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non interventional) study. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Dry skin, Infantile spitting up, Nasal congestion, Wheezing
Clinical narrative: Initial report was received from a consumer, who was also the patient's mother, on 01 July 2013. This reporter also reported another adverse event which was captured in case number 2013-07467. A 2-month-old male patient had received an an injection of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer, lot number, route and site not reported) on 10 June 2013 and the same day experienced spitting up "like with bad reflux" and dry skin around the wrists, ankles, legs, face and cheeks. Then started experiencing wheezing and stuffy nose. The patient's medical history was not reported. The patient's mother had a history of severe nickel allergy. Outcome was not recovered. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Drug administered at inappropriate site, Muscle strain, Tendonitis
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 01 July 2013. This reporter also reported another adverse event which was captured in case number 2013-07465. A 37-year-old female patient had received an injection of Tdap (manufacturer, lot number, route and date of administration not reported) in the rotator cuff and an unspecified amount of time later experienced bursitis, tendonitis and tear in muscle. The patient had a severe allergy to nickel. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity
Clinical narrative: Initial case received from a consumer who is the patient on 02 July 2013. It represents one of a cluster of four patients reported by the same reporter who each experienced an adverse reaction following administration of IMOVAX and hrig (manufacturer unknown). The events for the other patients are captured in case number 2013-07503. On an unspecified date in 1990 the female patient, age not reported, was administered IMOVAX (batch number not reported) and Hrig, manufacturer unknown, dose, route and site not reported. Concomitant medications and preexisting medical conditions were reported as unknown. It is unknown of the patient received other vaccinations within 4 weeks of vaccination. On an unspecified date in 1990 the patient experienced "Universal reactions to most substances" which has been worsening since 1998 and it is described as being "at it's height now". The patient required an ER/doctor visit on an unspecified date for an unspecified duration. The reporter refused to give her physician's name or any other information. The patient outcome is not recovered. Documents held by sender: None.
Age: 1.09
Sex: F
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster in a 1-dose varicella vaccine recipient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Pyrexia, Swelling
Clinical narrative: Very swollen and feverish with bumpy feel to surface. Larger than a golf ball and very hard. Did not appear until 14 hrs. later. Got worse over three days and ice was used nearly constantly. Also took anti-inflammatory. No visible effect. Began hurting on second day after onset. Blisters have not formed yet. Ongoing today 07/15/2013.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness around injection site, patient states swelling has diminished over past 48 hours, no treatment provided, will continue to monitor.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash, seen in office 7/15/2013.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Crying and fever times 3 days, since vaccines were administered.
Age: 22.0
Sex: F
Vaccine: TYP, YF
Symptoms: Throat tightness, Urticaria
Clinical narrative: Pt stated that she had hives on her feet and behind her ears. Also felt she had "tightening of her throat."
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy hands, with red marks.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Swelling and redness in the injection area. Arm was hurting all the way to wrist. Injection area felt warm.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Contraception, Menorrhagia, Menstruation irregular
Clinical narrative: My period started 10 days earlier then usual and is still going on, today is 11th day already. Also, I'm on birth control.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC
Symptoms: Abdominal pain upper, Diarrhoea, Diet refusal, Insomnia, Irritability
Clinical narrative: Not eating, not sleeping, not drinking, fever of 103.6. Diarrhea, upset, cranky, stomach seem like in pain. Every three hrs been giving him Motrin then Tylenol swiching back in forth for the past 7 days. Fever has not gone down.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC
Symptoms: Mood altered, Pyrexia
Clinical narrative: Not eating, not sleeping, not drinking, fever of 103.6. Diarrhea, upset, cranky, stomach seem like in pain. Every three hrs been giving him Motrin then Tylenol swiching back in forth for the past 7 days. Fever has not gone down.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Hallucination, auditory, Hyperhidrosis, Migraine, Nausea
Clinical narrative: Vertigo, Blurred Vision, Sweating, Arm Pain, Severe Back Pain, Fainting, Nausea, Auditory Migraine (2 days later).
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Syncope, Vertigo, Vision blurred
Clinical narrative: Vertigo, Blurred Vision, Sweating, Arm Pain, Severe Back Pain, Fainting, Nausea, Auditory Migraine (2 days later).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Allergy test, Dyspnoea, Ear discomfort, Eye pruritus, Eye swelling
Clinical narrative: Swollen eyes and face, whole head filled with fluid, sneezing, watery eyes, difficulty breathing and sleeping, stuffed up nose/ears, red and itchy eyes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Insomnia, Lacrimation increased, Nasal congestion, Ocular hyperaemia, Sneezing
Clinical narrative: Swollen eyes and face, whole head filled with fluid, sneezing, watery eyes, difficulty breathing and sleeping, stuffed up nose/ears, red and itchy eyes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face, Upper respiratory tract congestion
Clinical narrative: Swollen eyes and face, whole head filled with fluid, sneezing, watery eyes, difficulty breathing and sleeping, stuffed up nose/ears, red and itchy eyes.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Acute myocardial infarction, Death
Clinical narrative: This case was reported in a literature article and described the occurrence of acute myocardial infarction in a 53-year-old male subject who was vaccinated with DTPa (with small D and P, manufacturer unspecified). Concurrent medical conditions included multiple cardiac and neurological conditions. On an unspecified date, the subject received unspecified dose of DTPa (with small D and P) (administration site and route unknown, batch number not provided). 69 days after vaccination with DTPa (with small D and P), the subject experienced acute myocardial infarction and died. It was unknown whether an autopsy was performed. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports distributed. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's Palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Fundoscopy abnormal, Optic discs blurred, Optic neuritis, Papilloedema
Clinical narrative: This case was reported in a literature article and described the occurrence of bilateral optic neuritis in a 15-year-old female subject who was vaccinated with DTPa (with small D and P), manufacturer unspecified) and Hepatitis A. On an unspecified date, the subject received an unspecified dose of DTPa (with small D and P) (administration site and route unknown) and an unspecified dose of Hepatitis A (administration site and route unknown). 18 days after vaccination with DTPa (with small D and P) and Hepatitis A, the subject experienced bilateral optic neuritis. This case was assessed as medically serious by GSK. The fundoscopy revealed bilateral disk edema with blurring of disk margins. At the time of reporting, the outcome of the event was unspecified. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ration was about 2 to 1. The majority of reports distributed. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's Palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Myelitis transverse, Paraplegia
Clinical narrative: This case was reported in a literature article and described the occurrence of idiopathic transverse myelitis in a 11-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). 30 days after vaccination with DTPa (with small D + P), the subject experienced paraplegia at the T10-T11 level. The subject was hospitalised and was diagnosed with idiopathic transverse myelitis. At the time of reporting, the outcome of the events was unspecified. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 11.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Ataxia, Dizziness, Encephalopathy, Incoherent
Clinical narrative: This case was reported in a literature article and described the occurrence of encephalopathy in a 11-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified) and Hepatitis B. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Hepatitis B (administration site and route unknown, batch number not provided). 2 days after vaccination with DTPa (with small D + P) and Hepatitis B, the subject experienced photophobia, progressive weakness, dizziness, incoherent speech, mental status changes and ataxia. Encephalopathy was diagnosed. This case was assessed as medically serious by GSK. After 1 day, encephalopathy was resolved. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 11.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Mental status changes, Photophobia
Clinical narrative: This case was reported in a literature article and described the occurrence of encephalopathy in a 11-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified) and Hepatitis B. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Hepatitis B (administration site and route unknown, batch number not provided). 2 days after vaccination with DTPa (with small D + P) and Hepatitis B, the subject experienced photophobia, progressive weakness, dizziness, incoherent speech, mental status changes and ataxia. Encephalopathy was diagnosed. This case was assessed as medically serious by GSK. After 1 day, encephalopathy was resolved. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Photophobia, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of acute meningoencephalitis in a 28-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified) and Seasonal trivalent Influenza vaccine. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Seasonal trivalent Influenza vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with DTPa (with small D + P), 10 days after vaccination with Seasonal trivalent Influenza vaccine, the subject experienced nausea, vomiting and headache. The subject was hospitalised with photophobia, progressive weakness, acute change in mental status, confusion, expressive aphasia, neck pain and stiffness. The final diagnosis was acute meningoencephalitis with encephalopathy. At the time of reporting, the events were resolved. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 0.91
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives within few minutes after receiving PREVNAR vaccine. Patient was given PO BENADRYL in office and was observed in office for 30 minutes. Hives improved upon leaving the office.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: A case of pertussis disease in a two year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL, dose one lot number C3683AA received on 01 September 2010, dose two lot number C3713AA received on 12 November 2010 and dose three lot number C3771AA received on 18 January 2011 and one dose of DAPTACEL, lot number C4002BA on 24 January 2012 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 03 June 2013, approximately 16 months after the last dose. On 03 June 2013, the subject developed a cough. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 09 June 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 09 June 2013 for three days. The subject was not hospitalized. At the time of final contact on 20 June 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: A case of pertussis disease in a two year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL, dose one lot number C3683AA received on 01 September 2010, dose two lot number C3713AA received on 12 November 2010 and dose three lot number C3771AA received on 18 January 2011 and one dose of DAPTACEL, lot number C4002BA on 24 January 2012 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 03 June 2013, approximately 16 months after the last dose. On 03 June 2013, the subject developed a cough. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 09 June 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 09 June 2013 for three days. The subject was not hospitalized. At the time of final contact on 20 June 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient. On 21-JUN-2013 the patient was vaccinated with the first dose of GARDASIL in the right arm. On 21-JUN-2013, the patient experienced an episode of fainting within 15 minutes of administration. The patient recovered in the Physician's office without further incident. The outcome of an episode of fainting was reported as recovered/resolved in June 2013. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. In August 2012 the patient was vaccinated with ZOSTAVAX, subcutaneous. Lot number, dose and frequency were not provided. In April 2013, reported as 8 months after receiving ZOSTAVAX, the patient experienced post herpetic neuralgia. The outcome of post herpetic neuralgia was unknown. The reporter causality was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 48 year old female patient. On an unknown in January 2013 date the patient was vaccinated with ZOSTAVAX (strength, route, dose and lot # were unknown). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On a unknown date, the patient was vaccinated with the first and second dose of GARDASIL injection, (dose, frequency and lot # were not provided). On an unknown date in 2008 (administered between the dates of March 2008 and September 2008) the patient was vaccinated with the third dose of GARDASIL injection, (dose, frequency and lot # were not provided) which was invalid dose because the vaccine was stored incorrectly during that period of time. The patient was told that she needed to have her third dose of GARDASIL re-administered, because GARDASIL that was used for the third dose only, was warm, exact temperatures that the GARDASIL was exposed to was unspecified. No adverse effect reported. The outcome, action taken and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a 27 year old female patient with no drug reactions / allergies and no pertinent medical history, who on 12-JAN-2012, was vaccinated with a dose of VARIVAX (Merck), a Pregnancy Registry Product, SC, (lot number 670801/0816AA, expiration date 07-JUN-2013) (dose not reported). There was no concomitant medication. It was reported that the patient received ad ose of VARIVAX (Merck) and she was 3 to 4 weeks pregnant. Her last menstrual period was in December, 2011. Estimated date of delivery was 27-SEP-2012. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date of 2008 (administered between the dates of March 2008 and September 2008) the patients were vaccinated with GARDASIL, injection, (dose, frequency and lot# were not provided) which was invalid dose because the vaccine was stored incorrectly during that period of time. The outcome, action taken and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old male patient. Nurse reported two patients (brothers) received first dose of VAQTA 25/0.5 intramuscular on 06-FEB-2013 and the second dose of VAQTA 25/0.5 (lot# unknown) intramuscular five months after the first dose on 02-JUL-2013. No co-suspected medicine reported. No concomitant medication reported. No adverse effect reported. The outcome was unknown. Action taken not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old male patient. Nurse reported two patients (brothers) received first dose of VAQTA 25/0.5 intramuscular on 06-FEB-2013 and the second dose of VAQTA 25/0.5 (lot# unknown) intramuscular five months after the first dose on 02-JUL-2013. No co-suspected medicine reported. No concomitant medication reported. No adverse effect reported. The outcome was unknown. Action taken not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 07-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (dose and lot # not reported) intramuscularly. The patient was vaccinated with the second dose of GARDASIL (dose and lot # not reported) on 07-MAY-2013. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Dizziness, Fall, Feeling abnormal
Clinical narrative: Immediately after receiving the two vaccines patient stood up and felt lightheaded, was weak, said he felt bad and fell back into his chair. He trembled a little and father picked him up in his arms. I was called in immediately and was told he had fainted. He was pale and diaphoretic but responsive and oriented with normal vital signs. He stayed in the office for 45 minutes for observation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope, Tremor
Clinical narrative: Immediately after receiving the two vaccines patient stood up and felt lightheaded, was weak, said he felt bad and fell back into his chair. He trembled a little and father picked him up in his arms. I was called in immediately and was told he had fainted. He was pale and diaphoretic but responsive and oriented with normal vital signs. He stayed in the office for 45 minutes for observation.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 29 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 10 days after the subject had received the following vaccines on 31 July 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 29 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 10 days after the subject had received the following vaccines on 31 July 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Insomnia, Pain
Clinical narrative: Called on 7/11/13 stating flu shot from last year caused pain in arm and shoulder. Was "sick" for 2-3 days after got flu shot then arm/shoulder hurt. Notified MD after 6 mo. MD told him he had pinched nerve and prescribed pain pills. Still having pain in left arm and shoulder. Just called us today.
Age: 86.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Malaise, Musculoskeletal pain, Nerve compression, Pain in extremity
Clinical narrative: Called on 7/11/13 stating flu shot from last year caused pain in arm and shoulder. Was "sick" for 2-3 days after got flu shot then arm/shoulder hurt. Notified MD after 6 mo. MD told him he had pinched nerve and prescribed pain pills. Still having pain in left arm and shoulder. Just called us today.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Paraesthesia oral
Clinical narrative: Administered Hep B to right deltoid 30 min later c/o "can't lift my right arm", "tingling lips". Called Dr. - on call doc. Administered 50mg BENADRYL IM and EPIPEN, sent to ER.
Sex: F
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: Initial case received from a consumer who is the patients' parent on 02 July 2013. It represents three unidentified female patients of a cluster of four patients reported by the same reporter who each experienced an adverse reaction following administration of IMOVAX RABIES and HRIG (manufacturer unknown). The events for the other patient are captured in case number 2013-07502. On an unspecified date in 1998 the patients were administered IMOVAX RABIES (batch number not reported) and HRIG, manufacturer unknown, dose, route and sites not reported. Concomitant medications and preexisting medical conditions were reported as unknown. It is unknown if the patients received other vaccinations within 4 weeks of vaccination. On a unspecified date in 1998 the patients experienced "Universal reactions to most substances" which has been worsening since 1998 and it is described as being "at it's height now". One unspecified daughter can only eat 10 substances. Another sleeps on the floor with a mask filter on. One has thyroid failure, one has seizures and one has migraine heads. The patients required an ER/doctor visit on an unspecified date for an unspecified duration. The reporter refused to give her physician's name or any other information. The patients outcomes are not recovered. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear infection, Erythema, Infection, Pain in extremity
Clinical narrative: She complained of redness and pain in her arm. After it continued for several day she went to the doctor where they said she had an infection along with an ear infection. She was given an antibiotic and an ear drop.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Mother states is red rash that started on abdomen. States very sparse type rash that does not appear to itch child. Denies any fluid filled blisters.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Hypoaesthesia, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: Client said that right side of face felt numb, food tasted funny, and tongue felt numb. Client reported drooping right side of face.  Client went to ER for medical eval. Dx. was Bells Palsy, rare side effect from Shingles shot. Treatment ordered Prednisone x5 days, Famciclovir x3 days, Refresh eye gtts right eye as needed.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Cardiac monitoring normal, Computerised tomogram thorax normal, Cyanosis, Electrocardiogram normal
Clinical narrative: After finishing bottle of formula, baby passed out and stopped breathing, turned blue.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: After finishing bottle of formula, baby passed out and stopped breathing, turned blue.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-06-18.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Ear pain, VIIth nerve paralysis
Clinical narrative: Bell's palsy on 2013-06-18, clinician comment: presented 2 weeks after Tdap with right ear pain, then developed Bell's palsy one day later.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Adv eff tetanus vaccine on 2013-06-21.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 102.5 for six hours until Aleve was given and severe nausea (no vomiting).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of leg on 2013-06-22, clinician comment: Cellulitis was really on inner thigh under buttock and not at the site of vaccination.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-06-25.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cyanosis, Febrile convulsion, Pallor, Skin warm, Unresponsive to stimuli
Clinical narrative: Mother states child was laying on the floor and she noticed her lips were blue and face was white.  They picked her up and were yelling her name with no response from child.  They called 911.  While they were waiting for medics they continued to try to arouse the child.  The child vomited and became responsive.  She was checked out by EMS personnel but parents decided not to take child to the hospital that night.  They saw the Nurse Practitioner the next day and nothing medically was found with the child.  Mother states that child did feel warm during all this and was told it was probably a febrile seizure by the NP.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Mother states child was laying on the floor and she noticed her lips were blue and face was white.  They picked her up and were yelling her name with no response from child.  They called 911.  While they were waiting for medics they continued to try to arouse the child.  The child vomited and became responsive.  She was checked out by EMS personnel but parents decided not to take child to the hospital that night.  They saw the Nurse Practitioner the next day and nothing medically was found with the child.  Mother states that child did feel warm during all this and was told it was probably a febrile seizure by the NP.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site affecting entire upper arm. Duration of two days.
Age: 21.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram, Encephalitis post immunisation, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in the trial on 05 July 2013. An 21 year-old male subject whose past medical history included chest pain and headaches was found to have encephalitis following immunization procedures 10 days after the subject had received the following vaccines on 09 June 2009: an injection of ACAM2000, (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hep A - Adult 1 (manufacturer, lot number, route and site of administration not reported). A Troponin I, ECG, Echocardiogram, Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging spinal, Troponin I
Clinical narrative: This study case was received from the investigator in the trial on 05 July 2013. An 21 year-old male subject whose past medical history included chest pain and headaches was found to have encephalitis following immunization procedures 10 days after the subject had received the following vaccines on 09 June 2009: an injection of ACAM2000, (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hep A - Adult 1 (manufacturer, lot number, route and site of administration not reported). A Troponin I, ECG, Echocardiogram, Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at site ice, acetaminophen. Rx for SEPTRA should he not improve.
Age: 73.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Tenderness near injection site with slight swelling. No erythema or temperature.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Hypotonia, Pallor
Clinical narrative: Following imms mom had left office, but then came back because he looked really pale and somewhat tired and limp on exam looked really pale and tired. Watch pt. in office on continuous pulse ox, nl with HR around 100 and pulse ox 95% or greater. He fed during timeframe, color started to return to normal, but not yet normal. They left office, nl cap refill. Good pulses. MA in room with mom, color coming back vitals normal. Blanching well.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain surrounding the injection site and extending four inches outward along with the arm, duration of 3 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose normal, Bradycardia, Loss of consciousness, Pallor
Clinical narrative: Fainted x several second and pale (LOC). then again near fainted. Pale. Bradycardia x2 times. BP and glucose NM. PE = unremarkable except weak.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Fainted x several second and pale (LOC). then again near fainted. Pale. Bradycardia x2 times. BP and glucose NM. PE = unremarkable except weak.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness
Clinical narrative: Patient experienced symptoms: "Light headed" placed pt in supine position with feet elevated... Also gave her crackers, juice, and water. This occurred in 15 min. time span. BP and Pulse were within normal limits, then pt's symptoms relieved.