chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. However, no pregnant patients were reported. On an unknown dates the patients were vaccinated with GARDASIL (lot # J007354, expiration date: 20-FEB-2016), injection (dose and route not provided). The reporter mentioned that 200 doses were given to an unknown number of patients and some of those unknown number of patients (specific number unspecified) reported at the time of vaccination that it hurt a little more then before. The patient sought medical attention - were in the office. The patients were instructed to put ice at the injection site and took TYLENOL or MOTRIN. The outcome of event was reported as recovered/resolved on an unspecified date. The relatedness between vaccination with GARDASIL and event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 06-SEP-2013. This is the one of several reports from the same source. J0030722 is not valid lot number for hepatitis b vaccine (recombinant). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccine administered were RECOMBIVAX HB and VAQTA) but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reports that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 06-SEP-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA) but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 26-AUG-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second all was reported that no doses of VAQTA were involved in this excursion. Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 26-SEP-2013. This is one of several reports from the same source. J0030722 is not valid lot number for hepatitis b vaccine (recombinant). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-SEP-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 74 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date in June 2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). There was no concomitant therapy. Approximately on an unknown date in 2010 (reported as within the last 10 days after vaccination), the patient developed full blown case of shingles around her breast. The patient sought medical attention (office visit). The patient was treated with an unspecified antiviral medication. No lab test was performed. The patient was recovering from full blown case of shingles around her breast. The relatedness for the event was unknown for ZOSTAVAX. VZVIP packet faxed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 10-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 14-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report revers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 21-MAY-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives 6 hours after receiving vaccines. Hives disappeared and did not recur after one dose of BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 24-SEP-2013 (lot number: H010915; exp date: 13-FEB-2015) No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Troponin I increased
Clinical narrative: Pt received smallpox vaccine at the beginning of Jan. around mid Jan pt reported 24 hrs of constant chest pain that worsened as he laid down. Labs show elevated cardiac enzymes.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Had injection site reaction that became rash and grew larger over 2 days. Instructed patient to go to MD to double check and she did.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 03-OCT-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 0.9
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule, Rash pustular
Clinical narrative: Pt exposed to shingles, vaccinated early on 1-7-14 on 1-15-14 mom noted pustular lesions at injection site. On 1-20-14 more lesions on lower extremities. Non pruritic or with drainage. No treatment.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 20-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Adverse reaction, Product quality issue
Clinical narrative: This spontaneous report as received from a consumer (patients mother) refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with GARDASIL (dosage unknown). No concomitant medications were provided. The reporter could not confirm the patient had received all three shots of GARDASIL. On an unknown date the patient experienced unspecified adverse reactions. The reporter then stated that she knows that the GARDASIL that the patient received was part of the GARDASIL "recall". The reporter then stated that she does not have the lot number, expiry date or any specific information in regards to the GARDASIL that the patient received. The outcome of unspecified adverse reactions is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-AUG-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 1615162, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to a adult male patient. Patient had no pertinent medical history of drug reactions or allergies. On 06-JUN-2013 the patient was vaccinated with GARDASIL (lot # H020603, exp. date 15-AUG-2015) dose 1, 0.5 ml, intramuscular. On 08-JUL-2013 the patient was vaccinated with GARDASIL (lot # H021194, exp. date 15-AUG-2015) dose 2, 0.5 ml, intramuscular. Concomitant therapies included PROPECIA. On an unknown date, after patient received first two doses of GARDASIL, the patient experienced "outbreak in genital area" and was diagnosed with hpv. Patient's unspecified, long term girlfriend had been diagnosed with HPV, by an unspecified physician. No lab diagnostic studies were performed. Patient sought medical attention at school physician. No intervention was taken to prevent serious criteria. No further information was provided. The outcome of "outbreak in genital area" and was diagnosed with hpv was unknown. Causality was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On 25-JUN-2012 the patient was vaccinated with GARDASIL dose 1 (reported as "Prevention of HPV"). On 30-JAN-2013 the patient received the second dose of GARDASIL. On 16-APR-2013 the patient was vaccinated with third dose of GARDASIL (which was considered inappropriate schedule of vaccine administration). Dose and route of administration were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 30-SEP-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Heat, redness, and swollen on (R) arm injection site.
Age: 1.62
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 222 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 14 January 2014. These 222 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 14 January 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3253AA received on 10 February 2010, lot number C3554AA on 14 April 2010, lot number C3232AA on 09 June 2010 and lot number C3754AA received on 25 July 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 November 2013, approximately 2 years after the last dose. On 03 November 2013, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 18 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.62
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 222 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 14 January 2014. These 222 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 14 January 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3253AA received on 10 February 2010, lot number C3554AA on 14 April 2010, lot number C3232AA on 09 June 2010 and lot number C3754AA received on 25 July 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 November 2013, approximately 2 years after the last dose. On 03 November 2013, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 18 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Headache, Pyrexia, Viral infection, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), meningitis vaccine and strain not specified Meningococcal ACWY vaccine (Non-GSK). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC. On 6 August 2013 the subject received 1st dose of CERVARIX (1 dose, unknown route, unknown arm), 2nd dose of Meningitis vaccine (unknown details). On 6 August 2013, on the same day as vaccination with CERVARIX and Meningitis vaccine, the subject experienced fever and headache. On the morning of 9 August 2013, 3 days after vaccination with CERVARIX and Meningitis vaccine, the subject experienced vomiting. At the time of reporting the events of fever and headache were improved. The event of vomiting was unresolved. Follow up was received from the physician on 3 September 2013. The physician considered this case to be non-serious. The physician reported that viral illness could have been associated with the events of fever, headache, and vomiting. However, the physician did not report the onset dates of the viral illness. The physician reported that the subject did not use alcohol or tobacco. On follow up, the physician reported that it was unknown if the subject had experienced any adverse events following previous vaccinations; however, previously, the physician reported that there were no reactions to previous vaccinations.
Sex: M
Vaccine: FLUC3
Symptoms: Prostatic specific antigen abnormal
Clinical narrative: Case number PHEH2014US001607 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a male patient of an unknown age. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unknown date. On an unknown date in Dec 2013, after vaccination his prostate specific antigen changed. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Novartis; unknown; right arm given on 12 July 2013. On 12 July 2013 the subject received 1st dose of CERVARIX (.5 unknown, unknown route, left arm). On the morning of 13 July 2013, 1 day after vaccination with CERVARIX, the subject experienced fever. On the morning of 14 July 2013, 2 days after vaccination with CERVARIX, the subject experienced fatigue, headache, myalgia. Within days of vaccination with CERVARIX (specific date not reported), the subject experienced arthralgia, injection site pain, injection site redness, and swelling injection site. On 13 July 2013, the subject experienced bad feeling (awoke "feeling really bad"). On 14 July 2013, the subject experienced premature onset of menses and sore throat. The subject sought medical attention through her doctor's office on 15 July 2013. The subject reported to the nurse that she woke on 13 July 2013 and felt "really bad and the issues have progressed over the weekend." The nurse noted that the subject had a regular menses cycle of one week that ended on 4 July 2013 but began again on 14 July 2013. The nurse was considering whether the 2nd and 3rd injections of the series should be continued. Relevant test results included body temperature taken on 13 July 2013 and the result was 101.5 degrees Fahrenheit. At the time of reporting the outcome of the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Injection site pain, Injection site swelling, Myalgia, Oropharyngeal pain, Polymenorrhoea
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Novartis; unknown; right arm given on 12 July 2013. On 12 July 2013 the subject received 1st dose of CERVARIX (.5 unknown, unknown route, left arm). On the morning of 13 July 2013, 1 day after vaccination with CERVARIX, the subject experienced fever. On the morning of 14 July 2013, 2 days after vaccination with CERVARIX, the subject experienced fatigue, headache, myalgia. Within days of vaccination with CERVARIX (specific date not reported), the subject experienced arthralgia, injection site pain, injection site redness, and swelling injection site. On 13 July 2013, the subject experienced bad feeling (awoke "feeling really bad"). On 14 July 2013, the subject experienced premature onset of menses and sore throat. The subject sought medical attention through her doctor's office on 15 July 2013. The subject reported to the nurse that she woke on 13 July 2013 and felt "really bad and the issues have progressed over the weekend." The nurse noted that the subject had a regular menses cycle of one week that ended on 4 July 2013 but began again on 14 July 2013. The nurse was considering whether the 2nd and 3rd injections of the series should be continued. Relevant test results included body temperature taken on 13 July 2013 and the result was 101.5 degrees Fahrenheit. At the time of reporting the outcome of the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Novartis; unknown; right arm given on 12 July 2013. On 12 July 2013 the subject received 1st dose of CERVARIX (.5 unknown, unknown route, left arm). On the morning of 13 July 2013, 1 day after vaccination with CERVARIX, the subject experienced fever. On the morning of 14 July 2013, 2 days after vaccination with CERVARIX, the subject experienced fatigue, headache, myalgia. Within days of vaccination with CERVARIX (specific date not reported), the subject experienced arthralgia, injection site pain, injection site redness, and swelling injection site. On 13 July 2013, the subject experienced bad feeling (awoke "feeling really bad"). On 14 July 2013, the subject experienced premature onset of menses and sore throat. The subject sought medical attention through her doctor's office on 15 July 2013. The subject reported to the nurse that she woke on 13 July 2013 and felt "really bad and the issues have progressed over the weekend." The nurse noted that the subject had a regular menses cycle of one week that ended on 4 July 2013 but began again on 14 July 2013. The nurse was considering whether the 2nd and 3rd injections of the series should be continued. Relevant test results included body temperature taken on 13 July 2013 and the result was 101.5 degrees Fahrenheit. At the time of reporting the outcome of the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Age: 16.0
Sex: F
Vaccine: HPV2, MNQ, TDAP, VARCEL
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a physician (subject's mother) and described the occurrence of fever in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination on the same date as suspect product included meningococcal acwy vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2000; tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; manufacturer unspecified; unknown; unknown given in 2000; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2000. Medical history included: the subject "had swelling as an infant to DTwP." In 2000 or 2001, the subject received 1st dose of CERVARIX (1 dose, unknown route, right arm). Per the physician, the subject received CERVARIX 2 to 3 years ago. Less than one day ("within 24 hours") after vaccination with CERVARIX, the subject experienced fever and lymphadenopathy. The subject received other vaccinations on the same date, but the physician was attributing the reaction to CERVARIX. At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age. On an unknown date the unknown number of patients were vaccinated with LIQUID PEDVAXHIB and GARDASIL which was improperly stored. The patients did not experience any adverse effect. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician, initially via a company representative, refers to a 13 year old patient of unknown gender. No medical history provided. On 10-FEB-2004 the patient was vaccinated with VARIVAX (dose 1). No concomitant medications were provided. On 22-JAN-2014 the patient was supposed to receive a 2nd dose of VARIVAX, but received ZOSTAVAX by accident. No adverse events were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Impaired work ability, Local swelling, Migraine, Syncope
Clinical narrative: Initial report received from a patient on 17 January 2014. A female adult patient (date of birth not reported) was vaccinated 8 - 9 years ago with ADACEL; lot number, route, site and date of administration were not reported. On unreported date, the patient developed syncope, a "terrible" migraine and the arm she received the vaccine was swelled, red and tender to the touch. She was unable to work for 2 -3 days. The patient denied being sick at the time of vaccination. Concomitant medications and medical history were reported as none. Laboratory tests were not reported. The patient had recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Initial report received from a patient on 17 January 2014. A female adult patient (date of birth not reported) was vaccinated 8 - 9 years ago with ADACEL; lot number, route, site and date of administration were not reported. On unreported date, the patient developed syncope, a "terrible" migraine and the arm she received the vaccine was swelled, red and tender to the touch. She was unable to work for 2 -3 days. The patient denied being sick at the time of vaccination. Concomitant medications and medical history were reported as none. Laboratory tests were not reported. The patient had recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Sex: M
Vaccine: RAB
Symptoms: Drug administration error, Dyspnoea, Feeling abnormal, Injection site pain, Motor dysfunction
Clinical narrative: Initial information received from a consumer on 20 January 2014. An adult male patient, date of birth not reported received a dose of IMOVAX (batch not reported) intramuscularly into the right deltoid for post exposure from an animal bite on an unreported date. On the same day, (date not specified) the patient experienced "hard to breath" within 20 minutes of receiving the vaccine. he felt "like he was going to die". The patient denied having any allergies, medical conditions and illness at the time of vaccination. The patient was seen by a cardiologist that he knew who gave him a tetanus shot (manufacturer, batch, date of administration and route were not reported). He was not sure of the timeframe. The tetanus shot made him feel better. The patient drank respiratrol, Vit B6 and took vitamin enhanced waters. The patient also experienced pain down his right arm from the injection site to his hand and he thought he lost some dexterity in his hand. The patient stated that he saw lots of air bubbles in the syringe and associated this with not "repressurizing" the vaccine before administration. He was now "ok" except for arm pain and dexterity problem. The patient was advised to see his family doctor for an evaluation. The patient's outcome was not recovered. No further details were available at the time of this report. Documents held by sender: None.
Sex: M
Vaccine: RAB
Symptoms: Pain in extremity
Clinical narrative: Initial information received from a consumer on 20 January 2014. An adult male patient, date of birth not reported received a dose of IMOVAX (batch not reported) intramuscularly into the right deltoid for post exposure from an animal bite on an unreported date. On the same day, (date not specified) the patient experienced "hard to breath" within 20 minutes of receiving the vaccine. he felt "like he was going to die". The patient denied having any allergies, medical conditions and illness at the time of vaccination. The patient was seen by a cardiologist that he knew who gave him a tetanus shot (manufacturer, batch, date of administration and route were not reported). He was not sure of the timeframe. The tetanus shot made him feel better. The patient drank respiratrol, Vit B6 and took vitamin enhanced waters. The patient also experienced pain down his right arm from the injection site to his hand and he thought he lost some dexterity in his hand. The patient stated that he saw lots of air bubbles in the syringe and associated this with not "repressurizing" the vaccine before administration. He was now "ok" except for arm pain and dexterity problem. The patient was advised to see his family doctor for an evaluation. The patient's outcome was not recovered. No further details were available at the time of this report. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Insomnia
Clinical narrative: Case number PHEH2014US001487 is an initial spontaneous report from the consumer received on 16 Jan 2014. This report refers to a 54-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 14 Jan 2014. On the same date, immediately after vaccination she experienced shortness of breath, chest tightness and pain that radiated along her back. She stated that she had mild shortness of breath at the time of reporting, but the event was extremely difficult on the night, where she had to sit in a chair with a heated vibrator to get some sleep. It was reported that the patient had a concern that she would get a condition like asthma after FLUVIRIN administration. The outcome of the events was unknown.
Sex: M
Vaccine: FLUX
Symptoms: Optic neuritis
Clinical narrative: Case received from a non-healthcare professional (patient's mother) on 17-Jan-2014. A male patient (no details provided), with no relevant medical history reported and no reported concomitant therapies, had received his dose of flu vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 13-Oct-2013. On 15-Nov-2013, i.e. just over 4 weeks post-vaccination, the patient experienced optic neuritis, confirmed on 20-Nov-2013. He was evaluated by a neurologist and a neuro-ophthalmologist. His condition resolved on an unspecified date. The reporter was calling to inquire about his ability to receive another flu vaccine. The reporter did not want to give more information. The patient's condition led to a required doctor visit. Upon internal review, this case was assessed as serious, i.e. as an important medical event.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Heart rate increased, Hyperhidrosis, Immediate post-injection reaction, Vaccination complication
Clinical narrative: Case number PHEH2014US001112 is an initial spontaneous report received from a consumer on 13 Jan 2014. This report refers to a 39-year-old female patient. She had a significant medical history of dysautonomia. She denies any allergies but explains that she gets sick to her stomach after eating eggs. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on either Dec 2004 or Jan 2005. She experienced an adverse reactions immediately after receiving the flu shot stating that her heart was beating fast, the room was spinning, sweating, vomiting and couldn't breathe. She did not receive any medical care after the incident. Outcome of the events was unknown. Seriousness and causality were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vertigo, Vomiting
Clinical narrative: Case number PHEH2014US001112 is an initial spontaneous report received from a consumer on 13 Jan 2014. This report refers to a 39-year-old female patient. She had a significant medical history of dysautonomia. She denies any allergies but explains that she gets sick to her stomach after eating eggs. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on either Dec 2004 or Jan 2005. She experienced an adverse reactions immediately after receiving the flu shot stating that her heart was beating fast, the room was spinning, sweating, vomiting and couldn't breathe. She did not receive any medical care after the incident. Outcome of the events was unknown. Seriousness and causality were not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash
Clinical narrative: Case number PHEH2014US001595 is an initial report received from a pharmacist on 15 Jan 2014. This report refers to a 24-year-old female patient. Current condition of this patient includes lactose intolerance. He was vaccinated with FLUVIRIN (batch number: 13472P; expiry date: not reported) intramuscularly on 14 Jan 2014. On the same day after vaccination the patient presented with breathing difficulty and rash. Outcome of the events was reported as recovered completely. Seriousness and causality were not reported.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis
Clinical narrative: This initial case was received from a consumer on 16 January 2014. Two cases of unidentified patients, who each experienced pertussis following administration of ADACEL, were reported by the same reporter. The other report is captured in case number 2014SA007169. An 13 year old female patient was vaccinated with ADACEL lot # U4308BA in May of 2012, date not specified. The route, site of administration and dose were not reported. On an unreported date the patient experience coughing lasting for past 4 weeks. Blood work for each patient was positive for pertussis on an unreported date. The reporter stated that they do not have any cultures. The patient's medical history and concomitant medications were not reported. The patient outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis
Clinical narrative: This initial case was received from a consumer on 16 January 2014. Two cases of unidentified patients, who each experienced pertussis following administration of ADACEL, were reported by the same reporter. The other report is captured in case number 2014SA007170. An 11 year old female patient was vaccinated with "ADACEL" lot # U4418AA (lot number corresponding to MENACTRA in SP) in April of 2013, date not specified. The route, site of administration and dose were not reported. On an unreported date the patient experience coughing lasting for past 4 weeks. Blood work for each patient was positive for pertussis on an unreported date. The reporter stated that they do not have any cultures. The patient's medical history and concomitant medications were not reported. The patient outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash 4-5 hrs after 1st dose.
Age: 0.62
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting about hourly. Had similar symptoms after 6 mo immunizations which included flu dose #1, vomiting then started within 12 hours of vaccination.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Erythema, Induration, Injection site cellulitis, Local swelling, Skin warm
Clinical narrative: Red, hard and swollen arm, warm to touch.  Cellulitis to site treated with cephalexin.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Myalgia, Nausea
Clinical narrative: Sever vomiting, tachycardia (149), severe watery diarrhea, muscle pain everywhere, fever 101.1.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Tachycardia, Vomiting
Clinical narrative: Sever vomiting, tachycardia (149), severe watery diarrhea, muscle pain everywhere, fever 101.1.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Presented for post vaccination check and reported numbness and tingling to wrist on arm of vaccination. This progressed to include the hand the following day.  01/24/2014 all symptoms have resolved.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Local swelling, Pain, Swelling
Clinical narrative: Aching and soreness and swelling immediately - continued swelling and redness that traveled down arm to wrist. Symptoms lasted a week. Took acetaminophen.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in shoulder (left) muscle after couple days of receiving vaccine. Has not taken any medication or has not put ice pack. Suggested to take NSAIDs put ice pak on site. Discussed about filing report (VAERS). He also started taking Atorvastatin. Not know if pain is due to the medication.
Age: 75.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Erythema, Pruritus
Clinical narrative: Itch and redness (R) arm 23 x 10 cm about 5 d after shot (L) arm red only 5 x 10 cm.
Age: 67.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Body temperature increased, Pain, Pain in extremity
Clinical narrative: Had a temperature of 102 for 3 days, ached all over, both arms very sore.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Local swelling
Clinical narrative: Patient received her FLUZONE HIGH DOSE vaccine at 4:30 pm on Monday (01/13). Later in the pm she stated she experienced swelling an redness on her (L) arm. She did not seek med. attention and stated it was better the next day. Notified pharmacy on Friday (1/17). She reported feeling weakness at 6:30 pm, but did not notice redness until the next morning (8 am).
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Tuberculin test negative
Clinical narrative: 4 cm diameter area of warmth and erythema to right deltoid. 1.5 cm diameter area of warmth and erythema to left deltoid. No treatment. PPD negative.
Age: 15.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Dizziness, Erythema, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Yesterday got swelling of the left arm, started at 3 am it got swollen and red. She was given the PPSV 23 at the lower site of the arm. The area is warm and swollen and in a lot of pain. She is dizzy and fever of 102 extreme pain and swelling discoloration in and around injection site.
Age: 15.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Local swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Yesterday got swelling of the left arm, started at 3 am it got swollen and red. She was given the PPSV 23 at the lower site of the arm. The area is warm and swollen and in a lot of pain. She is dizzy and fever of 102 extreme pain and swelling discoloration in and around injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age with vaccination. On an unknown date the patient was vaccinated with VARIVAX (Merck). On an unknown date the physician informed the representative that a patient had a negative titer for varicella and needed a booster dose of VARIVAX for her work (Unspecified if the patient had a prior dose of VARIVAX, but could not rule out that a prior dose of VARIVAX was not administered). No adverse event if reported other than the negative varicella titer. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: On 1-24-14 mom called and then came to clinic. The PROQUAD was given left leg. The area where given was red, hard and swollen the size of a 50 cent piece.
Sex: U
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL for immunization. On an unknown date the patient's menstrual cycle was all messed up after immunization. The outcome of menstrual cycle is all messed up was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Nuclear magnetic resonance imaging brain, Optic ischaemic neuropathy, Red blood cell sedimentation rate
Clinical narrative: Non-arteritic ischemic optic neuritis (NAION).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound Doppler
Clinical narrative: Non-arteritic ischemic optic neuritis (NAION).
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Onset of non stop crying following vaccine administration and lasting 4 hours per mother's history. Patient could not be comforted nursing spoke with mother 2 days later (10-24-14) and patient had stopped by 7 pm on 10-22-14.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Haematoma, Local swelling, Muscle injury, Nerve compression
Clinical narrative: Pt c/o pain after vaccination, swelling, redness, tingling and radiating pain traveling down arm to hand. Pt saw neurology - R/O'd nerve involvement. DX: by provider as prob muscle tear vs. hematoma with nerve pressure.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt c/o pain after vaccination, swelling, redness, tingling and radiating pain traveling down arm to hand. Pt saw neurology - R/O'd nerve involvement. DX: by provider as prob muscle tear vs. hematoma with nerve pressure.
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure increased, Hypertension, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. On an unknown date in October 2013 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date not reported). It was unknown if this was the patient's first, second or third dose in the GARDASIL series. There was no concomitant medication reported. The physician stated that the patient fainted 7 times and had high blood pressure since receiving GARDASIL on an unspecified date in October 2013. It was also reported that the patient was seen as an outpatient in a hospital in November 2013, and the cause of the patient's symptoms was not found. The outcomes of the events were unknown. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Local reaction
Clinical narrative: Red, indurated lesion in dermal layer with sore vesicles at epidermal level. Pronounced local reaction (thickness).