chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, lot# and expiry date unspecified) post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Chorioretinal scar, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of Intermittent floaters and flashing lights in his right eye. Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant).
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Photopsia, Retinal depigmentation, Vitreous floaters
Clinical narrative: A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of Intermittent floaters and flashing lights in his right eye. Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant).
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Chorioretinal disorder, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of Intermittent floaters and flashing lights in his right eye. Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant).
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Intraocular pressure test normal, Photopsia, Retinal depigmentation, Slit-lamp tests abnormal, Visual acuity tests normal
Clinical narrative: A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of Intermittent floaters and flashing lights in his right eye. Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant).
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Vitreous floaters
Clinical narrative: A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of Intermittent floaters and flashing lights in his right eye. Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant).
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received FLUARIX QUADRIVALENT (batch number MM773, expiry date 30th June 2015). Concomitant products included Hepatitis A vaccine. In 2014, the patient received FLUARIX QUADRIVALENT (intramuscular). On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received on 14 November 2014: No adverse event was reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Rash
Clinical narrative: Case number PHHY2013US117224 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 494372) on 15 Oct 2013. This report refers to a 30-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, she experienced anaphylaxis and rash. No further information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2013US106825 is an incomplete literature case received on 23 Sep 2013: in this article the author discussed about the high rates of influenza vaccination and decrease in safety concerns among pregnant women during 2010-11 influenza season. This report refers to multiple female patients whose identifiers were not reported. Their medical history and concomitant medications was not reported. On an unspecified date were vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) who are in the first and second trimester screenings. No adverse events were reported following this administration error. The results showed concerns about two thirds expressing about H1N1 influenza vaccine in particular and half expressing concerns about flu shots in general. The author concluded that influenza vaccination rates among pregnant women may continue to decline over subsequent post-pandemic years, as the memories of those severely ill pregnant women reported in 2009 continue to fade in the minds of both healthcare providers and the public. However, it is also possible that enough new infrastructures was created, such as nurse-driven vaccination protocols and enhancements in vaccine accessibility in new clinical settings, that influenza vaccination rates during pregnancy will be remain sustained.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2012US024261 is an initial spontaneous report from a consumer on 07 Dec 2012. This report refers to a male patient of unknown age. The patient was vaccinated with a seasonal influenza vaccine (manufacture and batch number: unknown) on an undetermined date. After vaccination, the patient experienced Guillain Barre Syndrome on an unspecified date. Seriousness and outcome of the event were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Myelitis transverse
Clinical narrative: Case number PHEH2013US001091 is an initial spontaneous report received from a physician on 10 Jan 2013: This report refers to an adult female patient. She had no reported medical history and concurrent conditions. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date a year ago. The physician reported that after vaccination, she was diagnosed with transverse myelitis on an unspecified date. No further information about seriousness, outcome and causality was reported.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 26-month-old male patient who received FLUARIX (batch number 7TJ92, expiry date 30th June 2015). On 14th November 2014, the patient received the 2nd dose of FLUARIX (unknown) .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received on 14 November 2014: FLUARIX QIV mistakenly given to a 26 months child as 2nd flu shot instead of another flu vaccine approved for that age group. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 26-month-old male patient who received FLUARIX (batch number 7TJ92, expiry date 30th June 2015). On 14th November 2014, the patient received the 2nd dose of FLUARIX (unknown) .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received on 14 November 2014: FLUARIX QIV mistakenly given to a 26 months child as 2nd flu shot instead of another flu vaccine approved for that age group. No adverse event was reported.
Sex: U
Vaccine: RV1
Symptoms: Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a patient who received ROTARIX. On an unknown date, the patient received ROTARIX at an unknown dose. On an unknown date, an unknown time after receiving ROTARIX the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: A dose of ROTARIX diluent was given without the active drug in the diluent. The caller refused to give any information except the street address.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Soreness and small firm tissue mass at sight of injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Patient reports after receiving Influenza vaccine 12/18/14 started with low grade fever and body aches for over a week. Patient did not seek medical attention, just reported to CDC and PCP office.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 30-month-old male patient who received FLUARIX QUADRIVALENT (batch number DJ395, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Age: 1.6
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 18-month-old female patient who received FLULAVAL (batch number 2G3J4, expiry date 30th June 2015. On an unknown date, the patient received FLULAVAL 1 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information: A 18 month old patient was inadvertently administered FLULAVAL QUADRIVALENT.This case was reported by a nurse and described the occurrence of accidental overdose in a 18-month-old female patient who received FLULAVAL (batch number 2G3J4, expiry date 30th June 2015. On an unknown date, the patient received FLULAVAL 1 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information: A 18 month old patient was inadvertently administered FLULAVAL QUADRIVALENT.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 April 2013. ADACEL was given to a 4-year-old patient (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 August 2013. A female patient (age at the time of vaccination not reported) had received first dose of Tdap vaccine (lot number: "L4464AA" (invalid lot), anatomical site of administration was not reported) intramuscularly on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 29 December 2012 and the estimated date of delivery was 28 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". At the time of this report, the patient had not experienced any adverse event. Treatment for infertility was not reported. List of documents held by the sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 06-MAR-2014, the patient was vaccinated with PROQUAD (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014, reported as 08-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 June 2013. A 32-year-old male patient had received a dose of ADACEL and then it was determined that he had also received a dose of ADACEL in October 2012. No adverse event was reported. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report receied from a healthcare professional on 18 June 2013. A 16-year-old patient, whose age and concomitant medications were not reported, had received a dose of Tdap (manufacturer unknown, Lot number, route and administration of vaccination was not reported) on an unspecified date. It was reported that, the patient had received previous dose of Tdap on 04th April 2012. On 18 June 2013, it was reported that yesterday patient had received a dose of Tdap. Thus extra dose administered. As of 18 June 2013, there is no mention of adverse events. List of documents held by the sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 13 August 2013. A 38-year-old female patient had received an intramuscular dose 1 of ADACEL  vaccine (batch number: U4313AA and site of administration was not reported) on 12 August 2013. The patent's health during pregnancy and risk factors were reported as "N/A". Concomitant medications and past medical history were not reported. Treatment for infertility was reported as "N/A". The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 08 January 2013. The estimated dose of delivery was 08 October 2013. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 August 2013. A 13-year-old patient received a dose of ADACEL vaccine earlier than needed. No more information was provided. No adverse event was  reported. List of documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-MAY-2014, the patient was vaccinated with PROQUAD (Merck) (dose, strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck).
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial pregnancy report received from a healthcare professional on 23 JULY 2013. A 33-year-old female patient, whose medical history and concomitant medications were not reported, had received first dose of ADACEL (lot number: U4617AA, expiry date 22 OCTOBER 2015, anatomical site of administration was not reported) intramuscularly on 22 JULY 2013. The patient's last menstrual period date was 08 NOVEMBER 2012 and expected date of delivery was reported as 15 AUGUST 2013. Laboratory investigations were not reported. As of the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 16 April 2013. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine (Lot number: U4612AA, anatomical site of administration was not reported) on 16 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was on 13 September 2012 and the expected delivery date was 20 June 2013. The patient's medical history, risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. As of 16 April 2013, the patient had no adverse event. List of documents held by the sender: None.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product packaging quantity issue, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 29 April 2013. A female patient, whose age, date of birth, medical history and concomitant medications were not reported, had received first dose of 0.05 (unit not reported) ADACEL vaccine (batch number: C3897A, expiry date: 11-02-2013), route and anatomical site of administration were not reported) on an unspecified date. It was reported that, when the technician went to administer the second dose of 0.45 (unit not reported) ADACEL vaccine, there was only 0.3 (unit not reported) in the vial so they were unable to finish the challenge as they had no more in hand. The doses in both syringes were tripled checked each time. The reporter stated that, the vial was incomplete. At the time of this report, no information regarding occurrence of any adverse event were reported. List of documents held by sender: None
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 19 June 2013.  An over the age of 65-years male patient (exact age was not reported), had received an intramuscular dose of ADACEL Vaccine (batch number, dose number and anatomical reported) on an unspecified date. The reporter refused to provide information about illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. On an unspecified date, after vaccination, the patient developed swelling of hand and arm. Corrective treatment was not reported. The reporter refused to provide information about laboratory investigations. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Injection site pain
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent) on 09 September 2013. An 11-year-old female patient, had received an intramuscular dose of ADACEL vaccine (batch number: U4331BA, expiry date: 25 January 2015, dose in series was not reported) in the left deltoid on 17 July 2013. The patient had no known allergies or illness at time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks of vaccination. On 17 July 2013, the patient developed soreness in left arm at injection site which then extended to the area surrounding the injection site. On an unspecified date the patient had developed involuntary "head bobbing in a yes motion". The patient was unaware when it happened. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: Initial information received from other company (Merck service request number 1-7281445344) on 31 May 2013. The information was initially reported by a consumer. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of TDAP vaccine (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient developed an allergic reaction to the Pertussis Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 22 July 2013. A male patient (age reported as "30's") had received a dose of ADACEL vaccine (batch number: U4618AA, dose number and route of administration were not reported) in left deltoid on 19 July 2013. The patient had no illness at the time of vaccination and no known allergies, birth defects and medical conditions. On 19 July 2013, in the evening; the patient experienced chills, fever of temperature 102 degree Fahrenheit, malaise and nausea which persisted over the weekend. Laboratory investigations and corrective treatment were not reported. At the time of this report the patient was feeling better, able to eat a little but had not recovered from the events. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Anxiety, Erythema, Hyperhidrosis, Pallor
Clinical narrative: Initial report received on 26 September 2013 from a Registered nurse. A 11 years old male patient, with no known drug allergy, foramen ovale and surgically repaired and concomitant medications were unknown, was vaccinated  with (lot number U46688BA, intramuscularly on left arm) and possibly PRIORIX on 25 September 2013. Within 5 minutes of vaccination on 25 September 2013, the patient experienced diaphoresis, stomach pains, was anxious, he became pale, clavical just above the elbow became red, welts appeared, fever and vomiting. The patient was referred to the emergency room. The events were ongoing at the time of the report. No further relevant information was reported.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Initial report received on 26 September 2013 from a Registered nurse. A 11 years old male patient, with no known drug allergy, foramen ovale and surgically repaired and concomitant medications were unknown, was vaccinated  with (lot number U46688BA, intramuscularly on left arm) and possibly PRIORIX on 25 September 2013. Within 5 minutes of vaccination on 25 September 2013, the patient experienced diaphoresis, stomach pains, was anxious, he became pale, clavical just above the elbow became red, welts appeared, fever and vomiting. The patient was referred to the emergency room. The events were ongoing at the time of the report. No further relevant information was reported.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Initial information received on 27 September 2013 from a physician. A 52-year-old female patient whose medical history and concomitant medication were not reported, received in DTP (lot number U4646AA, Expiry date unknown). It was reported that the patient experienced significant reaction at deltoid site of injection, warmth, redness, and swelling. Patient had fever 99.3 and body aches on 27 September 2013. Itching and nausea at injection at site on 27 September 2013. Administration site reaction was not reported. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Initial information received on 27 September 2013 from a physician. A 52-year-old female patient whose medical history and concomitant medication were not reported, received in DTP (lot number U4646AA, Expiry date unknown). It was reported that the patient experienced significant reaction at deltoid site of injection, warmth, redness, and swelling. Patient had fever 99.3 and body aches on 27 September 2013. Itching and nausea at injection at site on 27 September 2013. Administration site reaction was not reported. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site. No specific treatment - recommended ice.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had erythema, slight swelling, increased warmth at injection site on left upper arm.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus, Sensation of foreign body, Wheezing
Clinical narrative: Day 1 - evening of vaccination - injection area was red and sore. Day 2 - injection site still sore and area of redness was spreading. Day 3 - redness still spreading, itchiness, and development of wheezing and felt like a "lump" or "egg" in her throat.
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient's mother) on 05 September 2013. A female patient had received a dose of DTaP (manufacturer unknown, batch number was unknown, dose in series, route and site of administration were not reported) on an unspecified date in 1988. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was unknown. The patient's concomitant medications were not reported. On an unspecified date after vaccination the patient developed fever and swelling at injection site. Laboratory investigations and corrective treatment were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received on 04 September 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) which expired on 19-Aug but was given on 03-Sep. As of 04 September 2013, the patient did not have any adverse events. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying
Clinical narrative: This case is linked to 2013-09758 and 2013-09796 (Same patient). Initial report received from a non-healthcare professional (patient's parent) on 23 September 2013. A 06-month-old male patient had received a dose of IPOL, a dose of Hib vaccine (unknown manufacturer), a dose of DTaP (unknown manufacturer) and a dose of "RV" (unknown manufacturer) (batch number, dose number, route and site of administration were not reported for all vaccines), all on an unspecified date. The patient experienced reaction after receiving DTaP, RV, HIB and IPOL vaccine at 02 and 04 months age with crying for days (Details were not provided). The patient's pre-existing physician diagnosed drug allergies, birth defects, medication conditions, concomitant medications and illness at time of vaccination were not reported. On an unspecified date, after vaccination, the patient experienced crying for days. The corrective treatments and laboratory investigations were not reported. The patient had recovered from the event on an unspecified date. Documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from healthcare professional on 18 September 2013. A female patient, who has no relevant medical history with no illness at the time of vaccination and concomitant medications were not reported, had received intramuscular dose of ADACEL, batch number: U4646AA having expiry date 28 November 2015 in right deltoid on 16 September 2013. It was reported that on an unspecified date, after receiving ADACEL vaccine, the patient's right deltoid became red, hot and tender to touch. Clindamycin was prescribed as a corrective treatment and laboratory investigations were not performed. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 June 2013. A 4-year-old patient had received a dose of ADACEL in March date instead of DTaP for the firth dose. No adverse event was reported. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a reporter (other) on 24-Sep-2013: A female patient (age unknown) had received intramuscular (IM) ADACEL vaccine (lot # C4456AA and expiration date unknown) on right deltoid on 20-Sep-2013. Within next few days, she has experienced 3.5 inch around, red, swollen, hot to touch, itchy, area at injection site of right arm. The patient continue to experience these symptoms to today, 24-Sep-2013. The patient's medical history includes allergic to Penicillin. Documents held by sender: non.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Initial report received from healthcare professional on 28 September 2013. A male patient in the 20's, whose date of birth, medical history and concomitant medications were not reported, had received intramuscular dose of ADACEL vaccine (batch number, dose number and anatomical site of administration were unknown) on 26 September 2013. It was reported that on 27 September, one day after receiving ADACEL vaccine, the patient experienced fever, arm pain and shaking in the arm. It was reported that, the fever was lessened. The patient received KEFLEX, Ibuprofen and advised to use compresses as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Groin pain, Injection site erythema, Injection site swelling
Clinical narrative: This case is part of 2 cluster cases and is linked to case number 2013-09010 with same reporter, similar events after receiving ADACEL (lot number: C4432AB) and MENACTRA (lot number: U4648AA). Initial report received from a healthcare professional on 16 August 2013. A male patient, whose age at the time of event was not reported, had received intramuscular first dose of ADACEL vaccine (batch number: C4432AB) in the left deltoid and intramuscular first dose of MENACTRA vaccine (batch number: U4648AA, side: Right, anatomicl site of vaccination was not reported) on 14 August 2013. The patient had no known drug allergies or illness at the time of vaccination. The patient's concomitant medications were not reported. On 16 August 2013, 2 days after receiving ADACEL and MENACTRA, the patient developed reaction of redness and swelling at injection site at left deltoid. The corrective treatments and laboratory investigations were not reported. The patient had recovered from the events on an unspecified date. Follow up information received from a healthcare professional on 12 November 2013. The patient complained of pain in left groin hip area at the time of vaccination. The patient was 11 year old at the time of event. The patient had received ADACEl vaccine in left arm and MENACTRA vaccine in right arm. At the time of this report, the cessation date was unknown. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Initial report received from a healthcare professional on 29 August 2013. A 48-year-old female patient, had received an intramuscular dose of ADACEL vaccine (batch number: U4618AA, expiry date: 23 October 2015) in the left deltoid on 23 August 2013. The patient had medical history of hypothyroidism and had no acute illness at time of vaccination. The patient received Synthroid for hypothyroidism. The patient also has sulfa drug allergies. On 27 August 2013 i.e. 4 days post vaccination, the patient developed redness, itching and a welt like area at the injection site. Laboratory investigations were not reported and the patient advised over the phone by the practice to take OTC ALLEGRA 80 mg (Fexofenadine) or BENADRYL as corrective treatments. The patient outcome was unknown. Documents held by sender: none. The follow up was received from Health care professional on 07 October 2013. Patient's address detail added. Responsible physician's name updated.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Lymphadenopathy, Rash generalised, Rash pruritic, Vaccination site pain
Clinical narrative: Initial report received from a healthcare professional on 29 August 2013. A 51-year-old female patient, had received a dose of ADACEL vaccine (lot number U4618AA, expiry date: 10/23/2015, dose number was not reported) intramuscularly in the left deltoid on 20 August 2013. The patient's medical history included: Hypothyroidism, Meniscus tears, Depression, Anxiety, High cholesterol, Latex allergy, Back pain and Sinus headaches. The patient had illness at the time of vaccination. On 22 August 2013, the patient developed redness, pain and swelling at vaccination site, lymphadenopathy and generalized rash with itching. Laboratory details were not reported. On an unspecified date, the patient had received DEPO-MEDROL Injection 80 mg and advised to take OTC BENADRYL on 20 August 2013 and OTC ALLEGRA. On 27 August 2013, the patient started treatment with MEDROL dose pack. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none. The follow up information received from health care professional on 07 October 2013: The patient's address details added.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Initial report received from a healthcare professional on 29 August 2013. A 51-year-old female patient, had received a dose of ADACEL vaccine (lot number U4618AA, expiry date: 10/23/2015, dose number was not reported) intramuscularly in the left deltoid on 20 August 2013. The patient's medical history included: Hypothyroidism, Meniscus tears, Depression, Anxiety, High cholesterol, Latex allergy, Back pain and Sinus headaches. The patient had illness at the time of vaccination. On 22 August 2013, the patient developed redness, pain and swelling at vaccination site, lymphadenopathy and generalized rash with itching. Laboratory details were not reported. On an unspecified date, the patient had received DEPO-MEDROL Injection 80 mg and advised to take OTC BENADRYL on 20 August 2013 and OTC ALLEGRA. On 27 August 2013, the patient started treatment with MEDROL dose pack. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none. The follow up information received from health care professional on 07 October 2013: The patient's address details added.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Hot flush, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional (consumer) on 03 SEPTEMBER 2013. A 64-year-old female patient whose medical history includes acid reflux and hiatal hernia and concomitant medication was not reported, had received a ADACEL (batch number: site of administration and dose number were not reported) intramuscularly on 13 AUGUST 2013. On 14 AUGUST 2013, 24 hours after vaccination the patient experienced symptoms of arm soreness and stiffness. On 17 AUGUST 2013, the patient experienced episodes of flushing and it was hot flash, symptom remains as it on day and night. On unspecified date in next week the patient had episode of frequent flushing which were sporadic and lasted from just a few minutes to hours. Symptoms continue to occur. No laboratory investigations were done and corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow up received on 03-OCT-2013. No new information was reported.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose abnormal, Foetal exposure during pregnancy, Foetal growth restriction, Pyrexia
Clinical narrative: This case is linked to case number 2012-08522 (mother case). Initial report received from a healthcare professional on 06 September 2013. An infant, whose gender, weight and height were not reported was exposed to ADACEL vaccine via transplacental route (lot number unknown) on 12 September 2012. The baby's personal and family history was not reported. The baby had intrauterine growth retardation (IUGR). Other diagnosis included fever and glucose problems. No laboratory tests and corrective treatment were reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.