chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Fatigue
Clinical narrative: 1 hour after vaccine administration developed chest pain, fatigue, SOB. "Like hit by a train" Recommended rest, Benadryl prn
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Pain, Pain in extremity
Clinical narrative: Deep radiating pain in upper left arm. When I lie down on left side painful. Through the day off and on pain. Lift arm painful. Wake up from pain in arm at night. Very uncomfortable.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Amnesia, Confusional state, Hallucination, visual, Memory impairment, Palpitations
Clinical narrative: Heart palpitation 1st day Sleepiness     2  day Visions-hallucinations 3rd day Memory loss 2 wks later Confusion    3 wks later Forgetfulness   3 wks later
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: Heart palpitation 1st day Sleepiness     2  day Visions-hallucinations 3rd day Memory loss 2 wks later Confusion    3 wks later Forgetfulness   3 wks later
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Td vaccine administered 11/4/19. Patient called 11/7 to discuss ongoing pain. Reports sharp pain @ site to finger tips. F/U call to pt. on 11/11, reports inability to lift arm over head, pain still present.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling heat redness pain > insertion site
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1 DAY after flu immunization area LUA - Red - got worse, hot too touch & tender too touch.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood test normal, Dehydration, Erythema, Feeling abnormal
Clinical narrative: Client reported waking up Thursday 10/17/19 vomited 1 time and left arm was swollen above the elbow to the injection site. Arm was red and warm to touch and she felt week and not good. Friday the arm was still swollen & she was still week so went to FNP at medical office they gave her a breathing treatment and and told her she was dehydrated and had fever of 102 so advised her to the ER at the ER Patient states they took her blood and told her all her labs were ok and sent her home. No meds given per pt repot. On Saturday she was feeling better and the swelling had went down a little and has continued to go down each day until It was completely gone on Tuesday the 22nd.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Vomiting
Clinical narrative: Client reported waking up Thursday 10/17/19 vomited 1 time and left arm was swollen above the elbow to the injection site. Arm was red and warm to touch and she felt week and not good. Friday the arm was still swollen & she was still week so went to FNP at medical office they gave her a breathing treatment and and told her she was dehydrated and had fever of 102 so advised her to the ER at the ER Patient states they took her blood and told her all her labs were ok and sent her home. No meds given per pt repot. On Saturday she was feeling better and the swelling had went down a little and has continued to go down each day until It was completely gone on Tuesday the 22nd.
Age: 68.0
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Chills, headache, redness & swelling @ injection site, area was hot
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: The patients doctor called and stated that the patient got a pneumonia shot and came into the doctor's office and had what appeared to be cellulitis, and the doctor called in an antibiotic (Augmentin 875mg)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Influenza like illness
Clinical narrative: I had a mild headache and felt tired a few hours after the vaccine. Approximately 12 hours later, I felt very cold and could not get warm. I spent the night shivering tossing and turning with a bad headache, and woke up around 5 AM with a slight fever. I was very ill the rest of that next day, unable to get out of bed, with a bad headache and feeling very sleepy and sick like I have the flu. Plus my arm where I had the shot is and was very sore.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Mobility decreased, Pyrexia, Restlessness
Clinical narrative: I had a mild headache and felt tired a few hours after the vaccine. Approximately 12 hours later, I felt very cold and could not get warm. I spent the night shivering tossing and turning with a bad headache, and woke up around 5 AM with a slight fever. I was very ill the rest of that next day, unable to get out of bed, with a bad headache and feeling very sleepy and sick like I have the flu. Plus my arm where I had the shot is and was very sore.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: I had a mild headache and felt tired a few hours after the vaccine. Approximately 12 hours later, I felt very cold and could not get warm. I spent the night shivering tossing and turning with a bad headache, and woke up around 5 AM with a slight fever. I was very ill the rest of that next day, unable to get out of bed, with a bad headache and feeling very sleepy and sick like I have the flu. Plus my arm where I had the shot is and was very sore.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 101.4 fever, soreness at injection site, joint pain, itching around injection site, redness at injection site, nausea, light headed. Soreness, swelling, redness continues 6 days after injection. Redness, swelling and itching is not getting better.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: 101.4 fever, soreness at injection site, joint pain, itching around injection site, redness at injection site, nausea, light headed. Soreness, swelling, redness continues 6 days after injection. Redness, swelling and itching is not getting better.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Hypoaesthesia
Clinical narrative: possible Guillian Barre syndrome.  Progressive weakness, numbess beginning at feet and progressing upwards
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient had indicated he had not received a pneumonia shot previously.  He was given Prevnar 13 on 11/15/19 and it was later noticed that he had previously received Prevnar 13 on 10/24/18.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Rash, hives, itching on hives on abdomen, neck, and palm of left hand.  Upper lip slightly swollen.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; one dose of improperly stored MMR II  was inadvertently administered to the one patient on 10/3/2019.; Information has been received from a medical assistant, referring to an 18 months old patient of unknown gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.     On 03-OCT-2019, the patient was inadvertently vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) Albumin status rHA (recombinant Human albumin) (one dose, lot number R028003, expiration date 1-OCT-2020; route unknown) for prophylaxis (product storage error). The sterile diluent used to reconstitute the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) was stored properly. No adverse effect was reported, no product quality complaint (PQC) was involved. Temperature was above 47 Fahrenheit (52 Fahrenheit). Time frame was 10 hours. There was no previous temperature excursion. The call was because of a data logger.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On 26-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (strength was reported as 25/0.5; dose, route, lot #, expiration date were unknown) for prophylaxis, which had been following a temperature excursion (lowest temperature below 36 degrees Fahrenheit/2 degrees Celcius (35 degrees Fahrenheit) for 430 minutes) (incorrect product storage). There was no previous temperature excursion. No data logger was involved. No adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Patient inadvertently received a dose of GARDASIL 9 instead of a flu shot on 10/7/2019 and patient was approximately 24 weeks gestation at time of vaccination; Patient inadvertently received a dose of GARDASIL 9 instead of a flu shot on 10/7/2019; This spontaneous prospective pregnancy report was received from a physician concerning to a 21 year old female patient. Information concerning the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 07-OCT-2019, the patient was inadvertently  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (strength, dose, lot # and expiration date were not provided), instead of a flu shot (wrong product administered), and patient was approximately 24 weeks gestation at time of vaccination (exposure during pregnancy). The estimated last menstrual period (LMP) was 20-MAY-2019 and EDD of 24-FEB-2020. The pregnancy outcome was outcome pending.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; Patient received an improperly stored ROTATEQ; This spontaneous report was received from a nurse practitioner, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 05-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as prophylaxis (concentration, number of administered dose and vaccination scheme frequency were not reported; lot number R035374,  has been verified to be a valid lot number, expiration date reported was 15-SEP-2020). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 47.1 degrees Fahrenheit for a time frame of 30 minutes on an unspecified date (product storage error), with a previous temperature excursion of 32.9 degress Fahrenheit for 24 hours; which was detected by a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event.; A patient was administered an improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 01-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as prophylaxis (concentration, number of administered dose and vaccination scheme frequency were not reported; lot number 1660935 has been verified to be a valid lot number, expiration date 06-OCT-2020). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 51.28 degrees Fahrenheit, also reported as total time with the highest temperature above 47 degrees Fahrenheit / 9 degrees Celsius for a time frame of 2 hours and 16 minutes (product storage error), without any previous temperature excursion; no digital data logger was involved.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; dose of GARDASIL may have been administered subcutaneously; dose of GARDASIL may have been administered subcutaneously; This spontaneous report was received from a patient of an unknown age and gender, who is also a physician. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unspecified date in April 2019, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose number, anatomical location of vaccination, lot number and expiration date were not provided) that may had been administered subcutaneously (circumstance or information capable of leading to medication error and incorrect route of product administration). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; ursv; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 05-NOV-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1658256 has been verified to be a valid lot number, expiration date was reported as 18-NOV-2020) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of above 9 degrees Celsius (9.4 C) for 20 minutes (product storage error). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785: US-009507513-1911USA002735: US-009507513-1911USA003116: US-009507513-1911USA003130:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; one dose of improperly stored ROTATEQ was inadvertently administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1658256 expiry date 18-NOV-2020, 1 dosage form for prophylaxis (route was not reported) (product storage error). The vaccine was stored at a temperature of above 9 degree Celsius (C) (9.4 degree C) for a time frame of 20 minutes. There was no previous temperature excursion. The digital data logger was involved. The patient did not experience any adverse effects.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one dose of improperly stored ROTATEQ  was inadverently administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 05-NOV-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, formulation, dose/frequency were not reported) (lot# 1658256, expiry date: 18-NOV-2020) for prophylaxis. On 05-NOV-2019, one dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was inadvertently administered to the patient (product storage error). The vaccine was stored at a temperature of above 9.4 Celsius. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003116: US-009507513-1911USA003130: US-009507513-1911USA002735: US-009507513-1911USA002713:
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: severe symptoms after her second Gardasil vaccine; This spontaneous report was received from a physician via IQVIA, concerning  a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unspecified date, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route, lot#, expiration date were not provided) as prophylaxis.             On an unknown date, after the second vaccine, the patient experienced severe symptoms, therefore her mother contacted me last fall for an appointment. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported. At the time of the report, the outcome of the event was not reported.    The causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was considered as related.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of proquad following temperature excursion; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 13-NOV-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: data logger) (lot # S017240 exp.date: 01-DEC-2020) (strength, dose, frequency, lot/batch number and anatomical location was unknown) for prophylaxis following a temperature excursion (product storage error).        No adverse events were reported. It was reported that the vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (9 degree Celsius to 25 degree Celsius) (47 Fahrenheit) for a time frame of 47 hours. There is no previous temperature excursion. No product quality compliant was reported.  The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; one dose of improperly stored vacine; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 05-NOV-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036581 for prophylaxis.       On 05-NOV-2019, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of HEPLISAV-B Given; Initial Report Received: 09-Aug-2019  and 09-Oct-2019  A pharmacy technician reported that a 61-year-old female, received an expired dose of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history was not reported.     Concomitant medications were not reported.   On 09-Aug-2019, the patient received an expired dose of HEPLISAV-B (lot #103384, expiration date: 06-Apr-2019, NDC# not reported) in the left deltoid. The injection was administered by a Licensed Practical Nurse (LPN) at a clinic. It was reported that the patient was unaware that she was given an expired dose of medication at the time of this report. It was reported that the vaccine was found expired after patient received the vaccine.  On 31-Aug-2019, the patient received the second dose of HEPLISAV-B (lot #, expiration date, and NDC # not reported).   At the time of the report, there were no adverse events reported.   The reporter reported the event as resolved, non-serious and of mild severity.    Company comment:  The company assessed the event of expired dose of Heplisav-B given as non-serious. The event of expired dose of Heplisav-B given is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired dose of Heplisav-B given as non-serious. The event of expired dose of Heplisav-B given is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Student Under Age 18 Received a Dose of Heplisav-B; Initial Report Received on 03-Sep-2019 and 04-Sep-2019   A nurse reported that "two students" under the age of 18 received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Of the two students, one was a 16-year-old female, who received two doses of HEPLISAV-B.   Relevant medical history and allergies were reported as none.   Concomitant medications were not provided.   On 07-Jan-2019, the patient was administered with the first dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).   On 28-Feb-2019, the patient was administered with second dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).   On 03-Sep-2019, the nurse reported via email that two students under the age of 18 received a dose of HEPLISAV-B.   On 04-Sep-2019, the nurse reported that of the two students, one was a 16-year-old female, who received two doses of HEPLISAV-B. No other information was provided.  At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment:   The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Student Under Age 18 Received a Dose of Heplisav-B; Initial Report Received on 03-Sep-2019 and 04-Sep-2019   A nurse reported that "two students" under the age of 18 received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Of the two students, one was reported as a 17-year-old male, who received one dose of HEPLISAV-B.    Relevant medical history and allergies were reported as none.   Concomitant medications were not provided.   On 25-Oct-2018, the patient was administered with the first dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).    On 03-Sep-2019, the nurse reported via email that two students under the age of 18 received a dose of HEPLISAV-B.   On 04-Sep-2019, the nurse reported that of the two students, one was a 17-year-old  male, who received one dose of HEPLISAV-B. He did not return for a second dose. No other information was provided.  At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Vaccination error
Clinical narrative: A Patient Received a Dose of Heplisav-B by Error; Initial Report Received 06-Sep-2019  A physician reported that a patient (unknown age, race, and gender) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization by error.    Relevant medical history and concomitant medications were reported as unknown.    On an unknown date, the patient previously completed the Engerix-B (hepatitis B vaccine) three series vaccine.   On an unknown date, the patient was administered a dose of HEPLISAV-B (lot # 933837, expiration date: 08-May-2021, and NDC # unknown).   On 06-Sep-2019, the physician reported that a patient received a dose of HEPLISAV-B by error. No further information was provided.   At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of vaccination error as non-serious. The event of vaccination error is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of vaccination error as non-serious. The event of vaccination error is unlisted per HEPLISAV-B.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: Patient Given Heplisav-B Intravenously; Partial Dose of Heplisav-B Administered; Decreased Blood Pressure with Treatment; Initial Report Received 11-Sep-2019  A pharmacist reported that a 26-year-old male dialysis patient (unknown race) received a "partial dose" of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization intravenously.    Relevant medical history and concomitant medications were reported as unknown.    On 11-Sep-2019, a pharmacist reported via phone that the patient received a "partial dose" of HEPLISAV-B (lot # L9539, expiration date: Dec 2021, and NDC # unknown) intravenously on this date. A physician was present for the phone call report. The physician telephoned the licensed vocational nurse (LVN), who joined the call with the physician and pharmacist. The LVN stated that the patient had not had any adverse reactions or symptoms of distress. The LVN also stated that the patient arrived at their facility for dialysis with elevated blood pressure. The blood pressure was monitored after the intravenous administration of HEPLISAV-B and it was at 173/96 while on treatment and that this was a normal pressure for him before dialysis. Clonidine was administered for the elevated pressure. At the time of this report, his blood pressure was decreasing. The physician and LVN reported that they would like to be contacted if further information was needed. No further information was provided.   At the time of the report, the LVN noted that the patient had not had any adverse reactions or distress.  The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of incorrect route of product administration, incorrect dose administered by product and blood pressure management as non-serious. The events of incorrect route of product administration, incorrect dose administered by product and blood pressure management are unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the events of incorrect route of product administration, incorrect dose administered by product and blood pressure management as non-serious. The events of incorrect route of product administration, incorrect dose administered by product and blood pressure management are unlisted per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Chills, Constipation, Decreased appetite, Headache, Nausea
Clinical narrative: Increased Nausea; Constipation; Headache; Loss of Appetite; Chills, Fever 1 Week After Injection; Initial Report Received on 23-Sep-2019 and 24-Sep-2019   A pharmacist reported that a 64-year-old female patient (unknown race) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced increased nausea, constipation, headache, no appetite, and "chills, and fever for 1 week after injection".    Relevant medical history included liver cirrhosis. The patient has an allergy to penicillin.   Concomitant medications were not provided.     On 11-Sep-2019, the patient received a dose of HEPLISAV-B (lot # 933842, expiration date: 30-May-2021, and NDC # not reported) via a prefilled syringe. It was reported that the patient received HEPLISAV-B at the direction of her healthcare provider.   On 19-Sep-2019, the patient called the pharmacist stating that she was experiencing an increase of nausea, constipation, headache, loss of appetite, and "chills and fever for a week" following administration of HEPLISAV-B. The pharmacist instructed the patient to report this to her healthcare provider and to go to the emergency department if the symptoms did not improve. No further information was provided.   At the time of the report, the outcome of all events was not reported.    The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of nausea, constipation, headache, loss of appetite and chills, fever as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.; Sender's Comments: The company assessed the events ofnausea, constipation, headache, loss of appetite and chills, fever  as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.
Sex: U
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Increased Nausea; Constipation; Headache; Loss of Appetite; Chills, Fever 1 Week After Injection; Initial Report Received on 23-Sep-2019 and 24-Sep-2019   A pharmacist reported that a 64-year-old female patient (unknown race) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced increased nausea, constipation, headache, no appetite, and "chills, and fever for 1 week after injection".    Relevant medical history included liver cirrhosis. The patient has an allergy to penicillin.   Concomitant medications were not provided.     On 11-Sep-2019, the patient received a dose of HEPLISAV-B (lot # 933842, expiration date: 30-May-2021, and NDC # not reported) via a prefilled syringe. It was reported that the patient received HEPLISAV-B at the direction of her healthcare provider.   On 19-Sep-2019, the patient called the pharmacist stating that she was experiencing an increase of nausea, constipation, headache, loss of appetite, and "chills and fever for a week" following administration of HEPLISAV-B. The pharmacist instructed the patient to report this to her healthcare provider and to go to the emergency department if the symptoms did not improve. No further information was provided.   At the time of the report, the outcome of all events was not reported.    The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of nausea, constipation, headache, loss of appetite and chills, fever as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.; Sender's Comments: The company assessed the events ofnausea, constipation, headache, loss of appetite and chills, fever  as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Patient Not Seroconverted; Initial Report Received on 25-Sep-2019   A nurse reported that a female patient (unknown age and race) was administered 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and that the "patient (had) not seroconverted."     Relevant medical history and concomitant medications were not provided.     On unknown dates, the patient previously received three doses of hepatitis B vaccination (vaccine name not reported).   On 12-Jul-2019, the patient received the first dose of Heplisav-B (lot#, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe.  On 16-Aug-2019, the patient received the second dose of Heplisav-B (lot#, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe.  On 20-Sep-2019, a titer was checked and was noted that the patient had not seroconverted. No further information was provided.   At the time of the report, the outcome of the event was not reported.    The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Heplisav accidentally given to a 17 yo; Heplisav accidentally given for 3rd dose; Initial Report Received on 02-Oct-2019  A reporter reported that a 17-year-old (unknown gender and race) was accidentally administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for their third dose.   Relevant medical history and concomitant medications were not provided.   On an unknown date, the patient accidentally received Heplisav-B (lot #, expiration date, and NDC # not reported) for their third dose. It was unknown if the vaccine was administered from a vial or prefilled syringe.   No further information was provided.   At the time of the report, the outcome of the event was not reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of product administered to patient of inappropriate age and extra dose administered as non-serious. The events of product administered to patient of inappropriate age and extra dose administered are unlisted per HEPLISAV-B.; Sender's Comments: : The company assessed the events of product administered to patient of inappropriate age and extra dose administered as non-serious. The events of product administered to patient of inappropriate age and extra dose administered are unlisted per HEPLISAV-B.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Patient Non-Reactive; Initial Report Received on 09-Oct-2019  A nurse reported that a patient (unknown age, gender, and race) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was non-reactive.   Relevant medical history and concomitant medications were not provided.   On 07-Jul-2019, the patient received the first dose of Heplisav-B (lot #, expiration date, and NDC # unknown).   On 19-Aug-2019, the patient received the second dose of Heplisav-B (lot #, expiration date, and NDC # not reported). The nurse did not provide the lot number, but stated it was a prefilled syringe.   On 19-Sep-2019, approximately 1 month after having received the second dose, the nurse reported that the patient's titer was checked, and showed that the patient was non-reactive.   At the time of the report, the outcome of the event was not reported.  The caller did not want to provide additional information.    The reported did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder  as non-serious. The event is listed per HEPLISAV-B USPI and IB.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old Received Heplisav-B; Initial Report Received on 18-Oct-2019 and 07-Nov-2019 (non-significant)  A pharmacist reported that a 16-year-old patient (unknown gender and race) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history and concomitant medications were not provided.   On an unknown date, the patient received a dose of Heplisav-B (lot #, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe. The pharmacist stated he did not have any other information to provide.   On 07-Nov-2019, the reporter confirmed that additional information was not available.   At the time of the report, the outcome of the event was not reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI and IB.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV, UNK, UNK
Symptoms: Intestinal obstruction
Clinical narrative: INTESTINAL OBSTRUCTION; Information has been downloaded (US-EMA-20110128-slalp-153927830).  This spontaneous report was received from a physician referring to a 2 month old female patient.  No information was provided regarding the patient's medical history, current conditions or concomitant medication.     On 30-APR-1999, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # 0602 for an unspecified indication (dose, route of administration, and expiration date were not reported).    On 27-MAY-1999, the patient was vaccinated with hib conj vaccine (crm197)(HIB-TITER VACCINE), lot # 402203A, poliovirus vaccine inactivated (unspecified)(POLIO VACCINE "PASTEUR"), lot #M1295, both therapies for an unspecified indication (dose, route of administration, and expiration date were not reported).  Other suspect therapies administered on the same day included rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD) oral solution, lot # 4988055, via oral, for immunisation, and diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid(TRIPEDIA)., lot # 0089570 (dose, route of administration, lot number and expiration date were not reported).      On 30-MAY-1999, the patient experienced intestinal obstruction and was hospitalized.  The outcome of intestinal obstruction was reported as recovered (on an unspecified date).   The reporter did not assess the causal relationship between suspect therapies and the event.  The Agency considered intestinal obstruction medically significant.  Lot number 0602 is an invalid lot number for hepatitis b vaccine (recombinant).
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, UNK, UNK, UNK
Symptoms: Intestinal obstruction, Intussusception
Clinical narrative: intussusception; INTESTINAL OBSTRUCTION; Information has been downloaded (US-EMA-20110131-rtevhumanwt-190240506).  This spontaneous report was received from a health professional concerning a 3-month-old female patient. Medical history, concomitant medications and concurrent conditions were not provided.   On 12-MAR-1999, the patient was vaccinated with a dose of diphtheria toxoid, pertussis acellular 4-component vaccine, tetanus toxoid (ACEL-IMUNE) (dose, route, frequency and the expiration date were not reported) Lot# 457-790 for prophylaxis; Hib conj vaccine (CRM197) (dose, route, frequency, lot# and the expiration date were not reported) for prophylaxis and polio vaccine (unspecified)lot# N0957 (dose, route, frequency and the expiration date were not reported) for prophylaxis.  On 16-APR-1999, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# reported as 0079J (dose, route, frequency and the expiration date were not reported) for prophylaxis and rotavirus vaccine (unspecified)lot# 4988086, 1 dose orally (frequency and the expiration date were not reported) for immunisation.   On 19-APR-1999, the patient experienced intestinal obstruction.  On an unknown date the patient experienced intussusception and due to these events, the patient was hospitalized.      At the time of reporting, the outcome of intestinal obstruction was reported as recovered. The outcome of intussusception was unknown.  The relatedness between the suspect therapies and adverse events were not provided.; Sender Comments:Fax-ref: F2057F1
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was given to 58 years old patient, No AE; Fluzone High Dose was given to 58 years old patient, No AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received other healthcare professional.  This case involves a 58 year old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot-UJ271AA,exp- 13-MAY-2020) via intramuscular route injection in the left deltoid on 21-Oct-2019.  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 age at vaccine administration and overdose.  At the time of reporting, 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 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.
Age: 38.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 38 year-old patient received fluzone HD instead of fluzone quadrivalent with no AE; 38 year-old patient received fluzone HD with no AE; 38 year-old patient received fluzone HD with no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 38 years old patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ221AB, expiry date: 01-Apr-2020), via Intramuscular route in the right deltoid instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 28-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: consumer received a partial dose of the Pentacel described as the consumer only receiving the Dtap-IPV portion and not the ActHIB, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who received a partial dose of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot, expiry date, route and site was not reported) as only receiving the DTAP-IPV portion and not the ACT-HIB, on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no 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 and Module VI of the 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. Information on the batch number was requested.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: teh patient received a first dose of Menactra on 10 Oct 2019 and then on 12 Oct 2019 inadvertently, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old female patient who received a 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6208AB via intramuscular route in the left deltoid 10-Oct-2019 and again received a 0.5 ml dose of the same on 12-Oct-2019, inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) on 10-Oct-2019; HPV VACCINE (HPV VACCINE) on 10-Oct-2019; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) on 12-Oct-2019.  It was a case of actual medication error due to extra dose administered.  At the time of reporting, 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 holder's compliance with the requirements set out in Directive and Module VI of the 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.