🏥 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.
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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)
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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
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⚠️ 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 19,001 to 19,050 of 34,052 reports (Page 381 of 682)

« First ‹ Prev 1 ... 378 379 380 381 382 383 384 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿	⚠️
2842628		F	NM	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Blister, Pain in extremity Blister, Pain in extremity	Blisters; pain in hands/pain in feet; This non-serious case was reported by a physician via sales re... Blisters; pain in hands/pain in feet; This non-serious case was reported by a physician via sales rep and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 17-APR-2025, the patient received the 1st dose of Shingrix. On 07-MAY-2025, 20 days after receiving Shingrix, the patient experienced blister (Verbatim: Blisters) and pain in extremity (Verbatim: pain in hands/pain in feet). The outcome of the blister and pain in extremity were not resolved. The reporter considered the blister and pain in extremity to be related to Shingrix. The company considered the blister and pain in extremity to be related to Shingrix. Additional Information: GSK receipt date: 21-MAY-2025 The physician reported that the patient had received 1st dose of Shingrix vaccine and experienced blisters and pain on hands and feet. The reporter mentioned that blister and pain on hands and feet was reported as worsened. The expiry date of Shingrix was unknown. This case had been link with US2025063517, reported by the same reporter.; Sender's Comments: US-GSK-US2025063517:same reporter More
2842629		M	MA	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	recived 1st dose in 2023 and did not go back to receive the second dose of the vaccine series; This ... recived 1st dose in 2023 and did not go back to receive the second dose of the vaccine series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2023). 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: recived 1st dose in 2023 and did not go back to receive the second dose of the vaccine series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 22-MAY-2025 The reporter was the patient who received the Shingrix vaccine in 2023 and did not go back to receive the second dose of the vaccine series. The patient did not wanted to give any information after he was told that a safety report would be filed. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2842630		F	WI	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Extra dose administered Extra dose administered	received a 3rd dose of Shingrix; This non-serious case was reported by a other health professional v... received a 3rd dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date). On 25-MAR-2025, the patient received the 3rd dose of Shingrix. On 25-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 22-MAY-2025 The reporter reported that the patient completed her series of Shingrix (dates not provided). The reporter reported that on 25th March 2025 received a 3rd dose of Shingrix which led to, extra dose administered. No further information was obtained/provided. More
2842631		F	IL	05/26/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	92DJ3	Expired product administered Expired product administered	Expired vaccine used; This non-serious case was reported by a other health professional via call cen... Expired vaccine used; 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 17-year-old female patient who received HBV (Engerix B) (batch number 92DJ3) for prophylaxis. On 22-MAY-2025, the patient received Engerix B (intramuscular) .5 ml. On 22-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). 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: 22-MAY-2025 The medical assistant reported that she gave a dose of Engerix-B on the day of reporting which was expired on 03rd May 2025 which led to expired vaccine used. More
2842632				05/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspeceted vaccination failure; I have shingles with the vaccine, got it from a friend who received ... Suspeceted vaccination failure; I have shingles with the vaccine, got it from a friend who received the 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. 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles with the vaccine, got it from a friend who received the vaccine). 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles with the vaccine, got it from a friend who received the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2842633				05/26/2025	RVX VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Somnolence; Somnolence Somnolence; Somnolence	Only side effects were being sleepy; This non-serious case was reported by a consumer via interactiv... Only side effects were being sleepy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and RSV vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced sleepiness (Verbatim: Only side effects were being sleepy). The outcome of the sleepiness was not reported. It was unknown if the reporter considered the sleepiness to be related to Shingles vaccine and RSV vaccine. It was unknown if the company considered the sleepiness to be related to Shingles vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 18-MAY-2025 The patient saw doctor for annual exam and was told about a patient that got shingles in her eye and went thru excruciating pain and ended up having her eye removed. The patient took his advice and got the shingles vaccine along with the Rsv vaccine. The only side effects were being sleepy. The second shingles dose was due in 2 to 6 months. More
2842634		M	TN	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Feeling abnormal Feeling abnormal	The patient felt badly; This non-serious case was reported by a physician via sales rep and describe... The patient felt badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: The patient felt badly). The outcome of the feeling abnormal was not reported. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix. It was unknown if the company considered the feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 20-MAY-2025 The patient felt badly after dose 1 of Shingrix. The patient refused to take dose 2 of Shingrix due to the side effects of dose 1. More
2842635		M		05/26/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	5P4A5	Expired product administered Expired product administered	has administered Expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharm... has administered Expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis. On 21-MAY-2025, the patient received the 1st dose of Arexvy (left arm). On 21-MAY-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: has administered Expired Arexvy vaccine to 2 patients). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that the patient had received expired Arexvy vaccine which led to, expired vaccine used. As it was administered to 2 patients, there were 2 initials by pharmacist as they was husband and wife. This case had been link with US2025063393, reported by the same reporter.; Sender's Comments: US-GSK-US2025063393:Female patient More
2842636				05/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Illness Illness	Sickness; This non-serious case was reported by a consumer via interactive digital media and describ... Sickness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Had shingles before vaccine). 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 sickness (Verbatim: Sickness). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-MAY-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she was sick after 1st dose. Followed through 2nd but, no reaction. Patient had shingles before vaccine. Patient hoped never to have it again. More
2842637				05/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pain Pain	severe pain that lasted for several months; This non-serious case was reported by a consumer via int... severe pain that lasted for several months; 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. 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 pain (Verbatim: severe pain that lasted for several months). The outcome of the pain was resolved. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient via interactive digital media. The vaccine gave me severe pain that lasted for several months, so patient not getting the second shot. More
2842638		M	FL	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	got a dose of shingrix in december of 2022; This non-serious case was reported by a other health pro... got a dose of shingrix in december of 2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in December 2022). 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: got a dose of shingrix in december of 2022). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that they had a patient who received a dose of Shingrix in December 2022 but did not return for the second dose until May 2025. The patient was wondering if they needed to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2842639		F	MO	05/26/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	39LB7	Product storage error Product storage error	Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached). The outcome of the incorrect storage of drug 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheits as the lowest reached Boostrix (39LB7 and 2B723), which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date given for the vaccines nor date of administration. This is 1 of 35 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061551:same patient,Different suspect US-GSK-US2025061545:same reporter,Different suspect US-GSK-US2025061574:Same reporter,Different patient US-GSK-US2025061573:Same reporter,Different patient US-GSK-US2025061572:Same reporter,Different patient US-GSK-US2025061571:Same reporter,Different patient US-GSK-US2025061570:Same reporter,Different patient US-GSK-US2025061569:Same reporter,Different patient US-GSK-US2025061568:Same reporter,Different patient US-GSK-US2025061567:Same reporter,Different patient US-GSK-US2025061565:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061563:Same reporter,Different patient US-GSK-US2025061562:Same reporter,Different patient US-GSK-US2025061561:Same reporter,Different patient US-GSK-US2025061560:Same reporter,Different patient US-GSK-US2025061559:Same reporter,Different patient US-GSK-US2025061558:Same reporter,Different patient US-GSK-US2025061557:Same reporter,Different patient US-GSK-US2025061556:Same reporter,Different patient US-GSK-US2025061555:Same reporter,Different patient US-GSK-US2025061554:Same reporter,Different patient US-GSK-US2025061553:Same reporter,Different patient US-GSK-US2025061552:Same reporter,Different patient US-GSK-US2025061550:Same reporter,Different patient US-GSK-US2025061549:Same reporter,Different patient US-GSK-US2025061537:Same reporter,Different patient US-GSK-US2025061536:Same reporter,Different patient US-GSK-US2025061534:Same reporter,Different patient More
2842640	0.17	F	IL	05/26/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Incomplete course of vaccination; This non-serious case was reported by a nurse via call center repr... Incomplete course of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 2-month-old female patient who received DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (On 03-MAR-2020, the patient received 1st dose) and Kinrix (On 15-JUL-2024, the dose was received with batch number 3RT93 and expiry date 03-APR-2026). On an unknown date, the patient did not receive the 2nd dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination 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: 15-MAY-2025 The patient already got kinrix before. The reporter wanted to catch them up because they were not up to date on their DTAP or their polio. They have only had a dose of the DTAP and those were the only ones they had with the DTAP and same with the Polio, they just have those two doses in her life. The reporter consented to follow up. Health care professional (HCP) called to inquire the safety of administering a Second dose of Kinrix. They've administered a first dose of Kinrix in July 15th, 2024. The Patient only received one dose of DTAP vaccine and one Kinrix and those were the only two doses of DTAP or Polio IPV that the patient received in her life. More
2842641	46		AK	05/26/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	cx4hl	Product storage error Product storage error	Administration after Temperature excursion; This non-serious case was reported by a nurse via call c... Administration after Temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number cx4hl, expiry date 09-NOV-2026) for prophylaxis. On 21-MAY-2025, the patient received Boostrix. On 21-MAY-2025, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after Temperature excursion). The outcome of the incorrect storage of drug 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: 21-MAY-2025 A nurse called in to request data about the need to revaccinate a patient after a dose of Boostrix was given after a temperature excursion which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. More
2842642			VA	05/26/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS		Product storage error Product storage error	Vaccine stored outside recommended conditions and administered to patient/administration of the vacc... Vaccine stored outside recommended conditions and administered to patient/administration of the vaccine was probable; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient/administration of the vaccine was probable). The outcome of the incorrect storage of drug 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: 22-MAY-2025 The pharmacist reported a Bexsero vaccine was left out of the fridge for 14 hours at room temperature and the pharmacist stated that the vaccine was not administered but he mentioned that the vaccine was at the patient's home so, administration of the vaccine was probable, which led to incorrect storage of drug More
2842643	50	M	PA	05/26/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	TX77L	Underdose Underdose	accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix); patient that is 50 yea... accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix); patient that is 50 years old, and accidentally they gave it Dtap (Infanrix) to him; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 28-SEP-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 21-MAY-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 21-MAY-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix)) and inappropriate age at vaccine administration (Verbatim: patient that is 50 years old, and accidentally they gave it Dtap (Infanrix) to him). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 22-MAY-2025 The physician reported that they had a little issue with one of their patient and a vaccine administration as there have been a mix up, they order Tdap (Boostrix) for a patient that was 50 years old and accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix), which led to wrong vaccine administered and inappropriate age at vaccine administration The Vaccine Administration Facility is the same as Primary Reporter More
2842644	73	M	IL	05/26/2025	HEPAB HEPAB	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	P2443	Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More	early 3rd dose; Late 2nd dose; This non-serious case was reported by a pharmacist via call center re... early 3rd dose; Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 22-MAY-2025, the patient received the 3rd dose of Twinrix. On 09-APR-2025, the patient received the 2nd dose of Twinrix. On 09-APR-2025, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 22-MAY-2025, the patient experienced drug dose administration interval too short (Verbatim: early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 22-MAY-2025 The reporter called and reported that they gave a Twinrix vaccine outside the normal interval, so they wanna now if did they need to repeat the dose. they gave the 3rd dose to soon. The vaccine administration facility was the same as primary reporter. The healthcare professional reported that the 2nd dose was a late 2nd dose which led to lengthening of vaccination schedule, and the 3rd dose was an early which led to shortening of vaccination schedule. More
2842645	0.58	M	CA	05/26/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	92DJ3	Expired product administered Expired product administered	Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a ot... Maladministration of Engerix-B After the Expiration Date; 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 7-month-old male patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis. On 21-MAY-2025, the patient received the 1st dose of Engerix B. On 21-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). 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: 22-MAY-2025 The medical assistance reported that a pediatric male patient received on 21th May 2025 an expired Engerix-B first dose which led to expired vaccine administered. The patient already has a combination vaccine with hep B. The vaccine administration facility was the same as primary reporter. More
2842646				05/26/2025	DTAPIPVHIB	SANOFI PASTEUR		No adverse event, Product preparation issue No adverse event, Product preparation issue	incorrect administration of pentacel as only the hib component was reconstituted with sterile water ... incorrect administration of pentacel as only the hib component was reconstituted with sterile water with no reported adverse event; incorrect administration of pentacel as only the hib component was reconstituted with sterile water with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who had incorrect administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] as only the hib component was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient had incorrect administration of an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization as only the hib component was reconstituted with sterile water with no reported adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842647	0.33		CA	05/26/2025	DTAPIPVHIB	SANOFI PASTEUR		Exposure via skin contact, No adverse event Exposure via skin contact, No adverse event	PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported ad... PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 4 months old and unknown gender patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received less than 0.5 mL dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in the thigh NOS (not otherwise specified) for immunization however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event. Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842648	5		TN	05/26/2025	TDAP	SANOFI PASTEUR		No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	5-year-old patient was given ADACEL in error, with no reported adverse event; Initial information re... 5-year-old patient was given ADACEL in error, with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old and unknown gender patient who was given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in error, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, in error, with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842650	74	M	TX	05/26/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS		Erythema, Impaired healing, Scab Erythema, Impaired healing, Scab	red spot with scab that never heals; red spot with scab that never heals;
2842651	42	F	MN	05/26/2025	COVID19	PFIZER\BIONTECH		Deafness unilateral, Ear infection, Ear operation, Tympanic membrane perforation Deafness unilateral, Ear infection, Ear operation, Tympanic membrane perforation	Double ear infection the right ear drum ruptured and after three surgeries to fix it I have lost mos... Double ear infection the right ear drum ruptured and after three surgeries to fix it I have lost most of my hearing in the right ear More		✓
2842675	0.5		TX	05/26/2025	VARCEL	MERCK & CO. INC.	y013346	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No other AE; Inbound call from HCP stating that they administered VARIVAX to a patient who was 6 mon... No other AE; Inbound call from HCP stating that they administered VARIVAX to a patient who was 6 months old at the time/date of administration. The patient is now 8 months old. No further information provided. No symptoms described by HCP. No further patient info; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-Mar-2025, at the age of 6 months, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot #y013346, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not provided), for prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). At the reporting time, the patient was 8 months old. No further information was provided. No symptoms were described by HCP and no other adverse event was reported. More
2842676		F		05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Pruritus, Rash vesicular Pruritus, Rash vesicular	itching; still getting chicken pox like spots; This non-serious case was reported by a consumer and ... itching; still getting chicken pox like spots; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included acrivastine (Benadryl). On 29-APR-2025, the patient received Shingrix. On 04-MAY-2025, 5 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: still getting chicken pox like spots). On an unknown date, the patient experienced pruritus (Verbatim: itching). The outcome of the varicella-like rash was not resolved and the outcome of the pruritus was not reported. It was unknown if the reporter considered the varicella-like rash and pruritus to be related to Shingrix. It was unknown if the company considered the varicella-like rash and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 16-MAY-2025 The patient self-reported this case for herself. The patient reported that she took the Shingrix vaccine and experienced symptoms such as still getting chicken pox like spots and started taking Benadryl to help with itching but spots were ongoing. The symptoms were not treated. No other products were received by the patient. More
2842677				05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth	Today it is very warm and red; Today it is very warm and red; It is painful but not above and beyond... Today it is very warm and red; Today it is very warm and red; It is painful but not above and beyond; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 17-MAY-2025, the patient received Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: It is painful but not above and beyond). On 18-MAY-2025, the patient experienced injection site erythema (Verbatim: Today it is very warm and red) and injection site warmth (Verbatim: Today it is very warm and red). The outcome of the injection site erythema, injection site pain and injection site warmth were not reported. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix. Additional Information: GSK receipt date: 18-MAY-2025 The case was reported by the patient via (Shingrix GSK Chatbot) interactive digital media. The patient had a vaccine of Shingrix early afternoon one day prior to the reporting day on Saturday. On the day of reporting, it was very warm and red and about 3 x 3 in diameter. It was painful but not above and beyond. The patient asked that he/she should take Benadryl or put a cold compress on the area. After taking Shingrix how he/she calm the redness and pain. More
2842678				05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Malaise, Pain in extremity Malaise, Pain in extremity	my arm still hurts; made me ill; This non-serious case was reported by a consumer via interactive di... my arm still hurts; made me ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: my arm still hurts) and illness (Verbatim: made me ill). The outcome of the pain in arm was not resolved and the outcome of the illness was not reported. It was unknown if the reporter considered the pain in arm and illness to be related to Shingrix. It was unknown if the company considered the pain in arm and illness to be related to Shingrix. Additional Information: GSK Receipt Date: 19-MAY-2025 This case was reported by a patient via interactive digital media. The patient received the Shingrix vaccine and his/her arm still hurts and this made him/her ill. More
2842679		F	TN	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Product administered at inappropriate site, Skin irritation Product administered at inappropriate site, Skin irritation	she got an irritation near her shoulder; injected very high on the shoulder above the area where sho... she got an irritation near her shoulder; injected very high on the shoulder above the area where shots are usually given; This non-serious case was reported by a nurse via sales rep and described the occurrence of skin irritation in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin irritation (Verbatim: she got an irritation near her shoulder) and vaccine administered at inappropriate site (Verbatim: injected very high on the shoulder above the area where shots are usually given). The outcome of the skin irritation was resolved and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the skin irritation to be related to Shingrix. It was unknown if the company considered the skin irritation to be related to Shingrix. Additional Information: GSK Receipt Date :20-MAY-2025 Patient has had 1 dose of Shingrix. She reported the lady who did the injection injected very high on the shoulder (above the area where shots are usually given) which led to vaccine administered at inappropriate site and that she got an irritation near her shoulder that looked like cellulitis. The site has healed and she planed to get dose 2, but not to allow that same lady to administer dose. More
2842680				05/26/2025	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; 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. 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: shingles). 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 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: 20-MAY-2025 This case was reported by a patient's friend via interactive digital media. The reporter reported that he/she had a friend who had shingles despite having received both vaccines. The reporter had a shingles (it was awful) and then was vaccinated. The reporter had a questioned was it unusual to have had them after being vaccinated. That caused him/her some concern he/she did not wanted to go through that again. This case was considered as suspected vaccination failure since the details regarding 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
2842681				05/26/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	A69CF724	Product preparation issue Product preparation issue	A patient has been given Priorix diluent at a local GP; patient has been given Priorix diluent; This... A patient has been given Priorix diluent at a local GP; patient has been given Priorix diluent; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number A69CF724) and (batch number A69CE762A) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: A patient has been given Priorix diluent at a local GP) and inappropriate dose of vaccine administered (Verbatim: patient has been given Priorix 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: 19-MAY-2025 The reporter reported that a patient had been given Priorix diluent at a local General Practitioner. They need to identify which patients received it, they have 18 vaccinations and 17 of them have batch numbers recorded as A69CF724 and one is recorded as A69CE762A. Could this be the number off the diluent. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2842682			PA	05/26/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	UNK	Inappropriate schedule of product administration Inappropriate schedule of product administration	Hepatitis A vaccine was given couple months too soon to a patient about an year ago; This non-seriou... Hepatitis A vaccine was given couple months too soon to a patient about an year ago; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Hepatitis A vaccine was given couple months too soon to a patient about an year ago). 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: 20-MAY-2025 The reporter called to state that the Hepatitis A vaccine was given couple months too soon to a patient about a year ago which led to drug dose administration interval too short. Upon clarification, the reporter stated that the product was Havrix and not VAQTA. The reporter stated that she would call the corresponding manufacturer. More
2842683				05/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspeceted vaccination failure; shingles for the 3rd time; This serious case was reported by a consu... Suspeceted vaccination failure; shingles for the 3rd time; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles for the 3rd time). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 21-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she was hopefully just getting over shingles for the third time he/she had been vaccinated. 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine. . More
2842684			PA	05/26/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS		Inappropriate schedule of product administration, Incomplete course of vaccinati... Inappropriate schedule of product administration, Incomplete course of vaccination More	Possible wrong schedule; Possible wrong schedule; This non-serious case was reported by a consumer v... Possible wrong schedule; Possible wrong schedule; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate schedule of drug administration in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of drug administration (Verbatim: Possible wrong schedule) and incomplete course of vaccination (Verbatim: Possible wrong schedule). The outcome of the inappropriate schedule of drug administration and incomplete course of vaccination 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: 16-MAY-2025 The doctor was inquiring on why they don't need to bring back the patients if they gave them Bexsero at the 0-1 month when Bexsero has an accelerated dosing of 0-1-2 and 6 months which led to inappropriate schedule of drug administration and incomplete course of vaccination. She understood that the 0 1-2 6 is for specific patients however were those patients she gave 0-1 month protected since we have a 3 dose indication. The dosing schedule was confusing her. The Vaccine Administration Facility is the same as Primary Reporter No more information shared. More
2842685	40	F	OH	05/26/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	797F9	Inappropriate schedule of product administration Inappropriate schedule of product administration	Twinrix late second dose; This non-serious case was reported by a pharmacist via call center represe... Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 40-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis. Previously administered products included Twinrix (1st dose received on 20-MAY-2019 with batch number-95KG9 and expiry date 29-OCT-2020). On 22-APR-2025, the patient received the 2nd dose of Twinrix. On 22-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). 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: 20-MAY-2025 The patient received 2nd dose at longer interval than recomeded which led lengthening of vaccination schedule. Registered pharmacist wanted to know if he should restart the series or how much time to wait before giving a third dose of Twinrix after his patient received the first dose. The reporter consented to follow up. More
2842686		F	IN	05/26/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Incomplete scheme dose; This non-serious case was reported by a physician via call center representa... Incomplete scheme dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (received 1st dose of vaccine on an unknown date), Infanrix (received 2nd dose of vaccine on an unknown date) and Infanrix (received 3rd dose of vaccine on 23rd June 2023). On an unknown date, the patient did not receive the 4th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete scheme dose). The outcome of the incomplete course of vaccination 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: 20-MAY-2025 On 20th May 2025, an physician requested information regarding a 7 year old patient and the possibility of administering a Boostrix booster dose for the DTaP vaccine scheme. The physician stated that the patient was from another country and had received only three doses of DTaP. Since the patient had not completed the full DTaP vaccination schedule, local authorities required a Boostrix booster dose. The physician reported that the DTaP vaccines the patient had received were Infanrix, with the last dose administered on 23rd June 2023. During the call, the healthcare professional noted that the patient had received the three doses as an infant but did not provide specific dates, only mentioning that the last dose was given on 23rd June 2023. The MD consented to follow up. Till the time of reporting, the patient did not receive 4th dose of Infanrix, which led to incomplete course of vaccination. More
2842687		F	FL	05/26/2025	RV1	GLAXOSMITHKLINE BIOLOGICALS	UNK	Inappropriate schedule of product administration Inappropriate schedule of product administration	Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional... Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a female patient who received Rota (Rotarix liquid formulation) for prophylaxis. Previously administered products included Rotarix (Patient receive 1st dose of Rotarix on 27th December 2024 with batch number 32PF3 expiry 15 May 2027). On an unknown date, the patient did not receive the 2nd dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the inappropriate schedule of vaccine administered was not applicable. Additional Information: GSK receipt date: 21-MAY-2025 HCP reported about late dose of Rotarix. Patient received 1st dose on December 27, 2024 at 2 months of age and is back to received 2nd dose at 7 months of age. Also asked what was the recommendation beyond the 24 weeks for 2nd dose? It was unknown at time of reporting if patient would be receiving 2nd dose on the day of reporting. Till the time of reporting patient did not receive 2nd dose of vaccination which led to incomplete course of vaccination. More
2842688	7		MO	05/26/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS		Product administered to patient of inappropriate age Product administered to patient of inappropriate age	Boostrix + possible use before recommended age; This non-serious case was reported by a physician vi... Boostrix + possible use before recommended age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix + possible use before recommended age). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 22-MAY-2025 Doctor called to ask information about approved age of Boostrix being to patients older than 10 years of age. They did not have a specific case at the moment of call but mentioned sometime in her facility they receive 7-year-old patients that need to catch-up on the Dtap vaccine schedule which led to inappropriate age at vaccine administration, and wanted to review information to make clinical decision. More
2842689				05/26/2025	COVID19	MODERNA		Peripheral swelling, Pharyngeal swelling, Pruritus, Swelling Peripheral swelling, Pharyngeal swelling, Pruritus, Swelling	severe itching; swelling of body; swelling of body hands feet; swelling of body hands feet and throa... severe itching; swelling of body; swelling of body hands feet; swelling of body hands feet and throat; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer Vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer Vaccine. Concurrent medical conditions included Iodine allergy (severe) and Fish allergy (fish oil and all fish). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat). At the time of the report, PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat) was resolving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. The patient received the Covid -19 vaccine of Moderna in September and experienced severe itching, swelling in body, hands, feet, and throat. Patient still have some attacks, but they were less frequent and patient was afraid. The patient usually took Pfizer vaccine and never experienced a reaction. No treatment medications were reported. More
2842690	50	F	WA	05/26/2025	COVID19 COVID19 FLU3 FLU3 HEP HEP MMR MMR PNC21 PNC21 COVID19 COVID19 HEP HEP UNK UNK UNK UNK UNK UNK	MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Arthralgia, Loss of personal independence in daily activities, Product administe... Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain; Arthralgia, Loss of personal independence in daily activities, Product administered at inappropriate site, Vaccination site pain More	Loss of personal independence in daily activities/ This has completely affected every area of my lif... Loss of personal independence in daily activities/ This has completely affected every area of my life.; Arthralgia; The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable; Product administered at inappropriate site/ The pharmacist gave me two shots on each shoulder, and one in my left forearm; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities/ This has completely affected every area of my life.), ARTHRALGIA (Arthralgia), VACCINATION SITE PAIN (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Product administered at inappropriate site/ The pharmacist gave me two shots on each shoulder, and one in my left forearm) in a 50-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Hepatitis b vaccine rHBsAg (yeast) (Engerix b) for an unknown indication, Influenza vaccine inact split 3v (Afluria) for an unknown indication, Mmr ii for an unknown indication and Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: Clindamycin. Past adverse reactions to the above products included Allergy to antibiotic with Clindamycin. Concurrent medical conditions included Diabetes, Rheumatoid arthritis and Allergy to antibiotic (Clindamycin). Concomitant products included Insulin porcine (Insulin), Methylphenidate hydrochloride (Ritalin), Metformin hydrochloride (Metformin), Meloxicam, Ibuprofen (Motrin), Prenatal vitamins, Magnesium, Tocopherol (Vitamin e), Ascorbic acid (Vitamin C), Ergocalciferol (Vitamin d) and Calcium for an unknown indication. On 03-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form, dose of Hepatitis b vaccine rHBsAg (yeast) (Engerix b) (unknown route) 1 dosage form, dose of Influenza vaccine inact split 3v (Afluria) (unknown route) 1 dosage form, dose of Mmr ii (unknown route) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (unknown route) 1 dosage form. On 03-Dec-2024, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Product administered at inappropriate site/ The pharmacist gave me two shots on each shoulder, and one in my left forearm). On 05-Dec-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities/ This has completely affected every area of my life.), ARTHRALGIA (Arthralgia) and VACCINATION SITE PAIN (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities/ This has completely affected every area of my life.), ARTHRALGIA (Arthralgia), VACCINATION SITE PAIN (The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Product administered at inappropriate site/ The pharmacist gave me two shots on each shoulder, and one in my left forearm) had not resolved. Route of administration of Moderna COVID-19 vaccine, Afluria, MMR II was reported as OT, Engerix-B and Capvaxive was reported as UN. Site of administration was reported as OT for Moderna COVID-19 vaccine and Afluria. It was reported that the pharmacist gave patient two shots on each shoulder, and one in left forearm. On her right shoulder he did one too high and she still had pain in that shoulder and pharmacist did two in her left shoulder and the pain was unbearable. She had to go to the emergency room a couple days after because the pain was too much. She had been to the emergency room three times since Dec-2024 and 05-Feb-2025. This had completely affected every area of her life. The pain had not gotten better, and she did not know where to go from there. She underwent laboratory test and X-ray, but no results were reported. Treatment information was not reported. More
2842691	35	M		05/26/2025	TD	SANOFI PASTEUR	U7745AA	Expired product administered, No adverse event Expired product administered, No adverse event	patient got administered expired Tenivac vaccine with no reported adverse event; Initial information... patient got administered expired Tenivac vaccine with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 35 years old male patient who got administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-May-2025, the patient got administered expired 0.5 ml dose 2 of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength- standard) Suspension for injection lot U7745AA and expiry date- 20-May-2025 via intramuscular route in the deltoid nos (not specified) for Immunization with no reported adverse event (expired product administered) (latency- same day). Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842692			HI	05/26/2025	TDAP	SANOFI PASTEUR	4CA04C1	Product storage error Product storage error	inappropriate use due to possible administration of vaccine post excursion with no reported adverse ... inappropriate use due to possible administration of vaccine post excursion with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] vaccine post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot 4CA04C1 and expiry date-31-Oct-2026) (strength-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) post excursion with no reported adverse event (poor quality product administered) (latency-same day). Reportedly- The patient received vaccine that was stored at -0. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842693			HI	05/26/2025	DTAPIPVHIB	SANOFI PASTEUR	UK114A	No adverse event, Product storage error No adverse event, Product storage error	inappropriate use due to administration of vaccine post excursion as stored at -0 with no reported a... inappropriate use due to administration of vaccine post excursion as stored at -0 with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who had inappropriate use due to administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] post excursion as stored at -0 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK114A and expiry date 30-Sep-2025) via unknown route in unknown administration site for immunization that had inappropriate use post excursion as stored at -0 with no reported adverse event (poor quality product administered) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842694	30	F	MA	05/26/2025	COVID19 COVID19	MODERNA MODERNA		Abortion spontaneous, Exposure during pregnancy, Oligohydramnios, Preterm premat... Abortion spontaneous, Exposure during pregnancy, Oligohydramnios, Preterm premature rupture of membranes, Ultrasound antenatal screen abnormal; Uterine dilation and curettage, Vaginal haemorrhage More	I was 13 weeks pregnant and received this vaccination. I started bleeding vaginally the next day. Ov... I was 13 weeks pregnant and received this vaccination. I started bleeding vaginally the next day. Over the next several days, bleeding increased each day from what looked like spotting to full period type of bleeding. Initial ultrasound could not find what was wrong. Bleeding continued as full period for several weeks until later ultrasound revealed oligohydramnios and PPROM requiring D&C procedure at 18 weeks (miscarriage/pregnancy loss due to no viability). More
2842695	55	F	KY	05/26/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Asthenia, Fatigue, Gait disturbance, Hallucination, Headache; Injection site pai... Asthenia, Fatigue, Gait disturbance, Hallucination, Headache; Injection site pain, Pyrexia More	Bilateral weakness that required assistance to walk headache fever. Soreness at site. Hallucination ... Bilateral weakness that required assistance to walk headache fever. Soreness at site. Hallucination times 1 Fatigue. More
2842696	49	F		05/26/2025	COVID19	MODERNA	031M20A	Anaphylactic reaction Anaphylactic reaction	Patient was seen in ER on 2/26/21 for an anaphylactic (acute allergic) reaction to the Moderna COVID... Patient was seen in ER on 2/26/21 for an anaphylactic (acute allergic) reaction to the Moderna COVID Vacine. Patient was given 2 epipens, steroids, benadryl for symptoms as well as some medications for nausea and stomach irritation. Patient's breathing and symptoms improved with these medications. Patient was sent home with prescriptions for epi-pens Patient went on to successfully receive 3 Pfizer doses following this. More
2842697	36	F	CA	05/26/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS		Eczema, Exposure during pregnancy, Rash, Tinea infection Eczema, Exposure during pregnancy, Rash, Tinea infection	I was approximately 4 months pregnant and the OBGYN recommended the tdap vaccine. I stated I already... I was approximately 4 months pregnant and the OBGYN recommended the tdap vaccine. I stated I already had the tdap vaccine 5 years prior and she recommended it further so I got the shot. Approximately 2 weeks later I got a ringworm eczema rash on my hand. When it didn't respond to ringworm treatment I went to my general doctor and he diagnosed me with eczema. I have never had eczema prior. I've lived with consistent eczema flares ever since. I have present day annual checkups that document my eczema and I have a standing prescription medication for. More
2842698	38	F	CO	05/26/2025	COVID19 COVID19	MODERNA MODERNA	030H21B 030H21B	Catheterisation cardiac, Echocardiogram, Electrocardiogram, Immediate post-injec... Catheterisation cardiac, Echocardiogram, Electrocardiogram, Immediate post-injection reaction, Magnetic resonance imaging heart; Malaise, Pericardial effusion, Pericardial excision, Pericarditis More	Got very sick immediately and never recovered. Ended up in hospital in Feb/22 with pericardial effus... Got very sick immediately and never recovered. Ended up in hospital in Feb/22 with pericardial effusion. Developed chronic pericarditis leading to pericardectomy on 9/14/22. More	✓	✓	✓
2842699	68	M	VA	05/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	3x97j	Arthralgia, Shoulder injury related to vaccine administration Arthralgia, Shoulder injury related to vaccine administration	Patient experienced pain in shoulder approximately 2 days after receiving vaccine. When symptoms di... Patient experienced pain in shoulder approximately 2 days after receiving vaccine. When symptoms did not improve he sought medical care. His orthopedist believes his shoulder pain may be a result of his vaccine administration. Possible SIRVA, shoulder injury related to vaccine administration, is suspected. More
2842700	35	M	FL	05/26/2025	HEP MMR	DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS	946060 4N222	Incorrect route of product administration, No adverse event; Incorrect route of ... Incorrect route of product administration, No adverse event; Incorrect route of product administration, No adverse event More	Priorix was given intramuscularly, instead of subcutaneously. No adverse effects have been reported. Priorix was given intramuscularly, instead of subcutaneously. No adverse effects have been reported.
2842701	32	F	OH	05/26/2025	COVID19	MODERNA		Lacrimation decreased Lacrimation decreased	Within 4 days eyes became very dry difficult to produce tears Within 4 days eyes became very dry difficult to produce tears

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