chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count, Influenza virus test, Injection site rash, Metabolic function test
Clinical narrative: Patient had shingrix vaccine on 1/31/24, then on 2/3/24 he started developing body aches, fatigue, weakness, myalgias in legs, neck & back pain, went to ER on 2/4/24 to be evaluated had following labs drawn: CMP, CBC, Creatine kinase, lactate venous, Influenza & covid test. On 2/9/24 he followed up with our office he was improving at that time. pt called office on 2/27/24-he developed a rash on his arm in the same site shingrix vaccine was given on left arm, left arm, pain, painful muscles/myalgias, pt was seen in office on 3/1/24-labs were drawn today for  CBC, CMP, sed Rate, Creatine kinase total results are pending.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Patient had shingrix vaccine on 1/31/24, then on 2/3/24 he started developing body aches, fatigue, weakness, myalgias in legs, neck & back pain, went to ER on 2/4/24 to be evaluated had following labs drawn: CMP, CBC, Creatine kinase, lactate venous, Influenza & covid test. On 2/9/24 he followed up with our office he was improving at that time. pt called office on 2/27/24-he developed a rash on his arm in the same site shingrix vaccine was given on left arm, left arm, pain, painful muscles/myalgias, pt was seen in office on 3/1/24-labs were drawn today for  CBC, CMP, sed Rate, Creatine kinase total results are pending.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Patient received HPV and Menveo.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gastrointestinal disorder, Lymphadenopathy, Malaise
Clinical narrative: Patient reports swollen lymph nodes in the arm and neck, GI adverse effects, and non-covid illness in the two months post-vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: We are a mobile clinic. The nurse who transported the vaccines to our location for the day did not review the Beyond Use Date (BUD) prior to packing vaccines and prior to our team administering the vaccines. The nurse who transported and monitored the vaccine did not successfully or accurately check the date and I as the vaccinator was unaware of the BUD at the time.  The BUD was 02/28/2024 @ 0900 and I was handed a vial and prepared and administered the vaccine approximately 3 hours and 15 minutes later at 12:15pm on 02/28/2024. This error was not discovered til close of clinic the following day (12/29/2024) when I transported the vaccine back and notified the head of the immunizations department at our facility.  No symptoms or signs reported by patient in their 15 minute wait time, no adverse reaction to the vaccine. The adverse event was solely related to the vaccine being outside of the BUD 10 week span by approximately 3 hours and 15 minutes day.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: The nurse failed to reconstitute the Hib component of Pentacel with the Dtap/polio components of Pentacel. She administered only the Dtap/polio components. No adverse reaction occurred.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse event.  Pharmacist used 2 vials of diluent and no vials of active vaccine.  Per CDC patient will need to be revaccinated
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram head normal, Computerised tomogram neck, Computerised tomogram normal, Electrocardiogram normal, Heart rate increased
Clinical narrative: on 2/24 had hign blood pressure, high heart rate and ringging in the ear - ended up in an ER.  HBP and heart rate are under contol with medication - changed it to amlodipine/benazepril 5-20 mg and rosuvastain 40 mg.  The ringing has not stopped.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension, Tinnitus
Clinical narrative: on 2/24 had hign blood pressure, high heart rate and ringging in the ear - ended up in an ER.  HBP and heart rate are under contol with medication - changed it to amlodipine/benazepril 5-20 mg and rosuvastain 40 mg.  The ringing has not stopped.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Glomerulonephritis membranous, Peripheral swelling, Protein urine present
Clinical narrative: Swelling of the legs.  Membranous Nephropathy
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 RSV vaccinations (1 on 10/02/2023 & 1 on 11/14/2023); patient had requested & completed consent form on 2 occasions.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness/stiffness in arm pain at the injection site along with painful nodule and redness at the injection site.
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired Hep B vaccine on 2/28/24. Date of expiration of the vaccine was 2/26/24. Appointment made for pt to return in a week to receive repeat dose per recommendations.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Proquad given and within 5minutes had hives on her face, back and at site of injection on the left side.  Evaluated no difficulty with swallowing, no shortness of breath, or trouble speaking.  Benadryl given and stayed in office for next 45 minutes. Hives subsided and patient mom educated on what to look for if more reaction.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Ultrasound scan
Clinical narrative: Arm red and swollen, sore arm, fever, extreme arm pain
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Arm red and swollen, sore arm, fever, extreme arm pain
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered 5 days after expiry (vaccine expired 02/25/24, was administered on 03/01/24)
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Abrysvo on 10/19/2023. She had already received Arexvy on 9/21/2023.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood iron normal, CSF cell count normal, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal
Clinical narrative: Woke up the day after vaccination with weakness in legs and paresthesia in hands and feet. Tested for possible Guillain Barre (lumbar puncture, MRI, EMG). Labs were negative, but symptoms persisted. Hopspitalized on 11/12/2023 for one night for observation. Released the next day. Symptoms continued and progressed to dizziness, pre-syncope, and fatigue. Orthostatic test performed at both PCP and Neurology and a diagnosis of Neuropathic POTS was given on 1/4/2024.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Differential white blood cell count normal, Dizziness, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electromyogram normal
Clinical narrative: Woke up the day after vaccination with weakness in legs and paresthesia in hands and feet. Tested for possible Guillain Barre (lumbar puncture, MRI, EMG). Labs were negative, but symptoms persisted. Hopspitalized on 11/12/2023 for one night for observation. Released the next day. Symptoms continued and progressed to dizziness, pre-syncope, and fatigue. Orthostatic test performed at both PCP and Neurology and a diagnosis of Neuropathic POTS was given on 1/4/2024.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Full blood count normal, Iron binding capacity total normal, Laboratory test normal, Magnetic resonance imaging head normal
Clinical narrative: Woke up the day after vaccination with weakness in legs and paresthesia in hands and feet. Tested for possible Guillain Barre (lumbar puncture, MRI, EMG). Labs were negative, but symptoms persisted. Hopspitalized on 11/12/2023 for one night for observation. Released the next day. Symptoms continued and progressed to dizziness, pre-syncope, and fatigue. Orthostatic test performed at both PCP and Neurology and a diagnosis of Neuropathic POTS was given on 1/4/2024.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging normal, Magnetic resonance imaging spinal normal, Metabolic function test normal, Muscular weakness, Paraesthesia
Clinical narrative: Woke up the day after vaccination with weakness in legs and paresthesia in hands and feet. Tested for possible Guillain Barre (lumbar puncture, MRI, EMG). Labs were negative, but symptoms persisted. Hopspitalized on 11/12/2023 for one night for observation. Released the next day. Symptoms continued and progressed to dizziness, pre-syncope, and fatigue. Orthostatic test performed at both PCP and Neurology and a diagnosis of Neuropathic POTS was given on 1/4/2024.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Scan with contrast normal, Urine analysis normal, Vitamin B12 normal
Clinical narrative: Woke up the day after vaccination with weakness in legs and paresthesia in hands and feet. Tested for possible Guillain Barre (lumbar puncture, MRI, EMG). Labs were negative, but symptoms persisted. Hopspitalized on 11/12/2023 for one night for observation. Released the next day. Symptoms continued and progressed to dizziness, pre-syncope, and fatigue. Orthostatic test performed at both PCP and Neurology and a diagnosis of Neuropathic POTS was given on 1/4/2024.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Laboratory test normal
Clinical narrative: I have 3  special needs adult daughters.  All were given moderna covid 19  at same time, all were given 2nd dose at same time one month after.  all received booster in sept the same year.  All stopped having  their menstrual cycles for 2 years.  I took them to Dr. who did blood draws to check hormone levels...all had normal hormone levels...  he gave them progesterone to start their menstrual cycles back..
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Magnetic resonance imaging, Mobility decreased, Neck pain
Clinical narrative: She got her vaccine, went to sit down for 10 minutes, she got up and getting ready to go the counter everything went black like she was going to faint.  She went back and sat down until she could get herself back to be able to get back and sat for another 5 minutes and then got up and went and got her card.  It felt like she had a reaction to one of the antibiotics that she is allergic to.  She went home and finished cooking.  The arm pain started about a month or so later.  The pain was in her was in her arm like a nerve or something was dying in her arm.  It went up into her neck, and then into her shoulder, then it got so bad that she could not lift the shoulder much, and goes to her hands.  She went to her doctor for the arm pain and sent her to a pain specialist who did an MRI and put her on Gabapentin for the pain.  He feels it might be fibromyalgia and she had no problems with her arm or shoulder prior to the vaccine.  She still continues with the pain in her shoulder.  If she does not take the medication she has severe pain.  She has things that she needs to do and feels that the medicine is still too strong for her to do as it knocks her day and cannot be under the influence of strong medicine.  The arm is painful to drive and pulls on it and stretches on it and it still hurts her so badly.  Her brother had the vaccine as well and has problems with his arm, as well as her two sisters.  It is painful to lift her arm to get dressed, has a hard time getting her hair done due to her pain and regrets taking the vaccine as it has changed her with the pain, all the way down to her hand.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: She got her vaccine, went to sit down for 10 minutes, she got up and getting ready to go the counter everything went black like she was going to faint.  She went back and sat down until she could get herself back to be able to get back and sat for another 5 minutes and then got up and went and got her card.  It felt like she had a reaction to one of the antibiotics that she is allergic to.  She went home and finished cooking.  The arm pain started about a month or so later.  The pain was in her was in her arm like a nerve or something was dying in her arm.  It went up into her neck, and then into her shoulder, then it got so bad that she could not lift the shoulder much, and goes to her hands.  She went to her doctor for the arm pain and sent her to a pain specialist who did an MRI and put her on Gabapentin for the pain.  He feels it might be fibromyalgia and she had no problems with her arm or shoulder prior to the vaccine.  She still continues with the pain in her shoulder.  If she does not take the medication she has severe pain.  She has things that she needs to do and feels that the medicine is still too strong for her to do as it knocks her day and cannot be under the influence of strong medicine.  The arm is painful to drive and pulls on it and stretches on it and it still hurts her so badly.  Her brother had the vaccine as well and has problems with his arm, as well as her two sisters.  It is painful to lift her arm to get dressed, has a hard time getting her hair done due to her pain and regrets taking the vaccine as it has changed her with the pain, all the way down to her hand.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient came in for a shingrix shot on 2/8/24. She said she had not received a shingles vaccine. I looked in the web vaccine reporting system under the name and her birthday and discovered she had not received her vaccine for shingles. When the patient returned to get a second dose it was discovered that she had received another dose under a different first name Patient had no side effects  and was made aware.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: Wrong product administered
Clinical narrative: 5M XD FEMALE PATIENT RECIEVED KINRIX INSTEAD OF PEDIARIX
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Scab
Clinical narrative: Rash - turned to several large scabs - not panful but itchy.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Electromyogram, Magnetic resonance imaging, Pain in extremity
Clinical narrative: COMPLAINS OF PAIN AND BURNING TO LEFT ARM SINCE 12/7/23
Age: 35.0
Sex: F
Vaccine: FLUC4, HEPAB, TDAP
Symptoms: Cold sweat, Syncope
Clinical narrative: Cold sweat followed by fainting
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: no adverse events
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who experienced improperly stored administered ROTATEQ. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #). No additional AE/PQC.  Product Name: ROTATEQ (Lot: 2003138 | Exp: 3/25; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-FEB-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003138, expiration date: 29-APR-2025, administered orally for prophylaxis (strength was not provided). On unknown date, this vaccine underwent temperature excursion in 60 Farenheit for 13 hours with no previous excursion (Product storage error). No additional adverse event was reported.
Age: 2.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of VARIVAX and MMR-II to a patient after a temperature excursion that occurred on 22FEB2024. HCP also stated that the patient was "behind schedule on their vaccinations." Patient is 1 year and 15 months; "behind schedule on their vaccinations; This spontaneous report was received from medical assistant and refers to a 2-year-old (also reported as 27-months).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-FEB-2024, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #X007686, expiration date: 14-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W023508, expiration date: 05-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided); and first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X021281, expiration date: 20-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) or varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X021284, expiration date: 20-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) or varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X018954, expiration date: 13-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion on 22-FEB-2024 in 5.5 Farenheit for 36 minutes with no previous excursion (Product storage error). The patient was also behhind schedule on their vaccination (Product administered to patient of inappropriate age). No additional adverse event was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Healthcare worker called and was unwilling to share their full demographics. Caller inquired if there is any information on if a dose of PROQUAD is administered to a 15 or 16 year old. Agent asked caller if a dose of PROQUAD was administered to a pat; No additional AE; This spontaneous report was received from healthcare worker and refers to a patient of 15 or 16-years-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (at the patient ae of 15 or 16-years-old), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported,
Sex: U
Vaccine: PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/; HCP reported that an unknown 25 year old patient was administered "PREVNAR 15" vaccine on Nov 2022. HCP stated that the same patient was administered the VAXNEUVANCE vaccine on Nov 2023.; This spontaneous report was received a Nurse and refers to a 25-year-old patient of unknown gender.   The patient's concurrent conditions, medical history, previous drug reactions or allergies and concomitant therapies were not reported. The patient's historical vaccine included with pneumococcal vaccine (unknown) (also reported as ''PREVNAR 15").   On an unknown day in November 2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (dose, frequency, lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered). The operator of device was health professional. No additional adverse event (AE) (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored administered GARDASIL 9 on 2/26/2024; This spontaneous report was received from an office manager and refers to a patient with unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-FEB-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #1965079, expiration date: 01-FEB-2026, administered for prophylaxis; strength, anatomical location, and route of administration were not provided) which had undergone temperature excursion (77 Fahrenheit (F) for 24 hours 0 minutes 0 seconds) (Product storage error). There was no previous temperature excursion. No symptoms reported/ No additional adverse event (AE) (No adverse event)
Age: 0.5
Sex: M
Vaccine: DTAPIPV, PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was given VAXELIS and QUADRACEL, was supposed to get VAXELIS and VAXNEUVANCE (still not given yet); This spontaneous report was received from a physician referring to a 6-month-old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 12-JAN-2024, the patient was vaccinated with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) and diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), administered by a healthcare professional at a private doctor's office/hospital (strength, dose, route of administration, lot number, expiration date and indication were not reported). However, the patient was supposed to receive pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (wrong vaccine administered). At the reporting time, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was still not given to the patient. There was no adverse event, and the patient was fine.  This is one of two reports received from the same reporter.
Sex: F
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: Took Vivotif 4 hours late, not on an empty stomach, and while drinking soda; A spontaneous report was received from a pharmacist on 27MAR2023 regarding a female patient of unknown age who "took Vivotif 4 hours late, not on an empty stomach, and while drinking soda" (PT: Wrong technique in product usage process). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered Vivotif 4 hours late, not on an empty stomach, and while drinking soda. Furthermore, it was reported that the patient had no side effects due to Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif 4 hours late, not on an empty stomach, and while drinking soda (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif 4 hours late, not on an empty stomach, and while drinking soda (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Completed 3 of 4 doses and had to travel for family emergency forgot to bring 4th dose; A spontaneous report was received from a nurse practitioner on 29MAR2023 regarding a patient of unknown age and gender who "completed 3 of 4 doses and had to travel for family emergency forgot to bring 4th dose" (PT: Incomplete course of vaccination) of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported. Reportedly, the patient had previously been vaccinated with oral typhoid in 2018.  It was reported that the patient had recently completed 3 of 4 doses of oral typhoid vaccine and then had to travel for a family emergency. Reportedly, the patient forgot to bring the fourth dose, and now it has been more than two weeks since the patient had not taken the last dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer completed 3 of 4 doses and had to travel for family emergency forgot to bring 4th dose (incomplete course of vaccination). Vivotif dose should be taken every other day, and the causality of incomplete course of vaccination is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer completed 3 of 4 doses and had to travel for family emergency forgot to bring 4th dose (incomplete course of vaccination). Vivotif dose should be taken every other day, and the causality of incomplete course of vaccination is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Forgot to take a dose of Vivotif; A spontaneous report was received from a nurse on 30MAR2023 regarding a female patient of unknown age who "forgot to take a dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient forgot to take a dose of Vivotif and remembered 28 hours later. Reportedly, the patient took unknown number of Vivotif doses and did not experience any side effects.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer forgot to take a dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer forgot to take a dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Forgot to take second dose of Vivotif; A spontaneous report was received from a pharmacist on 30MAR2023 regarding a female patient of unknown age who "forgot to take second dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 26MAR2023, Sunday, the patient took the first dose of Vivotif. However, she forgot to take the second dose on 28MAR2023 and has not taken any capsules since then. Reportedly, the patient had no side effects from the medication.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer forgot to take second dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer forgot to take second dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the last dose of Vivotif on day 6; A spontaneous report was received from a nurse on 04APR2023 regarding an 18-year-old male patient who "took the last dose of Vivotif on day 6" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 30MAR2023, the patient received the first dose of Vivotif, followed by the second dose on 01APR2023, third on 03APR2023 and the fourth on 04APR2023. Reportedly, the patient did not experience any side effects.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took the last dose of Vivotif on day 6 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took the last dose of Vivotif on day 6 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Took Vivotif on days 1 and 2; A spontaneous report was received from a 43-year-old female patient on 05APR2023 who "took Vivotif on days 1 and 2" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 04APR2023 the patient received the first dose of Vivotif, followed by the second dose on 05APR2023. Reportedly, the patient did not experience any side effects from either of the dose.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif on days 1 and 2 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif on days 1 and 2 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Eat a meal about 30 minutes after taking the pill of Vivotif/ a dose right after eating a meal; A spontaneous report was received from a pharmacist on 10MAR2023 regarding a patient of unknown age and gender who "eat a meal about 30 minutes after taking the pill of Vivotif/ a dose right after eating a meal" (PT: Product administration error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took a dose of Vivotif and ate a meal about 30 minutes after taking the pill and took another dose right after eating a meal.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer ate a meal about 30 minutes after taking the pill of Vivotif/ a dose right after eating a meal (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a consumer ate a meal about 30 minutes after taking the pill of Vivotif/ a dose right after eating a meal (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif capsules on days 1, 2, 4 and 6; A spontaneous report was received from a physician on 17APR2023 regarding a patient of unknown age and gender who "took Vivotif capsules on days 1, 2, 4 and 6" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient erroneously took Vivotif capsules on days 1, 2, 4 and 6. Reportedly, the patient would be living for two years as a missionary.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif on days 1, 2, 4 and 6 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took Vivotif on days 1, 2, 4 and 6 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product prescribing error
Clinical narrative: Prescribed Vivotif with the directions to take once weekly for 4 weeks; Took Vivotif once weekly for 3 weeks; A spontaneous report was received from a pharmacist on 21APR2023 regarding female patient (age: unknown) who was "prescribed Vivotif with the directions to take once weekly for 4 weeks" (PT: Product prescribing error) and "took Vivotif once weekly for 3 weeks" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient was prescribed Vivotif with directions to take the doses once a week for 4 weeks. The patient began taking the doses once weekly for 3 weeks before a family member inquired about the difference in the dosage regimen of her and family member. Reportedly, it has been over 48 hours since the last dose of Vivotif was administered. Furthermore, the patient alerted the pharmacy about the error.  The outcome of the reported events was not applicable. The action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a patient was prescribed Vivotif with the directions to take once weekly for 4 weeks (product prescribing error) and took Vivotif once weekly for 3 weeks (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration and product prescribing error is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient was prescribed Vivotif with the directions to take once weekly for 4 weeks (product prescribing error) and took Vivotif once weekly for 3 weeks (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration and product prescribing error is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Forgot to take 4th dose of Vivotif; A spontaneous report was received from a clinical pharmacist on 24APR2023 regarding a 37-year-old male patient who "forgot to take the 4th dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took three doses of Vivotif on days 1, 3 and 5 and missed taking the fourth dose on day 7. Reportedly, the patient hasn't taken the fourth dose yet and no side effects were reported.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was provided.  Company comment: It was reported that a consumer forgot to take the 4th dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer forgot to take the 4th dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Patient won't be able to administer the third dose on day 5; A spontaneous report was received from a nurse on 27APR2023 regarding a 54-year-old male patient who "won't be able to administer the third dose on day 5" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 24APR2023 the patient received the first dose of Vivotif followed by the second dose on 26APR2023. Reportedly, the patient was traveling and would not be able to administer the third dose until 30APR2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer would not be able to administer the third dose on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer would not be able to administer the third dose on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Taking all the 4 doses of Vivotif unrefrigerated; A spontaneous report was received from a female patient of unknown age on 19JUN2023 who has been "taking all the 4 doses of Vivotif unrefrigerated" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003831) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient forgot to keep the Vivotif under refrigeration and kept the medication at a temperature of 58-73 F for a duration of 8 days. Reportedly, the patient took all four doses of Vivotif that were unrefrigerated, the first dose on 13JUN2023 and the last on 19JUN2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had been "taking all the 4 doses of Vivotif unrefrigerated" (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer had been "taking all the 4 doses of Vivotif unrefrigerated" (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Taken 4 capsules of Vivotif within 4 days; A spontaneous report was received from the pharmacy technician on 21JUN2023 regarding a 17-year-old patient of unknown gender who had "taken 4 capsules of Vivotif within 4 days" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 18JUN2023, Sunday, the patient took the first dose of Vivotif and then took the next three doses between 18JUN2023 and 21JUN2023 (Wednesday). Reportedly, the did not experience any side effects.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had taken 4 capsules of Vivotif within 4 days (inappropriate schedule of product administration) and did not experience any reaction. Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer had taken 4 capsules of Vivotif within 4 days (inappropriate schedule of product administration) and did not experience any reaction. Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: Administered first 3 doses of Vivotif consecutively; Vivotif was left at room temperature for 9 days; A spontaneous report was received from a pharmacist on 18JAN2023. It described a 36-year-old male patient who "administered first 3 doses of Vivotif consecutively" (PT: Inappropriate schedule of product administration) which was "left at room temperature for 9 days" (PT: Product storage error). The patient took Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered the first 3 doses of Vivotif consecutively (3 days straight) after the medication was left at room temperature for 9 days with first dose being administered on 16JAN2023. Reportedly, the patient did not experience any side effects.  The outcome of the reported events was not applicable. Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer administered first 3 doses of Vivotif consecutively (inappropriate schedule of product administration) which was left at room temperature for 9 days (product storage error). Vivotif dose should be taken every other day and should always be stored in the refrigerator at the recommended temperature. The causality of inappropriate schedule of product administration and product storage error is assessed as not applicable to Vivotif due to the nature of the events.; Sender's Comments: It was reported that a consumer administered first 3 doses of Vivotif consecutively (inappropriate schedule of product administration) which was left at room temperature for 9 days (product storage error). Vivotif dose should be taken every other day and should always be stored in the refrigerator at the recommended temperature. The causality of inappropriate schedule of product administration and product storage error is assessed as not applicable to Vivotif due to the nature of the events.