chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aortic dilatation, Aortic dissection, Cardiac imaging procedure abnormal, Condition aggravated, Sudden death
Clinical narrative: Patient was perfectly fine one day and the next she was gone.  We believe having the vaccines aided in her passing away.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Dry mouth, Throat tightness
Clinical narrative: 33-year-old female presented emergency department for evaluation. Patient received a Tdap immunization today.  Shortly after receiving the vaccination, she was sitting in her car and began feeling as if her mouth was dry and throat was tightening up.  This was followed by some mild discomfort in her chest described as tightness which has now improved.  She was brought over by EMS for further evaluation.  She did take his dose of Zyrtec prior to arrival.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired dose of covid vaccine (bud date was expired by one day) no side effects, parent was contacted, and declined revaccination.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Paralysis, Peripheral swelling, Skin tightness
Clinical narrative: She received her high dose Fluzone on 11/07/2023 by that evening her legs began to swell similar to lymphadema. She described them as "feeling like they were going to burst open."  She couldn't walk.  She verbalized that her daughter, whom she cares for, had to call for an ambulance 4 times that night due to her rolling off of the couch.  She continues to have problems ambulating.  Her medical provider thinks that she has partial paralysis due to her flu vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Haematoma, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Large hematoma on left arm.  Area is red , warm and swollen. Area is painful to the touch
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Rotavirus infection
Clinical narrative: Suspected contraction of Rotavirus for live vaccine. This client presented to the ER on 2/28/2024 for severe diarrhea...5 days post vaccination
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: deceased 2-25-24 after admission on 2-20-24.
Age: 55.0
Sex: F
Vaccine: FLU4, HIBV, PNC20
Symptoms: Expired product administered
Clinical narrative: Nurse noted the expiration date after vaccinated patient. Vaccine expired on 2/22/2024. Nurse did inform the patient
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt given expired covid vaccine by 6 days.  (BUD) was Feb 20,2024 vaccine given on Feb 26,2024.  Parent notified. No side effects reported, parent deferred vaccination for 8 weeks.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL, MMR
Symptoms: Expired product administered
Clinical narrative: Noted expiration date after administering vaccine of 3/1/2024
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Noted expiration date after administering vaccine of 3/1/2024
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain, Product administered at inappropriate site
Clinical narrative: AT TIME OF INJECTION PATIENT REPORTED PAIN, UNLIKE ANY OTHER PAIN SHE HAS HAD FROM NUMEROUS OTHER VACCINATIONS SHE'S RECEIVED IN THE PAST. IN THE NEXT COMING DAYS PATIENT WAS UNABLE TO RAISE HER RIGHT ARM WITHOUT PAIN, AND HAD A RASH DEVELOP AT THE INJECTION SITE AFTER A COUPLE OF WEEKS. IT WAS HARD FOR HER TO SLEEP ON THAT ARM BECAUSE OF THE PAIN. SHE ENDED UP MAKING AN APPOINTMENT WITH HER PHYSICIAN IN EARLY JANUARY 2024 TO EXAMINE HER ARM BECAUSE THE PAIN/RASH WAS NOT SUBSIDING. THE PHYSICIAN CONCLUDED THAT THE VACCINATION SITE WAS NOT IN THE PROPER MUSCLE LOCATION AND WAS TOO HIGH. HER PHYSICIAN PRESCRIBED HER A SYSTEMIC AND TOPICAL STEROID AND AN ANTIBIOTIC TO HELP RELIEVE HER PAIN. TODAY ON 3/4/2024, THE PATIENT CONTACTED THE PHARMACY AND I REACHED OUT TO HER TO GATHER ALL OF THIS INFORMATION. AS OF TODAY THE RASH IS GOING AWAY BUT THERE IS STILL REDNESS AT THE SITE AND HER ARM ONLY HURTS WHEN THAT INJECTION SITE IS TOUCHED WITH PRESSURE. PER PATIENT IT FEELS LIKE A BRUISE.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Sleep disorder
Clinical narrative: AT TIME OF INJECTION PATIENT REPORTED PAIN, UNLIKE ANY OTHER PAIN SHE HAS HAD FROM NUMEROUS OTHER VACCINATIONS SHE'S RECEIVED IN THE PAST. IN THE NEXT COMING DAYS PATIENT WAS UNABLE TO RAISE HER RIGHT ARM WITHOUT PAIN, AND HAD A RASH DEVELOP AT THE INJECTION SITE AFTER A COUPLE OF WEEKS. IT WAS HARD FOR HER TO SLEEP ON THAT ARM BECAUSE OF THE PAIN. SHE ENDED UP MAKING AN APPOINTMENT WITH HER PHYSICIAN IN EARLY JANUARY 2024 TO EXAMINE HER ARM BECAUSE THE PAIN/RASH WAS NOT SUBSIDING. THE PHYSICIAN CONCLUDED THAT THE VACCINATION SITE WAS NOT IN THE PROPER MUSCLE LOCATION AND WAS TOO HIGH. HER PHYSICIAN PRESCRIBED HER A SYSTEMIC AND TOPICAL STEROID AND AN ANTIBIOTIC TO HELP RELIEVE HER PAIN. TODAY ON 3/4/2024, THE PATIENT CONTACTED THE PHARMACY AND I REACHED OUT TO HER TO GATHER ALL OF THIS INFORMATION. AS OF TODAY THE RASH IS GOING AWAY BUT THERE IS STILL REDNESS AT THE SITE AND HER ARM ONLY HURTS WHEN THAT INJECTION SITE IS TOUCHED WITH PRESSURE. PER PATIENT IT FEELS LIKE A BRUISE.
Age: 41.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, HIBV, IPV, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client was in to get vaccines after bone marrow off her specialist recommendations. Kinrix was given with adult IPV. No adverse reactions, client notified
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient is pregnant with due date of 4/17/2024. Redness, blisters, swelling and burning sensation at injection site.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not have adverse event
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin exfoliation, Skin texture abnormal
Clinical narrative: Reports red leathery skin that eventually peeled
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient was given .25ML of the 6mo-11year Modera Covid vaccine when he should have been given the SpikeVax Covid Vaccine. No symptoms or outcomes.
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Off label use
Clinical narrative: I completed a off-label (2) dose 0.5 mL regimen; No additional AE; This spontaneous report was received from consumer, referring to himself, a 70-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 milligram, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), and complete a 2-dose vaccine regimen as per physician (Off label use). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, No adverse event, Poor quality device used, Syringe issue
Clinical narrative: liquid came out of the side of the syringe at Luer Lock Hub and not from dispensing point; Poor quality device used; No reported injury from administration, but nurse who administered the injection stated that she did not believe that the patient received any of the vaccination; No additional AE/PQC; This spontaneous report was received from a pharmacist and refers to an infant patient (reported as baby) of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  It was reported that on 03-FEB-2024, a nurse was administered a hepatitis b vaccine (recombinant) (RECOMBIVAX HB), strength: 0.5 microg/ml intramuscular injection, lot #X017743, expiration date: 21-FEB-2026, intramuscularly in the left outer thigh, for prophylaxis. When a nurse was administering the suspect vaccine, liquid came out of the side of the syringe Luer Lock (not from a dispensing point) (device leakage). It was verified with the reporter, that nurse was injecting the medication into the patient when the defect was noted (poor quality device used), (accidental underdose). The nurse stopped administering the suspect vaccination immediately upon seeing the liquid come out from the side of the pre-filled syringe (PFS). The amount of suspect vaccine administered into the patient was unknown; the nurse, who administered the injection stated that she did not believe that the patient received any of the vaccination. No additional adverse event (AE) was reported (no adverse event). The patient's parents wish to discussed administration of the suspect vaccine with pediatrician.
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: red streaking from injection site down their arm to the elbow area; red streaking from injection site down their arm to the elbow area; discomfort; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-FEB-2024, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (0.5 milliliter, lot #X018278 was valid for formulation pre-filled syringe, expiration date: 24-NOV-2024, route of administration and anatomical location were not provided) for prophylaxis.  On 21-FEB-2024, the patient experienced red streaking from injection site down their arm to the elbow area and discomfort. At the time of reporting, the patient was recovering from the events. The action taken with suspect vaccine regarding the events was reported as not applicable.  The causal relationship between discomfort and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The first dose was administered at the age of 13 and the second dose at 18 years of age; No symptoms reported; This spontaneous report has been received from a nurse referring to a 18-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date, at the age of 13, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided).  It was reported that the patient had an interrupted schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date at 18 years of age, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No symptoms reported (No adverse event) and no additional details provided. No other adverse event (AE) or product quality complaint (PQC).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP has no further AE information. No PQC.; HCP called to report that a single dose of PROQUAD was given on 2/5/2024 and expired on 1/24/2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-FEB-2024, the patient was vaccinated with a single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, (lot #W023868, expiration date: 24-JAN-2024), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). Health care professional (HCP) had no further adverse event (AE) information (no adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: The patient threw-up the third capsule of Vivotif; Case reference number US-BN-2023-010590 initially downloaded from Company (reference number USBAV23-1969) on 27-Nov-2023, is a spontaneous case received from healthcare professional and concerns a patient of unknown gender and age.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient received first and second doses of Vivotif (batch number unknown), at an unknown dose, administered orally, for an unknown indication.  On unspecified date, an unknown amount of time after second dose, the patient received the third dose of Vivotif (batch number unknown), at an unknown dose, administered orally. As reported, the patient threw-up the Vivotif capsule and the reporter asked how to proceed.  At the time of the initial report, the outcome for the event of vomiting of medication was unknown.  The reporter assessed the event of vomiting of medication as non-serious and possibly related to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown gender and age received the third dose of Vivotif (unknown time after second dose), at an unknown dose, administered orally and reportedly, the patient threw-up the Vivotif capsule. Vomiting is listed and expected according to CCDS v1 and PI for Vivotif. The outcome was unknown. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as related due to suggestive temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of unknown gender and age received the third dose of Vivotif (unknown time after second dose), at an unknown dose, administered orally and reportedly, the patient threw-up the Vivotif capsule. Vomiting is listed and expected according to CCDS v1 and PI for Vivotif. The outcome was unknown. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as related due to suggestive temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Malaise, Vomiting
Clinical narrative: Not felt well; The fourth dose of Vivotif ended throwing up; Stomach ache; Case reference number US-BN-2023-010601 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV23-1991) on 28-Nov-2023 and concerns a 51-year-old female patient.   The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient received first, second and third dose of Vivotif (batch number: unknown), at an unknown dose, administered orally, for upcoming travel.  On unspecified date, unknown amount of time after receiving the third dose and reported as today, the patient received the fourth dose of Vivotif (batch number: 3003830), at an unknown dose, administered orally.   On the same day the patient ended up throwing up the fourth dose, experienced stomach ache and not felt well. As reported, the patient experienced stomach-ache and not felt well after each administered dose of Vivotif.  At the time of the initial report, the outcome for the events of vomited, stomach ache and not felt well was unknown.  The reporter assessed the events of vomited, stomach ache and not felt well as non-serious and possibly related to Vivotif administration.  Additional information received from Med Communications on 29-Nov-2023 included additional reference number (USBAV23-1993).  This case is linked to case US-BN-2023-010602 (same reporter).; Reporter's Comments: A 51-year-old female patient experienced non-serious event vomiting on the same day she took a fourth dose of Vivotif, and also experienced stomach-ache and not felt well (non-serious) after each administered dose of Vivotif. Malaise is considered listed per convention, vomiting and stomach ache are considered listed per the (Privacy) and the (Privacy). The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and product's safety profile, causality is assessed as related to Vivotif.; Sender's Comments: A 51-year-old female patient experienced non-serious event vomiting on the same day she took a fourth dose of Vivotif, and also experienced stomach-ache and not felt well (non-serious) after each administered dose of Vivotif. Malaise is considered listed per convention, vomiting and stomach ache are considered listed per the (Privacy) and the (Privacy). The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and product's safety profile, causality is assessed as related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Malaise
Clinical narrative: Not felt well; Stomach ache; Case reference number US-BN-2023-010602 is a spontaneous case report initially received from a consumer via Company (reference number: USBAV23-1993) on 28-Nov-2023 and concerns a 11-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient received first, second and third dose of Vivotif (batch number: unknown), at an unknown dose, administered orally, for upcoming travel.  On unspecified date, unknown amount of time after receiving the third dose and reported as today, the patient received the fourth dose of Vivotif (batch number: 3003830), at an unknown dose, administered orally.   On the same day, the patient did not feel well and was picked up from school. As reported, the patient experienced stomach-ache and not felt well after each administered dose of Vivotif.  At the time of the initial report, the outcome for the events of not felt well and stomach ache was unknown.  The reported assessed the events stomach ache and not felt well as non-serious and possibly related to Vivotif.  Additional information received on 29-Nov-2023 from Company included reference number, patient details and further description of the events.  This case is linked to case US-BN-2023-010601 (same reporter).; Reporter's Comments: An 11-year-old male patient experienced stomach-ache and did not felt well, on the same day when he was vaccinated with the fourth dose (administered unknown time after the third dose) of Vivotif, at an unknown dose, administered orally. Malaise and abdominal pain upper are both listed and expected according to CCDS v1 and PI for Vivotif. the outcome of the events malaise and abdominal pain upper was unknown. The patient's medical history and concomitant medication details were not provided. Malaise and abdominal pain upper are both assessed as related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: An 11-year-old male patient experienced stomach-ache and did not felt well, on the same day when he was vaccinated with the fourth dose (administered unknown time after the third dose) of Vivotif, at an unknown dose, administered orally. Malaise and abdominal pain upper are both listed and expected according to CCDS v1 and PI for Vivotif. the outcome of the events malaise and abdominal pain upper was unknown. The patient's medical history and concomitant medication details were not provided. Malaise and abdominal pain upper are both assessed as related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product solubility abnormal
Clinical narrative: The patient swallowed the second dose Vivotif and seemed like it dissolved in the middle of throat; Case reference number US-BN-2023-010610 is a spontaneous case report initially received on 29-Nov-2023 from a pharmacist via Company (reference number: USBAV23-2001) and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medications details were not provided.  On unspecified date, the patient received the first dose of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication.  On unspecified date, unknown amount of time after the first dose, the patient received the second dose of Vivotif (batch number: unknown), at an unknown dose, taken orally.  On the same date, reported as when the patient swallowed the second dose, it seem like it dissolved in the middle of the throat. As reported, the patient took the dose with normal temperature water, same as with other unspecified medications.  At the time of the initial report, the outcome for the event of 'abnormal physical sensation' was unknown.  The reporter assessed the event of 'abnormal physical sensation' as non-serious and possibly related to Vivotif administration.   No further information provided.; Reporter's Comments: A female patient of unspecified age swallowed the second dose of Vivotif, and reported it seemed like it dissolved in the middle of the throat. Abnormal physical sensation is unlisted and unexpected for Vivotif per the CCDS v8 and the PI. Further details, relevant medical history and concomitant medications details were not provided. Considering plausible temporal relationship, event has been considered as related to Vivotif.; Sender's Comments: A female patient of unspecified age swallowed the second dose of Vivotif, and reported it seemed like it dissolved in the middle of the throat. Abnormal physical sensation is unlisted and unexpected for Vivotif per the CCDS v8 and the PI. Further details, relevant medical history and concomitant medications details were not provided. Considering plausible temporal relationship, event has been considered as related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product solubility abnormal
Clinical narrative: Patient felt like the second dose of Vivotif dissolved in mouth; Case references number US-BN-2023-010616 is a spontaneous case initially received from a nurse via Communication (reference number USBAV23-2011) on 30-Nov-2023 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 26-Nov-2023, the patient received the first dose of Vivotif (batch number unknown), for at an unknown dose, taken orally, for the upcoming trip.   On 28-Nov-2023, two days after the first dose, the patient received the second dose of Vivotif (batch number unknown), at an unknown dose, taken orally.   On the same day, the patient felt like the second dose dissolved in mouth.  On 30-Nov-2023, two days after the second dose, the patient received the third dose of Vivotif (batch number unknown), at an unknown dose, taken orally.  As reported, the fourth dose was scheduled to be taken on 02-Dec-2023.  At the time of the initial report, the outcome for the event of 'abnormal physical sensation' was unknown.   The reporter assessed the event of 'abnormal physical sensation' as non-serious and possibly related to Vivotif administration.  No further information was provided.; Reporter's Comments: A female patient of unspecified age swallowed the second dose of Vivotif, and reported that felt like the dose dissolved in mouth. Abnormal physical sensation is unlisted and unexpected for Vivotif per the CCDS v8 and the USPI. Further details, relevant medical history and concomitant medications details were not provided. Considering plausible temporal relationship, event has been considered as related to Vivotif.; Sender's Comments: A female patient of unspecified age swallowed the second dose of Vivotif, and reported that felt like the dose dissolved in mouth. Abnormal physical sensation is unlisted and unexpected for Vivotif per the CCDS v8 and the USPI. Further details, relevant medical history and concomitant medications details were not provided. Considering plausible temporal relationship, event has been considered as related to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The third and fourth doses of Vivotif were taken after the temperature excursion; The third and fourth doses of Vivotif were taken after the temperature excursion; Case reference number US-BN-2023-010625 initially downloaded from Company (reference number USBAV23-2014) on 30-Nov-2023, is a spontaneous case received from a pharmacist and concerns a patient of unknown gender and age.  The patient's medical history and concomitant medications were not provided.  On unspecified dates, the patient took the first and the second dose of Vivotif (batch numbers: 3003901), at an unknown dose, or route of administration, for an unknown indication.   On unspecified dates, after the temperature excursion, as reported Vivotif was stored on ice and melted, the patient took the third and the fourth dose of Vivotif (batch numbers: 3003901), at an unknown dose, or route (explicitly codded as 'product storage error' and 'product administration error'). As reported, the reporter could not confirm that the temperature was not above 25 Celsius degrees, and time out of range was 12 hours.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: Reportedly, after the temperature excursion, Vivotif was stored on ice and melted and the patient took the third and the fourth dose of Vivotif at an unknown dose, or route which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: Reportedly, after the temperature excursion, Vivotif was stored on ice and melted and the patient took the third and the fourth dose of Vivotif at an unknown dose, or route which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: The patient did not refrigerate Vivotif and took it, and then realized it should have been refrigerated; The patient did not refrigerate Vivotif and took it, and then realized it should have been refrigerated; Case reference number US-BN-2023-010671 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV23-2069) on 11-Dec-2023 and concerns female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient took a dose of Vivotif (batch number: not reported) at an unknown dose, orally for typhoid prophylaxis. As reported, the Vivotif vaccine was not refrigerated for a week and a half and the patient took the vaccine and then realized it should had been refrigerated (explicitly coded as 'product administration error' and 'product storage error').   At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A female patient of unspecified age took a dose of Vivotif, at an unknown dose, orally for typhoid prophylaxis and reportedly, the Vivotif vaccine was not refrigerated for a week and a half and the patient took the vaccine and then realized it should had been refrigerated which is considered as product administration error and product storage error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took a dose of Vivotif, at an unknown dose, orally for typhoid prophylaxis and reportedly, the Vivotif vaccine was not refrigerated for a week and a half and the patient took the vaccine and then realized it should had been refrigerated which is considered as product administration error and product storage error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: The patient was taking the typhoid vaccine and it looked like the patient vomited one of them; Case reference number US-BN-2023-010676 is a spontaneous case report initially received from a pharmacist via Company (reference number: USBAV23-2079) on 12-Dec-2023 and concerns an 18-years-old female patient.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, administered orally, for an unknown indication. As reported, it was unspecified how many doses the patient took but the patient vomited one of them and the reporter asked how to proceed.  At the time of the initial report, the outcome for the event of vomiting of medication was unknown.  The reporter assessed the event of vomiting of medication as non-serious and possibly related to Vivotif.  No further information was provided.; Reporter's Comments: An 18-year-old female patient took a dose of Vivotif for an unknown indication. As reported, it was unspecified how many doses the patient took but the patient vomited one of them. Vomiting is listed and expected for Vivotif according to the CCDS v1 and PI. The patient's relevant medical history and concomitant medication details were not provided. The outcome for the event of vomiting of medication was unknown. Considering suggestive temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: An 18-year-old female patient took a dose of Vivotif for an unknown indication. As reported, it was unspecified how many doses the patient took but the patient vomited one of them. Vomiting is listed and expected for Vivotif according to the CCDS v1 and PI. The patient's relevant medical history and concomitant medication details were not provided. The outcome for the event of vomiting of medication was unknown. Considering suggestive temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the event has been considered as related to Vivotif. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took the second and the third dose on consecutive days rather than skipping the day between; Case reference number US-BN-2023-010677 is a spontaneous case report initially received from a nurse via  Communication (reference number: USBAV23-2081) on 12-Dec-2023 and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose and route of administration for unknown indication.  On an unspecified date, unknown amount of time after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, administered orally, for typhoid prophylaxis.   On an unspecified date, reported as on consecutive days rather than skipping the day between, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, administered orally (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A female patient of unspecified age took the second and the third dose on consecutive days rather than skipping the day between, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took the second and the third dose on consecutive days rather than skipping the day between, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: TYP
Symptoms: Product administration error, Product use complaint
Clinical narrative: A child patient had trouble swallowing with the Vivotif capsule; A child patient had trouble swallowing with the Vivotif capsule; Case reference number US-BN-2023-010687 is a spontaneous case report initially received from other health care professional via Company (reference number: USBAV23-2082) on 12-Dec-2023 and concerns a child patient of unspecified age and gender.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose and route of administration for unknown indication. As reported, the patient had a trouble swallowing the Vivofif capsule (explicitly coded as product difficult to swallow' and product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.  Non-significant case correction was performed on 17-Jan-2024 for the information received from the reporter on 04-Jan-2024 included confirmation that the patient followed up with primary care physician and did not get the vaccine from the reporter. The patient got the vaccine from pharmacy. The reporter did not have patient information and no further follow up was possible.; Reporter's Comments: A child patient of unspecified age and gender took a dose of Vivotif and as reported, the patient had a trouble swallowing the Vivofif capsule, which is considered as product difficult to swallow and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product use complaint and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product use complaint and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A child patient of unspecified age and gender took a dose of Vivotif and as reported, the patient had a trouble swallowing the Vivofif capsule, which is considered as product difficult to swallow and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product use complaint and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product use complaint and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product administration error, Product blister packaging issue
Clinical narrative: When Vivotif box was opened, it was noticed the blister pack was cut, one of the pills separated from the rest. Patient took one of the pills; When Vivotif box was opened, it was noticed the blister pack was cut, one of the pills separated from the rest. Patient took one of the pills; Case reference number US-BN-2023-010694 is a spontaneous case report initially received from a consumer (patient wife) via Company (reference number: USBAV23-2088) on 14-Dec-2023 and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: 3003852) at unknown dose, taken orally, for unknown indication. As reported the patient's wife stated when they open the box, they noticed the blister pack was cut, one of the pills separated from the rest (explicitly coded as product blister packaging separated and product administration error). As reported that patient will take the package back to the pharmacy and they had call to the pharmacy and had a replacement ready for her in an hour.  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received from consumer via Company on 15-Dec-2023 included additional reference number (USBAV23-2103), and update of the handling of the defective package and is blended in the narrative above.  Additional information received from consumer via Company on 22-Dec-2023 included additional reference number (USBAV23-2165), and updated one more reporter.; Reporter's Comments: An adult male patient took a dose of Vivotif vaccine after the blister pack was cut, and one of the pills separated from the rest, which is considered as product blister packaging separated and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product blister packaging issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product blister packaging issue and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient took a dose of Vivotif vaccine after the blister pack was cut, and one of the pills separated from the rest, which is considered as product blister packaging separated and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product blister packaging issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product blister packaging issue and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: The patient left the Vivotif vaccine out of the refrigerator for all the schedule; The patient left the Vivotif vaccine out of the refrigerator for all the schedule; Case reference number US-BN-2023-010701 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23-2108) on 15-Dec-2023 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, as reported, the patient left Vivotif vaccine (batch number: unknown) at unknown dose, route and site of administration, for unknown indication, for all schedules out of the refrigerator, reporter wanted to know the efficacy of the vaccine when its given as opposed to be under refrigeration (explicitly coded as 'product storage error' and 'product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender left Vivotif vaccine for all schedules out of the refrigerator, and the reporter wanted to know the efficacy of the vaccine when it's given as opposed to be under refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender left Vivotif vaccine for all schedules out of the refrigerator, and the reporter wanted to know the efficacy of the vaccine when it's given as opposed to be under refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: Vivotif was out of the refrigerator for 14 days, the temperature reached 69 Fahrenheit degrees and was taken; Vivotif was out of the refrigerator for 14 days, the temperature reached 69 Fahrenheit degrees and was taken; Case reference number US-BN-2023-010721 initially downloaded from Communications (reference number: USBAV23-2141) on 20-Dec-2023, is a spontaneous case received from a pharmacist and concerns a 45-years-old patient of unspecified gender.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the Vivotif vaccine was exposed to the first temperature excursion reaching a maximum temperature of 69 Fahrenheit degrees for 14 days (explicitly coded as 'product storage error').   On an unspecified date, an unknown amount of time after the first temperature excursion, the patient took, as reported, all doses of Vivotif (batch number: 3003907), at an unknown dose, or route of administration, for an unknown indication (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.   No further information was provided.; Reporter's Comments: A 45-year-old patient of unspecified gender took all doses of Vivotif, at an unknown dose, or route of administration, for an unknown indication, after the Vivotif vaccine was exposed to the first temperature excursion reaching a maximum temperature of 69 Fahrenheit degrees for 14 days, which is considered as product administration error and product storage error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications were not provided. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 45-year-old patient of unspecified gender took all doses of Vivotif, at an unknown dose, or route of administration, for an unknown indication, after the Vivotif vaccine was exposed to the first temperature excursion reaching a maximum temperature of 69 Fahrenheit degrees for 14 days, which is considered as product administration error and product storage error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications were not provided. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.