chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine.  Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Chills, Cough, Decreased appetite
Clinical narrative: Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea:  Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling cold, Hypoaesthesia oral, Nausea
Clinical narrative: Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea:  Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 test, Somnolence, X-ray
Clinical narrative: Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea:  Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Respiratory symptom
Clinical narrative: Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea:  Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red tiny bumps all over my body
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, nausea on day #3 of not being able to work.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Normal arm soreness, very achy, tiredness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: mild headache; tiredness; This is a spontaneous report from a contactable other healthcare professional reported for himself (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5130) into right arm on 17Dec2020 10:00 AM at single dose for covid-19 immunization in Public health. Medical history was not reported. Other medications in two weeks included irbesartan (AVAPRO), amlodipine besilate (NORVASC) and HCTZ. No other vaccine in four weeks (Also reported "other vaccine same date product was PFIZER, other vaccine same date lot number was 1600, other vaccine same date dose number was 2, other vaccine same date vaccine location was Right arm", pending clarification). Patient experienced mild headache and tiredness on 17Dec2020 07:00 PM. No covid prior vaccination. Covid test post vaccination via Blood test with unknown results. No treatment received. outcome of the events was unknown.
Sex: U
Vaccine: MMR
Symptoms: Product storage error, Unevaluable event
Clinical narrative: M-M-R II administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-JAN-2021,  the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, recombinant human albumin (rHA) (M-M-R II) Lot number S032036, expiration date 10-OCT-2021, at a dose of 0.5 milliliters intramuscularly as prophylaxis.  The vaccine experienced a temperature excursion of 9.6 degree Celsius (°C) for 7 hours on an unknown date; no previous temperature excursions were reported. The call was made due to a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Unevaluable event
Clinical narrative: incorrect product storage; This spontaneous report was received from a registered Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On 25-JAN-2021, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which has a lot # 1688504 and expiration date on 18-NOV-2021 (dose, strength and frequency were not reported) for prophylaxis.    It was reported that the vaccines were exposed to temperature of 13.4 Centigrade range for a time frame of 2 hours and 9 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Sex: U
Vaccine: HEPA, HPV9, UNK, UNK
Symptoms: Product storage error
Clinical narrative: an improperly stored vaccine was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent condition, pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 25-JAN-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 injection, lot # T026954, expiration date 13-APR-2022, strength and route were unknown) for prophylaxis and Hepatitis A Vaccine, Inactivated (VAQTA) (1 injection, lot # T013546, has been verified to be a valid lot number, expiration date was reported as 27-OCT-2021, but upon internal validation established as 28-OCT-2021, strength and route were unknown) for prophylaxis.   Administered vaccines were stored above 9 degree Celsius (13.4 degree Celsius) for 2 hours and 9 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details are available; ROTATEQ and PEDVAX HIB which were administered after improper storage; ROTATEQ Dose/Frequency: 0.5 mL; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 01-FEB-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # 1742461 with expiry date 17-NOV-2021, 0.5 milliliter (underdose) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, 0.5 milliliter, lot # T026959 with expiry date 11-MAR-2023 (route of administration and vaccination site were not specified), both for prophylaxis. The vaccines underwent a temperature excursion at 9.9 Celsius degrees for 35 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse event was reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 26-JAN-2021 , the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; vaccine was improperly stored and administered; This spontaneous report was received from a medical assistant, who refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 11-JAN-2021, the patient received a dose of an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), dose reported as 0.5 ml, lot # T011167, expiry date 27-MAY-2022, for prophylaxis (formulation, concentration, dose number, route of administration and frequency were not reported). Digital data logger was involved. The vaccine underwent the temperature excursion below36 degrees of Fahrenheit (F) (35.70F) for 1 hour and 30 minutes on 27-OCT-2020 and below 36 F (30.20F) for 1 hour and 30 minutes on 28-OCT-2020. There was previous temperature excursion on 14-OCT-2020: the vaccine underwent the temperature excursion above 47F (64.36 F) for 3 hours. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: administered a varicella vaccine that expired yesterday; This spontaneous report was received from a consumer referring to a patient of unknown age.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 13-FEB-2021,  the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S004091 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 11-FEB-2021.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neurological symptom, Parkinson's disease, Post herpetic neuralgia, Visual impairment
Clinical narrative: Parkinson's disease; other serious neurological problems; postherpetic neuralgia; vision problems; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 06-SEP-2012 (at approximately 73 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia, vision problems, Parkinson's disease and other serious neurological problems. The outcome of the events was unknown. The causality assessment was considered as related by the lawyer.   Upon internal review, Parkinson's disease was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Sinus disorder, Vulvovaginal pruritus
Clinical narrative: sinus problems; vaginal itching; shingles; shingles to the left buttock; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date before May 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider in a pharmacy, for the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. She began having outbreaks as frequently as twice per month. On 07-MAY-2015, the pt went to see a doctor and stated she thought she might have had the beginning of shingles on her left buttock and stated she had had the vaccine. She was given acyclovir (ZOVIRAX) for 7 days. On 30-JUN-2016, the patient presented to the doctor for shingles to the left buttock and was again given acyclovir (ZOVIRAX) for 7 days. On 09-JAN-2018, she presented to the doctor for sinus problems, shingles and vaginal itching. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered painful and debilitating symptoms, which had resulted in physical and mental and emotional pain an distress not present to using zoster vaccine live (ZOSTAVAX). As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the patient had 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 had incurred and would incur medical expenses and other economic harm as a direct result of the usage of zoster vaccine live (ZOSTAVAX). The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the events of shingle, sinus problems and vaginal itching were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Herpes zoster
Clinical narrative: developed various autoimmune maladies; developed the first of several outbreaks of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.      On or around April 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).         On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) vaccine being administered, pt developed the first of several outbreaks of shingles (herpes zoster) and various autoimmune maladies (autoimmune disorder). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to this vaccine use and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Pt sustained severe and permanent personal injuries; 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. Pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At reporting time, pt was not recovered from the events and they were considered to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and autoimmune disorder were considered as disabling events.  Upon internal review, autoimmune disorder was considered to be a medically significant event.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: patient was administered PNEUMOVAX 23 that underwent a temperature excursion; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T024557 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-MAR-2022 (route of administration, anatomical location were not provided) for prophylaxis.  The temperature excursion was 75 degrees Fahrenheit (F) for 4 hours and 30 minutes. There were no previous excursions reported. The digital data logger was not involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information.; Improperly stored vaccines administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On an unknown date, the patient received an improperly stored vaccines: measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II), lot # S014430, expiry date 09-MAY-2021 and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S030243, expiry date 26-SEP-2021, both in dose reported as 0.5 mL, both for prophylaxis (concentration, dose number, route of administration and frequency for both vaccines were not reported). Digital data logger was not involved. Between 12-AUG-2020 (reported also as August 2020) to an unknown date in September 2020, vaccines underwent a temperature excursions at 6.5 degrees of Fahrenheit (F) for 45 minutes. There was no information regarding previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008312:
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: "bump" at injection site; This spontaneous report was received from a pharmacist and refers to a 20-year-old female patient. The patient's concurrent conditions, medical histories, concomitant medications, drugs reactions or allergies were not provided.  On an unknown date (reported as last week), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, strength, lot # and expiration date were not provided) for prophylaxis. The patient complained of a "bump" at injection site a few days after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the event was unknown.  The causal relationship between "bump" at injection site and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: She reports a female of adolescent age fainted after receiving GARDASIL 9.; This spontaneous report was received from a physician via field representative, referring to a female adolescent patient of unknown age. The patient's pertinent medical history, previous drug allergies or reactions, and concomitant medications were unknown by the reporter.  On an unknown date in 2020 (also reported as "sometime in 2020"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number, and expiration date were unknown) as prophylaxis.   On an unknown date in 2020 (also reported as "sometime in 2020"), after receiving the vaccine, the patient fainted (syncope). It was unknown if the patient received treatment for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of the event syncope, and the causal relationship between the event syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.   Upon internal review, the event syncope was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008675:
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: She also had another female patient of adolescent age that became light headed after receiving GARDASIL 9.; This spontaneous report was received from a physician via field representative, referring to a female adolescent patient of unknown age. The patient's pertinent medical history, previous drug allergies or reactions, and concomitant medications were unknown by the reporter.  On an unknown date in 2020 (also reported as "sometime in 2020"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number, and expiration date were unknown) as prophylaxis.   On an unknown date in 2020 (also reported as "sometime in 2020"), after receiving the vaccine, the patient became light headed (dizziness). It was unknown if the patient received treatment for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of the event dizziness, and the causal relationship between the event dizziness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008637:
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on days 1, 3, and 4; Spontaneous report received on 29JAN2020.  A nurse manager reported that a consumer "took Vivotif on days 1, 3, and 4" (PT: Inappropriate schedule of product administration) for immunisation. The consumer took first, second and third dose of Vivotif on 24JAN2020, 26JAN2020 and 27JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doseson day 1, 3, and 4 (Inappropriate schedule of product administration) instead of taking on alternate days. The causality of inappropriate schedule of product administration is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif doseson day 1, 3, and 4 (Inappropriate schedule of product administration) instead of taking on alternate days. The causality of inappropriate schedule of product administration is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Forgot to skip a day prior to taking the third dose; Spontaneous report received on 05FEB2020.  A nurse reported that a female consumer who "forgot to skip a day prior to taking the third dose" (PT: Inappropriate schedule of product administration), while being on Vivotif capsule for immunisation. The consumer took her first and second dose of Vivotif on 01FEB2020 and 03FEB2020 respectively according to schedule. However, she forgot to skip a day prior to taking the third capsule and took it on 04FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to skip a day prior to taking the third dose (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to skip a day prior to taking the third dose (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Consumer will be completing their dose of Vivotif during the travel; Spontaneous report received on 06FEB2020.  A pharmacist reported that a "consumer will be completing their dose of Vivotif during the travel" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had only one dose of Vivotif left to take. The consumer will take the last dose during the travel. The pharmacist did not provide the date of travel for the consumer. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer will be completing last dose of Vivotif during the travel (Inappropriate schedule of product administration). Vivotif course should be completed one week prior to the travel. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer will be completing last dose of Vivotif during the travel (Inappropriate schedule of product administration). Vivotif course should be completed one week prior to the travel. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had not taken Vivotif according to the recommended schedule; Spontaneous report received on 07FEB2020.  A nurse reported that a consumer "had not taken Vivotif according to the recommended schedule" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. The consumer had not taken Vivotif doses according to the recommended schedule. The doses were taken on Tuesday, Saturday, Monday, and Wednesday (dates unspecified). Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on Tuesday, Saturday, Monday and Wednesday (Inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif doses on Tuesday, Saturday, Monday and Wednesday (Inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: She will not be taking her third dose of Vivotif on 07FEB2020; Spontaneous report received on 07FEB2020.  A female consumer reported that "she will not be taking her third dose of Vivotif on 07FEB2020" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. She had taken her first two doses of Vivotif as per the schedule. She reported that she would not be able to take her third dose of Vivotif on 07FEB2020. She did not identify the reason why she will not be able to take her dose on 07FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer reported on the morning of 07Feb2020 that she would not be taking her third dose of Vivotif on the scheduled date, 07Feb2020 (missed dose). Further details of the event is limited. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.  .; Sender's Comments: A consumer reported on the morning of 07Feb2020 that she would not be taking her third dose of Vivotif on the scheduled date, 07Feb2020 (missed dose). Further details of the event is limited. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated dose of Vivotif; Spontaneous report received on 06FEB2020.  A male consumer reported that he "took unrefrigerated dose of Vivotif" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer finished his last dose of Vivotif but, the vaccine was exposed out of the refrigerator for a total cumulative time of 16 hours. He could not confirm the temperature. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of  product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of  product storage error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Did not take the third and fourth dose of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "did not take the third and fourth dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The consumer did not take their third and fourth dose of Vivotif which were due on 07FEB2020 and 09FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the third and fourth dose of Vivotif (missed dose) on the dates when they were due. Vivotif dose should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer did not take the third and fourth dose of Vivotif (missed dose) on the dates when they were due. Vivotif dose should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Age: 13.0
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated doses of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "took unrefrigerated doses of Vivotif" (PT: Product storage error) while being on Vivotif for immunisation. On 02FEB2020, the consumer took the first dose of Vivotif which was refrigerated. The consumer took the remaining three doses of Vivotif which were unrefrigerated. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took 3 unrefrigerated doses; Spontaneous report received on 10FEB2020.  A pharmacist reported that a 49-year-old adult female consumer "took 3 unrefrigerated doses" (PT: Product storage error) while being on Vivotif (lot number: 3003307; expiry date: Nov 2020; 1 capsule alternate day) for immunisation. She took her first and second dose of Vivotif on 02FEB2020 and 04FEB2020 respectively and then took her next two doses on alternative days. The last three doses were not refrigerated and were kept at room temperature. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.   Concurrent condition included hypothyroidism.  Concomitant medications medication included Nature throid (thyroid; 65 mg) for hypothyroidism.  Company Comment: A consumer took three unrefrigerated doses of Vivotif (Product storage error). The last three doses of Vivotif were kept at room temperature and were unrefrigerated. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three unrefrigerated doses of Vivotif (Product storage error). The last three doses of Vivotif were kept at room temperature and were unrefrigerated. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: Injection site bruising
Clinical narrative: Bruising at the injection site; Spontaneous report received on 11FEB2020.  A male consumer reported that he developed bruising at the injection site (PT: Injection site bruising) following the immunisation with BioThrax (anthrax vaccine adsorbed). On 05FEB2020 at 11:05 am, the patient received BioThrax via intramuscular route in left arm. Few days after administration of BioThrax, he developed bruising at the injection site. It was reported that there was no requirement of treatment. The event was resolved at the time of report.  Company Comment: A consumer received BioThrax via intramuscular route on his left arm and after a few days, he developed injection site bruising which resolved without any treatment. Emergent considers the reported term of bruising at the injection site (PT: Injection site bruising)  a non-serious event, although expected according to the CCSI and package insert. Local injection site reactions like bruising could happen after BioThrax vaccination, therefore given the temporal relationship causality of the event is assessed as related.  .; Sender's Comments: Company Comment: A consumer received BioThrax via intramuscular route on his left arm and after a few days, he developed injection site bruising which resolved without any treatment. Emergent considers the reported term of bruising at the injection site (PT: Injection site bruising)  a non-serious event, although expected according to the package insert. Local injection site reactions like bruising could happen after BioThrax vaccination, therefore given the temporal relationship causality of the event is assessed as related.  .
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Did not take the last dose of Vivotif; Spontaneous report received on 11FEB2020.  A pharmacist reported that a female consumer who "did not take the last dose of Vivotif" (PT: Product dose omission). She was taking the Vivotif for immunisation. On an unknown date, the consumer took first and second dose of Vivotif according to schedule. On 07FEB2020, the consumer took third dose of Vivotif as per the schedule. The consumer did not take the last and fourth dose of Vivotif. Action taken with Vivoitf with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the last dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer did not take the last dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not taken any dose after taking first dose of Vivotif; Spontaneous report received on 13FEB2020.  A physician assistant reported that a male consumer who "has not taken any dose after taking first dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. On 07FEB2020, the consumer took first dose of Vivotif. He took his second dose out of the fridge but fell asleep before taking the dose and did not take his second dose on 09FEB2020. The consumer had discarded his second dose on Monday, 10FEB2020. The reporter stated that the consumer had not taken any doses after his first one. Action taken with Vivoitf with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer has not taken any dose after taking first dose of Vivotif (Missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer has not taken any dose after taking first dose of Vivotif (Missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Had taken all four doses of Vivotif without them being refrigerated; Spontaneous report received on 19FEB2020.  A pharmacist reported that a consumer "had taken all four doses of Vivotif without them being refrigerated" (PT: Product storage error). The consumer was receiving Vivotif (lot number: 3003317) for immunisation. The consumer had taken all four doses of Vivotif which were not refrigerated. It was reported that consumer had taken all the doses correctly. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer had taken all four doses of Vivotif without them being refrigerated" (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer had taken all four doses of Vivotif without them being refrigerated" (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed to take last dose of Vivotif; Spontaneous report received on 19FEB2020.  A male consumer reported that he "missed to take last dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer started taking Vivotif on 13FEB2020 and took the first three doses as per schedule. His last dose of Vivotif was scheduled on 19FEB2020 but he will not be able to take it because someone accidentally threw his last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed to take last dose of Vivotif (missed dose) as someone accidentally threw his last dose. Vivotif doses should be taken every other day, and the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed to take last dose of Vivotif (missed dose) as someone accidentally threw his last dose. Vivotif doses should be taken every other day, and the causality of missed dose is not applicable to Vivotif.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Large edema and redness around injection site; Large edema and redness around injection site; Hardening of skin around the injection site; Pain upon palpation; Spontaneous report received on 17FEB2020.  A male consumer reported that he developed large edema and redness around injection site (PT: Injection site oedema/Injection site erythema), had hardening of skin around the injection site (PT: Injection site induration), and pain upon palpation (PT: Injection site pain) following the immunisation with BioThrax (anthrax vaccine adsorbed). On 13FEB2020 at 09:00 am, he received BioThrax via intramuscular route in right arm. On 14FEB2020 at 09:00 am, he developed large edema and redness around injection site (approximately 3 inches in diameter); his skin became hard around the injection site (approximately 1 inch in diameter) and he had pain upon palpation. The symptoms were not resolved at the time of report.  Concurrent condition included pet allergies, Schmorl's node and sleep apnea.  Company Comment: A consumer received BioThrax vaccination via intramuscular route on his right arm, and on the next day he developed injection site edema, injection site erythema, injection site induration, and injection site pain. These events have not resolved at the time of the report. Local injection site reactions like edema, erythema, induration and pain could happen after receiving BioThrax.  Given the temporal relationship and biologic plausibility, causality of all these events is assessed as related.; Sender's Comments: Company Comment: A consumer received BioThrax vaccination via intramuscular route on his right arm, and on the next day he developed injection site edema, injection site erythema, injection site induration, and injection site pain. These events have not resolved at the time of the report. Local injection site reactions like edema, erythema, induration and pain could happen after receiving BioThrax.  Given the temporal relationship and biologic plausibility, causality of all these events is assessed as related.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif every day instead of every other day; Spontaneous report received on 21FEB2020.  A nurse reported that a consumer "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had taken Vivotif every day instead of every other day. The consumer will be travelling on 05MAR2020 as a one time visit. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif for 4 days in a row; Spontaneous report received on 24FEB2020.  Based on the information obtained from a consumer, two individual case safety reports PVX2020-401 (20000166SP; wife) and PVX2020-403 (20000167SP; husband) were created and cross-linked in the database.  This case described a female consumer who "took Vivotif for 4 days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif capsule for prevention of typhoid. The consumer took four doses of Vivotif every day from 19FEB2020 to 22FEB2020. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the event was unknown.  Concomitant medications included paroxetine, metformin, omeprazole, atorvastatin for an unknown indication.  Company Comment: A consumer took Vivotif for four days in a row ( Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of  Inappropriate schedule of product administration is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif for four days in a row ( Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of  Inappropriate schedule of product administration is assessed as not applicable with Vivotif.