chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Metabolic function test, Pain in extremity, Platelet count, Pyrexia
Clinical narrative: Fever 102 degrees, Headache, Weakness, Swelling and Hives/Welts from Shoulder under arm and on top to elbow, Painful, Basic Metabolic Panel (8), CBC w/differential, CBC w/differential w platelet, Urinalysis w/culture reflex.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling, Urine analysis, Urticaria
Clinical narrative: Fever 102 degrees, Headache, Weakness, Swelling and Hives/Welts from Shoulder under arm and on top to elbow, Painful, Basic Metabolic Panel (8), CBC w/differential, CBC w/differential w platelet, Urinalysis w/culture reflex.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Fatigue, Injection site pain, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Patient states that she had soreness at injection site, fever, and body aches that began 24 hours after administering the vaccines. Then on 9-14-2018 in the evening she states that her feet, arms, hands and face began to swell. She also stated that she was extremely tired and unable to move. She states that she did not call 911, or seek medical attention. She instead went to a friend's house.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Pyrexia, Swelling face
Clinical narrative: Patient states that she had soreness at injection site, fever, and body aches that began 24 hours after administering the vaccines. Then on 9-14-2018 in the evening she states that her feet, arms, hands and face began to swell. She also stated that she was extremely tired and unable to move. She states that she did not call 911, or seek medical attention. She instead went to a friend's house.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, shivering, muscle aches - lasted for the whole day. Took some TYLENOL.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient donated 879 mL of plasma and shortly after received Tdap injection (at 2:22 pm), Patient stayed at the center for 15 minutes with no reaction. Patient states that she walked to the bus and boarded a bus. Patient states that it was a very hot day and she walked over a mile to the bus depot before boarding the bus. Patient states that approximately 1 hour after she left the plasma center, she was standing on the bus and fainted and had no other symptoms. Patient is unsure how long she had LOC and a bystander called an ambulance. Donor states she was evaluated by paramedics, but it was not recommended by paramedics to be transported to the hospital. Patient states she has felt fine since regained consciousness.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient stated that following flu vaccine, she passed out due to fatigue and slept most of the day. In the middle of the night, she had nausea, vomiting, and diarrhea up until 3 am on 9/18/18. She stated she did not eat anything after the vaccine because she did not feel good. She is sweating and possibly running a fever so she took three 81mg aspirins. She is chronically taking oxycodone 5 mg twice daily for pain as well. Patient was counseled to rest and stay hydrated. She was told to monitor her symptoms and to reach out to her PCP to follow up. She was also told to go to urgent care/ER if symptoms continue to worsen (nonstop vomiting/diarrhea and if temperature doesn't go down with 24 hours).
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient stated that following flu vaccine, she passed out due to fatigue and slept most of the day. In the middle of the night, she had nausea, vomiting, and diarrhea up until 3 am on 9/18/18. She stated she did not eat anything after the vaccine because she did not feel good. She is sweating and possibly running a fever so she took three 81mg aspirins. She is chronically taking oxycodone 5 mg twice daily for pain as well. Patient was counseled to rest and stay hydrated. She was told to monitor her symptoms and to reach out to her PCP to follow up. She was also told to go to urgent care/ER if symptoms continue to worsen (nonstop vomiting/diarrhea and if temperature doesn't go down with 24 hours).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to three 17 year old patients of unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with an adult dose of VAQTA (lot number R000180 with expiration date: 21-MAR-2019) for prophylaxis; the strength and doses were not reported for the vaccines. No adverse effects reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to an 18 year old female patient. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 31-AUG-2018, the patient was inadvertent vaccinated with GARDASIL 9 (dose number, dosage, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) for prophylaxis. No adverse events were reported. The patient became pregnant with Last Menstrual Period (LMP) of approximately 05-JAN-2018 and Estimated Delivery Date (EDD) of approximately 12-OCT-2018. Initial exposure to GARDASIL 9 was at 34 weeks.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot number R007684, expiration date on 11-SEP-2019 (strength, dose number, anatomical location and route of administration were not reported). The temperature excursion was from 6 degrees Fahrenheit (degrees F) to 14 degrees F for a time frame of 58 minutes without a previous temperature excursion and was called because a digital data logger. There was not adverse effect reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA002675.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 received 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 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 received 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 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 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 a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-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 received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
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 patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-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: 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 a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-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: 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 27-JUL-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: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-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: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-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:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 14-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-NOV-2012, the patient received the ZOSTAVAX (dose, route, and lot number not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 07-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of use of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a adult female patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), tremor of hands (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was resolved with sequelae and the outcome of the tremor of hands was not recovered/not resolved and the outcome of the paralysis was unknown. It was unknown if the reporter considered the Guillain Barre syndrome, tremor of hands and paralysis to be related to Flu trivalent vaccine. Additional details were provided as follows: This case was reported by the patient for herself. The patient developed Guillain Barre Syndrome after receiving unknown flu shot when she was 16 years old. She was paralyzed, caused her to only be able to blink her eyes. She was in the hospital for two years. She stated that she had recovered but was left with tremors in her hands. The patient had denied permission to contact their physician. The reporter was unable to provide any additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in adult's unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, malaise and fever. On an unknown date, the outcome of the pain, malaise and fever were unknown. It was unknown if the reporter considered the pain, malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The health care professional reported that he had seen multiple patients who had experienced some or all of the reported symptoms (pain, fever, malaise, aches) as noted in the prescribing information. The health care professional did not administer the vaccine; his patients had been vaccinated at various locations.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Influenza like illness, Malaise, Myalgia, Nausea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 17-year-old male patient who received BEXSERO for prophylaxis. On 13th August 2018, the patient received BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced influenza-like symptoms, myalgia, arthralgia, malaise and nausea. On an unknown date, the outcome of the influenza-like symptoms, myalgia, arthralgia, malaise and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, myalgia, arthralgia, malaise and nausea to be related to BEXSERO. Follow up information received from nurse via licensee on 11th September 2018: For 24 hours the patient experienced flu like symptoms, myalgia, arthralgia, malaise and nausea. By 48 hours the symptoms were gone. The patient's mother was the reporting physician and stated no other vaccines were given at that visit. This case was linked to the case US2018GSK164091, reported by the same reporter.
Age: 15.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Arthralgia, Influenza like illness, Malaise, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 15-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 13th August 2018, the patient received BEXSERO .5 ml and GARDASIL. On an unknown date, less than a month after receiving BEXSERO, the patient experienced myalgia, arthralgia, malaise and influenza-like symptoms. The patient was treated with MOTRIN. On an unknown date, the outcome of the myalgia, arthralgia, malaise and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the myalgia, arthralgia, malaise and influenza-like symptoms to be related to BEXSERO. Follow up information received from nurse via licensee on 11th September 2018: The patient's mother was the reporting physician. The patient received BEXSERO in the left arm. The patient also received GARDASIL (HPV) at the same time. The symptoms lasted for 24 hours. The patient did take Motrin. This case was linked to the case US2018GSK164081, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration from 11Sep2018 single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient developed body aches, pain up to her shoulder and a low grade fever (99.7 degrees F but it might have been higher) on an unspecified date. Outcome of the events was unknown. Information about the lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (medical assistant) and a physician. A female patient of unspecified age received TRUMENBA (lot number: T52806 and expiration date: 31Dec2019), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the day after the patient received meningococcal group B rlp2086, she was having a reaction they never heard before, she started feeling the pain in her arm and shoulder but that didn't surprise them because she received the vaccine. There was no redness and no swelling but the pain was now spread, taking up most of her body, her legs, back and chest so it's like she was just getting full body pains and aches from the vaccine. There was no redness and swelling at the site of injection. Outcome of the events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A female patient of an unspecified age received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of TRUMENBA on an unspecified date. It was reported that back in Jul2018, the patient experienced malaise, feverish and fatigue after meningococcal group b rlp2086 was received on an unspecified date in 2018. This was the second dose and the nurse was unsure if anything happened with the first dose but they did complete the 2 dose series. Outcome of the events was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves two- patients (gender and age at the time of reaction were not reported) who were vaccinated with a dose (reported as invalid doses) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, dose in series, site and route of administration were unknown) on an unspecified date. The patient's medical history, concomitant diseases, family history, risk factors and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that two patient received invalid doses of flu vaccine, package of vaccines shipped on 30 Aug 2018 that arrived on 04 Sept 2018. It was not reported whether the patients experienced any adverse events 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 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
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a six months old male patient who was vaccinated with a dose of PENTACEL (batch number, 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 product storage error (vaccine was exposed to temperature below 0 degree C). No 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: FLU4, HEP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 9 months old patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (lot number: UT5897MA; expiry date: 30-Jun-2018) (route and site of administration was not reported) on 10-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) on the same day (dates 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 events or not. 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 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 athorization 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: 58.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-health care professional. This case involves a 58 years old patient (gender was not reported) and caller stated that a 58 year old received the high dose and should have received the FLUBLOK, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 10-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI995AA) (expiry date, dose in series and route was not reported) in the left deltoid. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse effects were 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: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case is linked to case 2018SA258056 (same reporter). This case involves a 30 years old female patient who received 0.5 ml booster dose of ADACEL (expiry date 22 June 2020 and lot details U5980DA) on 10 Sep 2018 while she was pregnant. The date of last menstrual period was reported as 23-Jan-2018. The estimated due date is 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant. It was a case actual medication error due to incorrect product storage as ADACEL too long in shipping (greater than 2 days) after dose given to pregnant female outside of stability recommendations. It was unknown if any adverse event 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. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial unsolicited pregnancy report received from a nurse via phone on 11-Sep-2018. This case involves a 23 years old female patient who was exposed to vaccine ADACEL at 24 weeks and 1 day gestational age. The patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 27 weeks of pregnancy, during third pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 07-Mar-2018. The estimated due date is 12-Dec-2018. The patient previous pregnancies was unknown. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is a case of vaccine exposure during pregnancy. Relevant prenatal testing after exposure included was unknown. Other relevant tests included no lab data. Additionally, at time of reporting, the pregnancy is still ongoing. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient (age not reported) who received a dose of FLUZONE QUADRIVALENT lot UT6290MA, expiry date: 30-Jun-2019, via intramuscular route in the deltoid NOS on an unknown date, which was not stored correctly. 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 incorrect product storage. It was reported that the vial of FLUZONE had taken 5 days in shipping instead of 2 days of shipping and was warm to the touch before injecting. The patient did not experience any adverse effects 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 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves 200 patients of an unknown demographics who received a 0.5 mL dose of FLUZONE lot UI998AC via intramuscular route on an unknown date, which was stored incorrectly. 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 incorrect product storage. It was reported that FLUZONE delivery came three days later than expected. Delivered on 20-Aug-2018 instead of 17-Aug-2018. Approximately 200 doses had been administered. The vaccines were cool to the touch but unknown temperature. The patients did not experience any adverse effects 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: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA258575 (same reporter). This case involves a seven-years old patient (gender not reported) who received a 0.5 mL dose of FLUZONE QUADRIVALENT lot UI998AC via intramuscular route in the left deltoid on 24-Aug-2018. 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 incorrect product storage. It was reported that the FLUZONE QUADRIVALENT was delivered later than it should have and the product was out of temperature range. 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: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves an 88 years old female patient who received a 0.5 mL dose of FLUZONE HIGH DOSE lot UI977AB, expiry date: 09-Mar-2019, via intramuscular route in the left deltoid and then again a 0.5 mL dose of it lot UJ006AB, expiry date:14-Apr-2019, via intramuscular route in the left deltoid. 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 extra dose administered. It was reported that patient was accidentally administered FLUZONE HIGH DOSE on 13-Aug-2018 and then again on 12-Sep-2018 due to a clerical error. The previous immunization was not documented so they reinjected the FLUZONE HIGH DOSE. The patient did not experience any 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. List of documents held by the sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA258725 (same reporter). This case involves a 11 years old male patient who received a dose of MENACTRA lot U6152AA in the right arm on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that some vaccines that arrived after 72 hours rather than 48 and that vaccines should not be used. It was not reported if the patient experienced any adverse event. 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 weeks old female patient who received a dose of PENTACEL C5545AA, 06-Oct-2019, in the left thigh on 11-Sep-2018, which was incorrectly reconstituted. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the liquid portion was not given at all and the lyophilized powder portion was reconstituted with 0.5 NS/ 5 ml. Liquid lot number: C5408AB and Lyophilized Powder: Lot C5545AA, expiry date: 06-Oct-2019 for both. It was reported the patient did not experience 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 the sender: none.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient claimed at the 2nd dose that she has developed Shingle around her mouth ~ 2 months after the 1st shingle shot and was treated by her primary dr with valcyclovir.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rashes, high temps.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Very Sore Arm. Patient states soreness set in soon after injection, same afternoon.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Pyrexia
Clinical narrative: Extreme bruising and pain. Fever the night of.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Mom called and reported both arms swollen and warm to touch, right arm worse than left arm. Told mom to put cool compress on them. She will follow up if not better in a couple of days.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: Swelling of fingers and forearms, no pain, no fever, no itching or irritation. No irritation or swelling of injection site.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccination at 2pm on 9/16/18. By 4pm on 9/16/18 patient stated that her arm started hurting. Patient went to doctor the following day and the doctor stated that the injection was given too high on the patient's arm.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Syncope
Clinical narrative: The affected individual donated a unit of plasma and then, shortly thereafter, received the TENIVAC vaccine. After receiving the vaccine, the individual had a syncopal episode the lasted approximately 10-15 seconds. The individual recovered quickly and had no further symptoms.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: My son received the vaccine Meningococcal B on Friday, September 14, 2018 at 3:30 pm. We went home after the injection and my son complained that his arm was very sore. I told him to ice it, and he tried but it was very painful to keep the ice on it. He went to his dads for dinner and came home saying he was very dizzy and had a bad headache. He felt very hot so I took his temperature. It was 101.5.  He said he was going to lay down as he felt like he was going to pass out. He slept all night and most of the next day. He woke up hungry but had a fever of 102.1. He tried eating some spaghetti, but he was very nauseous. He had a bad headache, all his joints ached, and muscles ached and very tired. He had the chills and fever still 102. The injection site was very hot and red and swollen. I took him to the ER to have him checked. The doctor thought he had an abscess at the injection site as it was so swollen and red. He did an ultrasound on his arm, and it looked ok.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: My son received the vaccine Meningococcal B on Friday, September 14, 2018 at 3:30 pm. We went home after the injection and my son complained that his arm was very sore. I told him to ice it, and he tried but it was very painful to keep the ice on it. He went to his dads for dinner and came home saying he was very dizzy and had a bad headache. He felt very hot so I took his temperature. It was 101.5.  He said he was going to lay down as he felt like he was going to pass out. He slept all night and most of the next day. He woke up hungry but had a fever of 102.1. He tried eating some spaghetti, but he was very nauseous. He had a bad headache, all his joints ached, and muscles ached and very tired. He had the chills and fever still 102. The injection site was very hot and red and swollen. I took him to the ER to have him checked. The doctor thought he had an abscess at the injection site as it was so swollen and red. He did an ultrasound on his arm, and it looked ok.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: My son received the vaccine Meningococcal B on Friday, September 14, 2018 at 3:30 pm. We went home after the injection and my son complained that his arm was very sore. I told him to ice it, and he tried but it was very painful to keep the ice on it. He went to his dads for dinner and came home saying he was very dizzy and had a bad headache. He felt very hot so I took his temperature. It was 101.5.  He said he was going to lay down as he felt like he was going to pass out. He slept all night and most of the next day. He woke up hungry but had a fever of 102.1. He tried eating some spaghetti, but he was very nauseous. He had a bad headache, all his joints ached, and muscles ached and very tired. He had the chills and fever still 102. The injection site was very hot and red and swollen. I took him to the ER to have him checked. The doctor thought he had an abscess at the injection site as it was so swollen and red. He did an ultrasound on his arm, and it looked ok.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Mom states a rash covering most of child's right thigh that looks like a sunburn.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Tic
Clinical narrative: Motor tic.