🏥 VAERS Vaccine Data Browser

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This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

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Data Interpretation

The presence of a report does not mean the vaccine caused the adverse event.
Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
Serious adverse events must be reported by law, even if unrelated to the vaccine.
The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
State: Enter 2-letter state code (e.g., CA, NY, TX)
Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

Reports are unverified: VAERS accepts all reports without medical verification
Not proof of causation: A report does not mean the vaccine caused the event
Anyone can report: Healthcare providers, patients, and family members can submit reports
Multiple vaccines: One report may list multiple vaccines given at the same time
Blank fields: Not all fields are required, so some data may be missing

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
Expand text: Click "More" to see full narrative or symptom text
Navigate pages: Use pagination controls at top and bottom of table
Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 27,301 to 27,350 of 34,052 reports (Page 547 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀
2829313	1	F	IA	03/04/2025	MMR	MERCK & CO. INC.	X027902	Needle issue Needle issue	The needle came loose while injection vaccine. The needle came loose while injection vaccine.
2829315	12	M	TX	03/04/2025	HEPA HPV9	MERCK & CO. INC. MERCK & CO. INC.	DN273 Y011500	Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Patient given extra dose of Hep A and HPV. Patient given extra dose of Hep A and HPV.
2829316	1	F	WY	03/04/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS		Polymerase chain reaction negative, Rash Polymerase chain reaction negative, Rash	Full body rash. Full body rash.
2829317	56	F	PA	03/04/2025	COVID19	PFIZER\BIONTECH	LN0590	Bradycardia, Dizziness, Hypotension, Urticaria Bradycardia, Dizziness, Hypotension, Urticaria	Pt developed hives on L arm, became light headed and needed to lay down, hypotensive, bradycardic . ... 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 More
2829318	65	F	CO	03/04/2025	UNK	UNKNOWN MANUFACTURER		Arthritis, Mobility decreased, Peripheral swelling Arthritis, Mobility decreased, Peripheral swelling	Arthritis- which i had never experienced before. My hands swelled so much I couldn't bend my fi... Arthritis- which i had never experienced before. My hands swelled so much I couldn't bend my fingers. More
2829319	2	M	OR	03/04/2025	HEPA TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	c24b9 x449y	No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More	I requested DTaP to give to patient, RN pulled Tdap. Tdap vaccine was given, despite patient being &... I requested DTaP to give to patient, RN pulled Tdap. Tdap vaccine was given, despite patient being <7yo. No adverse reactions. More
2829320	10	F	MI	03/04/2025	MNQ	SANOFI PASTEUR		Unevaluable event Unevaluable event	none none
2829321	18	F	MO	03/04/2025	HPV9 MNQ	MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS	X022735 NR394	Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered	HPV immunization given was incorrect vaccine that was administered to the patient. Patient was here ... 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. More
2829322	48	F	TX	03/04/2025	MMR PNC21	MERCK & CO. INC. MERCK & CO. INC.	Y011637 Y013009	Dyspnoea; Dyspnoea Dyspnoea; Dyspnoea	shortness of breath and trouble breathing starting later that day or next day shortness of breath and trouble breathing starting later that day or next day
2829323	46	M	CO	03/04/2025	COVID19	MODERNA	3044091	No adverse event, Underdose No adverse event, Underdose	Client came in to receive COVID and Flu vaccines. This RN administered the child dose 6mo-11yr of Pr... 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. More
2829324	80	F	SC	03/04/2025	RSV TDAP VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	LN4P2 XN575 93KK4	Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripher... Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling More	Patient called stating her arm was red and swollen from the vaccines she received. Patient called stating her arm was red and swollen from the vaccines she received.
2829325			TN	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	Patient took Vivotif four doses correctly, but all stored at room temperature range from 71-75 F for... 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. More
2829326	73	F	MN	03/04/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	3X97J	Cellulitis, Injection site rash Cellulitis, Injection site rash	per pt, initially a rash developed after receiving her vaccine. After a few days she contacted her p... 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 More
2829327	16	F	CO	03/04/2025	COVID19 FLU3 MNQ	MODERNA SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS	B0004 UT8415MA X7R4Z	Injection site erythema, Injection site pain, Injection site warmth; Injection s... Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth More	Patient received four injections in left deltoid on 2/28/25-- Depo Provera as well as the vaccines f... 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. More
2829329	21	F	VA	03/04/2025	FLU3	SANOFI PASTEUR	UT8514KA	Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered	21 year old patient seen for pregnancy. Provider asked patient if she received the flu shot and pat... 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. More
2829330	59	F	MD	03/04/2025	COVID19 COVID19	MODERNA MODERNA	364248B 364248B	Cardiac assistance device user, Death, Pulse absent, Respiratory arrest, Resusci... Cardiac assistance device user, Death, Pulse absent, Respiratory arrest, Resuscitation; Unresponsive to stimuli More	Resident unresponsive, not breathing, no pulse. CPR, AED, IVF, 911 initiated; resident expired Resident unresponsive, not breathing, no pulse. CPR, AED, IVF, 911 initiated; resident expired	✓
2829331	55	F	FL	03/04/2025	COVID19	PFIZER\BIONTECH	LMO589	Chest pain, Fatigue, Mobility decreased, Pain, Palpitations Chest pain, Fatigue, Mobility decreased, Pain, Palpitations	After a week of getting the injection, I felt severe exhaustion and could barely get out of bed. My ... 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. More
2829332	52	F	CA	03/04/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	39H2S 39H2S	Chills, Injection site erythema, Injection site pain, Injection site swelling, I... Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Pain, Pyrexia More	Fever, chills, aches, swelling /redness/tenderness at the site of injection, reports of the area bei... 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 More
2829333	1.08	M	VA	03/04/2025	MMRV	MERCK & CO. INC.	Y013576	Extra dose administered, No adverse event Extra dose administered, No adverse event	No symptoms at this time No symptoms at this time
2829334	60	F	MI	03/04/2025	PPV	MERCK & CO. INC.		Erythema, Pain, Pruritus Erythema, Pain, Pruritus	2.5 after I go the vaccine it was very itchy, it was not that bad at that time and i took some aller... 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. More
2829335	66	F	PA	03/04/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	7ZM55	Erythema, Pain in extremity Erythema, Pain in extremity	pt states very large and red upper arm, pt states very sore and had to use cold compress pt states very large and red upper arm, pt states very sore and had to use cold compress
2829336	66	F	AL	03/04/2025	FLU3 TDAP VARZOS	SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	388478 L5229 7ZM55	Chest pain, Diarrhoea, Nausea; Chest pain, Diarrhoea, Nausea; Chest pain, Diarrh... Chest pain, Diarrhoea, Nausea; Chest pain, Diarrhoea, Nausea; Chest pain, Diarrhoea, Nausea More	Within 2 days of the shot the patient was complaining of chest pain and diarrhea. At three days, the... 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. More
2829337	51	F	TX	03/04/2025	FLU3	SEQIRUS, INC.	AW1696A	Arthralgia, Neck pain, Neuralgia, Pain, Pain in extremity Arthralgia, Neck pain, Neuralgia, Pain, Pain in extremity	Patient received Flu vaccine on 2/8/25. Two days after vaccine, patient states she was experiencing... 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. More
2829338	46	F		03/04/2025	COVID19 FLU3 HEP MMR VARCEL	MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	8080803 UT8488LA 5JX2E X028354 Y002061	Exercise tolerance decreased, Muscle fatigue, Rash; Exercise tolerance decreased... Exercise tolerance decreased, Muscle fatigue, Rash; Exercise tolerance decreased, Muscle fatigue, Rash; Exercise tolerance decreased, Muscle fatigue, Rash; Exercise tolerance decreased, Muscle fatigue, Rash; Exercise tolerance decreased, Muscle fatigue, Rash More	Patient received Covid, Flu, MMR, Varicella, and Hep B vaccines at facility for employment. She was ... 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. More
2829339	32	F	IA	03/04/2025	MMR	MERCK & CO. INC.	Y003677	Contraindication to vaccination, Exposure during pregnancy Contraindication to vaccination, Exposure during pregnancy	MMR vaccine was given and patient is pregnant. Did not share how many weeks as has not met with phy... 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. More
2829340	17	M	NC	03/04/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS	B4J4B	Loss of personal independence in daily activities, Myalgia, Sleep disorder, X-ra... Loss of personal independence in daily activities, Myalgia, Sleep disorder, X-ray limb More	Severe right arm pain over deltoid. Waking him from sleep. Senior, baseball player - has not rec... Severe right arm pain over deltoid. Waking him from sleep. Senior, baseball player - has not recovered and can not play. More
2829341			GA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	On the same day, the patient took the first dose of Vivotif and doxycycline; Case reference number U... 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. More
2829342		M	AZ	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004007	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took accidentally took two doses of Vivotif vaccine two days on a row, second dose on da... The patient took accidentally took two doses of Vivotif vaccine two days on a row, second dose on day 2, third dose on day 4 and fourth dose on day 6; Case reference number US-BN-2024-002050 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-1379) on 14-Jun-2024 and concerns an 18-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 07-Jun-2024, the patient took first dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally, for immunization against disease caused by Salmonella typhi. On 08-Jun-2024, one day after the first dose of Vivotif, the patient took second dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally. As reported, the patient accidentally took two doses two days on a row (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 10-Jun-2024, three days after the first dose of Vivotif, the patient took third dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 12-Jun-2024, five days after the first dose of Vivotif, the patient took fourth dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally (explicitly coded as '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. Additional information received from Med Communications on 14-Jun-2024: new information included patient details, Vivotif dosing information for all four doses and additional reference number.; Reporter's Comments: An 8-year-old male patient accidentally took two doses of Vivotif vaccine two days in a row, the second dose on the day 2, the third dose on the day 4 and the fourth dose on the day 6, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's 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: An 8-year-old male patient accidentally took two doses of Vivotif vaccine two days in a row, the second dose on the day 2, the third dose on the day 4 and the fourth dose on the day 6, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's 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. USBAV24-1380: USBAV24-1379: More
2829343				03/04/2025	TYP	BERNA BIOTECH, LTD.	3004008	Product storage error Product storage error	The patient took one dose of Vivotif vaccine which spent two weeks out of refrigerator, maximum temp... 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: More
2829344		F	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Vomiting Vomiting	Patient took first dose of Vivotif on empty stomach, ended up vomiting about an hour after taking it... 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. More
2829345				03/04/2025	TYP	BERNA BIOTECH, LTD.	3004044	Inappropriate schedule of product administration, Product storage error Inappropriate schedule of product administration, Product storage error	The patients took the first and the second doses of Vivotif which were out of refrigerator, total du... The patients took the first and the second doses of Vivotif which were out of refrigerator, total duration 75 hours, maximum temperature was 73 Fahrenheit degrees; The patients took the first and the second doses of Vivotif which were out of refrigerator, total duration 75 hours, maximum temperature was 73 Fahrenheit degrees; Case reference number US-BN-2024-002066 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-1403) on 18-Jun-2024 and concerns two patients 16-years-old and 18-years-old of unspecified gender. The patients' medical history and concomitant medication details were not provided. On an unspecified date, as reported last Friday at 5 PM, eight pills of Vivotif vaccine were purchased and were out of the refrigerator, maximum temperature was 73 Fahrenheit degree (explicitly coded 'product storage error'). On 14-Jun-2024, as reported last Friday at 7:30 PM, as reported two hours after purchase and not refrigerated, patients took the first dose of Vivotif (batch number: 3004044), at unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error'). On 16-Jun-2024, as reported on Sunday, three days after the first dose of Vivotif, patients took the second dose of Vivotif (batch number: 3004044), at unknown dose, orally (explicitly coded as 'product administration error'). As reported, total duration of excursion was 75h. 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 18-Jun-2024 via Med Communications (reference number: USBAV24-1408) included: age for second patient, and an additional reference number.; Reporter's Comments: Two patients, a 16-year-old and 18-year-old of unspecified gender took the first and the second dose of Vivotif, after Vivotif vaccines were out of the refrigerator, maximum temperature was 73 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: Two patients, a 16-year-old and 18-year-old of unspecified gender took the first and the second dose of Vivotif, after Vivotif vaccines were out of the refrigerator, maximum temperature was 73 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. More
2829346				03/04/2025	TYP	BERNA BIOTECH, LTD.	3004044	Product storage error Product storage error	Patients took two doses of Vivotif that haven't been refrigerated at all and the temperature ar... 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. More
2829347				03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	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; 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. More
2829348		F		03/04/2025	TYP	BERNA BIOTECH, LTD.	3004043	Product storage error Product storage error	Patient left Vivotif out of refrigeration for approximately two and a half to three hours and had ta... Patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose of Vivotif; Patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose of Vivotif; Case reference number US-BN-2024-002083 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1443) on 21-Jun-2024 and concerns 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: 3004043) at an unknown dose, route for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration (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 Vivotif. Additional information received from a nurse via Med Communication (reference number: (USBAV24-1444) on 21-Jun-2024: included added reporter details, event verbatim and confirmation on Vivotif dosage information, confirmation on patient gender and additional reference number (USBAV24-1444). Additional information received from a nurse via Med Communication (reference number: (USBAV24-1442) on 21-Jun-2024: included additional reference number (USBAV24-1442). Additional information received from a health care professional via Med Communication (reference number: (USBAV24-1449) on 26-Jun-2024: included additional reference number (USBAV24-1449).; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event Vivotif. 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 female patient of unknown age took the first dose of Vivotif for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event Vivotif. 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. More
2829349			VA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product dose omission issue Product dose omission issue	The patient took first dose of Vivotif and was due to take second dose yesterday, but missed that do... 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. More
2829350		F	UT	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration, Product administration error Inappropriate schedule of product administration, Product administration error	The patient was late about 16 hours with fourth dose of Vivotif vaccine; The patient ate one half ch... 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: More
2829351		M		03/04/2025	TYP	BERNA BIOTECH, LTD.	3004044;3004043	Product storage error Product storage error	The patients took first doses of Vivotif vaccines which were out of refrigerate five days, maximum t... 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: More
2829352		M	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004009	Product administration error Product administration error	Patient did not take Vivotif doses one hour before the meal; Case reference number US-BN-2024-002106... 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. More
2829353			UT	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	A patient took two doses of Vivotif, two days in a row instead of alternated days.; Case reference n... A patient took two doses of Vivotif, two days in a row instead of alternated days.; Case reference number US-BN-2024-002104 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1494) on 26-Jun-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as two days in a row instead of alternated days, the patient took the first and the second dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication (explicitly coded as '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 vaccination. No further information was provided.; Reporter's Comments: A patient of unknown demographics took the first and the second dose of Vivotif, at an unknown dose, orally, for an unknown indication which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccination. The patient's medical history and concomitant medication details 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 patient of unknown demographics took the first and the second dose of Vivotif, at an unknown dose, orally, for an unknown indication which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829354				03/04/2025	TYP	BERNA BIOTECH, LTD.	3004045	Product storage error Product storage error	One box of Vivotif was at 76 degrees Fahrenheit for eight hours; patient took one pill; One box of V... One box of Vivotif was at 76 degrees Fahrenheit for eight hours; patient took one pill; One box of Vivotif was at 76 degrees Fahrenheit for eight hours; patient took one pill; Case reference number US-BN-2024-002111 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1511) on 27-Jun-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as yesterday, the patient picked up Vivotif., but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours (explicitly coded as 'Product storage error'). On 27-Jun-2024, the patient took the first dose of Vivotif (batch number: 3004045), at an unknown dose, orally, 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 the Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown demographics picked up Vivotif, but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for an 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 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 unknown demographics picked up Vivotif, but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for an 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 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. USBAV24-1511: More
2829355		M	UT	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004008	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the first dose of Vivotif on 24-Jun-2024, and the second dose on 27-Jun-2024; Case ... The patient took the first dose of Vivotif on 24-Jun-2024, and the second dose on 27-Jun-2024; Case reference number US-BN-2024-002114 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1514) on 27-Jun-2024 and concerns a 17-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 24-Jun-2024, the patient took the first dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally, for indication reported as prior to travel. On 27-Jun-2024, three days after the first dose, the patient took the second dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally. As reported, the patient forgot to take yesterday's dose so was advised to take it as long as it was on an empty stomach and could wait to eat (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the third dose was scheduled for 29-Jun-2024, and the fourth dose for 01-Jul-2024. 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 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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. More
2829356				03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took dose of Vivotif which one box had temperature excursion for five hours, maximum tem... The patient took dose of Vivotif which one box had temperature excursion for five hours, maximum temperature was 70 Fahrenheit; The patient took dose of Vivotif which one box had temperature excursion for five hours, maximum temperature was 70 Fahrenheit; Case reference number US-BN-2024-002120 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1528) on 01-Jul-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, one box of Vivotif vaccine had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (explicitly coded 'Product storage error'). On 29-Jun-2024, the patient took first dose of Vivotif vaccine (batch number: unknown), at unknown dose, route or site of administration for 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 vaccine. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender took first dose of Vivotif vaccine, which had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (considered as product storage error) at unknown dose, route or site of administration for unknown indication which is considered as product administration error. Product administration error and product storage error are both considered listed per company convention. 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. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender took first dose of Vivotif vaccine, which had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (considered as product storage error) at unknown dose, route or site of administration for unknown indication which is considered as product administration error. Product administration error and product storage error are both considered listed per company convention. 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. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1528: More
2829357		F	IA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Vomiting Vomiting	The patient experienced vomiting within first few hours after the first dose of Vivotif; Case refere... The patient experienced vomiting within first few hours after the first dose of Vivotif; Case reference number US-BN-2024-002119 is a spontaneous case initially received from other health professional via Med Communications (reference number USBAV24-1539) on 01-Jul-2024 and concerns a female patient of unspecified age, reported as 65+. 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 unknown dose, orally, for typhoid Immunization. On the same day, reported as within first few hours, the patient experienced vomiting. At the time of the initial report, it was unknown if the patient recovered from the event of vomiting. The reporter assessed the event of vomiting as non-serious, and causality for the event of vomiting was reported as possible. No further information was provided.; Reporter's Comments: A female patient of unspecified age, reported as 65+, experienced vomiting, on the same day she took the first dose of Vivotif, at unknown dose, orally, for typhoid Immunization. Vomiting is listed and expected according to CCDS v8 and USPI. At this point, it was unknown if the patient recovered from the event of vomiting. The patient's medical history and concomitant medication details were not provided. Causality is 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: A female patient of unspecified age, reported as 65+, experienced vomiting, on the same day she took the first dose of Vivotif, at unknown dose, orally, for typhoid Immunization. Vomiting is listed and expected according to CCDS v8 and USPI. At this point, it was unknown if the patient recovered from the event of vomiting. The patient's medical history and concomitant medication details were not provided. Causality is 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. USBAV24-1539: More
2829358		M	MA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took all four doses of Vivotif vaccine which were unrefrigerated; The patient took all f... The patient took all four doses of Vivotif vaccine which were unrefrigerated; The patient took all four doses of Vivotif vaccine which were unrefrigerated; Flu like symptoms; Case reference number US-BN-2024-002129 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-1556) on 03-Jul-2024 and concerns a 19-years-old male patient. The patient's medical history and concomitant medication details were not provided. As reported, the patient did not refrigerate Vivotif vaccine (explicitly coded as 'Product storage error') On 27-Jun-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally, for unknown indication (explicitly coded as 'Product administration error') On 29-Jun-2024, two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error'). On 01-Jul-2024, two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error'). On 03-Jul-2024, two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error'). At the time of initial report, it was unknown if the patient recovered form event of flu like symptoms. The reporter assessed the event of flu like illness as non-serious and did not provide causality assessment for the event flu like illness. Additional information received on 03-Jul-2024 from Emergent BioSolutions included additional reference number (EMG224-751) and confirmation that the patient took Vivotif vaccine without it being under the refrigeration.; Reporter's Comments: A 19-years-old male patient did not refrigerate Vivotif vaccine which is considered as product storage error and took the first dose of Vivotif vaccine, at an unknown dose, orally, for unknown indication which is considered as product administration error. Two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless, at an unknown dose, orally which is also considered as product administration error. At this point, it was unknown if the patient recovered form event of flu like symptoms. Influenza like illness is listed according to CCDS v8 and unexpected according to USPI while product administration error and product storage error are both considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Influenza like illness is assessed as related due to plausible temporal relationship and known product safety profile. 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 19-years-old male patient did not refrigerate Vivotif vaccine which is considered as product storage error and took the first dose of Vivotif vaccine, at an unknown dose, orally, for unknown indication which is considered as product administration error. Two days after first dose of Vivotif, the patient took the second dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after second dose of Vivotif, the patient took the third dose of Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Two days after third dose of Vivotif, as reported, the patient started with flu like symptoms, but took the fourth dose of Vivotif regardless, at an unknown dose, orally which is also considered as product administration error. At this point, it was unknown if the patient recovered form event of flu like symptoms. Influenza like illness is listed according to CCDS v8 and unexpected according to USPI while product administration error and product storage error are both considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Influenza like illness is assessed as related due to plausible temporal relationship and known product safety profile. 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. USBAV24-1556: More
2829359		F	MD	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004043	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took first and second dose of Vivotif vaccine in two consecutive days instead of skippin... The patient took first and second dose of Vivotif vaccine in two consecutive days instead of skipping day; Case reference number US-BN-2024-002164 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1593) on 08-Jul-2024 and concerns a 21-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 06-Jul-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004043), at an unknown dose, orally for typhoid immunization. On 07-Jul-2024, one day after first dose of Vivotif vaccine, the patient took the second dose of Vivotif vaccine (batch number: 3004043), at an unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). As reported, the patient knew that doses were every other day, but mistakenly took one of the doses in two consecutive days, instead of skipping day. 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 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration 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 medications 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 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration 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 medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1593: More
2829360		F	MA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	Patient took first dose of Vivotif and forgot to take second dose, its been about a week from the fi... Patient took first dose of Vivotif and forgot to take second dose, its been about a week from the first dose; Case reference number US-BN-2024-002159 is a spontaneous case initially received from physician via Med Communication (reference number: USBAV24-1588) on 08-Jul-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 and route for unknown indication. As reported, the patient forgot to take second dose and it has been about a week from the first dose (explicitly coded as '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. No further information was provided. Non-significant case correction performed after internal review for information received on 08-Jul-2024 included company comment correction.; Reporter's Comments: A female patient of unknown age forgot to take second dose and it has been about a week from the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration 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 medications 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 female patient of unknown age forgot to take second dose and it has been about a week from the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration 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 medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829361		F	ME	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	Patient took the first dose of Vivotif according to the schedule, but patient took a cup of coffee, ... Patient took the first dose of Vivotif according to the schedule, but patient took a cup of coffee, ten minutes later after the dose; Case reference number US-BN-2024-002165 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV24-1590) on 08-Jul-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, via oral use for unknown indication. As reported, the patient took Vivotif according to the schedule, but the patient took a cup of coffee ten minutes later after the dose (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took a cup of coffee ten minutes later after the dose of Vivotif 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 medications 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 female patient of unknown age took a cup of coffee ten minutes later after the dose of Vivotif 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 medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829362		M	IN	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004007	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	The patient received fourth dose of Vivotif on day 12; Case reference number US-BN-2024-002175 is a ... The patient received fourth dose of Vivotif on day 12; Case reference number US-BN-2024-002175 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1609) on 09-Jul-2024 and concerns a 57-year-old male patient. The patient's medical history and concomitant medication were not provided. On 03-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule orally, for immunization against disease caused by salmonella typhi. On 05-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally. On 07-Jul-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally. On 15-Jul-2024, 12 days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004044, expiry date: Nov-2024) one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of follow up report, the patient did not experience any adverse event due to Vivotif. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 20-Aug-2024: New information included added patient demographic details (initials), Vivotif dosage information and updated event verbatim. Follow up information received from a nurse on 04-Sep-2024: New information included confirmation on the adverse events during the administration of Vivotif.; Reporter's Comments: A 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829363				03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Expired product administered Expired product administered	Patient received last dose of Vivotif two weeks after the expiry date 30-Jun-2024; Case reference nu... Patient received last dose of Vivotif two weeks after the expiry date 30-Jun-2024; Case reference number US-BN-2024-002185 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1634) on 12-Jul-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took the last dose of Vivotif (batch number: unknown, expiry date: 30-Jun-2024) two weeks after the expiry date, at an unknown dose or route, for unknown indication (explicitly coded as 'expired vaccine used'). 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 and gender took the last dose of Vivotif (expiry date: 30-Jun-2024) two weeks after the expiry date, for unknown indication, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Expired product administered is 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 took the last dose of Vivotif (expiry date: 30-Jun-2024) two weeks after the expiry date, for unknown indication, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Expired product administered is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829364		F	MT	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004043	Inappropriate schedule of product administration, Product storage error Inappropriate schedule of product administration, Product storage error	Patient left fourth dose of Vivotif on kitchen counter for 72 hours; Patient left fourth dose of Viv... Patient left fourth dose of Vivotif on kitchen counter for 72 hours; Patient left fourth dose of Vivotif on kitchen counter for 72 hours; The patient received fourth dose of Vivotif, 14 days after the first dose; Patient received four capsules of Vivotif as a fourth dose; Case reference number US-BN-2024-002190 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-1640) on 12-Jul-2024 and concerns a 71-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 02-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule, orally, for typhoid immunization. On 04-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule, orally. On 06-Jul-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004043, expiry date: 30-Nov-2024), one capsule, orally. On 16-Jul-2024, 14 days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004044, expiry date: 31-Jul-2024), at a dose reported as four capsules, orally. As reported, the patient left fourth dose of Vivotif on kitchen counter for 72 hours (explicitly coded as 'vaccine overdose', 'product storage error', 'product administration error' and 'inappropriate schedule of vaccine administered'). At the time of follow up report, the patient did not experience any adverse event due to Vivotif. Follow up information received from a health care professional on 26-Jul-2024: New information included patient demographic details (patient initials and age), Vivotif dosage information, and confirmation that the patient did not experience any adverse event due to Vivotif.; Reporter's Comments: A 71-year-old female patient took the fourth dose of Vivotif on day 14 from the first one, which is considered inappropriate schedule of vaccine administered. The patient received four doses on this day, which is considered overdose. The capsules had been kept at room temperature for 72 hours, which is considered product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are not related to the suspect vaccine, but to human factor. This case is considered as non-serious.; Sender's Comments: A 71-year-old female patient took the fourth dose of Vivotif on day 14 from the first one, which is considered inappropriate schedule of vaccine administered. The patient received four doses on this day, which is considered overdose. The capsules had been kept at room temperature for 72 hours, which is considered product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration, product storage error, product administration error and vaccine overdose are not related to the suspect vaccine, but to human factor. This case is considered as non-serious. More

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