🏥 VAERS Vaccine Data Browser

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

Data Source & Accuracy

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

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Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

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

Understanding the Data

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

Using the Table

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

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

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

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

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Showing 20,151 to 20,200 of 34,052 reports (Page 404 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿
2840989			NM	05/14/2025	RV5	MERCK & CO. INC.	2088619	No adverse event, Product storage error No adverse event, Product storage error	No additional AE reported.; patient was administered ROTATEQ during a temperature excursion.; This s... No additional AE reported.; patient was administered ROTATEQ during a temperature excursion.; This spontaneous report was received from an office manager concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 25-Apr-2025, during a temperature excursion of 0 degrees Celsius (C) for 1 hour 0 minutes and 0 seconds, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619 has been verified to be a valid batch lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration reported and confirmed as 09-Mar-2026) 1 dosage form (dosage regimen not reported) administered by oral route as prophylaxis (product storage error.) There were no additional adverse events (AE) reported (no adverse event). There were no additional details reported. More
2840990			PA	05/14/2025	HPV9	MERCK & CO. INC.	Y012508	No adverse event, Product storage error No adverse event, Product storage error	No additional adverse event reported; HCP calling to report T/E. VFC data logger was off. HCP could ... No additional adverse event reported; HCP calling to report T/E. VFC data logger was off. HCP could not provide any temperature and time information to further evaluate GARADSIL 9. HCP did state GARDASIL 9 was administered. See T/E case# 02799358.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2025, a temperature excursion occurred. On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #Y012508; which has been verified to be valid, expiration date reported and upon internal validation establish as 01-JAN-2027 (strength, dose number, exact quantity volume, route and anatomical site of administration were not provided) administered for prophylaxis (Improper storage of product in use). It was also reported that the data logger was off so the reporter could not provide any temperature and time information to further evaluate the vaccine. No previous temperature excursion. No additional adverse event reported (No adverse event). More
2840991	25	F	MD	05/14/2025	HPV4 HPV4	MERCK & CO. INC. MERCK & CO. INC.		Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More	HCP reported that the patient has not received her third dose of the GARDASIL vaccine and has not co... HCP reported that the patient has not received her third dose of the GARDASIL vaccine and has not completed her vaccination series.; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. In 2021, the patient received the first two doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis. The patient has not received her third dose of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine and has not completed her vaccination series (Inappropriate schedule of product administered). No additional adverse event was reported. Lot# is being requested and will be submitted if received. More
2840992			KY	05/14/2025	HEPA	MERCK & CO. INC.	X026485	Expired product administered, No adverse event Expired product administered, No adverse event	No additional AE; Inbound call from HBP calling to report administration of VAQTA that was expired. ... No additional AE; Inbound call from HBP calling to report administration of VAQTA that was expired. Caller states a medical assistant accidently administered the dose on 13-MAY-2025 and expired on 11-MAY-2025; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 13-MAY-2025, the patient was vaccinated accidently with an expired dose of Hepatitis A Vaccine, Inactivated Injection (VAQTA) injection, dose reported as 0.5 mL (conflicting information) administered as prophylaxis (lot number X026485 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated injection], expiration date reported and established as 11-May-2025) (expired product administered) (strength, dose number, route of administration, vaccination scheme frequency and anatomical site of application were not provided). No additional adverse events were reported (No adverse event). More
2840993			MI	05/14/2025	HIBV	MERCK & CO. INC.	W028532	Expired product administered, No adverse event Expired product administered, No adverse event	No additional AEs reported; Nurse reported that a patient received expired PEDVAX HIB on 5/13/2025. ... No additional AEs reported; Nurse reported that a patient received expired PEDVAX HIB on 5/13/2025. No additional AEs were reported, no further information provided. No PQC.; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 13-MAY-2025, the patient was vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) administered as the first dose for prophylaxis (lot number reported as W028532, which has been verified as valid, expiration date reported and validated as 09-MAY-2025) (strength, dose, route of administration, and anatomical site of injection were not reported) (Expired product administered). No additional events were reported. More
2840994		F		05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	4479Y	Erythema, Incorrect route of product administration, Peripheral swelling Erythema, Incorrect route of product administration, Peripheral swelling	patient received Shingrix subcutaneous instead of intramuscular; Arm red; Arm swollen; This non-seri... patient received Shingrix subcutaneous instead of intramuscular; Arm red; Arm swollen; This non-serious case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) (batch number 4479Y) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). In JAN-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient received Shingrix subcutaneous instead of intramuscular). On an unknown date, the patient experienced erythema of extremities (Verbatim: Arm red) and swelling arm (Verbatim: Arm swollen). The outcome of the intramuscular formulation administered by other route was not applicable and the outcome of the erythema of extremities and swelling arm were resolved (duration 3 weeks). It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix. It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix. Additional Information: GSK receipt date: 30-APR-2025 The nurse reported that the patient received 1stdose of Shingrix subcutaneous instead of intramuscular which led to, intramuscular formulation administered by other route. The patient said her arm was red and swollen for three weeks but did not seek medical attention. She informed the practice of it when she returned for her 2nd dose. More
2840995		F	TX	05/14/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Erythema, Injection site induration, Injection site pain, Injection site pruritu... Erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction; Injection site swelling, Injection site warmth, Oropharyngeal pain, Rash erythematous More	a big red circle rash at the injection site; Redness; "it is hot, hard and swollen; "it is... a big red circle rash at the injection site; Redness; "it is hot, hard and swollen; "it is hot, hard and swollen ( at injection site); "it is hot, hard and swollen ( at injection site); Sore throat; it was extremely itchy yesterday; soreness and pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-APR-2025, the patient received Shingrix (intramuscular, right arm) .5 ml. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness and pain at the injection site). On 30-APR-2025, the patient experienced injection site itching (Verbatim: it was extremely itchy yesterday). On 01-MAY-2025, the patient experienced sore throat (Verbatim: Sore throat). On an unknown date, the patient experienced injection site rash (Verbatim: a big red circle rash at the injection site), injection site erythema (Verbatim: Redness), injection site swelling (Verbatim: "it is hot, hard and swollen), injection site warmth (Verbatim: "it is hot, hard and swollen ( at injection site)) and injection site induration (Verbatim: "it is hot, hard and swollen ( at injection site)). The outcome of the sore throat, injection site erythema and injection site pain were not resolved and the outcome of the injection site rash, injection site itching, injection site swelling, injection site warmth and injection site induration were resolving. It was unknown if the reporter considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix. It was unknown if the company considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix. Additional Information: GSK Receipt Date 01-MAY-2025: It was reported that the patient received the 1st dose of Shingrix in her right arm on April 28th, 2025, at a local pharmacy. She reports she has "a big red circle rash at the injection site". She reports, "it is hot, hard and swollen." The patient reports soreness and pain at the injection site. The patient reports "it was extremely itchy yesterday, but it is getting better". The patient reports the symptoms have improved but the pain, redness, and soreness are still present. The patient reports, "on the reporting day I have a sore throat, asked is this related to the vaccine. The patient was referred to HCP. More
2840996			RI	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	99d52	Underdose Underdose	partial dose; This non-serious case was reported by a pharmacist via call center representative and ... partial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) (batch number 99d52, expiry date 25-MAR-2027) for prophylaxis. On 09-MAY-2025, the patient received Shingrix. On 09-MAY-2025, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: partial dose). The outcome of the accidental underdose was not applicable. Additional Information: GSK Receipt Date: 09-MAY-2025 The pharmacist reported that a patient received a partial dose of Shingrix on the day of reporting due to an issue with the needle during administration, which led to accidental underdose. There was no product quality complaint. More
2840997		M		05/14/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	9SB34	Arthralgia, Muscular weakness Arthralgia, Muscular weakness	Muscle weakness both hips, both knees, both shoulders; joint pain in both hips, both knees, both sho... Muscle weakness both hips, both knees, both shoulders; joint pain in both hips, both knees, both shoulders; This non-serious case was reported by a consumer and described the occurrence of muscle weakness in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9SB34) for prophylaxis. On 22-APR-2025, the patient received Arexvy .5 ml. On 25-APR-2025, 3 days after receiving Arexvy, the patient experienced muscle weakness (Verbatim: Muscle weakness both hips, both knees, both shoulders) and joint pain (Verbatim: joint pain in both hips, both knees, both shoulders). The outcome of the muscle weakness and joint pain were not resolved. It was unknown if the reporter considered the muscle weakness and joint pain to be related to Arexvy. It was unknown if the company considered the muscle weakness and joint pain to be related to Arexvy. Additional Information: GSK Receipt Date: 11-MAY-2025 Patient experienced muscle weakness and joint pain in both hips, both knees and both Shoulders after Arexvy administration. More
2840998		M		05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Product preparation issue Product preparation issue	the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with t... the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial; the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a male 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 inappropriate preparation of medication (Verbatim: the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial) and inappropriate dose of vaccine administered (Verbatim: the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 12-MAY-2025 The reporter reported that while getting the Shingrix vaccine, the pharmacy injected him first with the adjuvant suspension by itself without reconstituting with the antigen vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacy then noted the mistake and administered him the reconstituted vaccine. More
2840999		M	MN	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Vaccination failure, Zoster sine herpete Vaccination failure, Zoster sine herpete	Suspected vaccination failure; Subclincal shingles; This serious case was reported by a consumer via... Suspected vaccination failure; Subclincal shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a elderly male 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: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: Subclincal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was resolved. The reporter considered the vaccination failure and zoster sine herpete to be related to Shingrix. The company considered the vaccination failure and zoster sine herpete to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2025 The reporter reported that patient received Shingrix vaccine and experienced subclincal shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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
2841000				05/14/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; small shingles outbreak on my lower back; This serious case was repor... Suspected vaccination failure; small shingles outbreak on my lower back; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by the patient via (Shingrix Chatbot) interactive digital media. The patient was fully vaccinated against shingles, yet he/she just recently had a small shingles outbreak on lower back. The reporter wanted to know if he/she should consider getting the Shingrix vaccine and booster again. 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 vaccine Shingrix (Dose 1 and Dose 2). More
2841001				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pain Pain	have been to the Urgent Care And ER twice this week in severe psin; This non-serious case was report... have been to the Urgent Care And ER twice this week in severe psin; 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 Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain (Verbatim: have been to the Urgent Care And ER twice this week in severe psin). The outcome of the pain was not 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 01-MAY-2025: This case was reported by a patient via interactive digital media. The patient received 2 shot series Shingle vaccine, 2 years today, 4/30 and have been to the Urgent Care and emergency care twice this week in severe pain. It's going on 3 weeks now. More
2841002		F		05/14/2025	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; got shingles 4 times; This serious case was reported by a consumer vi... Suspected vaccination failure; got shingles 4 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (got chicken pox when 8 months pregnant). 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: got shingles 4 times). 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: 30-APR-2025 This case was reported by a patient via interactive digital media. The patient took the two vaccines and got shingles 4 times the patient had the worst breakout now. The patient never had the chicken pox vaccine but got chicken pox 8 months pregnant. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2). More
2841003				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Asthenia, Dizziness, Pulmonary pain Asthenia, Dizziness, Pulmonary pain	I feel weak; dizzy; lungs aching; This non-serious case was reported by a consumer via interactive d... I feel weak; dizzy; lungs aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 30-APR-2025, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feelings of weakness (Verbatim: I feel weak), dizziness (Verbatim: dizzy) and pulmonary pain (Verbatim: lungs aching). The outcome of the feelings of weakness, dizziness and pulmonary pain were not reported. It was unknown if the reporter considered the feelings of weakness, dizziness and pulmonary pain to be related to Shingles vaccine. It was unknown if the company considered the feelings of weakness, dizziness and pulmonary pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient questioned that what if lungs were aching. The patient further stated that he/she got his/her 2nd shot yesterday (day before reporting). The patient felt weak, dizzy with lungs aching in 2025. More
2841004				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	suspected vacination failure; shingles; This serious case was reported by a consumer via interactive... suspected vacination 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 vacination 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. 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: 07-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles, despite having received the vaccine three years ago. The vaccine did not prevent, but they did seem to had a much milder case than most of the comments indicated. 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 Shingles vaccine. More
2841005				05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Immediate post-injection reaction Herpes zoster, Immediate post-injection reaction	I got shingles again right after getting the shot; This non-serious case was reported by a consumer ... I got shingles again right after getting the shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: I got shingles again right after getting the shot). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient recently got second dose of Shingrix. The patient now had shingles. The reporter asked could the shingles come from getting the immunization. The reporter asked that the patient did not understand why he/she got shingles again right after getting the shot but thank you for the information. More
2841006				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise Malaise	sick; This non-serious case was reported by a consumer via interactive digital media and described t... sick; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 1 week). 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: 08-MAY-2025 This case was reported by a patient via interactive digital media. The new shot series made patient sick as a dog for a week. More
2841007				05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Asthenia, Headache, Scar Asthenia, Headache, Scar	Weakness/Loss of strength; Headache; This non-serious case was reported by a consumer via interactiv... Weakness/Loss of strength; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness in a 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 weakness (Verbatim: Weakness/Loss of strength) and headache (Verbatim: Headache). The outcome of the weakness and headache were not reported. It was unknown if the reporter considered the weakness and headache to be related to Shingrix. It was unknown if the company considered the weakness and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 07-MAY-2025 This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media. The patient received Shingrix vaccine had weakness, headache, loss of strength. The reporter was ask could he/she took aspirin or Tylenol, was there anything to use to get rid of the scars and what to did if the second Shingrix dose was missed. More
2841008				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Injection site pain Injection site pain	local site injection soreness; This non-serious case was reported by a consumer via interactive digi... local site injection soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: local site injection soreness). The outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine. It was unknown if the company considered the injection site pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. It was reported as none at all. The patient had Just a little local site injection soreness. The patient got protected soon. More
2841009		F		05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	mother got the shot and 10 days later had full blown shingles; This non-serious case was reported by... mother got the shot and 10 days later had full blown shingles; 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, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: mother got the shot and 10 days later had full blown shingles). 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: 12-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient got the shot and 10 days later had full blown shingles . She was in agony the rest of her life. The reporter said that did they resent the medical industry for her misery at a point in her life that should have been the best time. More
2841010		F		05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	suspected vaccination failure; had them 3 or 4 times after the vaccine; This serious case was report... suspected vaccination failure; had them 3 or 4 times after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 3 or 4 times after the vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. 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: 02-MAY-2025 This case was reported by a consumer via interactive digital media. Patient had Shingles 3 or 4 times after the vaccine and stated that they were really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix. More
2841011	1.25	F		05/14/2025	DTAP HIBV PNC	GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER PFIZER\WYETH	UNK UNK UNK	Paralysis; Paralysis; Paralysis Paralysis; Paralysis; Paralysis	type of palsy had a reaction to the 15 month shots; This serious case was reported by a other health... type of palsy had a reaction to the 15 month shots; This serious case was reported by a other health professional via other manufacturer and described the occurrence of palsy in a 15-month-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevenar 20) for prophylaxis and HIB vaccine for prophylaxis. On an unknown date, the patient received Infanrix, Prevenar 20 and HIB vaccine. On an unknown date, an unknown time after receiving Infanrix, the patient experienced palsy (Verbatim: type of palsy had a reaction to the 15 month shots) (serious criteria GSK medically significant). The outcome of the palsy was unknown. It was unknown if the reporter considered the palsy to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the palsy to be unrelated to Infanrix and Infanrix Pre-Filled Syringe Device. 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: 06-MAY-2025 The Inbound warm transfer from agent with Pfizer Medical Information, agent relays she has a medical assistant on the line regarding DTaP (Infanrix) , HiB or Prevnar 20. The reporter stated they had a 15 month old female that had a reaction to the 15 month shots. They are trying to figure out if it is from the DTaP (Infanrix) , HiB or Prevnar 20 vaccine. The caller stated she has no patient information to provide and was just calling on behalf of the provider for information. The reporter stated the reaction was like a type of palsy. The child was followed by an allergist and this made the allergist think there was an egg or animal component that could have caused the episode. The caller was unable to clarify palsy further to include location on body. The reporter stated that the DTaP they get from GSK and HiB they get from Sanofi and does not know what doses in the series these were. The complainant does not have the product with them at the time of call. It was unknown if the reporter considered the palsy to be related to HiB or Prevnar 20 vaccine.; Sender's Comments: Paralysis is an unlisted event which is considered unrelated to GSK vaccine Infanrix and Infanrix PRE-FILLED SYRINGE DEVICE More
2841012			TN	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was reporte... patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was reported by a consumer via sales rep 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 of Shingrix vaccine on an unknown date 6 months prior). 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 that went beyond 6 months for the second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-MAY-2025 A doctor had a patient that went beyond 6 months for the second dose of Shingrix which led to incomplete course of vaccination. He wanted to know if the patient needed to re-start the 2 dose series over or if the patient could just get the second dose even though it was past 6 months. More
2841013				05/14/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise, Vaccine positive rechallenge Malaise, Vaccine positive rechallenge	they both made me sick; This non-serious case was reported by a consumer via interactive digital med... they both made me sick; 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. Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date, For tolerance to 1st dose, refer case US2025AMR056759). 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 sickness (Verbatim: they both made me sick). Rechallenge with Shingles vaccine was positive. 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: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated they both made them sick. This case is 1 of 2 cases created for both doses.; Sender's Comments: US-GSK-US2025AMR056759:same patient 1 st dose More
2841014			IL	05/14/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS		Erythema, Pain, Swelling, Wrong technique in product usage process Erythema, Pain, Swelling, Wrong technique in product usage process	An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if a... An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.; swelling; redness; viscous state like honey appearance, if she administer Bexsero in that viscous; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of patients 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 pain (Verbatim: An HCP lets Bexsero warm up before giving to patients because otherwise it has a viscous state, if administer Bexsero in that viscous state patients reports pain in the area, swelling and redness.), swelling (Verbatim: swelling), erythema (Verbatim: redness) and wrong technique in product usage process (Verbatim: viscous state like honey appearance, if she administer Bexsero in that viscous ). The outcome of the pain, swelling and erythema were unknown and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the pain, swelling and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the pain, swelling and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: On 01/MAY/2025 a Sales representative from GSK contacted MI on behalf of an HCP with issue regarding the air bubble in the Bexsero syringe. They could not expel the air bubble, the HCP lets Bexsero warm up for 10 or 15 minutes when she takes out the vaccine from the fridge before giving to patients because otherwise it has a viscous state like honey appearance, if she administer Bexsero in that viscous state patients reports pain in the area, swelling and redness, so it is easier for them to let warm up the vaccine, this led to wrong technique in product usage process. After contacting the HCP MI letter of the Bexsero Air bubble was shared, and HCP did not mention anything about the viscous state like honey appearance of Bexsero and she did not provide anymore details about this patients who experienced pain, swelling and redness. More
2841015		F	OR	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Cheilitis, Lip pain, Oral discomfort, Oral herpes zoster Cheilitis, Lip pain, Oral discomfort, Oral herpes zoster	burning lips; sensitive lips; Suspected Oral herpes zoster/I got a mild casr of shingles; sores arou... burning lips; sensitive lips; Suspected Oral herpes zoster/I got a mild casr of shingles; sores around lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced oral herpes zoster (Verbatim: Suspected Oral herpes zoster/I got a mild casr of shingles) and sores lip (Verbatim: sores around lips). On 21-APR-2025, the patient experienced burning lips (Verbatim: burning lips) and sensitive lips (Verbatim: sensitive lips). The outcome of the oral herpes zoster was not reported and the outcome of the burning lips, sores lip and sensitive lips were not resolved. It was unknown if the reporter considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix. It was unknown if the company considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix. Additional Information: GSK receipt date: 07-MAY-2025 Reporter stated that vaccine she got was the Shingrix, and it was for shingles. And she was having, about 5 days after my vaccination, she had burning on her lips and tiny sores around the outside of her lips. At the time of reporting this was been going on about three weeks. a week after her first dose of Shingrix, lips got very sensitive and burning that was April 21, she initially thought it might be cold sores but still had not healed and it didn't respond to cold sore meds. Reporter asked was it possible that she got a mild case of Shingles from the vaccine. More
2841016			CA	05/14/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS		Underdose Underdose	Several adult patients received pediatric dose of Havrix; Several adult patients received pediatric ... Several adult patients received pediatric dose of Havrix; Several adult patients received pediatric dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patients received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Several adult patients received pediatric dose of Havrix) and underdose (Verbatim: Several adult patients received pediatric dose of Havrix). The outcome of the adult use of a child product and underdose 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: 07-MAY-2025 The several adult patients received pediatric dose of Havrix which led to Adult use of a child product and Underdose. Seeking information on vaccination next steps. More
2841017		F	CA	05/14/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	7PK53	Underdose Underdose	pediatric dose of Havrix to a 62 years old female patient; pediatric dose of Havrix to a 62 years ol... pediatric dose of Havrix to a 62 years old female patient; pediatric dose of Havrix to a 62 years old female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 62-year-old female patient who received HAV (Havrix pediatric) (batch number 7PK53, expiry date 20-MAR-2026) for prophylaxis. Previously administered products included Havrix adult (received 1st dose of Havrix on unknown date). On 04-JAN-2025, the patient received the 2nd dose of Havrix pediatric. On 04-JAN-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix to a 62 years old female patient) and underdose (Verbatim: pediatric dose of Havrix to a 62 years old female patient). The outcome of the adult use of a child product and underdose 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: 08-MAY-2025 The pharmacist called to report that they administered a pediatric dose of Havrix to a 62 years old female patient, which led to adult use of a child product and underdose. This pediatric dose of Havrix was administered on 4/JAN/2025 and was her second dose of the series. More
2841018		M	NY	05/14/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call c... hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose of Havrix 1 year ago). On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). 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: 09-MAY-2025 The pharmacist called to inform that a patient had received only one dose of Havrix one year ago (no exact date available), and hadn't received the 2nd dose yet. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting the patients did not receive the second dose of Havrix, which led to incomplete course of vaccination. More
2841019		F		05/14/2025	PNC20 PNC20 PNC20	PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH		Anxiety, Chest X-ray, Cough, Dizziness, Erythema; Headache, Malaise, Peripheral ... Anxiety, Chest X-ray, Cough, Dizziness, Erythema; Headache, Malaise, Peripheral swelling, Respiratory syncytial virus test negative, Respiratory tract congestion; SARS-CoV-2 test negative, Skin warm More	headache; dizziness; chest and head congestion; chest and head congestion; cough; arms swelled up an... headache; dizziness; chest and head congestion; chest and head congestion; cough; arms swelled up and hot and red; arms swelled up and hot and red; arms swelled up and hot and red; worry; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Apr2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "hard of hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumococcal vaccine (Dose number unknown, single; Manufacturer unknown), for Immunization, reaction(s): "never had side effects". The following information was reported: PERIPHERAL SWELLING (non-serious), FEELING HOT (non-serious), ERYTHEMA (non-serious) all with onset 25Apr2025, outcome "not recovered" and all described as "arms swelled up and hot and red"; RESPIRATORY TRACT CONGESTION (non-serious), UPPER RESPIRATORY TRACT CONGESTION (non-serious) all with onset 25Apr2025, outcome "not recovered" and all described as "chest and head congestion"; COUGH (non-serious) with onset 25Apr2025, outcome "not recovered"; DIZZINESS (non-serious) with onset 25Apr2025, outcome "not recovered"; HEADACHE (non-serious) with onset 25Apr2025, outcome "not recovered"; ANXIETY (non-serious) with onset 25Apr2025, outcome "unknown", described as "worry". The events "headache", "dizziness", "chest and head congestion", "cough" and "arms swelled up and hot and red" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, dizziness, respiratory tract congestion, upper respiratory tract congestion, cough, peripheral swelling, feeling hot, erythema. Additional information: while on the phone, the patient was having a hard time understanding due to hard of hearing but cannot wear a hearing aid while on the phone. Prevnar 20 was administered on 23Apr2025. Patient developed side effects: headache, dizziness, chest and head congestion, cough, arms swelled up and hot and red. Dizziness was the worst. Patient wants to know how to get rid of it and out of her system. She had taken other shots for pneumonia but have never had side effects. When she called the doctor, they told her she will have to take antihistamine and steroids long term. She does not typically take these at all. She had to take steroids this time because they were trying to get rid of what is in her system. She has had 2 chest x-rays and been on 2 different kinds of antibiotics, but nothing worked. Both RSV and COVID tests were negative, so it had to be the Prevnar 20 shot causing her side effects. She went in feeling ok on 23Apr2025 and got sick on 25Apr2025 (2 days after the shot) and still sick ever since. Patient had planned surgery with anesthesia the week after the shot, but surgery was cancelled since she was sick. She had developed pain and suffering and worry because of this. At time of report, she still had adverse reactions. She contacted the CDC and reported she was "allergic" to the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2841020				05/14/2025	COVID19	PFIZER\BIONTECH		Death Death	Died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient... Died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 4 days after the suspect product(s) administration, outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. 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-PV202500056859 same reporter/product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death More	✓
2841021	72	M	CA	05/14/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More	caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe... caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID; caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caller had taken Covid shots, prior to having Covid/they were all Pfizer shots/First was about maybe 2 or 3 year back, this is his second time having COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: first time (2 or 3 years ago); (12May2025) positive, notes: second time. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: This is the second time patient is having Covid and taking Paxlovid. First was about maybe 2 or 3 year back, this is his second time having COVID. Clarified, caller took Covid shots, and did not have Covid before that. This is second time patient had Covid. He believes first time was 2 or 3 years ago. Clarified, this is second time testing positive for Covid. Patient is trying to get Paxlovid, again, today. When clarifying this is first time reporting with Pfizer that, this is second time having Covid and taking Paxlovid, caller states, first time, does not know if he paid for it. Prescription was sent to drug store, has to go pick it up. When clarifying when patient tested positive for Covid this second time, he states, was at work Friday, came home with this bad runny nose, thought was just allergy. Then, today, went to work, asked to he if could take Covid test, sure enough, wound up having Covid. Clarified that on 12May2025 was the day he tested positive again for Covid. That is why he is calling, so he can go pick up the Paxlovid. First dose was 22Jan2021, Second Dose was 18Feb2021 and another dose was 02Dec2021.When providing date of last dose, 20Jun2021 (pending clarification), he states, that can't be right but, that is what is printed on card. More
2841022	50	F	CA	05/14/2025	COVID19	PFIZER\BIONTECH	ENQ205	Menopause Menopause	full menopause; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-o... full menopause; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 04Mar2021 as dose 01, single (Lot number: ENQ205) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Perimenopause" (unspecified if ongoing), notes: only about 6 months or so. Concomitant medication(s) included: ZOLOFT. The following information was reported: MENOPAUSE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "full menopause". Therapeutic measures were not taken as a result of menopause. Additional Information: The patient was newly in perimenopause, only about 6 months or so. Once she had the vaccine, she was in full menopause. This was diagnosed by an obgyn. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had no known allergies. No follow-up attempts are possible. More
2841023		M		05/14/2025	COVID19	PFIZER\BIONTECH		Fatigue, Headache Fatigue, Headache	Headaches; tired, fatigue; This is a spontaneous report received from an Other HCP. A 43-year-old m... Headaches; tired, fatigue; This is a spontaneous report received from an Other HCP. A 43-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "tired, fatigue". Additional information: Headaches, tired, fatigue; might be leftover from Covid but it might be the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2841024				05/14/2025	COVID19	PFIZER\BIONTECH		Death Death	died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient... died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 2 hrs after the suspect product(s) administration, outcome "fatal", described as "died". The date and cause of death for the patient were unknown. 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-202500099417 same reporter/product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death More	✓
2841025				05/14/2025	COVID19	PFIZER\BIONTECH		Chills, Headache Chills, Headache	Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache; ... Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache; Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Pfizer Covid 19 vaccine made patient sick. Patient was in bed for a day with chills and a headache". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2841029			NC	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	7zm55	Product complaint, Product packaging quantity issue, Underdose Product complaint, Product packaging quantity issue, Underdose	diluent to contain only 0.4 ml; reconstitute two of the vaccines in the box with the same results; P... diluent to contain only 0.4 ml; reconstitute two of the vaccines in the box with the same results; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7zm55, expiry date 15-NOV-2026) and (batch number 555hwztvaa) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: diluent to contain only 0.4 ml), product packaging quantity issue (Verbatim: reconstitute two of the vaccines in the box with the same results) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the incomplete dose administered, product packaging quantity issue and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 04-MAY-2025 The pharmacist reported that while reconstituting Shingrix vaccine, he/she found the diluent to contain only 0.4 ml which would not yield the 0.5 ml dose for the final vaccine which led to incomplete dose of vaccine administered and product packaging quantity issue. The pharmacist tried to reconstitute two of the vaccines in the box with the same results. The Medical Information team is submitting to safety out of abundant caution. As this potential product quality complaint (PQC) was noted during reconstitution of two doses within this box, this is being submitted as a potential near miss event. Even though the pharmacist does not provide patient details or state that the doses were administered, as the vaccine was being reconstituted, it is assumed there was a patients involved. More
2841030	53	F		05/14/2025	HEP PNC15 VARCEL	DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. MERCK & CO. INC.	945664 Y005351 Y017063	Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	no adverse events, patient dose invalid for varicella due to having MMR within the last 2 weeks no adverse events, patient dose invalid for varicella due to having MMR within the last 2 weeks
2841038	1.5	M	ID	05/14/2025	DTAP HIBV	GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR	9KB9G UK193AA	Injection site erythema, Injection site swelling, Irritability, Pyrexia; Injecti... Injection site erythema, Injection site swelling, Irritability, Pyrexia; Injection site erythema, Injection site swelling, Irritability, Pyrexia More	L thigh is red and swollen at injection site. Also has been fussy and febrile. L thigh is red and swollen at injection site. Also has been fussy and febrile.
2841039	38	F	SC	05/14/2025	HPV9	MERCK & CO. INC.	W026977	Expired product administered Expired product administered	Patient administered expired vaccine (lot# W026977; exp 1/4/2025; administered 2/15/2025) Patient administered expired vaccine (lot# W026977; exp 1/4/2025; administered 2/15/2025)
2841040	62	F	MI	05/14/2025	COVID19	MODERNA	037F	Fatigue, Injection site pain, Urticaria, Weight bearing difficulty Fatigue, Injection site pain, Urticaria, Weight bearing difficulty	The vaccine record from pharmacy incorrectly states that the injection was given in my left arm. I o... The vaccine record from pharmacy incorrectly states that the injection was given in my left arm. I objected to that since I am left-handed and he gave me the vaccine in my right arm but obviously never changed the record. I was prepared for my arm to be sore. The next day and for many days after the muscle at the injection site felt like a shard of hot glass had been inserted into it. I could not put any wait on it for months. Now, my arm still hurts at the injection site, not as bad as at first but it is still there and I now have this weird welt on my back on the same side connection to the muscle at the injection site. Also, I have crippling fatigue. More			✓
2841042	83	M	FL	05/14/2025	COVID19 HEPAB	PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS	MD3414 P2443	Blister, Erythema, Pruritus; Blister, Erythema, Pruritus Blister, Erythema, Pruritus; Blister, Erythema, Pruritus	Patient presented to pharmacy 05/14/25 to reports itching on back, leg and both hands and has bliste... Patient presented to pharmacy 05/14/25 to reports itching on back, leg and both hands and has blisters in the webbing of his left and right hands. He reports this began approximately 2 days after receiving the Hepatitis vaccine on 04/25/25. He states that another blister appeared on the outer side of his hand two days ago. He currently has a large, oval-shaped red spot on his left forearm which he states is itchy. More
2841043	88	M	AZ	05/14/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3042648 ut8419DA	Asthenia, Guillain-Barre syndrome, Mobility decreased; Asthenia, Guillain-Barre ... Asthenia, Guillain-Barre syndrome, Mobility decreased; Asthenia, Guillain-Barre syndrome, Mobility decreased More	PER PATIENT REPORTED WEAKNESS 10/8, (CLINIC ON 10/3). DECEMBER PT DIAG WITH GUILLAIN BARRE SYNDROME... PER PATIENT REPORTED WEAKNESS 10/8, (CLINIC ON 10/3). DECEMBER PT DIAG WITH GUILLAIN BARRE SYNDROME, MOBILITY LOSS More			✓
2841044	50	M	MI	05/14/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Oral herpes Oral herpes	Out break cold sores on face under eye, nose and lips . Putting abreva cream on them Out break cold sores on face under eye, nose and lips . Putting abreva cream on them
2841045	29	F	CA	05/14/2025	FLU3 FLU3	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	N737Y N737Y	Dizziness, Eructation, Fatigue, Headache, Nausea; Product after taste, Skin warm Dizziness, Eructation, Fatigue, Headache, Nausea; Product after taste, Skin warm	05/12/2025: Consent form signed by Pt. VIS form provided to Pt. Pt denied having Guillain-Barre Syn... 05/12/2025: Consent form signed by Pt. VIS form provided to Pt. Pt denied having Guillain-Barre Syndrome, allergy to egg components, and previous allergic reaction to flu shot or any vaccine. Pt in stable condition with no visible signs of nervousness/anxiety. Flu shot administered to Pt. Pt tolerated well. After about 20 minutes of Pt waiting in the waiting room, Pt started to experience nausea, unexplainable burping urges. lightheadedness, mild headache, "medicine-taste" in mouth, and warmth to bilateral ears. Water and emesis bag provided to Pt. Vitals signs taken. Pt's blood pressure was 150/95 at 1610. PA-C, consulted throughout visit and advised for Pt to be monitored for improvement. After about 50 minutes of monitoring, Pt's symptoms improved and Pt reported feeling "better" with only tiredness and mild headache remaining. Last blood pressure taken at 1659 was 128/82. Pt was wheeled out to personal car. Pt's mother present throughout this visit and available to drive Pt home. Pt left clinic in stable condition. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk Vital Signs day of adverse event: 05/12/25 16:10 - T: 98.3 F HR: 92 BP: 150/95 SPO2: 98% 05/12/25 16:15 - HR: 90 BP: 150/92 SPO2: 98% 05/12/25 16:24 - T: 98.4 F BP: 145/91 SPO2: 98% 05/12/25 16:41 - BP: 134/91 05/12/25 16:59 - T: 98.6 F HR: 91 BP: 128/82 SPO2: 96% 05/13/2025 @ 1510 Spoke with Pt. Pt states "feeling better" from yesterday's episode. She reports feeling tired and a mild headache. Advised Pt to seek immediate medical attention, if she experiences any of the following symptoms: - Allergic Reaction Sx (Facial Swelling, Rash, SOB, loss of consciousness, etc) - Chest Pain/Pressure - Sudden Numbness/Weakness - Trouble Speaking/Understanding Speech - Severe Headache - Confusion - Loss of Vision, Mainly in One Eye and/or Facial Drooping - Trouble or Change in Ability to Walk More
2841046	98	F	WI	05/14/2025	COVID19	MODERNA	3046714	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	THE PATIENT CAME IN FOR A COVID-19 BOOSTER. IT WAS INITIALLY NOTED THAT HER LAST SHOT WAS ON 9/23/25... THE PATIENT CAME IN FOR A COVID-19 BOOSTER. IT WAS INITIALLY NOTED THAT HER LAST SHOT WAS ON 9/23/25, SO A BOOSTER WAS IN ORDER ACCORDING TO THE GUIDE LINES ( TW MONTHS OR MORE FROM HER LAST SHOT IN THE FALL. LATER WHEN THE PATIENT GOT HOME ( ABOUT HALF HOUR AFTER SHE LEFT PHARMACY ( 12;30PM) ), HER DAUGHTER NOTICED THAT THE IMMUNIZATION REGISTRY SHOWED A DATE OF 4/1/25 AS HER LAST COVID-19 SHOT. THE PATIENT OR HER DAUGHTER DO NOT REMEMBER A VACCINE BEING GIVEN ON 4/1/25. NO ADVERSE EVENT REPORTED AT THIS TIME, BUT THE PATIENT MAY HAVE GOTTEN A BOOSTER TOO SOON. More
2841047	63	F	TX	05/14/2025	RSV TDAP	PFIZER\WYETH SANOFI PASTEUR	LN5486 U8115AA	Injection site erythema, Injection site pain, Paraesthesia; Injection site eryth... Injection site erythema, Injection site pain, Paraesthesia; Injection site erythema, Injection site pain, Paraesthesia More	PATIENT REPORTS HAVING INJECTION SITE PAIN AND REDNESS THAT RADIATED DOWN LEFT ARM TO RIGHT ABOVE TH... PATIENT REPORTS HAVING INJECTION SITE PAIN AND REDNESS THAT RADIATED DOWN LEFT ARM TO RIGHT ABOVE THE ELBOW. REPORTED PAIN WAS COMBINED WITH TINGLING SENSATION AND STATES SHE WAS UNABLE TO LIE DOWN ON THAT SIDE. PATIENT STATES IT TOOK 1-2 WEEKS FOR THE REDNESS AND PAIN TO GO AWAY, THOUGH SHE STILL REPORTS HAVING THE TINGLING SENSATION AND CANNOT LIE DOWN ON THAT SIDE. PATIENT STATED SHE USED OVER THE COUNTER PAIN MEDICINE TO HELP WITH PAIN. More
2841048	0.17	F	VA	05/14/2025	RV1 RV1	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Blood test, Colonoscopy, Diarrhoea, Haematemesis, Haematochezia; Large intestina... Blood test, Colonoscopy, Diarrhoea, Haematemesis, Haematochezia; Large intestinal ulcer, Vomiting projectile, Weight decreased More	Received vaccine at 2 month old checkup and was told she was completely healthy. Next day, symptoms ... Received vaccine at 2 month old checkup and was told she was completely healthy. Next day, symptoms of projectile vomiting, spent 3 days in pediatric hospital. Went home, started severe diarrhea, brought back to doctor and realized the baby had a 20% weight loss. Was admitted back to hospital and spent 3 weeks there. While at hospital the baby had ulcers in colon, bloody stool and bloody vomit. More		✓
2840607	76	F	LA	05/13/2025	PPV PPV PPV PPV	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y016291 Y016291	Chest pain, Erythema, Inappropriate schedule of product administration, Inflamma... Chest pain, Erythema, Inappropriate schedule of product administration, Inflammation, Injection site erythema; Injection site pain, Injection site swelling, Limb mass, Pain in extremity, Ultrasound scan abnormal; Chest pain, Erythema, Inappropriate schedule of product administration, Inflammation, Injection site erythema; Injection site pain, Injection site swelling, Limb mass, Pain in extremity, Ultrasound scan abnormal More	About a week after I had the PNEUOMVAX 23 injection, I developed a red, painful lump on my right le... About a week after I had the PNEUOMVAX 23 injection, I developed a red, painful lump on my right leg on the inner side just above the knee/they did an ultrasound which just showed inflammation.; and about 24 hours after I was administered the vaccine on 3/26/2025, my right arm became red, swollen, and painful from where the injection was given all the way down my right arm to my antecubital and even across the right side of my chest.; and about 24 hours after I was administered the vaccine on 3/26/2025, my right arm became red, swollen, and painful from where the injection was given all the way down my right arm to my antecubital and even across the right side of my chest.; and about 24 hours after I was administered the vaccine on 3/26/2025, my right arm became red, swollen, and painful from where the injection was given all the way down my right arm to my antecubital and even across the right side of my chest.; I was administered the PNEUMOVAX 23 vaccine on 3/26/2025; and about 24 hours after I was administered the vaccine on 3/26/2025, my right arm became red, swollen, and painful from where the injection was given all the way down my right arm to my antecubital and even across the right side of my chest.; This spontaneous report was received from a nurse regarding herself, a 76-year-old female patient. Her medical history was not reported. Historical drugs included Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), bacitracin, and Gentamycin (Gentamicin). The patient's concurrent conditions included hypothyroidism. Allergies included bacitracin, and Gentamycin (Gentamicin), nickel, and gold. Concomitant medications included Cyanocobalamin, Levothyroxine, Vitamin D2, and Valaciclovir. On 23-Mar-2023, the patient was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), Solution for injection, as prophylaxis (dose, route of administration, lot #, and expiration date were not reported), after which, there was no reaction (she also received Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)) on 13-Mar-2024, also with no reaction). On 26-Mar-2025, the patient was vaccinated with the second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #Y016291, that was a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent); expiration date: 06-Dec-2026), at a dose of 0.5 mL once, administered by intramuscular route in the right arm as pneumococcal prevention (Inappropriate schedule of vaccine administered). On the same day (conflicting information, also reported as about 24 hours after she was administered the vaccine), her right arm became red, swollen, and painful from where the injection was given all the way down to her right antecubital and even across the right side of her chest (Vaccination site erythema) (Vaccination site swelling) (Vaccination site pain) (Chest pain). On that day (also reported as when her symptoms began), she went to her doctor's office and they gave her an antibiotic injection of Rocephin (ceftriaxone) and a steroid injection (unspecified). She prescribed her prednisone 25 mg daily for 5 days, doxycycline 100 mg twice a day for 10 days, and a topical cream (unspecified) as needed. On an unspecified date in April 2025 (reported as about a week later, after she had the suspect vaccine's injection), she developed a red, painful lump on her right leg on the inner side just above the knee, so she went to see her vascular doctor on 03-Apr-2025 and they did an ultrasound which just showed inflammation (Inflammation localised). As a result of these events, her doctor told her that she would no longer be getting Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injections. Patient stated that all her issues had all resolved now (on an unspecified date in April 2025, for inflammation localized and on an unspecified date in 2025, for the remaining events). The causal relationship between all the events and the suspect vaccine was not provided. Lot # is being requested and will be submitted if received. More

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