chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 30-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored sterile diluent (MERCK). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6° F to 14°F for 6 minutes. Reportedly, there had been no previous temperature excursions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1809USA004794: US-009507513-1809USA006756.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from an office staff. This case involves an adult female patient (age was not reported) who was vaccinated once with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot number: UT6262KA; expiry date: 30-Jun-2019) on 04-Sep-2018. The patient's medical history, previous medications and concomitant medication were not reported. It was a case of actual medication error due to poor quality vaccine administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. It was not reported whether the patient experienced any adverse event following the vaccination. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 14 months old male patient who was vaccinated with a dose of QUADRACEL (batch number C5325BA) (expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered to patient of inappropriate age (the patient was vaccinated with QUADRACEL but do not have the required age (4-6)). No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252181 and 2018SA252198 (same reporter). This case involves patient (age and gender not provided), who was vaccinated with expired dose of PENTACEL (lot number: C5384AA and expiry date: 30-JUN-2018) (dose, dose in series and route of administration were not reported) in the left leg on an unspecified date. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (Lot number, dose, route and site of administration not provided) on an unknown date. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU4, HEPA, HIBV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient (gender not reported) who was vaccinated with 0.5 ml first dose of FLUZONE QUADRIVALENT (batch number UT6290KA and Exp. Date not reported) via intramuscular route in unknown administration site on 05-Sep-2018. The patient's medical history was not reported. Concomitant medications included HEPATITIS A VACCINE for Immunization; HIB VACCINE for Immunization; and PREVNAR for Immunization. It was an actual medication error due to overdose as the patient was given 0.5ml instead of the recommended 0.25ml. No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient (age unknown) who experienced bruising and soreness at the injection site, while she received vaccine INFLUENZA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious bruising and soreness at the injection site following the administration of INFLUENZA. It was reported that patient received another 3 strain flu vaccine last year and had smaller arms, and gets bruising and soreness at the injection site after her flu vaccines each year. Other relevant tests included no lab data. Final diagnosis was soreness at the injection site and bruising. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome is unknown for bruising and soreness at the injection site. List of documents held by sender none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a child male patient (age was reported as 2) who was mistakenly vaccinated with a 0.25 ml single expired dose of FLUZONE QUADRIVALENT (batch number: UT5897NA, expiration date: 07-Jun-2018, dose, dose in series, route and site of administration were not reported) on 06-Sep-2018. The patient's concomitant medications, medical history and previous medications was not reported. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse reactions following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 4 months old male patient who received expired dose of vaccine, no AE PENTACEL on 10-Sep-2018 which was expired on 02-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 10-Sep-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE lot C5403AB via intramuscular route. It was case of actual medication error due to expired vaccine use. It was also reported that patient did not visit any Emergency room. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703, 2018SA251366 and 2018SA251618 (Same reporter). This case involves a six-year-old patient (gender not reported) who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said it was still cool). No other vaccine was given to patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain, swelling at injection site, fever, headache, muscle aches, nausea, fatigue, soreness at site.  Treated with OTCs:  Tylenol #3, APAP, Benadryl, fluids. Did not go to ER.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Pain, swelling at injection site, fever, headache, muscle aches, nausea, fatigue, soreness at site.  Treated with OTCs:  Tylenol #3, APAP, Benadryl, fluids. Did not go to ER.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patients arm started to swell up on 09/12/2018 evening. Ice packs and Ibuprofen were given to help reduce swelling. However swelling got worse on 09/13/2018 and was very warm to the touch. Patient complained of itchiness and 3/4 of the circumference of the arm was red and swollen. Spot was also very hard to the touch. Patient was prescribed cephalexin suspension 250mg/5ml 10ml TID for 10 days and Orapred ODT 15mg 1 tab BID for 5 days.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient complained of redness in the arm where she received the vaccination. The red area had spread since she received the vaccine and she was becoming increasingly concerned.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Sore, swollen arm from shoulder to elbow. Pt elevated arm, applied heat and took ibuprofen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Shingles vaccine SHINGRIX. Increasing soreness initially. On the 2nd day, a red strip about 4 inches long going down my arm from the shot. On the 3rd day when I woke up it was triangular in shape and covered 1/3 of my upper arm under the shot site. It was very red and swollen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Diarrhoea, Discomfort, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Unable to move arm by 5pm same day of vaccine drowsiness; unable to undress-had to have help from neighbor; vomiting/diarrhea x2days; throbbing arm x4 days; upper arm/armpit painful; still uncomfortable as of 7/17/18.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Somnolence, Vomiting
Clinical narrative: Unable to move arm by 5pm same day of vaccine drowsiness; unable to undress-had to have help from neighbor; vomiting/diarrhea x2days; throbbing arm x4 days; upper arm/armpit painful; still uncomfortable as of 7/17/18.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: High Fever - 103, Chills, Joint pain, Fatigue, Headache. Started at about 6 hours after injection and lasted 2 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Axillary pain, Erythema, Fatigue, Myalgia
Clinical narrative: Redness/swelling about the size of baseball x5-7 days; arm/armpit pain on a scale of 7 out of 10 for 5-7 days; Fatigue/stomach cramping/muscle aches x1 day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Redness/swelling about the size of baseball x5-7 days; arm/armpit pain on a scale of 7 out of 10 for 5-7 days; Fatigue/stomach cramping/muscle aches x1 day.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Night sweats
Clinical narrative: Patient states they had cold chills, night sweats, and breathing difficulties. Stated the symptoms lasted 8-12hrs, but were worrisome. The patient states they are no longer having any symptoms, and did not seek medical treatment for the symptoms.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who was given solution and was not mixed with the powder for the dose of PENTACEL lot number not reported via unknown route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain
Clinical narrative: Patient complained of pain and soreness. When daughter checked it next day saw redness under the site of injection that has still not resolved after almost 72 hours.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Developed redness, warmth, swelling to right upper arm, low grade fever 99 degrees F. Pain to area of injection approx. 24 hours post injection. Administered on 9/10/18 by RN.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Abscess, Gait disturbance, Pyrexia, Skin lesion
Clinical narrative: Pt had target lesions from head to toe, no involvement of mucus membranes, fever after 5 days greater than 101, no joint swelling but by 5th day pt was refusing to ambulate but could have been due to abscess and well as fever.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus
Clinical narrative: ITCHY AND BLISTER ON FOOT ON THE FIRST DAY TOOK BENADRYL AND BETTER THE NEXT DAY.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Nausea, tired, weak, headache, chills, fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, tired, weak, headache, chills, fever.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Ear pain, Rash generalised, Streptococcus test positive, Swelling face
Clinical narrative: Rash head to toe, ear pain, stomach pain, swollen face. He was taken to his doctor and he tested positive for Strep. Was given antibiotics.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pruritus generalised, Wheezing
Clinical narrative: Developed redness and swelling at IM site. Generalized itching and SOB with wheezing.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, weak, headache, chills, fever.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Irritability, Pyrexia, Somnolence, Urticaria
Clinical narrative: Vaccines administered on 07-31-18 at 11:20am. Infant was at the babysitters that night and was noted to be very fussy and sleepy. Slept for three hours. At 10pm when mother returned home with infant she removed his sleeper and noted a large red raised hive on his right arm. Mother states the hive covered most of his arm. Infant had a low grade fever of 101.1. Acetaminophen given. Mother monitored infant closely thru out the night. Mother then noticed the large hive on left arm and the right arm hive faded. This then progressed to left side of face and forehead and then to right side of face and forehead with the left side faded. This lasted for approximately 24 hours. Then for the next 4-5 days mother noted smaller red raised hives over arms and legs and face that would be present and then fade away. Infant ran a low grade fever for 3 days which was controlled with Acetaminophen. Mother contacted family Dr, on 08/02/18. Doctor ordered ZRYTEC for infant once daily. Mom states the rash improved each day infant took ZRYTEC and only had to take the ZRYTEC for 3days before the rash was gone.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased
Clinical narrative: Limited range of movement of the shoulder since injection was given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Patient experienced headache the day she received the vaccine, then she had redness of her upper arm where she received the vaccine, pain at the site of the injection, intense itching.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Lethargy, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Around 12 hours post vaccination patient had severe soreness in arm. Woke her up from sleep painful. Around 24 hours patient arm pain was so bad she could not lift her arm. Had fevers (101) chills, lethargy. Today (3 days post imz) symptoms are much better and fever almost gone.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain
Clinical narrative: Patient received ADACEL vaccination. One day later started to experience chills and body aches without fever. The patient call pharmacy two days later still with same symptoms but starting to feel better. Pharmacy called Dr. Office and reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. The patient's concomitant therapies included sterile diluent. On 04-SEP-2018, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneous, lot # R011803, expiration date 21-OCT-2019 (dosage schedule, route and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of -9 to 8 degrees Celsius (-8.9) for 1 hour 29 minutes. The previous temperature excursion was -14 to -10 degrees Celsius for 4 hours and -9 to 8 degrees Celsius for 4 hours 34 minutes. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-JAN-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 23-JAN-2015, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding 17 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old male patient who received two does of vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication taken. On 07-Sep-2018, the patient received two 0.5 ml doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI985AC (expiry date: 30-MAR-2019) twice in the left and right deltoid. It was a case of actual medication error due to extra dose administered. No adverse event observed at the time of reporting.. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with 2018SA256110, 2018SA256129 (same reporter). This case involves a 10 years old female patient who received vaccine IPOL while it was stored at temperature of 49.8 degrees Fahrenheit. The excursion lasted approximately 4 hours. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunization; VARICELLA VACCINE (LIVE) for Immunization; and HEPATITIS A VACCINE for Immunization. On 01-Aug-2018, the patient received a once 0.5 ml dose of suspect IPV (VERO) lot N1J45 expiry date 05-Oct-2019 via subcutaneous route in the left arm. It was a case of actual medication error due to incorrect product storage. It was not reported any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an eighteen months old female patient and it was reported that 18 months 20 days female child was given DAPTACEL along with her other vaccines that included PENTACEL, she received vaccines PENTACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine; MMR; PREVNAR 13; and Varicella Zoster Vaccine. On an unknown date, the patient received a 1st dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C524AA and expiry date: 18-Sep-2019) via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ACTHIB portion lot number: C5543AA and Dtap portion lot number: C540AA and expiry date: 08-Sep-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error case due to inappropriate schedule of vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLUR4, MENB, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 17 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (lot number: QFFA1804 and expiry date: 01-Jun-2019) via intramuscular route in the left deltoid on 07-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation; and TRUMENBA for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Age: 2.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old female patient who received ADACEL instead of DAPTACEL in error which was her fourth in the series. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunization; and VAQTA for Immunization. On 06-Sep-2018, the patient received a Fourth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA expiry date 16-Jun-2020 via intramuscular route in the right thigh. Needle size was 25 gauge 5/8. It was a case of actual medication error due to Wrong vaccine administered and also for inappropriate age at vaccine administration as 24-month old patient was given ADACEL. No Adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 07-Sep-2018. This case involves a 17 years old male patient who was vaccinated with a dose of FLUBLOK QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (FLUBLOK vaccine was administered to a 17 year old patient). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a child patient (age and gender was not reported) who was vaccinated only with diluted part of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) and not the liquid component, no AE on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique and product use issue (it was reported that the caller had given the diluted part of the vaccination and not the liquid component). No further information was provided. No information about adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Liquid product physical issue, Product quality issue
Clinical narrative: Initial unsolicited report received from a pharmacist on 10-Sep-2018. This case involves a patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI996AB, expiration date: 30-Jun-2019, route and site of administration was not reported) on 09-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to and product quality issue and syringe issue. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to cases 2018SA255093 and 2018SA256110 (same reporter). This case involves a four-years one-month old female patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1J45, expiration date: 05-Oct-2019, subcutaneously in left side on 23-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunization; VARICELLA VACCINE (LIVE) for Immunization; and HEPATITIS A VACCINE for Immunization. It was a case of actual medication error due to incorrect product storage. It was also reported that vaccine was exposed to temperature of 49.8 degrees F. The excursion lasted approximately 4 hours. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case is linked to case 2018SA256161 and 2018SA256154 (same reporter). This case involves 67-years old female patient who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient was not pregnant. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-health care professional (office staff). This case is linked to cases 2018SA256146 and 2018SA256161 (same reporter). This case involves an 87-year-old male patient who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018 in the left arm. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from healthcare professional. This case is linked to cases 2018SA256146 and 2018SA256154 (same reporter). This case involves an elderly female patient (gender was not reported) who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018 in the left arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256201 (same reporter). This case involves a six-months old male patient who was vaccinated with a 0.25 ml single dose of FLUZONE QUADRIVALENT (lot number: UT6262MA; expiry date: 30-Jun-2019) (route of administration was not reported) in right thigh on 04-Sep-2018 that was in a shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; ROTATEQ for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to incorrect product storage. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA256264 (Same reporter). This case involves a 4 years old female patient who was vaccinated with 0.5 ml dose of IPOL (Batch number: NIG411M and expiry date: 28-Jul-2018) (dose in series, route and site of administration were not reported) on 28-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccine had been out of range for over 30 minutes and should of been discarded. Neither have an adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.