🏥 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:

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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)
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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
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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 20,951 to 21,000 of 34,052 reports (Page 420 of 682)

« First ‹ Prev 1 ... 417 418 419 420 421 422 423 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿
2839728	13	M	TX	05/06/2025	HPV9	MERCK & CO. INC.	002903	Dizziness, Nausea, Pallor, Presyncope Dizziness, Nausea, Pallor, Presyncope	PT become pale, dizzy, nausea, vasovagal PT become pale, dizzy, nausea, vasovagal
2839729	34	F	TX	05/06/2025	HEP MMR VARCEL	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	AZ453 Y000782 Y003891	Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More	Redness, swelling and warmth left upper arm site. Left arm site itching. No treatment, started 5/5/... Redness, swelling and warmth left upper arm site. Left arm site itching. No treatment, started 5/5/25 before midnight. More
2839730	65	F	WV	05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		IIIrd nerve paralysis, Laboratory test IIIrd nerve paralysis, Laboratory test	Third nerve palsy, left eye. Third nerve palsy, left eye.		✓	✓
2839731	2	M	VA	05/06/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	YC239	Circumstance or information capable of leading to medication error, Scratch, Und... Circumstance or information capable of leading to medication error, Scratch, Underdose More	Patient is a 2 year old male who presented to our office on 4/22/25 for his two year physical. While... Patient is a 2 year old male who presented to our office on 4/22/25 for his two year physical. While here, Dr. noticed that he had not received his 18 month vaccinations at his 18 month check up due to being under the weather and ordered those to be administered. While attempting to administer the first vaccination, Infanrix, CMA had explained to mom that it was important for her to hold patient's hands so he did not interfere with the administration. Mom had let go of his hands as the needle entered his left thigh. Patient grabbed the needle and rolled, causing the needle to exit his thigh and create a minor, inch-long scratch. The scratch was cleaned and a band-aid was placed on the scratch. Upon examination of the syringe, it was noted that roughly one third of the vaccine was administered to the child. The ordering provider was notified of the error. Mom refused to attempt to revaccinate that day as she stated that this situation was "traumatic" for patient and he was "too worked up". Mom stated she understood the risks of leaving unvaccinated but would be willing to come back in to fully vaccinate patient. I called GSK and spoke with the Medical Information Team. The situation was relayed and I asked for the recommendation for revaccination. This information was emailed to me, which I have attached. They also referred me to the CDC website where the "Clinical Implications of Nonstandard Vaccination Practices" citation reads as follows: "Administering volumes smaller than recommended (e.g., inappropriately divided doses) might result in inadequate protection. Using reduced doses administered at multiple vaccination visits that equal a full dose or using smaller divided doses is not recommended (4). Any vaccination using less than the standard dose should not be counted, and the person should be revaccinated according to age unless serologic testing indicates that an adequate response has developed. However, if 2 half-volume formulations of vaccine have already been administered on the same clinic day to a patient recommended for the full volume formulation, these 2 doses can count as one full dose. If less than a full General Best Practice Guidelines for Immunization: Vaccine Administration 100 recommended dose of a vaccine is administered because of syringe, applicator, or needle leakage, the dose should be repeated (5)." I have attached the CDC link to the bottom of this description. I spoke with mom on 4/23/25 to check on patient and overview the risks of not vaccinating with Infanrix again. Mom said that she understood and he was fine but was pointing out his scratch. I offered to move her vaccine appointment up from 4/30/25 to 4/24/25 at any time that would work best for her schedule to monitor the scratch to make sure it was healing properly and to also vaccinate patient. Mom agreed and was happy to schedule an appointment at 4/24/25 at 16:00. I verbally explained to Dr. that patient would be coming in to discuss the vaccinations and receive them as well as double check on the scratch. Dr. agreed with this and is prepared to see patient and his mother on 4/24/25. Patient was seen in our office 4/30/25 to check on his scratch and get the rest of his vaccinations. His scratch has fully healed. Dr. again explained the benefits of administering the full dose of Infanrix and mom agreed. Patient was fully vaccinated with Infanrix, Hiberix and Hepatitis A. CMA administered the vaccinations while mom and an additional CMA held him down appropriately. After today's visit, patient is fully vaccinated for his age and will not be due for additional vaccinations until he is four years of age. We did apologize again to mom for what happened last week; she was happy with today's visit. More
2839732	17	F	MO	05/06/2025	MNQ	SANOFI PASTEUR	U8494AA	Dyskinesia, Dysphemia, Eye movement disorder, Involuntary vocalisation Dyskinesia, Dysphemia, Eye movement disorder, Involuntary vocalisation	Patient with Tourette's like symptoms since receiving vaccine, increasing in severity. Abnormal... Patient with Tourette's like symptoms since receiving vaccine, increasing in severity. Abnormal neck and eye movements, speech outbursts, stuttering. More
2839734	1.25	M	GA	05/06/2025	MMRV	MERCK & CO. INC.	Y014436	Extra dose administered Extra dose administered	pt was given a Proquad and varicella at the same visit pt was given a Proquad and varicella at the same visit
2839735	88	M	MN	05/06/2025	COVID19	MODERNA	3044069	Death, Unresponsive to stimuli Death, Unresponsive to stimuli	Resident became non-responsive and died within 72 hours. Resident became non-responsive and died within 72 hours.	✓
2839736	20	F	MA	05/06/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH		Audiogram, Deafness neurosensory, Hypoacusis, Magnetic resonance imaging; Audiog... Audiogram, Deafness neurosensory, Hypoacusis, Magnetic resonance imaging; Audiogram, Deafness neurosensory, Hypoacusis, Magnetic resonance imaging More	Sudden sensorineural hearing loss of the left ear. Woke up on December 13, 2023 around 6am with dimi... Sudden sensorineural hearing loss of the left ear. Woke up on December 13, 2023 around 6am with diminished hearing in the left ear. By the afternoon, there was virtually no hearing in the ear. Despite oral steroid treatments, steroid injections, and hyperbaric chamber therapy, hearing was never regained. More			✓
2839737	5	F		05/06/2025	DTAPIPV HEPA MMR	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	5G23D J4K4X Y013576	Eye swelling, Injection site rash, Rash; Eye swelling, Injection site rash, Rash... Eye swelling, Injection site rash, Rash; Eye swelling, Injection site rash, Rash; Eye swelling, Injection site rash, Rash More	Pt in clinic 5/2/25,noted swelling in eyes, more on left one, rash noted on left arm at injection si... Pt in clinic 5/2/25,noted swelling in eyes, more on left one, rash noted on left arm at injection site, on left back of shoulder, both knuckles, more on left, small spot on forehead, marked sites except face with sharpie. Explained to parent to keep an eye and if it got outside the mark to go to ER. Explained to administer OTC Benadryl and apply Caladryl. Gave parent name, address, and phone # to facility. Followed up with parent on 5/5/2025. Parent stated did administer OTC meds and everything cleared. More
2839738	51	M	CA	05/06/2025	FLU3 HEP TDAP	SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR	UT8434JA CT3Z7 3CA17C1	Joint range of motion decreased, Pain in extremity; Joint range of motion decrea... Joint range of motion decreased, Pain in extremity; Joint range of motion decreased, Pain in extremity; Joint range of motion decreased, Pain in extremity More	Chronic pain of both upper extremities and impaired range of motion of both shoulders . On 3/18/25 ... Chronic pain of both upper extremities and impaired range of motion of both shoulders . On 3/18/25 patient reported trying naproxen and diclofenac topical gel. More
2839739	4	M	CT	05/06/2025	MMR	MERCK & CO. INC.		Malaise, Tremor Malaise, Tremor	Body shaking and feeling very sick Body shaking and feeling very sick
2839750	33	F	TX	05/06/2025	HPV9	MERCK & CO. INC.	Y012508	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	No adverse event; HCP reports female patient received her second dose of GARDASIL 9 early. HCP state... No adverse event; HCP reports female patient received her second dose of GARDASIL 9 early. HCP states second dose administered on 2/5/2025 and was due on 2/21/2025. No adverse effects reported. No other information provided. No additional AE. No PQC.; This spontaneous report was received from a Nurse and refers to a 33-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-FEB -2025, the patient was early vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #Y012508, expiration date: 01-JAN-2027), dose number 2, Single Dose, administered by Unknown route for Prophylaxis. The second dose was due on 21-FEB-2025 (Inappropriate schedule of product administration). No adverse effects were reported. More
2839751			IN	05/06/2025	HEP HEP HEP HPV9 HPV9 MMR MMR MMR RV5 RV5 RV5	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	X027728 Y007989 Y009551 Y012865 Y010466 X019103 Y009782 Y007623 2003174 2032351 2032354	Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More	Medical assistant reporting an unknown number of administrations of RECOMBIVAX HB, MMR II, GARDASIL ... Medical assistant reporting an unknown number of administrations of RECOMBIVAX HB, MMR II, GARDASIL 9 and ROTATEQ following a temperature excursion. No symptoms reported and no additional details provided. This agent is adding RECOMBIVAX HB and GAR; no AE; This spontaneous report was received from a medical assistant and refers to unknown number of unspecified patients. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with the following incorrectly stored vaccines: rotavirus vaccine (ROTATEQ) administered orally, lot # 2003174, expiration date 14-SEP-2025; lot # 2032351, expiration date 06-OCT-2025; lot # 2032354, expiration date 12-NOV-2025 (dose, anatomical location were not provided), Human Papillomavirus 9-valent Vaccine (GARDASIL 9) lot # y010466, expiration date 29-OCT-2026; lot # y012865, expiration date 10-OCT-2026 (dose, route of administration, anatomical location were not provided), measles (+) mumps (+) rubella vaccine (MMR II) lot # x019103, expiration date 16-JUL-2025, lot # y009782, expiration date 23-MAY-2026; lot # y007623, expiration date 11-APR-2026 (dose, route of administration, anatomical location were not provided), hepatitis B vaccine (RECOMBIVAX HB) lot # x027728, expiration date 16-OCT-2026; lot # y007989, expiration date 06-DEC-2026; lot # y009551, expiration date 08-DEC-2026 (dose, route of administration, anatomical location were not provided). The suspect vaccines were stored at the temperature of 0.6 degrees Celsius for 5 hours and at 11.1 degrees Celsius for 35 minutes (Product storage error). No adverse events were reported. This is an invalid report due to lack of the patients' identifiers.; Reporter's Comments: More
2839752		M	PA	05/06/2025	VARCEL	MERCK & CO. INC.	y011017	Device connection issue, No adverse event, Underdose Device connection issue, No adverse event, Underdose	No adverse event; PFS leaked between the Luer Lock/Hub and the needle while administering VARIVAX; r... No adverse event; PFS leaked between the Luer Lock/Hub and the needle while administering VARIVAX; resulting in the patient not receiving the full dose of VARIVAX; This spontaneous report was received from a Nurse and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at 0.5 mL (lot #y011017 was verified to be a valid number, expiration date: 18-Jun-2026) diluted with sterile diluent prefilled syringe (PFS) at 0.5 mL (lot #1973320 was verified to be a valid number, expiration date: 20-Nov-2026) (strength, scheme, vaccination site and route of administration were not reported); during the administration sterile diluent PFS leaked between the luer lock/hub and the needle (syringe issue), resulting in the patient not receiving the full dose of VARIVAX (incorrect dose administered). VARIVAX was wasted as a result of the leakage. The nurse confirmed there was no damage to the PFS or to the luer lock/hub when the needle was attached, and no breakage was observed. No photos were available and the product is not available for retrieval, as it has already been discarded into the sharps container. No additional adverse event was reported. More
2839754		F	PA	05/06/2025	MMRV	MERCK & CO. INC.	Y015992	No adverse event, Wrong product administered No adverse event, Wrong product administered	No adverse effects reported. No other information provided. No additional AE.; HCP reports 66 year o... No adverse effects reported. No other information provided. No additional AE.; HCP reports 66 year old female received pediatric dose of PROQUAD instead standard dose of MMR II.; This spontaneous report was received from a medical assistant and refers to a 66-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y015992; which has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as 32-MAR-2026 but upon internal validation establish as 23-Mar-2026 administered for prophylaxis (strength, exact quantity volume, dose number, route and anatomical site of administration were not provided) with the sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date were not reported) instead of standard dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) with the sterile diluent (BAXTER STERILE DILUENT) (Wrong product administered). No adverse effects reported. No other information provided (No adverse event). More
2839755	12	F		05/06/2025	HPV9	MERCK & CO. INC.		Presyncope, Syncope Presyncope, Syncope	Merck employee with MVCC called to report an adverse event for GARDASIL-9. A pharmacy technician rep... Merck employee with MVCC called to report an adverse event for GARDASIL-9. A pharmacy technician reported that when she was 12 years old, she received the 1st dose of GARDASIL-9 and fainted on the floor. She also reports that she almost fainted with; Almost faint with second and third dose; This spontaneous report was received from a currently 21-year-old female pharmacy technician, reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (indication, expiration date, and lot # were not reported). The patient reported that when she was 12 years old, and received the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) she fainted on the floor (syncope). She also reported that she almost fainted (presyncope) with the 2nd and 3rd doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), at unspecified age. No additional AE reported. No PQC reported. At the reporting time, the outcome of the events was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was determined as not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), was unknown. Upon internal review, the event of syncope was determined to be medically significant. More
2839756			TX	05/06/2025	HEPA	MERCK & CO. INC.	X006072	Expired product administered, No adverse event Expired product administered, No adverse event	No additional AE; a patient who was administered expired VAQTA; This spontaneous report was received... No additional AE; a patient who was administered expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-MAR-2025, the patient was vaccinated with expired Hepatitis A Vaccine, Inactivated (VAQTA), (invalid lot #X006072, expiration date: 01-Oct-2024) 1 mL (1ml/dose), as prophylaxis (expired product administered). No symptoms reported. No additional adverse event (AE) was reported More
2839757	53	F	MD	05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Back pain, Burning sensation, Laboratory test normal, Pain Back pain, Burning sensation, Laboratory test normal, Pain	Burning sensation in back; Back pain (with radiation); This serious case was reported by a consumer ... Burning sensation in back; Back pain (with radiation); This serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On 23-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular). On 23-AUG-2024, less than a day after receiving Shingrix, the patient experienced burning sensation (Verbatim: Burning sensation in back) (serious criteria hospitalization) and back pain (with radiation) (Verbatim: Back pain (with radiation)) (serious criteria hospitalization). The outcome of the burning sensation and back pain (with radiation) were not resolved. It was unknown if the reporter considered the burning sensation and back pain (with radiation) to be related to Shingrix. The company considered the burning sensation and back pain (with radiation) to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter was the patient who received her 2nd dose of Shingrix 23 AUG 2024 and had issues of back pain and burning sensation in her back mostly on the left side per the dosage. These symptoms were ongoing, and the reporter had been seen in the hospital a few times and had no positive test drawn at this time.; Sender's Comments: Burning sensation and Back pain are unlisted events which are considered unrelated to GSK vaccine Shingrix. More		✓
2839758				05/06/2025	RVX	UNKNOWN MANUFACTURER	UNK	Transient ischaemic attack Transient ischaemic attack	ministroke; This serious case was reported by a consumer via interactive digital media and described... ministroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of ministroke in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ministroke (Verbatim: ministroke) (serious criteria GSK medically significant). The outcome of the ministroke was not reported. It was unknown if the reporter considered the ministroke to be related to RSV vaccine. It was unknown if the company considered the ministroke to be related to RSV vaccine. Additional Information: GSK receipt date: 01-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she also had a mini stroke after the vaccine and patient's daughter had a heart attack. Patient also indicated they won't get another one. This case is 1 of 2 cases reported by same reporter.; Sender's Comments: Transient ischaemic attack is an unlisted event which is considered unrelated to GSK RSV vaccine. More
2839759		F	NY	05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Not received 2nd dose; This non-serious case was reported by a consumer via call center representati... Not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles (pre-existing)). Previously administered products included Shingrix (received first dose of Shingrix in 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient's husband. The patient received her first Shingrix dose about one year ago, in 2024. She has not yet received her second dose due to insurance. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. More
2839760	78	M	MO	05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Arthralgia, Joint swelling Arthralgia, Joint swelling	Right knee Swollen; knee was very sore; This non-serious case was reported by a physician via call c... Right knee Swollen; knee was very sore; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of knees in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-APR-2025, the patient received Shingrix (left arm). On 30-APR-2025, less than a day after receiving Shingrix, the patient experienced swelling of knees (Verbatim: Right knee Swollen) and knee pain (Verbatim: knee was very sore). The outcome of the swelling of knees was not resolved and the outcome of the knee pain was not reported. It was unknown if the reporter considered the swelling of knees and knee pain to be related to Shingrix. It was unknown if the company considered the swelling of knees and knee pain to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The physician reported that he received a left arm shot of the medication Shingrix and by this morning, once the patient went to the swimming pool to exercise he noticed his right knee was swollen and very sore compared to the day before. More
2839761		F		05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Abdominal discomfort, Back pain Abdominal discomfort, Back pain	abdominal discomfort; sore back; This non-serious case was reported by a consumer via sales rep and ... abdominal discomfort; sore back; This non-serious case was reported by a consumer via sales rep and described the occurrence of abdominal discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-APR-2025, the patient received the 2nd dose of Shingrix (unknown arm). On 30-APR-2025, 1 days after receiving Shingrix, the patient experienced abdominal discomfort (Verbatim: abdominal discomfort) and sore back (Verbatim: sore back). The outcome of the abdominal discomfort and sore back were resolving. It was unknown if the reporter considered the abdominal discomfort and sore back to be related to Shingrix. It was unknown if the company considered the abdominal discomfort and sore back to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The patient received subsequent dose of Shingrix. The patient experienced abdominal discomfort and sore back. More
2839762		M		05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Rash, Urticaria Rash, Urticaria	rash; Hives; This non-serious case was reported by a consumer and described the occurrence of rash i... rash; Hives; This non-serious case was reported by a consumer and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included acne rosacea. Concomitant products included doxycycline. On 29-APR-2025, the patient received Shingrix. On 01-MAY-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: rash) and hives (Verbatim: Hives). The outcome of the rash and hives were not resolved. It was unknown if the reporter considered the rash and hives to be related to Shingrix. It was unknown if the company considered the rash and hives to be related to Shingrix. Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for himself. More
2839764		F		05/06/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	UNK	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient received the 2nd dose of twinrix after 6 months instead of after 1 month; This non-serio... The patient received the 2nd dose of twinrix after 6 months instead of after 1 month; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose (Left arm) on 03-MAY-2024 with batch number: 429jj and expiry date: 01-APR-2026). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the 2nd dose of twinrix after 6 months instead of after 1 month). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-MAY-2025 The pharmacist reported that the patient received the 2nd dose of Twinrix after 6 months instead of after 1 month. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2839765			VA	05/06/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspeceted vaccination failure; recently had a small shingles outbreak on my lower back; This seriou... Suspeceted vaccination failure; recently had a small shingles outbreak on my lower back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: recently had a small shingles outbreak on my lower back). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 29-APR-2025 The reporter reported that he/she fully vaccinated against shingles (Zostavax and Shingrix), and recently had a small shingles outbreak on his/her lower back. The reporter had a questioned should he/she consider getting the Shingrix vaccine and booster again. The chat bot user mentioned that they noticed that patient mentioned more than one of our products. The patient reported that he/she only recived 1 product. The chat bot user reported that Shingrix was administered as a 2-dose series. The FDA-approved schedule did not include a booster dose of Shingrix or a repeat of the series. The chat bot user reported that they could not give medical advice. It was unknown if the reporter considered the vaccination failure and shingles to be related to Zostavax. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2839766			NC	05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Patient received 1st Shingrix dose 2.5 years; This non-serious case was reported by a consumer via c... Patient received 1st Shingrix dose 2.5 years; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2.5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received 1st Shingrix dose 2.5 years). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 29-APR-2025 The patient self-reported this case. The patient received 1st Shingrix dose 2.5 years ago and had not received the 2nd vaccine. The reporter asked does patient need to start series all over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2839767				05/06/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; people that took 2 shots and still got; This serious case was reporte... Suspected vaccination failure; people that took 2 shots and still got; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patients received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: people that took 2 shots and still got). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that they knew people (patients) that took 2 shots and still got them This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2839768				05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Arthralgia, Dizziness, Headache, Nausea Arthralgia, Dizziness, Headache, Nausea	nausea; dizziness; headache; joint pain; This non-serious case was reported by a consumer via intera... nausea; dizziness; headache; joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient had a very mild case of Shingles that was caught early), joint pain, nausea and dizziness. Concomitant products included VARICELLA ZOSTER VACCINE. In APR-2025, the patient received the 2nd dose of Shingles vaccine. On 25-APR-2025, less than a week after receiving Shingles vaccine, the patient experienced nausea (Verbatim: nausea), dizziness (Verbatim: dizziness), headache (Verbatim: headache) and joint pain (Verbatim: joint pain). The outcome of the nausea, dizziness, headache and joint pain were not resolved. It was unknown if the reporter considered the nausea, dizziness, headache and joint pain to be related to Shingles vaccine. It was unknown if the company considered the nausea, dizziness, headache and joint pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had a very mild case of Shingles that had been caught early. The pain had been horrible, not just from the blisters, but it had made his/her joints ache, caused horrible headaches, nausea, and dizziness. It had taken him/her 8 weeks to fully recover. Then he/she had waited another 2 weeks to get his/her 1st vaccine shot. He waited about 2 months between the 1st vaccine and the 2nd Shingles vaccine shot. He/she had his/her 2nd Shingles Vaccine shot 4 days ago. The first two days, he/she had not felt all that bad after his/her 2nd vaccine shot, but yesterday and today, he/she had experienced nausea, dizziness, headache, and joint pain. Nothing had been as bad as actually having Shingles, but he/she had been so glad to have had his/her 2nd vaccine and had prayed he/she would not get Shingles again. Unfortunately, that had happened to some people. He/she had highly recommended getting the Shingles vaccine. More
2839769				05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure	Suspected Vaccination failure; Now I still broke out; This serious case was reported by a consumer v... Suspected Vaccination failure; Now I still broke out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (I got shingles at the age of 26 years old). Concurrent medical conditions included nerve damage. Concomitant products included aciclovir sodium (Acyclovir) and gabapentin. On an unknown date, the patient received Shingles vaccine. In APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Now I still broke out). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 29-APR-2025 This case was reported by a patient via interactive digital media. He/she got shingles at the age of 26 years old. He/she now 60. The pain was no joke. He/she took Gabapentin for the nerve damage. Which helped. He/she took Acyclovir 400 miligrams daily to keep it suppressed. His/her doctor a few years ago told him/her to get the shot that it would help so he/she would not had to take meds. Now he/she still broke out. So took the meds everyday. He/she just broke out about a week ago. It had been a few years since he/she did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2839770		F		05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pruritus, Rash, Rash pustular Pruritus, Rash, Rash pustular	itchy; pus filled bumps on face and neck; This non-serious case was reported by a consumer and descr... itchy; pus filled bumps on face and neck; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: itchy) and pustule (Verbatim: pus filled bumps on face and neck). The outcome of the pruritus and pustule were resolved. It was unknown if the reporter considered the pruritus and pustule to be related to Shingles vaccine. It was unknown if the company considered the pruritus and pustule to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-APR-2025 The patient had first ever shingles vaccine and got itchy, pus filled bumps on face and neck that lasted for more than a month. The patient was on immune compromised, 65 year female actively in treatment for Rheumatoid arthritis. More
2839771				05/06/2025	VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK	COVID-19, Extra dose administered, Herpes zoster, Immunodeficiency, Neuralgia; V... COVID-19, Extra dose administered, Herpes zoster, Immunodeficiency, Neuralgia; Vaccination failure; COVID-19, Extra dose administered, Herpes zoster, Immunodeficiency, Neuralgia; Vaccination failure; COVID-19, Extra dose administered, Herpes zoster, Immunodeficiency, Neuralgia; Vaccination failure More	Suspected vaccination failure; immune system was compromised; I got shingles; had covid; nothing hel... Suspected vaccination failure; immune system was compromised; I got shingles; had covid; nothing helps the nerve pain; had 3 shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), immunocompromised (Verbatim: immune system was compromised) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles), covid-19 (Verbatim: had covid), post herpetic neuralgia (Verbatim: nothing helps the nerve pain) and extra dose administered (Verbatim: had 3 shingles vaccine). The outcome of the vaccination failure, immunocompromised, covid-19 and post herpetic neuralgia were not reported and the outcome of the shingles was resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure, immunocompromised, shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and immunocompromised to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a patient via interactive digital media. The patient had 3 shingles vaccines. The patient reported to had Covid and then got shingles. The doctor stated that his/her immune system was compromised. The pain was extremely painful and nothing helped the nerve pain. The patient stated hopefully he/she would not get them again. The patient had them in the same place as the woman above. The patient received 3 doses of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Immunodeficiency is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2839772				05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Fatigue, Inappropriate schedule of product administration, Pain Fatigue, Inappropriate schedule of product administration, Pain	make me hurt/achy; Tired; just got my 2nd shot. already had the first single shingle shot a few year... make me hurt/achy; Tired; just got my 2nd shot. already had the first single shingle shot a few years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st shot a few years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: make me hurt/achy), tiredness (Verbatim: Tired) and drug dose administration interval too long (Verbatim: just got my 2nd shot. already had the first single shingle shot a few years ago). The outcome of the pain and tiredness were not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the pain and tiredness to be related to Shingles vaccine. It was unknown if the company considered the pain and tiredness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-APR-2025 This case was reported by a patient via interactive digital media. The patient just got his/her 2nd shot and did it make me hurt, tired and achy. The patient hoped it kept him/her from getting shingles though and already had the first Shingle shot a few years ago. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. More
2839773		F		05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Immediate post-injection reaction Herpes zoster, Immediate post-injection reaction	on her head and forehead; This non-serious case was reported by a consumer via interactive digital m... on her head and forehead; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: on her head and forehead). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The reporter said that they did not always work and he/she thought may sometimes trigger the disease, 2 out of 3 friends that took the vaccine got shingles shortly after. One a light case the other more severe on her head and forehead. More
2839774		F		05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise Malaise	did not feel well; This non-serious case was reported by a consumer via interactive digital media an... did not feel well; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: did not feel well). The outcome of the feeling unwell was not reported. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a consumer via interactive digital media. A lady in line had said that make sure you get it on a day when you have nothing planned for the next couple of days. She had not felt well but had not asked for specifics. More
2839775				05/06/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected Vaccination failure; i have a mild case of shingles; This serious case was reported by a c... Suspected Vaccination failure; i have a mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i have a mild case of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date : 30-APR-2025 This case was reported by a patient via interactive digital media. He/she have had the 2 shingle shots, appox 4 years ago, now his/her doctor was told he/she had a mild case of shingles, he/she was 69 years old. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2839776				05/06/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspeceted vaccination failure; 7 years after the shingrex vaccine, i for shingles; This serious cas... Suspeceted vaccination failure; 7 years after the shingrex vaccine, i for shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 7 years after the shingrex vaccine, i for shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via (Chatbot) interactive digital media. The reporter reported that 7 years after the Shingrix vaccine, the patient had shingles. The patient asked could he/she got a booster. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2839777				05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient had a short bout of shingles last year in 2024. The patient had the Shingles shot several years ago so, with medication from an ER (emergency) nurse (the patient did not know it was shingles he/she had) it cleared within a week and did not experience any pain. She said a person could still get shingles even after having the shot, but it was not as severe. Further patient stated make sure you get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2839778				05/06/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; had them 8 times since; This serious case was reported by a consumer ... Suspected vaccination failure; had them 8 times since; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 8 times since). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 The case was received from the patient via interactive digital media. The patient got the shot, worst mistake ever and have had them 8 times since. The patient stated that do not put it in your body. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839780	71	F	MO	05/06/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	4KF75	Expired product administered Expired product administered	Expired dose administered/Twinrix expired dose; This non-serious case was reported by a pharmacist v... Expired dose administered/Twinrix expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis. On 29-APR-2025, the patient received Twinrix. On 29-APR-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered/Twinrix expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 The reporter reported regarding Twinrix vaccine, and was wondering if had this specific date of point about administration after the posted expiration date on the box, like was it percentage less effective. The healthcare professional confirmed that a patient received a Twinrix expired dose which led to Expired vaccine administered. More
2839781	0.17	F	PA	05/06/2025	RV1	GLAXOSMITHKLINE BIOLOGICALS	422GF	Expired product administered Expired product administered	Expired Dose Administered; This non-serious case was reported by a other health professional via cal... Expired Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis. On 29-APR-2025, the patient received Rotarix lyophilized formulation. On 29-APR-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 The reporter reported that they had gave a rotavirus vaccine on the day of reporting and did not realize that it actually expired on February 24th, which led to expired vaccine used. More
2839782	17	F	CA	05/06/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	AMVB030A	Product preparation error Product preparation error	administration of the lyophilized component of Menveo with sterile water diluent; administration of ... administration of the lyophilized component of Menveo with sterile water diluent; administration of the lyophilized component of Menveo with sterile water diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis. Previously administered products included Menveo (received first dose of Menveo on an unknown date). On 30-APR-2025, the patient received the 2nd dose of Menveo. On 30-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: administration of the lyophilized component of Menveo with sterile water diluent) and inappropriate dose of vaccine administered (Verbatim: administration of the lyophilized component of Menveo with sterile water diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-APR-2025 The pharmacist reported about the administration of the lyophilized component of Menveo with sterile water diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They mentioned the dose was administered on the day of reporting and being the second dose. The Vaccine Administration Facility was the same as Primary Reporter More
2839783			WI	05/06/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	7HG2A	Product preparation issue Product preparation issue	she may have only given the diluent; she may have only given the diluent; This non-serious case was ... she may have only given the diluent; she may have only given the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis. On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: she may have only given the diluent) and inappropriate dose of vaccine administered (Verbatim: she may have only given the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-MAY-2025 The pharmacist reported that a nurse said she gave Priorix but thought she may have only given the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2839784	16	M	TX	05/06/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS	2g3S9	Inappropriate schedule of product administration Inappropriate schedule of product administration	early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was ... early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 2g3S9, expiry date 30-SEP-2027) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 01-MAY-2025, the patient received the 2nd dose of Bexsero. On 01-MAY-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter reported that she had a patient that was given his first dose on 28th February 2025 and the second dose was actually administered on 01st May 2025, she was not informed of the change to dosing schedule for Bexsero and was following the old schedule. Note to PV-I am submitting as early dose since healthcare professional was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 months) which led to shortening of vaccination schedule. More
2839785		F	CA	05/06/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	E75E5	Headache, Nasal congestion Headache, Nasal congestion	severe headache; nasal congestion; This non-serious case was reported by a other health professional... severe headache; nasal congestion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number E75E5, expiry date 05-NOV-2025) for prophylaxis. On 30-APR-2025, the patient received Arexvy. On 01-MAY-2025, 1 days after receiving Arexvy, the patient experienced headache (Verbatim: severe headache) and nasal congestion (Verbatim: nasal congestion). The outcome of the headache and nasal congestion were not resolved. It was unknown if the reporter considered the headache and nasal congestion to be related to Arexvy. It was unknown if the company considered the headache and nasal congestion to be related to Arexvy. Additional Information: GSK Receipt Date: 01-MAY-2025 A pharmacy manager called to report that a patient who received Arexvy yesterday (day before reporting) was experiencing severe headache and nasal congestion one day after getting vaccine. Patient had to go to urgent care to check out this. Reporter wanted to know do GlaxoSmithKline have any information of this adverse reactions in their database. More
2839786	41	M		05/06/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH	UT7695NA	COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-Co... COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-CoV-2 test More	tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; tes... tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; This spontaneous case was reported by a physician assistant and describes the occurrence of DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UT7695NA) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past). At the time of the report, DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient was not allergic to any previous vaccination, medications, food or other products and had no other diagnosed illness/medical history/chronic health conditions. The patient did not receive any other vaccine on the same date as suspect vaccine. Patient was not taking any other medications within 2 weeks prior to the event onset nor received any other vaccines within 4 weeks prior to the first dose administration of the suspect vaccine. Event did not require emergency room visit nor physician's office visit. Infection from COVID occurred over a year after vaccination. There was no predisposing factor, and no culture analysis was performed and also no other relevant test(s) performed. No treatment was received for the adverse event.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report. More
2839787		F		05/06/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH		Death; Death Death; Death	Wife died from the Covid 19 vaccine called Moderna after two days that she got it; This spontaneous ... Wife died from the Covid 19 vaccine called Moderna after two days that she got it; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Wife died from the Covid 19 vaccine called Moderna after two days that she got it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. This case was created for reporter's wife. No concomitant medications were reported. It was reported that the reporter had a friend and his wife who died from the Moderna Covid-19 vaccine. The caller was asked if there was an adverse event that happened regarding flu shot, and the reporter asked if Pfizer or manufacturer of the shot be financially liable for the damages incurred from an adverse event or not. The reporter had lots of questions regarding Covid vaccine, he never got it and never got sick but reported that everybody that he knew who got the vaccine always became sick. The reporter did not mention the brand of Covid vaccine. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785516 (E2B Linked Report).; Reporter's Comments: Company Comments. The time between vaccination and the patient`s death is unknown. Tozinameran remained co-suspect product. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785516:Master case (Caller's friend case); Reported Cause(s) of Death: wife died from the Covid 19 vaccine called Moderna after two days that she got it More	✓
2839788	56	F	TN	05/06/2025	COVID19 COVID19	MODERNA MODERNA	031A21A 031A21A	Chronic inflammatory demyelinating polyradiculoneuropathy, Inappropriate schedul... Chronic inflammatory demyelinating polyradiculoneuropathy, Inappropriate schedule of product administration, Postural orthostatic tachycardia syndrome, Thyroid disorder, Tinnitus; Vertigo More	cidp; tinnitus; vertigo; pots; lost my thyroid; Inappropriate schedule of vaccine administered; This... cidp; tinnitus; vertigo; pots; lost my thyroid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) (seriousness criterion medically significant), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. No concomitant medication was reported. Patient administered dose on 20-Apr-2021 of batches (031A21A or 045A21A). It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2839789		M	GA	05/06/2025	COVID19 FLUX	PFIZER\BIONTECH UNKNOWN MANUFACTURER	GH9702	Eye disorder, Swelling, Vaccination site pain; Eye disorder, Swelling, Vaccinati... Eye disorder, Swelling, Vaccination site pain; Eye disorder, Swelling, Vaccination site pain More	walk slowly because here on left of my back has a some sort of swelling.; having eye problem; pain o... walk slowly because here on left of my back has a some sort of swelling.; having eye problem; pain on my right arm on that very spot where vaccine was administered into my body/I have been having pain on the spot all my arm, my right arm has been hurting, and I can hardly lift it; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "walk slowly because here on left of my back has a some sort of swelling."; EYE DISORDER (non-serious), outcome "unknown", described as "having eye problem"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain on my right arm on that very spot where vaccine was administered into my body/I have been having pain on the spot all my arm, my right arm has been hurting, and I can hardly lift it". Therapeutic measures were taken as a result of eye disorder. Additional information: Patient got this COVID Vaccine (Clarified as Pfizer COVID-19 Vaccine) back in October and since then he had been pain on the spot where he got the, where he was vaccinated on his right arm. It had been hurting him all the time. He receive the COVID Vaccine in October last year and ever since he had been having pain on the spot all his arm, his right arm had been hurting, and he can hardly lift it, and he went back to pharmacy to complain to them. Well, he thought it would go away but it did not. He walk slowly because here on left of his back had a some sort of swelling. He did not know if that was responsible for it? His back, on the right side is somewhat swollen. He said In past 2 weeks, no. He did not go to any blood work in the past, he also had been having eye problem. So, that one he had been going to the eye doctor for it. He do take medication, the eye medication they gave him eye drop. He always having the problem though. More
2839790		F		05/06/2025	COVID19	PFIZER\BIONTECH		Intracranial aneurysm Intracranial aneurysm	Brain aneurysm; This is a spontaneous report received from a Consumer or other non HCP. An elderly ... Brain aneurysm; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dementia" (unspecified if ongoing), notes: was in a nursing home and suffering with maybe like dementia (Intent: History); "in a nursing home" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTRACRANIAL ANEURYSM (death, medically significant), outcome "fatal", described as "Brain aneurysm". The patient date of death was unknown. Reported cause of death: "Brain aneurysm". It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500093770 same reporter/suspect vaccine/event; different patient;US-PFIZER INC-202500093769 same reporter/suspect vaccine; different patient/event;; Reported Cause(s) of Death: Brain aneurysm More	✓
2839791	46	M	AL	05/06/2025	COVID19	PFIZER\BIONTECH	EW0172	Diplopia Diplopia	Diplopia; This is a spontaneous report received from a Consumer or other non HCP. A 49-year-old mal... Diplopia; This is a spontaneous report received from a Consumer or other non HCP. A 49-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 at 08:30 as dose 2, single (Lot number: EW0172) at the age of 46 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Contrast dye" (unspecified if ongoing), notes: Known allergies: Contrast dye. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DIPLOPIA (disability) with onset 10Aug2024, outcome "not recovered". Therapeutic measures were taken as a result of diplopia. More			✓

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