chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood creatine phosphokinase normal, Blood lactic acid normal, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Per ER records and Parents: Pt had kinrix and proquad 02/28/2025. About 1 hour after the injections the patients arm began to swell and get red. 03/01/2025 the pt was complaining that his arm was hurting very bad. The swelling had increased and so had the redness. *triage assessment stated pt complains of pain appears in no apparent distress, swelling and redness noted.* Vitals Pulse: 94, Resp: 24, Temp: 98.3, O2: 99% on RA. Was given IV Ancef, IV Decadron, and IV Benadryl. Swelling had decreased by time of discharge and pt was sent home with prescriptions for Benadryl, Prednisolone sodium Phosphate 5mg/5ml (to take 10 ml PO QD for 5 days), Cefdinir 250mg/5ml (to take 3.5 ml PO BID for 10 days), and Diclofenac Sodium 1% topical gel (to apply 4 grams QID to single elbow, wrist or hand).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Red blood cell sedimentation rate increased, White blood cell count normal, X-ray limb normal, X-ray normal
Clinical narrative: Per ER records and Parents: Pt had kinrix and proquad 02/28/2025. About 1 hour after the injections the patients arm began to swell and get red. 03/01/2025 the pt was complaining that his arm was hurting very bad. The swelling had increased and so had the redness. *triage assessment stated pt complains of pain appears in no apparent distress, swelling and redness noted.* Vitals Pulse: 94, Resp: 24, Temp: 98.3, O2: 99% on RA. Was given IV Ancef, IV Decadron, and IV Benadryl. Swelling had decreased by time of discharge and pt was sent home with prescriptions for Benadryl, Prednisolone sodium Phosphate 5mg/5ml (to take 10 ml PO QD for 5 days), Cefdinir 250mg/5ml (to take 3.5 ml PO BID for 10 days), and Diclofenac Sodium 1% topical gel (to apply 4 grams QID to single elbow, wrist or hand).
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: At the time of vaccination the staff was told the child's DOB was 2012 and that he was 12 years old so a Proquad was administered. It was determined after vaccination that his DOB is 2010 and the child was 14 which is outside the range for the vaccine.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Infant irritability
Clinical narrative: Patient was to receive a diluted dosage due to age but instead received 0.3mL. Provider spoke with father at end of day on signs and symptoms to look out for over the weekend. Spoke with father and patient had been fussy all weekend but no other symptoms.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was accidentally given an expired dose of Gardisal 9. It was expired on 2/12/2025. Pt was notified immediately while still on site.  Merck was contacted and informed us that there was no need of revaccination.   Patient did not have any adverse reaction to this vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Central nervous system lesion, Gait disturbance, Laboratory test normal, Lumbar puncture normal
Clinical narrative: There were no signs until this happened: In September of 2021, after the first shot, I started having a tingling feeling go from three of my fingers (pinky, ring and middle only) and go up my arms to about my arm pits. After the second dose, in October 2021, I started feeling a tingling band feeling around my waist as if I had on a corset on. This feeling went away after 2 years of being bed ridden. Tingles took over my entire body and my left me not being able to walk on my own and rapid weight loss.  There was also an excruciating pain coming from the base of my spine. I am now taking Gabapentin in order to fully walk, function, and have less pain in my spine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Paraesthesia, Spinal pain, Weight decreased
Clinical narrative: There were no signs until this happened: In September of 2021, after the first shot, I started having a tingling feeling go from three of my fingers (pinky, ring and middle only) and go up my arms to about my arm pits. After the second dose, in October 2021, I started feeling a tingling band feeling around my waist as if I had on a corset on. This feeling went away after 2 years of being bed ridden. Tingles took over my entire body and my left me not being able to walk on my own and rapid weight loss.  There was also an excruciating pain coming from the base of my spine. I am now taking Gabapentin in order to fully walk, function, and have less pain in my spine.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Axillary mass, Bacterial infection, Biopsy breast, Biopsy breast abnormal
Clinical narrative: Idiopathic Granulomatous Mastitis
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast abscess, Breast discomfort, Breast inflammation, Breast mass, Breast operation
Clinical narrative: Idiopathic Granulomatous Mastitis
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast pain, Drain placement, Erythema, Joint stiffness, Mammogram
Clinical narrative: Idiopathic Granulomatous Mastitis
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Plasma cell mastitis, Ultrasound breast abnormal
Clinical narrative: Idiopathic Granulomatous Mastitis
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt inadvertently received extra dose of vaccine, no symptoms of adverse reactions.  No treatment required.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Vaccine administration error- VAXELIS inadvertently administered instead of PREVNAR 20 resulting in  patient then received 2 HIBS on same day and extra doses of  VAXELIS . Last dose of VAXELIS administered on 10/15/2024. Spoke to Parent on 3/4/2025- she reports no fever, no leg swelling, no other concerning signs or symptoms
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted about 1 minute after administering vaccination. Regained consciousness and then fainted again, upon which time I contacted 911. measuring his BP it was 60/39 pulse 52. The paramedics arrived within 4 minutes and took him away to the ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, WARMTH, AND PAIN AT INJECTION SITE 18.5 HOURS AFTER VACCINES GIVEN. MOTHER TREATED AT HOME WITH PO BENADRYL LIQUID 5ML COUPLE DOSES. INSTRUCTED AFTER VISIT - COOL COMPRESSES, TYLENOL OR IBUPROFEN PRN ANY PAIN OR SWELLING, FU PRN.  SEEN IN CLINIC TODAY 3/4/25 FOR CHECK OF REACTION. IMPROVED BUT STILL SOME REDNESS AND SLIGHT SWELLING, NO FURTHER WARMTH OR PAIN OR ANY FURTHER SYMPTOMS.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Diarrhoea, Dizziness, SARS-CoV-2 test
Clinical narrative: Cough, diarrhea, dizzy
Sex: M
Vaccine: TYP
Symptoms: Sinusitis
Clinical narrative: Sinus infection; Case reference number US-BN-2024-002045 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1331) on 11-Jun-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, the patient completed the dosing with Vivotif.  On an unspecified date, unknown amount of time after the dose of Vivotif, the patient had sinus infection and needs to begin a round of antibiotics for a sinus infection.  At the time of the initial report, the outcome of the event sinus infection was unknown.  The reporter assessed seriousness for the event sinus infection as non-serious and assessed the causality as possible for the event sinus infection.  No further information was provided.; Reporter's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: A rash developed from injection site down arm to the bend of the arm.  The rash began the day after the injection and lasted for 3 days.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Crossmatch, Disseminated intravascular coagulation, Exposure during pregnancy
Clinical narrative: Patient administered Adacel 2/25/25 and office, patient was admitted to hospital 2/26/25 for Placenta Abruption with IUFD and DIC. She was admitted at 36w3d
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal death, Full blood count, International normalised ratio, Metabolic function test, Pathology test
Clinical narrative: Patient administered Adacel 2/25/25 and office, patient was admitted to hospital 2/26/25 for Placenta Abruption with IUFD and DIC. She was admitted at 36w3d
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Premature separation of placenta, Prothrombin time, Reflex test
Clinical narrative: Patient administered Adacel 2/25/25 and office, patient was admitted to hospital 2/26/25 for Placenta Abruption with IUFD and DIC. She was admitted at 36w3d
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Somnolence
Clinical narrative: Patient reported itching, fever, sleepiness shortly after receiving vaccination and for the 4 days following vaccination. Patient reported symptoms to doctor who advised OTC medications. Patient reported relief after taking Benadryl and Tylenol.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Reporting administration error. MA administered COVID Moderna Vaccine 6m-11y to 20 year old patient. No adverse event, signs, or symptoms have been reported.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Decreased appetite, Dizziness, Nausea, Pyrexia
Clinical narrative: Patient's daughter called pharmacy and stated that the patient was feeling dizzy, nauseous, and had a fever. She also stated he did not have an appetite and did not eat all day.
Age: 44.0
Sex: M
Vaccine: CHIK
Symptoms: Angiogram, C-reactive protein, Full blood count, Headache, Magnetic resonance imaging head
Clinical narrative: severe bilateral headache and neck spasms beginning approximately 70 hours post vaccination. Increasing fever peaking at 103.1 degrees. Fever lasted for 48 hours. Treatment was palliative support of IV fluids, compazine, magnesium, torridol, acetemetaphine
Age: 44.0
Sex: M
Vaccine: CHIK
Symptoms: Muscle spasms, Pyrexia, Respiratory viral panel, Scan with contrast
Clinical narrative: severe bilateral headache and neck spasms beginning approximately 70 hours post vaccination. Increasing fever peaking at 103.1 degrees. Fever lasted for 48 hours. Treatment was palliative support of IV fluids, compazine, magnesium, torridol, acetemetaphine
Age: 57.0
Sex: M
Vaccine: TYP
Symptoms: Injection site pain
Clinical narrative: patient reporting that has continued pain at injection site for over a month, at first he though it was a pulled muscle but then realized it was related to the vaccine
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Intensive care, Laboratory test normal, Magnetic resonance imaging normal, Status epilepticus
Clinical narrative: Episodes of status epilepticus, generally occurring every 3 months.  Hospitalization required on many occasions, including overnight monitoring and ICU stay requiring intubation and sedation to stop the seizures.  Patient requires ongoing monitoring by a neurologist and daily anti-seizure medications.  Multiple tests, including MRI show no causation for the sudden onset of seizures and prior to the C19 vaccine, patient had no health conditions.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Needle issue
Clinical narrative: The needle came loose while injection vaccine.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient given extra dose of Hep A and HPV.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Polymerase chain reaction negative, Rash
Clinical narrative: Full body rash.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Hypotension, Urticaria
Clinical narrative: Pt developed hives on L arm, became light headed and needed to lay down, hypotensive, bradycardic . Pt was given 25mg oral benadryl, monitored vitals closely, O2 2L n/c applied. Epinephrine was not given as patients condition improved quickly with the forementioned interventions
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Mobility decreased, Peripheral swelling
Clinical narrative: Arthritis- which i had never experienced before. My hands swelled so much I couldn't bend my fingers.
Age: 2.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I requested DTaP to give to patient, RN pulled Tdap. Tdap vaccine was given, despite patient being <7yo. No adverse reactions.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: HPV immunization given was incorrect vaccine that was administered to the patient. Patient was here to get MCV4. HPV was given in error. Pt. was called and notified of error. I let Pt. know to return so we could give the correct vaccine. Pt. returned to office, within about 15 minutes of receiving the incorrect HPV vaccine, to receive the correct vaccine, MCV4. Information given on HPV for what is it and who it is for. Pt. verbalized understanding of HPV vaccine. She has no concerns at the time. No adverse reactions occurred from the HPV vaccine that was given in error.
Age: 48.0
Sex: F
Vaccine: MMR, PNC21
Symptoms: Dyspnoea
Clinical narrative: shortness of breath and trouble breathing starting later that day or next day
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Client came in to receive COVID and Flu vaccines. This RN administered the child dose 6mo-11yr of Private vaccine to client. No adverse symptoms noted at time of vaccination and none reported to clinic by client. This RN did call client on 3/4/2025 and rescheduled him for correct adult dose of COVID vaccine on 3/10/25.
Age: 80.0
Sex: F
Vaccine: RSV, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient called stating her arm was red and swollen from the vaccines she received.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took Vivotif four doses correctly, but all stored at room temperature range from 71-75 F for more that 24 hours; Patient took Vivotif four doses correctly, but all stored at room temperature range from 71-75 F for more that 24 hours; Case reference number US-BN-2024-002055 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1364) on 13-Jun-2024 and concerns a patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On unspecified dates, the patient took first, second, third and fourth dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, patient took all four doses correctly, but all stored at room temperature for more that 24 hours and range  was from 71-75 F (explicitly coded as 'product storage error' and '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 patient of unknown age took the first, second, third and the fourth dose of Vivotif, but all stored at room temperature for more than 24 hours and range was from 71-75 F, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Product storage error 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 patient of unknown age took the first, second, third and the fourth dose of Vivotif, but all stored at room temperature for more than 24 hours and range was from 71-75 F, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Product storage error 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.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash
Clinical narrative: per pt, initially a rash developed after receiving her vaccine. After a few days she contacted her prescriber who told her to come in to be seen right away.  She was diagnosed with cellulitis. Her arm being affected from injection site down to her elbow. she has now been on antibiotics for about 24 hours
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received four injections in left deltoid on 2/28/25-- Depo Provera as well as the vaccines for flu, COVID, and MCV. About 5 days after the injections (yesterday), she developed redness, warmth, and pain where one of the vaccines was administered. The reaction is consistent with a cellulitis vs localized allergic reactions. I decided to treat with antibiotics as I thought the delayed onset of symptoms was more consistent with an infection.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: 21 year old patient seen for pregnancy.  Provider asked patient if she received the flu shot and patient stated she did not.  Provider recommended she receive the flu shot due to history of asthma.  Patient agreed.  RN administered flu vaccine.  After administration, it was determined the patient already received 2024-25 flu vaccine on 10/21/2024. Patient did not experience any adverse event due to administration.  This is being reported FYI.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac assistance device user, Death, Pulse absent, Respiratory arrest, Resuscitation
Clinical narrative: Resident unresponsive, not breathing,  no pulse. CPR, AED, IVF, 911 initiated; resident expired
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Resident unresponsive, not breathing,  no pulse. CPR, AED, IVF, 911 initiated; resident expired
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Mobility decreased, Pain, Palpitations
Clinical narrative: After a week of getting the injection, I felt severe exhaustion and could barely get out of bed. My body hurt so bad for over two weeks. I also had some chest pain and heart palpitations.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever, chills, aches, swelling /redness/tenderness at the site of injection, reports of the area being warm to the touch started day after vaccination (2/27/25) and continued through 2/28 when report to the pharmacy was made. Per patient she was prescribed antibiotics
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, aches, swelling /redness/tenderness at the site of injection, reports of the area being warm to the touch started day after vaccination (2/27/25) and continued through 2/28 when report to the pharmacy was made. Per patient she was prescribed antibiotics
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms at this time
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: 2.5 after I go the vaccine it was very itchy, it was not that bad at that time and i took some allergra. And it started to come down. And yesterday it got very bad and went to the ER, my whole body was red from my ears down and everything but my head was red. Very painful like shingles. I went to the ER and they gave me meds but it is not getting any better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: pt states very large and red upper arm, pt states very sore and had to use cold compress
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Chest pain, Diarrhoea, Nausea
Clinical narrative: Within 2 days of the shot the patient was complaining of chest pain and diarrhea. At three days, the patient called back to complain of nausea with eating but no vomiting, sweating, fever, and aches and pains.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient received Flu vaccine on 2/8/25. Two days after vaccine,  patient states she was experiencing neck, shoulder, trunk and left arm pain.  She states it seems like it is "nerve pain."  She visited her provider and they prescribed her 9 day steroid course.  She said some pain has subsided, and will have another appointment with a specialist.  She notified me at the pharmacy on 03/03/25.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, VARCEL
Symptoms: Exercise tolerance decreased, Muscle fatigue, Rash
Clinical narrative: Patient received Covid, Flu, MMR, Varicella, and Hep B vaccines at facility for employment. She was due now (March 2025) for her second doses and mentioned to Employee Health (reporter of this VAERS submission) that she had a "bad reaction" and wanted to "opt out" of receiving the second doses. She stated that she developed a rash on her back, neck and hairline 4-5 days after receiving the vaccines. She denies any breathing trouble with the rash she developed. She also had muscle fatigue  and still has some muscle fatigue to the point her daily workout routine has been impacted. Patient never saw a provider about this but is encouraged to follow up.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Exposure during pregnancy
Clinical narrative: MMR vaccine was given and patient is pregnant.  Did not share how many weeks as has not met with physician due to just finding out was pregnant.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Myalgia, Sleep disorder, X-ray limb
Clinical narrative: Severe right arm pain over deltoid.  Waking him from sleep.    Senior, baseball player - has not recovered and can not play.
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: On the same day, the patient took the first dose of Vivotif and doxycycline; Case reference number US-BN-2024-002064 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1359) on 13-Jun-2024 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 11-Jun-2024, the patient took first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication.  On the same day, the patient took a dose of Doryx (doxycycline, batch number: unknown), delayed release, at a dose of 60mg, for an unknown indication (explicitly coded as 'Product administration error'). The reporter wondered if the therapy should be stopped, wait for three days, and restart the series, or should the Vivotif be continued, and the doxycycline be stopped.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown demographics took a dose of Doryx on the same day when the patient took first dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error 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 patient of unknown demographics took a dose of Doryx on the same day when the patient took first dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took one dose of Vivotif vaccine which spent two weeks out of refrigerator, maximum temperature was 70 degrees Fahrenheit; The patient took one dose of Vivotif vaccine which spent two weeks out of refrigerator, maximum temperature was 70 degrees Fahrenheit; Case reference number US-BN-2024-002058 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-1392) on 17-Jun-2024 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On 17-Jun-2024, as reported today, the patient took one dose of Vivotif vaccine (batch number: 3004008), at unknown dose, reported as one pill, orally, for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 Fahrenheit degree (explicitly coded 'Product storage error' and 'Product administration error').   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: A patient of unspecified age and gender took one dose of Vivotif vaccine for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 Fahrenheit degree, 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender took one dose of Vivotif vaccine for typhoid fever immunisation. As reported, one box of Vivotif vaccine spent two weeks out of the refrigerator, maximum temperature was 70 Fahrenheit degree, 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1392:
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Patient took first dose of Vivotif on empty stomach, ended up vomiting about an hour after taking it; Case reference number US-BN-2024-002054 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1398) on 17-Jun-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid Immunization.  On an unspecified date, reported as about an hour after taking first dose of Vivotif on empty stomach, patient ended up vomiting. As reported, it turned up that patient vomited the full capsule.  At the time of the initial report, it was unknown if the patient recovered from vomiting.  The reporter assessed the seriousness for the event vomiting as non-serious and assessed the causality as possible for the event vomiting.  No further information was provided.; Reporter's Comments: A female patient of unknown age ended up vomiting about an hour after taking first dose of Vivotif on empty stomach. Vomiting is listed and expected according to CCDS v8 and USPI. The outcome was unknown. Causality is assessed as related due to suggestive temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A female patient of unknown age ended up vomiting about an hour after taking first dose of Vivotif on empty stomach. Vomiting is listed and expected according to CCDS v8 and USPI. The outcome was unknown. Causality is assessed as related due to suggestive temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80°F and then 50°F, the vaccine was outside of the refrigerator for four days; Patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80°F and then 50°F, the vaccine was outside of the refrigerator for four days; Case reference number US-BN-2024-002067 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1404) on 18-Jun-2024 and concerns an unknown number of patients of unknown age and gender.  The patients' medical history and concomitant medication were not provided.  On unspecified dates, the patients took the first and second dose of Vivotif (batch number: 3004044) at an unknown dose, via oral use for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patients experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: An unknown number of patients of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication were not provided. Product storage error 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 unknown number of patients of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication were not provided. Product storage error 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The Vivotif vaccines were left out of the refrigerator for six hours and was given to five patients; The Vivotif vaccines were left out of the refrigerator for six hours and was given to five patients; Case reference number US-BN-2024-002062 is a spontaneous case initially received from a healthcare professional via Med Communications (reference number: USBAV24-1401) on 18-Jun-2024 and concerns five patients of unspecified age.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, Vivotif vaccines were left out of the refrigerator for six hours (explicitly coded as 'product storage error').  On an unspecified date, five patients took a dose of Vivotif (batch number: unknown), at an unknown dose and route of administration, for an unknown indication (explicitly coded as 'product administration error').  At the time of initial report, it was unknown if any of the patients experienced adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: Five patients of unspecified age took a dose of Vivotif, after Vivotif vaccines were left out of the refrigerator for six hours, for an unknown indication, 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Five patients of unspecified age took a dose of Vivotif, after Vivotif vaccines were left out of the refrigerator for six hours, for an unknown indication, 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient took first dose of Vivotif and was due to take second dose yesterday, but missed that dose; Case reference number US-BN-2024-002081 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1437) on 21-Jun-2024 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, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, or route, for an unknown indication.   On an unspecified date, as reported yesterday, an unknown amount of time after the first dose of Vivotif, the patient should take the second dose of Vivotif, but missed that dose (explicitly coded as 'missed dose').  At the time of the initial report, it was unknown if the patient experienced any adverse event Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender should take the second dose of Vivotif, an unknown amount of time after the first dose of Vivotif, but missed that dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue 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 patient of unknown age and gender should take the second dose of Vivotif, an unknown amount of time after the first dose of Vivotif, but missed that dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: The patient was late about 16 hours with fourth dose of Vivotif vaccine; The patient ate one half chocolate bar and fruit leather ten minutes prior to taking the fourth dose of Vivotif; Case reference number US-BN-2024-002087 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1459) on 24-Jun-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took three doses of Vivotif vaccine (batch number: unknown), at unknown dose, orally, for typhoid fever immunisation.  On an unspecified date, unknown amount of time after the third dose, as reported, dose was late about 16 hours, patient took fourth dose of Vivotif (batch number: unknown), at unknown dose, orally. As reported, the patient ate one half chocolate bar and fruit leather ten minutes prior to taking the dose (explicitly coded as 'Product administration error' and 'Inappropriate schedule of vaccine administered').  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: A female patient of unspecified age took the fourth dose of Vivotif, and the dose was late about 16 hours. As reported, the patient ate one half chocolate bar and fruit leather ten minutes prior to taking the dose, which is considered as product administration error and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration 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 female patient of unspecified age took the fourth dose of Vivotif, and the dose was late about 16 hours. As reported, the patient ate one half chocolate bar and fruit leather ten minutes prior to taking the dose, which is considered as product administration error and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration 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. USBAV24-1459:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patients took first doses of Vivotif vaccines which were out of refrigerate five days, maximum temperature was 75 Fahrenheit degrees; The patients took first doses of Vivotif vaccines which were out of refrigerate five days, maximum temperature was 75 Fahrenheit degrees; Case reference number US-BN-2024-002085 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-1451) on 24-Jun-2024 and concerns two patients, 14-years-old and 18-years-old male patients.  The patient's medical history and concomitant medication details were not provided.  On 23-Jun-2024, reported as yesterday, the patients took first dose of Vivotif (batch number: 3004044; 3004043), at unknown dose, orally, for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees (explicitly coded as 'Product storage error' and 'Product administration error').  At the time of the initial report, it was unknown if any of the patients experienced any adverse event due to Vivotif vaccine.  Additional information received from consumer on 24-Jun-2024 via Med Communications included age of second patient and additional reference number USBAV24-1449.; Reporter's Comments: Two patients, 14-year-old and 18-year-old male patients took the first dose of Vivotif for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees, which is considered as product storage error and product administration error. It was unknown if any of the patients 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients, 14-year-old and 18-year-old male patients took the first dose of Vivotif for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees, which is considered as product storage error and product administration error. It was unknown if any of the patients 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 as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1451:
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Patient did not take Vivotif doses one hour before the meal; Case reference number US-BN-2024-002106 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1504) on 26-Jun-2024 and concerns a male patient of unknown age.   The patient's medical history and concomitant medication were not provided.  On unspecified dates, the patient took the first, second, third and fourth dose of Vivotif (batch number: 3004009) four capsules, orally for unknown indication. As reported, the patient did took Vivotif according to the recommended schedule and took all four capsules on alternate days, but did not take Vivotif doses one hour before the meal (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.  Additional information received from a nurse via Med Communication (reference number: USBAV24-1504) on 28-Jun-2024: included updated reporter details.; Reporter's Comments: A male patient of unknown age took Vivotif according to the recommended schedule and took all four capsules on alternate days, but did not take Vivotif doses one hour before the meal which is considered as product administration error. Product administration error is considered listed per company convention. At this point it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took Vivotif according to the recommended schedule and took all four capsules on alternate days, but did not take Vivotif doses one hour before the meal which is considered as product administration error. Product administration error is considered listed per company convention. At this point it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.