🏥 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)
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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 28,901 to 28,950 of 34,052 reports (Page 579 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	🚑
2827342		F		02/20/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	Suspected Vaccination failure; Still developed respiratory syncytial virus infection; This serious c... Suspected Vaccination failure; Still developed respiratory syncytial virus infection; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included covid-19 (patient had Covid 19 multiple times). On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Still developed respiratory syncytial virus infection). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved. The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 22-JAN-2025 This case was reported by a patient mother via interactive digital media. The patient mother reported that her daughter had received the Respiratory syncytial virus infection vaccination and still developed Respiratory syncytial virus infection. She said it was worse than having covid the times The patient works with disability needs. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 vaccine Arexvy. More
2827343				02/20/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	UNK	Headache, Musculoskeletal stiffness, Myalgia Headache, Musculoskeletal stiffness, Myalgia	stiffness; upper body muscle aches; slight headache; This non-serious case was reported by a consume... stiffness; upper body muscle aches; slight headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of stiffness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 13-FEB-2025, the patient received Arexvy. In FEB-2025, an unknown time after receiving Arexvy, the patient experienced stiffness (Verbatim: stiffness), muscle pain (Verbatim: upper body muscle aches) and headache (Verbatim: slight headache). The outcome of the stiffness, muscle pain and headache were not reported. It was unknown if the reporter considered the stiffness, muscle pain and headache to be related to Arexvy. It was unknown if the company considered the stiffness, muscle pain and headache to be related to Arexvy. Additional Information: GSK Receipt Date: 14-FEB-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she experience upper body muscle aches, stiffness, slight headache after injection on February 13 2025 The follow-up could not be possible as no contact details were available. More
2827344	54	F	CO	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	X72D2	Facial paralysis, Headache, Pain in extremity, Swelling face Facial paralysis, Headache, Pain in extremity, Swelling face	new symptom of drooping on left lip has started; patient experienced right arm pain (vaccination was... new symptom of drooping on left lip has started; patient experienced right arm pain (vaccination was given there); headache; swollen from left eye down to lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number X72D2, expiry date 30-JAN-2027) for prophylaxis. On 17-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 17-JAN-2025, 12 hrs after receiving Shingrix, the patient experienced pain in arm (Verbatim: patient experienced right arm pain (vaccination was given there)), headache (Verbatim: headache) and facial swelling (Verbatim: swollen from left eye down to lips). On 20-JAN-2025, the patient experienced facial muscle weakness (Verbatim: new symptom of drooping on left lip has started). On 22-JAN-2025, the outcome of the pain in arm and headache were resolved and the outcome of the facial muscle weakness was resolved (duration 2 days). The outcome of the facial swelling was resolved. It was unknown if the reporter considered the pain in arm, headache, facial swelling and facial muscle weakness to be related to Shingrix. It was unknown if the company considered the pain in arm, headache, facial swelling and facial muscle weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 22-JAN-2025 Reporter was the patient who received her first Shingrix vaccine on 17th January 2025. Within the first 12 hours patient experienced right arm pain (vaccination was given there), headache, swollen from left eye down to lips. On the day of reporting 22nd January 2025, right arm pain, swelling from left eye down to lip and headache has subsided, however, on 20th January 2025, new symptom of drooping on left lip has started. Caller did reach out to the Clinic where she received the vaccine and was told to speak with her healthcare professional. More
2827345	18	F	AZ	02/20/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	944915	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	Havrix vaccine for adults but although she is 18 years old; This non-serious case was reported by a ... Havrix vaccine for adults but although she is 18 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number 944915) for prophylaxis. On 17-JAN-2025, the patient received the 1st dose of Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Havrix vaccine for adults but although she is 18 years old). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Upon internal review the case was updated on 20-FEB-2025 The Medical Assistant reported that the patient who got the Hepatitis A, Havrix vaccine for adults but although she was 18 years old. Reporter asked that was that is ok. Patient received adult dose instead of pediatric dose, which ed to in Inappropriate age at vaccine administration. Summary of Changes: General tab, Event tab, product tab and narrative was updated. More
2827346		F		02/20/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Injection site pain, Injection site reaction, Injection site swelling, Malaise, ... Injection site pain, Injection site reaction, Injection site swelling, Malaise, Mobility decreased; Myalgia, Pain in extremity, Pruritus More	few spots around injection site; arm is hurting at the injection site; muscle aches; not feeling wel... few spots around injection site; arm is hurting at the injection site; muscle aches; not feeling well; arm is painful; arm itching; having a hard time lifting her arm; Injection site bulge; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date). On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site bulge). In JAN-2025, the patient experienced injection site erythema (Verbatim: few spots around injection site), injection site pain (Verbatim: arm is hurting at the injection site), muscle pain (Verbatim: muscle aches), feeling unwell (Verbatim: not feeling well), pain in arm (Verbatim: arm is painful), itchy upper limbs (Verbatim: arm itching) and injected limb mobility decreased (Verbatim: having a hard time lifting her arm). The outcome of the injection site lump was resolved (duration 2 days) and the outcome of the injection site erythema, injection site pain, pain in arm, itchy upper limbs and injected limb mobility decreased were unknown and the outcome of the muscle pain and feeling unwell were resolved. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that she had her second dose of Shingrix administered on 9-JAN-2025. Immediately following the injection, the site of injection had a bulge that was present for a couple of days. Reporter stated after the injection she had muscle aches and was not feeling well. That symptoms did resolve within a few days. Two weeks after the injection her arm was painful, itching and her arm was hurting at the injection site. Also stated that she was having a hard time lifting her arm due to the pain when attempting to lift her arm. She had a few spots around the injection site. More
2827347	25	F	NY	02/20/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	9PT2F	Underdose, Wrong product administered Underdose, Wrong product administered	25 years old female patient accidentally get the infanrix instead of boostrix; 25 years old female p... 25 years old female patient accidentally get the infanrix instead of boostrix; 25 years old female patient accidentally get the infanrix instead of boostrix; female patient accidentally get the infanrix instead of boostrix; 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 25-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Boostrix (received 1st dose of vaccine on an unknown date). On 24-JAN-2025, the patient received the 1st dose of Infanrix. On an unknown date, the patient received Boostrix. On 24-JAN-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced adult use of a child product (Verbatim: 25 years old female patient accidentally get the infanrix instead of boostrix), accidental underdose (Verbatim: 25 years old female patient accidentally get the infanrix instead of boostrix) and wrong vaccine administered (Verbatim: female patient accidentally get the infanrix instead of boostrix). The outcome of the adult use of a child product, accidental underdose and wrong vaccine administered were unknown. 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: 27-JAN-2025 The Reporter called to report that they had a 25-year-old female patient who accidentally got the Infanrix instead of the Boostrix, which led to Adult use of a child product, Accidental underdose and Wrong vaccine administered. The patient was supposed to receive the second dose of Boostrix, but instead, she received Infanrix. More
2827348	34	F	PA	02/20/2025	TDAP TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	9429J	Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, E... Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered More	received a dose of Boostrix at 28 weeks; received a dose of Boostrix at 37 weeks; then mistakenly re... received a dose of Boostrix at 28 weeks; received a dose of Boostrix at 37 weeks; then mistakenly received another dose at 37 weeks; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9429J, expiry date 19-MAR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 27-JAN-2025, the patient received the 2nd dose of Boostrix. On an unknown date, the patient received the 1st dose of Boostrix. On 27-JAN-2025, an unknown time after receiving Boostrix and Boostrix, the patient experienced extra dose administered (Verbatim: then mistakenly received another dose at 37 weeks). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 28 weeks) and vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 37 weeks). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 37 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing 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: 28-JAN-2025 The nurse reported that they had a pregnant who received a dose of Boostrix at 28 weeks and then mistakenly received another dose at 37 weeks, which led to extra dose administered and vaccine exposure during pregnancy. The Vaccine Administration Facility was the same as Primary Reporter More
2827349	0.25	F	TX	02/20/2025	RVX	UNKNOWN MANUFACTURER		Product preparation issue Product preparation issue	only the diluent portion of Rotarix was given by mistake to a patient; only the diluent portion of R... only the diluent portion of Rotarix was given by mistake to a patient; only the diluent portion of Rotarix was given by mistake to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 14-week-old female patient who received Rotavirus vaccine for prophylaxis. On 17-DEC-2024, the patient received Rotavirus vaccine. On 17-DEC-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent portion of Rotarix was given by mistake to a patient) and inappropriate dose of drug administered (Verbatim: only the diluent portion of Rotarix was given by mistake to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of drug administered were unknown. Additional Information: GSK Receipt Date: 28-JAN-2025 Reporter called on 28th January 2025 to report on 17th December 2024, only the diluent portion of Rotarix had been given by mistake to a patient, which led to Inappropriate preparation of medication and Inappropriate dose of drug administered. More
2827350	62	F	IN	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Cough, Malaise, Nasopharyngitis, Rhinorrhoea, Sneezing Cough, Malaise, Nasopharyngitis, Rhinorrhoea, Sneezing	cold-like symptoms; coughing; sneezing; runny nose; feeling sick; This non-serious case was reported... cold-like symptoms; coughing; sneezing; runny nose; feeling sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-OCT-2022, the patient received the 1st dose of Shingrix. On 28-OCT-2022, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: feeling sick). On an unknown date, the patient experienced cold symptoms (Verbatim: cold-like symptoms), cough (Verbatim: coughing), sneezing (Verbatim: sneezing) and runny nose (Verbatim: runny nose). The patient was treated with phenoxymethylpenicillin (Penicillin). The outcome of the feeling unwell, cold symptoms, cough, sneezing and runny nose were not resolved. It was unknown if the reporter considered the feeling unwell, cold symptoms, cough, sneezing and runny nose to be related to Shingrix. It was unknown if the company considered the feeling unwell, cold symptoms, cough, sneezing and runny nose to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JAN-2025 The reporter reported that a patient received Shingrix and on that same day she started feeling sick. She did not get dose 2. She has had cold-like symptoms, coughing sneezing, and runny nose. Patient had penicillin twice and 3 rounds of antibiotics and states she has not gotten better since. She had not recovered. More
2827351	63	M	IN	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	4NG3F	Product preparation issue Product preparation issue	only gave the adjuvant diluent to the patient; only gave the adjuvant diluent to the patient; This n... only gave the adjuvant diluent to the patient; only gave the adjuvant diluent to the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4NG3F, expiry date 06-DEC-2025) for prophylaxis. On 28-JAN-2025, the patient received the 1st dose of Shingrix. On 28-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: only gave the adjuvant diluent to the patient) and inappropriate preparation of medication (Verbatim: only gave the adjuvant diluent to the patient). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional Information: GSK Receipt Date: 29-JAN-2025 The nurse practitioner explained that a first dose of Shingrix vaccine was administered but they only gave the adjuvant diluent to the patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The vaccine administration facility was the same as primary reporter. More
2827352	77	M	PA	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration Inappropriate schedule of product administration	Patient received 2nd dose of vaccine late; This non-serious case was reported by a pharmacist via ca... Patient received 2nd dose of vaccine late; 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 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included shingrix (Received 1st dose of vaccine in October 2022). On 31-AUG-2024, the patient received the 2nd dose of Shingrix. On 31-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received 2nd dose of vaccine late). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 30-JAN-2025 Reporter called to ask if a male patient had received a first dose in October 2022 and second dose in august 2024, whether he would be ok with this schedule or if they need to revaccinate. Patient received 2nd dose of vaccine late, which led to Drug dose administration interval too long. More
2827353		M	MI	02/20/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	D4774	Inappropriate schedule of product administration Inappropriate schedule of product administration	the administration of 2 doses of Twinrix at less than the recommended interval.; This non-serious ca... the administration of 2 doses of Twinrix at less than the recommended interval.; 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 60-year-old male patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2025) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 15-OCT-2024, the patient received the 2nd dose of Twinrix. On 15-OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: the administration of 2 doses of Twinrix at less than the recommended interval.). 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: 30-JAN-2025 The reporter request data about the administration of 2 doses of Twinrix at less than the recommended interval which led to drug dose administration interval too short. The provided data about vaccine, patient and even, consenting to receive follow-up. Vaccine administration facility was the same as primary reporter. More
2827354		F	FL	02/20/2025	VARZOS	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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 16-SEP-2022, batch no XM22G with expiry date 31-AUG-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: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 The pharmacist called to informed that till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. This case had been linked to the case US2025017228, reported by the same reporter.; Sender's Comments: US-GSK-US2025017228:same reporter More
2827355		M	NJ	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	patient received dose 1 on February 8, 2024 and has not received dose 2 yet; This non-serious case w... patient received dose 1 on February 8, 2024 and has not received dose 2 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 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received 1st dose on February 8, 2024 batch number 542E3). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received dose 1 on February 8, 2024 and has not received dose 2 yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that a patient had inquired about a Shingrix injection. The patient had received dose 1 on February 8, 2024, and had not received dose 2 yet. The reporter did not consent to follow-up Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. More
2827356	42	M	NJ	02/20/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration Inappropriate schedule of product administration	3rd dose of Twinrix in less than the 6 months period from the second dose; This non-serious case was... 3rd dose of Twinrix in less than the 6 months period from the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 42-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (2nd dose received on an unknown date) and Twinrix (1st dose received on an unknown date). On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: 3rd dose of Twinrix in less than the 6 months period from the second dose). 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: 13-FEB-2025 Nurse called to report that a patient received 3 doses of Twinrix, but the 3dr dose was too close in less than 6 months from the second dose, which led shortening of vaccine schedule. The reporter asked was this dose valid. She has in her stock Engerix-B and Havrix, a dose of each one would be enough to complete the series. The reporter consented to follow up. More
2827357	62	M	MI	02/20/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	X2FT9	Expired product administered Expired product administered	expired vaccine used; This non-serious case was reported by a pharmacist via call center representat... expired vaccine used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X2FT9, expiry date 02-FEB-2025) for prophylaxis. On 09-FEB-2025, the patient received Arexvy. On 09-FEB-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: expired vaccine used). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 14-FEB-2025 Pharmacist called to report a male patient was administered an expired dose of an Arexvy vaccine. Pharmacist asked if there is any advice recommendation on this topic. Patient received expired dose of Arexvy vaccine, which led to expired vaccine used. More
2827358			TX	02/20/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	BL452	Expired product administered Expired product administered	expired dose administered; This non-serious case was reported by a other health professional via cal... expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a patient who received MMR (Priorix) (batch number BL452, expiry date 17-DEC-2024) for prophylaxis. On 17-FEB-2025, the patient received Priorix. On 17-FEB-2025, an unknown time after receiving Priorix, the patient experienced expired drug used (Verbatim: expired dose administered). The outcome of the expired drug 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: 18-FEB-2025 Other HCP stated that their facility gave an expired dose of Priorix, which led to expired vaccine used. Reporter asked if this still be viable for the patient or should they get another dose. Patient had already been notified. HCP stated she cannot share the patient's information. More
2827359		F		02/20/2025	COVID19	MODERNA		Cellulitis Cellulitis	had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis; This ... had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. 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 CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) (seriousness criterion hospitalization). At the time of the report, CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. The reporter stated that, her sister had a reaction in the Moderna vaccine and ended up in the hospital with cellulitis, so they wanted to check the patient's genetics. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2025: Live follow-up received contains no new information.; Reporter's Comments: Temporal relationship between product administration and occurrence of Cellulitis remained unknown as there were no dates provided. Due to lack of information at this moment, causal relationship cannot be excluded and the event is assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report. More		✓
2827360		F	LA	02/20/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots; We used Pfize... We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots; We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 76-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots". The events "we used pfizer when we took the covid shots and the boosters/covid after pfizer shots" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the reporter stated, "We used Pfizer when we took the Covid shots and the boosters." Later on in the call, after they were provided with the voucher information, the reporter said, "We did this the other day for my husband, can you believe that's two people in one family have it now?". The reporter indicated Dr. (redacted) was their doctor; however, Dr. (redacted) is also in the same office and may have been the one who sent the prescription of Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500018818 Same reporter, product, event; different patient; More
2827361	65	M	MS	02/20/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	EW078 EW078 EW078 EW078 EW078 EW078	COVID-19, Disease recurrence, Drug ineffective; Back pain, Computerised tomogram... COVID-19, Disease recurrence, Drug ineffective; Back pain, Computerised tomogram, Deep vein thrombosis, Inappropriate schedule of product administration, Seizure; Thrombosis; COVID-19, Disease recurrence, Drug ineffective; Back pain, Computerised tomogram, Deep vein thrombosis, Inappropriate schedule of product administration, Seizure; Thrombosis More	COVID twice; COVID twice; COVID twice; This is a spontaneous report received from a Consumer or othe... COVID twice; COVID twice; COVID twice; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: E61686) and on 04Aug2021 as dose 2, single (Lot number: EW078) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID twice".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038522 same reporter/patient, different dose/AE;US-PFIZER INC-202500038523 same reporter/patient ,different drug/AE; More
2827362	64	M	MS	02/20/2025	COVID19	PFIZER\BIONTECH	E61686	Back pain, Computerised tomogram, Deep vein thrombosis, Pulmonary thrombosis, Th... Back pain, Computerised tomogram, Deep vein thrombosis, Pulmonary thrombosis, Thrombosis More	blood clot from my knee/five blood clots; Deep vein thrombosis; five blood clots/got them in your lu... blood clot from my knee/five blood clots; Deep vein thrombosis; five blood clots/got them in your lungs and both your lungs; hurting high on right side back; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: E61686) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (not ongoing), notes: about 50 years ago. There were no concomitant medications. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "recovered"; THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "recovered", described as "blood clot from my knee/five blood clots"; PULMONARY THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "recovered", described as "five blood clots/got them in your lungs and both your lungs"; BACK PAIN (hospitalization) with onset 2021, outcome "unknown", described as "hurting high on right side back". The patient underwent the following laboratory tests and procedures: Computerised tomogram: had five blood clots. Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis, pulmonary thrombosis. Clinical course: No previous Immunization with Pfizer Vaccine, no vaccine administered on the same date or other vaccinations four weeks prior to COVID Vaccine. Consumer stated he didn't get anything after the first two shots because his doctor told me not to, all of them. Indication: Consumer stated, the reason he got the shot was basically because of his age, being older and also to be able to go in and out of certain stores that wouldn't allow me to go in unless he had COVID shot even with a mask, he wore mask anyway. Anatomical Location: Consumer stated the best he could remember is in the Left arm because he is right-handed. So, he used to get shots in the left arm. Consumer stated he had been trying to find out some information after he had taken Pfizer COVID shot he had to be taken to the hospital because he had blood clot from his knee one or three went to one lung one went to the other lung and one went to still He had right knee and the doctor ask him did he have in the immersion to have he had, surgery on that he forget about 50 years ago and the, "you are going to have deep vein thrombosis and you are going to have to be on Eliquis for the rest of your life." So, at that time patient was with (Withheld) and Eliquis that's about (Withheld) a year. He never had any issue with blood clot ever. He have had surgery and the only reason he got the shot. So, there were certain places patient couldn't go unless had the card showing that he got the shot this if they had been for that patient would never got, and patient have had COVID twice. When paraphrased the above concern, consumer stated, that's not the whole problem, the problem is he was with (withheld) insurance. Patient was on (withheld) insurance, but had to get on the (Withheld) and well they did away with that plan and so they kick patient out. It's used to be as long as he was on (withheld) insurance who is (Withheld) a month and the least price now on Eliquis is (Withheld) but (withheld) insuranc would no longer recover him because of that because he is talking in 10 years that's (Withheld) and which he didn't think they should have been on the kick him out. The problem is this didn't occur to after he got the second shot and he asked the doctor he said do you think the COVID shot, he said so many things out there right now with Pfizer and Moderna all of that they are finding now that there is a side effects and all of this is where is this came from because it is happened until I asked you got the shots and, you haven't had blood clots and it's so weird. Is it when he asked me about that right knee? Patient said you are telling me that if I have had surgeries that something to do with a shot cause me to bleed from that error which is called deep vein thrombosis. He said that's correct, what I want you to understand is you can't just take this for a while you are going to have to take it from now on because you had three blood clots and one long one in the other long and those off could have killed you." Age at the time of event: Consumer stated, "Back up he got the shot in 2021 somewhere possibly around 65, 66. He can the exact date card it does have to pull it from the hospital because he had to go but he had his wife took him didn't go by him. They took him back and get CAT Scan. Patient had Pfizer Second dose on 04Aug2021. Patient couldn't go into certain places and because they asked for the card so that's reason he got the shot. He was going to do it at first because of his age and then his daughter is a RN and she worked during all the COVID stuff and she said dad I thought you get it because of your age you know well I will but patient said you know, he was very funny about vaccines that made him in a hurry time and you don't know anything about that thing except it's got a bunch of proteins and he was not the only one that's having problem especially the blood clot problem. Eliquis: Start date of medication: Consumer stated, It has been over 2 years, he didn't know the exact date of the first time it was it would be from the day that he went to the hospital because when he started they had to actually start they 'injected' him with blood thinners first and then you get on the Eliquis after that so he means it can get it to anybody except him, unless he offers somebody else to get them." Other medical condition and concomitant medication: Consumer stated he had a seizure (captured in linked case for dose 2) last year and in March, he never had a seizure before in his life so now he was on anti-seizure medication Levetiracetam, he couldn't drive for six years. Treatment: Consumer stated, there is no treatment other than he takes a blood thinner. Still experiencing blood clot: Consumer stated, "No, not since he has been on the Eliquis." Date of Hospitalization: Consumer stated didn't have the exact date, he knew it's on a Sunday morning he was in the bed when he freeze and he was on blood thinner and then, so he meant the seizure (on Mar2024) happened after the original blood clot and so he didn't remember. Reason of Hospitalization: Consumer stated, "That I had blood clot because I was hurting high on right side back and when I went in they took me back and did a CAT Scan and actually did that they said you have five blood clots have you ever had surgery on this right knee because that was clots were going up, that's how they do go up and they will go down and so well you got them in your lungs and both your lungs."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038434 same reporter/patient, different dose/AE;US-PFIZER INC-202500038523 same reporter/patient, different dose/AE; More		✓
2827364		F	CO	02/20/2025	PNC20	PFIZER\WYETH	LG5577	Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling	redness and swelling on the arm at the site of injection; redness and swelling on the arm at the sit... redness and swelling on the arm at the site of injection; redness and swelling on the arm at the site of injection; pain; This is a spontaneous report received from a Pharmacist from medical information team. A 54-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Feb2025 as dose number unknown, single (Lot number: LG5577, Expiration Date: 30Apr2026), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Feb2025, outcome "not recovered"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Feb2025, outcome "unknown" and all described as "redness and swelling on the arm at the site of injection". Additional information: the patient was experiencing redness and swelling on the arm at the site of injection after administration of PREVNAR 20 last 04Feb2025. The patient was still experiencing pain after 2 weeks. More
2827366		M	CA	02/20/2025	COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Amnesia, Brain fog, COVID-19, Cardiac disorder, Drug ineffective; Heart rate, SA... Amnesia, Brain fog, COVID-19, Cardiac disorder, Drug ineffective; Heart rate, SARS-CoV-2 test; Amnesia, Brain fog, COVID-19, Cardiac disorder, Drug ineffective; Heart rate, SARS-CoV-2 test More	got COVID; got COVID; Brain fog; heart problems; memory loss; The initial case was missing the follo... got COVID; got COVID; Brain fog; heart problems; memory loss; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 16Jan2024, this case now contains all required information to be considered valid. A 35-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID"; BRAIN FOG (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; AMNESIA (non-serious), outcome "unknown", described as "memory loss". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Heart rate: 100, notes: beats per minute; 105, notes: beats per minute; 80, notes: beats per minute; good. Clinical course: Patient reports having had COVID 3 times stated is having some health issues such as heart problems, brain fog, memory loss. Patient reports has taken vaccine. The patient stated "I keep prefacing everyone, is my doctor is like my brain fog and memory recall and stuff is real terrible sometimes so I'm good for a minute and then I'll forget halfway through your sentence if you speak slow, if it's real slow, like not in a bad way but the last person was speaking so slow that all of a sudden I'm like wait what was the first half, I don't remember now. I get flustered easy", "I got bad symptoms because, so I tend to like, I don't even know what I'm asking half the time" Later in the call the caller stated, "Brain fog, this is my third time with COVID, and I?ve gotten it", "I get asked questions and like I said you can ask me a question if it moves slow like that last person I, at points I didn't know what was happening". "Like I don?t, I don't know what's happening I'll lose track. Processes don't make sense right now". later the caller was told that we are just filling out some information and are still on the line. The caller replied "Ok". "If anything, I'll forget I'm on the phone till you start talking". "That's how it's been going". "See, comprehension, I am losing it". "It was perfect timing, the weekend I got COVID, I was coming back from moving my last remaining grandparent into a home because she has had Alzheimer's for years then I got back, got COVID and now I'm like I can't recall things and some days". "The worst day I couldn't remember any, like what happened when. I thought things that happened a year ago were last week and you just get so confused". "Yea it got bad". "You just spiral with confusion". "I tested positive". Regarding researching memory recall the caller stated "Some people call it brain fog". "There's rare cases of some people have like a schizophrenic type thing its temporary but like you kind of almost lose touch with what's happening". "I had close to that one night where I just I wasn't able to figure out, being in your own house you walk into a different room and then you're like why am I in this room, where is this room, where am I and then look around for a second and you're like what is happening, why am I, you just can't figure things out and if you get asked a question and you answer and it takes you more than 8 words that night and beyond is not going to happen you get there and you forget what the first part was. It's frustrating". The caller was asked if this is his third time having COVID and patient replied "Yea". The caller was asked does it seem to get worse each time and they replied "It depends which symptoms. So, my first time, it's never been fixed yet, my heart is different. So, I used to have a Athletic, I work out. I've always had a good heart rate. And then out of nowhere I got COVID. And that was around the time of work having you get the booster. I did the booster, I think and right around the same time COVID spiked my heart, it kind of went back down, I got the booster, it went back up, and my heart rate now on average while I'm awake it's around a hundred beats per minute or 105 it used to be like 80. so now I just, that was over a year ago, that was a year and a half ago. Never gone back down". "Then the second time just felt sick, I felt the confusion and brain fog, but it didn't last that long, so I just felt like it was part of the sickness". "Then this time it's just started to before I even knew I had COVID really. I kind of just getting spacey, but I was real busy and then the further it's gone this last weekend was the worst". "I couldn't figure things out I would start talking about something and then the anxiety that you're feeling about what your discussing". "You just get so confused that you just can't figure out what's going on and comprehension is really hard for me right now". "Now I'm not remembering things and that's a hard one to cope with when you got it real strong for so long, and now I'm having a hard time doing anything, it's scary.". The caller was asked if he had any questions and he replied, "No because I just keep getting confused." Later the caller states, "so slow lately. It's taken me two hours to make two phone calls." "I'm spacey, I can't figure out anything." More
2827367		M	TX	02/20/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	EW0175 EW0175 EW0175 EW0175 EW0175 EW0175	Arteriosclerosis, Asthenia, Blood pressure increased, Blood pressure measurement... Arteriosclerosis, Asthenia, Blood pressure increased, Blood pressure measurement, Cardiac arrest; Cardio-respiratory arrest, Dysphonia, Dyspnoea, Haemorrhage, Heart rate; Illness, Injection site reaction, Investigation, Laboratory test, Malaise; Muscle contusion, Physical examination, Pulmonary congestion, Pulmonary haemorrhage, Respiratory distress; Respiratory pathogen panel, SARS-CoV-2 test, Toxicologic test, Unresponsive to stimuli, Ventricular fibrillation; Viral upper respiratory tract infection More	cardiopulmonary arrest; evidence of profuse pulmonary bleeding/ acute pulmonary hemorrhage; ventricu... cardiopulmonary arrest; evidence of profuse pulmonary bleeding/ acute pulmonary hemorrhage; ventricular fibrillation; Autopsy findings revealed massive lung congestion without embolism; respiratory distress; injection site reaction; malaise; weakness; felt sufficiently ill that he could not work the next day; his blood pressure was found to be 134/87; moderate atherosclerosis in the aorta and basilar arteries to the neck/moderate coronary atherosclerosis without myocardial infarction; there were multiple small faint contusions on the arms and legs; cardiac arrest; atherosclerotic and hypertensive cardiovascular disease; hoarseness; bleeding profusely out of his mouth; fallen asleep around 14:50 on the floor and made some unusual snoring and gurgling sounds/unresponsive and turning blue; infected with a mild viral upper respiratory tract infection/mild respiratory infection; out of breath; This is a literature report from License Party and Regulatory Authority for the following literature source(s). Other Case identifier(s): AE-018020 (LLP-Biontech). A 47-year-old (withheld) male, weighing 173 pounds, was healthy in adult life, had no chronic illnesses and took no medications. He had a normal physical exam and routine laboratories on 15Sep2020. This was the last time h/e was examined by a doctor. He had no suspected or documented episodes of COVID-19 illness. On 01Jul2021, he completed a COVID-19 vaccination primary series with two doses of BNT162b2. With each COVID-19 vaccine administration, he had an injection site reaction, malaise, weakness, and felt sufficiently ill that he could not work the next day. After recovery from the primary series, his only health encounter was a dental appointment where his blood pressure was found to be 134/87. Four days before his death, on 03Jan2023, there was a fire drill at work and the elevators where stopped, so he had to go up 10 flights of stairs after which he remarked to a colleague that he was out of breath. The next day, both the patient and his wife were infected with a mild viral upper respiratory tract infection, and this was nearly resolved on the day of death. He awoke on the day of death with hoarseness. Throughout the day, his symptoms worsened. Around 12:30, the hoarseness became severe, and he could barely talk. The patient appeared to have fallen asleep around 14:50 on the floor and made some unusual snoring and gurgling sounds. His family noticed he was unresponsive and turning blue, so they called (withheld) for emergency medical assistance. The paramedic records indicate the estimated time of cardiac arrest was 15:00, the dispatch call was at 15:11, and the unit was on scene at 15:22. The paramedics indicated "patient was bleeding profusely out of his mouth." He received chest compressions and bag/valve ventilation throughout the resuscitation. The paramedics noted multiple times that profuse bleeding clogged up tubes, required suctioning and worked to prevent prompt airway access. The initial cardiac rhythm was ventricular fibrillation for which there were six defibrillation attempts at 360 J. He underwent successful endotracheal intubation on the second attempt at 15:45 and had intravenous lines placed. He received three doses of epinephrine 1:10, amiodarone 300 mg, 150 mg, normal saline 1000 ml, and tranexamic acid 1000 mg was given in an attempt to stop the hemorrhage. The patient remained unresponsive to these measures and was transported to the hospital where he was declared dead at 16:08 on 07Jan2023, which was 555 days after the last COVID-19 vaccination. Gross examination revealed evidence of oral expectoration of blood during cardiac arrest and massively congested lungs with blood. An autopsy was performed by the (withheld) Medical Examiner with the major findings of: 1) dark red, purple lungs with marked amounts of blood and frothy fluid, right lung weight: 1552 g, left lung weight: 1333 g (normal: 250 g-300g per lung), no pulmonary embolism, 2) heart weight was normal: 474 g (normal: Less-than 500 g) and myocardial tissue was normal, 3) coronary arteries estimated visually without detailed sectioning: left main normal, left anterior descending 90%, left circumflex 90%, right coronary 60%, stenoses without thrombus or occlusion, 4) moderate atherosclerosis in the aorta and basilar arteries to the neck, 5) there were multiple small faint contusions on the arms and legs. Pertinent negatives: no gastrointestinal or cerebral hemorrhage, no myocardial infarction, toxicology was negative, tests for COVID-19 and upper respiratory pathogens were negative. The medical examiner concluded that the patient died from atherosclerotic and hypertensive cardiovascular disease. However, the patient had no recorded history of hypertension and the pulmonary hemorrhage was not cited as the major cause of death or as a contributing factor by the medical examiner in the report or on the death certificate. There were no tests performed for the detection of COVID-19 vaccine mRNA or its encoded Spike protein. Discussion: Because the autopsy failed to investigate the presence of COVID-19 vaccine-specific components, we conducted a thorough analysis of the specific COVID-19 vaccine batch administered to this individual using a digital resource known as "How Bad is My Batch?". This tool aggregates data from VAERS, methodically organizing it to present all adverse events associated with specific vaccine batches. This approach allows for a detailed and systematic examination of the batch in question, providing a comprehensive view of any potential adverse effects reported. The patient received two doses of a BNT162b2 mRNA COVID-19 vaccine, which both belonged to the batch EW0175. A review of batch information indicates there were 29 reports of death from his batch through 02Feb2024, however, this case had not yet been reported to VAERS. Batch EW0175 is among the top 2.8% for number of reported deaths out of all Pfizer COVID-19 vaccine batches listed in VAERS (ranked 131 out of 4,730). Analysis of batch EW0175 indicated the lethality of injection (number of deaths among total EW0175 adverse event reports) was 1.69%. Among reported serious adverse events in this batch, there were 14 respiratory failure, 11 thrombosis, 7 myocarditis, 6 pericarditis, 5 cardiac arrest, 5 myocardial infarction, and 4 pulmonary embolism reports. Without proper post-mortem investigation into specific COVID-19 vaccine components residing in blood and tissues, it is difficult to confidently determine the cause of death in COVID-19 vaccinated subjects that present anomalous symptoms, as in our case. To ensure a comprehensive understanding of the potential impact of COVID-19 vaccines on adverse fatal outcomes, it is critical to conduct specific tests during postmortem procedures. Thus, we propose an autopsy checklist for deceased individuals that have received one or more COVID-19 vaccines to help improve diagnostic accuracy in future cases. The checklist indicates the vital need to test for the presence of Spike protein and vaccine derived mRNA within tissue samples. Additionally, a detailed antibody profile should be established, including tests for antibodies against platelet factor 4 (anti-PF-4), the SARS-CoV-2 Spike protein, the nucleocapsid component of the virus, antinuclear antibodies (ANA), and anti-neutrophil cytoplasmic antibodies (ANCA). Alongside these tests, an assessment of inflammation specific to various organs is necessary. These combined diagnostic efforts can reveal how the vaccine may contribute to unexpected fatal events, especially since most autopsies performed following COVID-19 vaccination don't include them. This checklist is intended to complement existing autopsy pathology standards by incorporating additional tests relevant to suspected vaccine-related cases. Cause of death is always a matter of expert analysis and cases like this deserve a second opinion. A standard methodology applied to post-mortem investigations is differential diagnosis. Despite having coronary atherosclerosis, this patient's vessels were patent and there was no myocardial infarction. The left ventricle was not hypertrophied nor dilated, so longstanding hypertension or heart failure can be excluded. Primary gastrointestinal and cerebral hemorrhage was excluded. The patient appeared to have died from acute pulmonary hemorrhage a few days after a viral infection. Primary pulmonary hemorrhage can occur in auto-immune syndromes including Goodpasture's syndrome and Wegener's granulomatosis. The hemorrhage was rapid and quickly made the patient hypoxemic, thus creating a secondary cardiac arrest given extensive coronary disease. The reports of copious blood coming from the patient requiring suctioning and tranexamic acid are distinctly unusual for a primary cardiac arrest. Importantly, the coronary disease does not appear to be the primary cause of death but there is no plaque rupture reported, nor evidence of myocardial infarction. Multiple ecchymoses and a lack of response to tranexamic acid suggests impaired coagulation from a variety of sources including thrombocytopenia. It is reasonable to conclude that primary pulmonary hemorrhage or secondary hemorrhage from acute pulmonary edema in a perfectly healthy man after a viral respiratory illness is quite anomalous. (withheld) summarized the range of upper respiratory infections that can result in diffuse alveolar hemorrhage, which include influenza A (H1N1), dengue, leptospirosis, malaria, and Staphylococcus aureus infection. None of these diseases fits the presentation or time course of this patient's mild 3-day viral illness. He had no travel history, fever, or productive cough. His upper respiratory pathogen panel was negative. Ischemic heart disease could have played a role in the downward spiral as the cardiac arrest ensued but could not account for the gross pulmonary hemorrhage which was the fatal event as reviewed by an expert cardiologist (PM). Primary pulmonary hemorrhage can occur after mRNA COVID-19 vaccination. The (withheld) for Biologics Evaluation and Research (CBER) regulatory window of concern for a novel genetic product, such as the BNT162b2 mRNA COVID-19 vaccine, is 5-15 years. That means unusual serious adverse events such as fatal pulmonary hemorrhage should not only be reported to VAERS, but also be considered as being a consequence of the novel product even months to years after the last injection. The COVID-19 vaccine batch EW0175 that this patient received has been associated with cardiovascular, hematological, and respiratory adverse events and exhibits a high degree of lethality compared to most batches. The Spike protein produced from COVID-19 vaccine mRNA is known to cause bleeding, thrombosis and specific hemorrhagic-thrombotic syndromes including vaccine-induced thrombotic thrombocytopenia (VITT) which has been reported after the Pfizer vaccine. The majority of VITT cases arising from vaccine induced anti-platelet factor-4 antibodies reported in the literature are caused by the adenoviral vector vaccines, however, "long VITT" has been reported where findings last for months after vaccine administration. It is possible that any mild viral upper respiratory infection in a mRNA COVID-19 vaccinated patient could result in acute hemorrhage. The systemic circulation and extensive persistence (Greater-than 4 months) of Spike protein from COVID-19 vaccination likely accelerated asymptomatic coronary atherosclerosis, pulmonary capillary disease, and alveolar inflammation as summarized by (withheld). Furthermore, COVID-19 vaccine-modified mRNA has been shown to persist in humans for up to 28 days. The discovery of residual plasmid DNA, including spike-coding sequences and the SV40 promoter/enhancer, in BNT162b2 vaccine lots highlights a potential mechanism for genome integration, potentially enabling prolonged spike protein production in transfected cells. Incorporating our proposed autopsy checklist would significantly improve diagnostic accuracy in this and similar cases reported following COVID-19 vaccination. Conclusion: In conclusion, this man died of a cardiopulmonary arrest most likely as a result of acute pulmonary hemorrhage. The coronary artery disease was coincident but was not the primary cause of the cardiac arrest. Because the autopsy ruled out other possible causes of death and the received BNT162b2 vaccine batch is associated with fatal hematological, respiratory, and cardiovascular syndromes including cardiac arrest, prior COVID-19 vaccination is potentially either the direct cause or contributed to the causal pathway leading to death. COVID-19 vaccine-induced Spike protein may have caused acceleration of asymptomatic coronary atherosclerosis via direct vessel injury and inflammation. Our recommendation for a specialized autopsy approach can help improve the diagnosis of COVID-19 vaccine-induced pathologies in future cases. Healthcare providers are encouraged to be aware of and monitor for any long-term cardiopulmonary complications that may arise after COVID-19 vaccination. No follow-up attempts are possible. BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Given the compatible time association, the reasonable possibility that the reported events are related to BNT162b2 administration cannot be completely excluded. Suspect drug BNT162b2 may have caused acceleration of asymptomatic coronary atherosclerosis via direct vessel injury and inflammation. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202500037459 same patient/drug, different dose/AE;; Reported Cause(s) of Death: cardiac arrest; Cardiopulmonary arrest; evidence of profuse pulmonary bleeding/ acute pulmonary hemorrhage; atherosclerotic and hypertensive cardiovascular disease More	✓
2827368		M	TX	02/20/2025	COVID19	PFIZER\BIONTECH		COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test	COVID; COVID; he came positive for COVID, this was the second time he had COVID; This is a spontaneo... COVID; COVID; he came positive for COVID, this was the second time he had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "he came positive for COVID, this was the second time he had COVID". The clinical course was reported as follows: The patient's wife took her husband to the emergency room where he came positive for COVID, so they sent a medication to the pharmacy. She also reported since the vaccine came out; he always used Pfizer. The patient was previously given nirmatrelvir, ritonavir (PAXLOVID). The event "he came positive for covid, this was the second time he had covid" required emergency room visit. The patient underwent the laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of covid-19, drug ineffective. More
2827370	30	M	NC	02/20/2025	COVID19	PFIZER\BIONTECH		Pain Pain	pain crisis; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old ... pain crisis; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (hospitalization), outcome "unknown", described as "pain crisis". The patient took the Pfizer COVID vaccine and was hospitalized that night with a pain crisis. Therapeutic measures were taken as a result of pain including Ibuprofen 800 mg 3x day as needed for pain and Oxycodone 10-325 mg, every 4-6 hour as needed for pain. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More		✓
2827371			NC	02/20/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ... COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 63-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Feb2025, outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: The patient had the Pfizer, the first Pfizer, then the patient had the booster, and then had another booster. The patient did not get the vaccine this year and actually got COVID 10 days ago. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2827372	50	M	OR	02/20/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	334T3	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	Patient received 2 doses of Shingrix back in 2021/2022 (before age 50) and it was not caught until a... Patient received 2 doses of Shingrix back in 2021/2022 (before age 50) and it was not caught until after administration of a 3rd dose on 12/5/24. Patient had no adverse reaction to 3rd dose. Reporting because vaccination is outside of recommended vaccine schedule. More
2827373	0.17	M	IA	02/20/2025	DTPPVHBHPB PNC20 RV1	MSP VACCINE COMPANY PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS	U7947AA LC5484 HP495	Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered	Patient was given a duplicate does of RSV. Patient had already received first dose of the RSV vaccin... Patient was given a duplicate does of RSV. Patient had already received first dose of the RSV vaccine on 12/5/2024. More
2827374	76	F	SC	02/20/2025	RSV RSV	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	52Z52 52Z52	Decreased appetite, Injected limb mobility decreased, Injection site erythema, I... Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities; Malaise, Pain, Pyrexia More	10 cm circumference circle red mark at vaccine site given in error not in muscle. Mild fever that n... 10 cm circumference circle red mark at vaccine site given in error not in muscle. Mild fever that night, next day pan increase and hard raised swelling at injection site ( have photos) that progressively became worse and still appears on day three. Day two fever between 99 and 100. 7 depending on when Tylenol was administered. Overall body aches and sick feeling. Still had some appetite but too achy to shower until third day. Fever gone 3rd day, arm circle darker and still sore more than previously with any vaccine. No fever but not feeling normal yet. Concern because pharmacist administered vaccine intradermally and low on arm and if this may have caused my stronger than usual reaction. More
2827375	10	M	OR	02/20/2025	UNK	UNKNOWN MANUFACTURER	T5727	Wrong product administered Wrong product administered	Patient was given Hep A instead of Hep B Patient was given Hep A instead of Hep B
2827376	70	F	GA	02/20/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	255t2	Extra dose administered Extra dose administered	Patient received vaccine and had previously received vaccine 12/04/2023 Patient received vaccine and had previously received vaccine 12/04/2023
2827377	53	M	OR	02/20/2025	COVID19 FLU3	PFIZER\BIONTECH SEQIRUS, INC.		Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More	duplicate vaccination (first time was 09/04/2024). This was not recorded in our system until after t... duplicate vaccination (first time was 09/04/2024). This was not recorded in our system until after the appointment. No adverse reaction has been noticed so far, but we will continue to monitor. More
2827378	1	F	CA	02/20/2025	HEPA HEPA MMR MMR VARCEL VARCEL	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Crying, Diarrhoea, Injection site erythema, Injection site swelling, Injection s... Crying, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth; Rash erythematous; Crying, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth; Rash erythematous; Crying, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth; Rash erythematous More	Abnormal swelling in the injection sites that occured weeks after injection (started on 2/16 and was... Abnormal swelling in the injection sites that occured weeks after injection (started on 2/16 and was the size of a half dollar red and hot to touch) , extreme crying from time of vaccine to current date, diarreah from 2/6 in the pm to current, red freckled rash from 2/8- 2/18 More
2827379	44	F	FL	02/20/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		Anger, Asthenia, Blood glucose increased, Blood pressure increased, Blood test n... Anger, Asthenia, Blood glucose increased, Blood pressure increased, Blood test normal; Brain fog, COVID-19, Cardiac imaging procedure normal, Chest discomfort, Chest pain; Condition aggravated, Confusional state, Cough, Crying, Depression; Dysgeusia, Ear pain, Facial pain, Fatigue, Fear; Feeling abnormal, Headache, Impaired work ability, Laboratory test normal, Magnetic resonance imaging normal; Magnetic resonance imaging spinal normal, Malaise, Marital problem, Menopause, Nasal septum deviation; Nasopharyngitis, Nausea, Neuralgia, Ocular discomfort, Oropharyngeal pain; Pain, Pain in extremity, Palpitations, Paraesthesia, Respiratory tract congestion; SARS-CoV-2 test negative, Sinusitis, Stress at work, Tremor, Urinary tract infection; Vision blurred, X-ray normal More	The 1st dose that I got, I was fine and had no adverse effect. The 2nd dose that I received on 10/29... The 1st dose that I got, I was fine and had no adverse effect. The 2nd dose that I received on 10/29/2021, gave me COVID and I was out of work for 3 days, and returned to work still not feeling well, but was told to wear a mask. The 1st time that I started to experience signs that anything was wrong was on 1/14/2022, this ended up being just a start to my downhill spiral of health symptoms, with an endless path of medical records with no explanation of what was and still is going on. On 1/14/22, I went to the ED (age 45 at the time) for sinusitis, confusion started the day before, fogginess, congestion, discomfort behind bilateral eyes with blurry vision, nausea, mild stabbing chest pain, metallic taste, and mild headache. The 1st time that I started to experience signs that anything was wrong was on 1/14/2022, this ended up being just a start to my downhill spiral of health symptoms, with an endless path of medical records with no explanation of what was and still is going on. On 1/14/22, I went to the ED (age 45 at the time) for sinusitis, confusion started the day before, fogginess, congestion, discomfort behind bilateral eyes with blurry vision, nausea, mild stabbing chest pain, metallic taste, and mild headache. From this point on I was in and out of Hospital ER, because my doctor would not see me. They were only accepting employees. In August 2022, I went to a new job that was stressful, and my marriage was taking a toll due to my health-related issues. One day while at work, my left arm started hurting and my heart started racing and tightening in my chest, an ambulance was called to me. I was in the hospital for 3 days as they observed me, ran tests, and took images of my heart. My blood pressure was through the roof and so was my blood sugar. They asked several questions, but nothing was found, I was told that everything looked good, and I was released. As days went on at work, trying to concentrate, remember simple math calculations, I had to have help from co-workers to keep me from getting fired from my new job. I felt embarrassed and was ready to quit, but I kept moving forward as I was not going to give up. One morning on my way to work, I ended up in a parking lot and was feeling ill like symptoms, my throat was hurting, coughing a little, dazed and confused. I just did not feel right, and I knew something was wrong. I called my supervisor, husband, and headed for the hospital. This was around November 5, 2022. They conducted a COVID 19 test and swabbed the back of my throat. I was told that I had a UTI and that may be what is causing my problems. A couple days later, I received a call from the hospital stating I did have a UTI and the common cold. I filled in the prescription they gave me and went about my life. Days, weeks went on I went to traveling for holiday and for my daughter s wedding, I started with shooting pain in head and my throat still was hurting. It seemed the pain was coming from my throat, running up the side of my left ear and into my temple down the side of my face. My daughter gave me a Hydrocodone that she had and for once the pain all over was gone. After the wedding, we returned home and the pain was dual but still there. Around December 19, 2022, I was heading to work and became confused again, dazed, shooting pain in my head, and my heart started racing again. I once again called my supervisor, husband and explained what was going on and that I was going back to General Hospital. They ran the usual MRI, x-rays, blood test, and all was normal, except my blood pressure and they noticed I had a deviated septum. They asked me to follow up with PCP on base and sent me on my way. As I was leaving the hospital, like I did all the time I called my husband, I was crying and really confused how to get home. He stated to me, You go the same way as you always do. What do you mean by how do you get home? You were right behind me, and you turn left to go back to the base. I said to him, No, you don t understand I don t know where I am at. I am scared. I don t know my way home and I can t get my GPS on my phone to work. What do I do? He came to where I was, and I followed him home. A few days later, I called my doctor on base and made an appointment. I went to the appointment and explained what had been happening since the last time she saw me. I was told that I was going through menopause, it was my depression, and this is what happens when you are under a lot of stress. I was furious when I was handed information on delirium and how to manage depression. I have never been so angry in all my life. I stated, NO. I have RA vasculitis, MTHFR, protein S deficiency, and ever since I received the COVID shots, I have not been the same . The doctor stated they had no record of me having RA Vasculitis. I left that day all fired up, I could feel my BP raising, I was crying, felt defeated, and maybe I am going crazy. I knew deep down that I wasn t going crazy, but everyone was trying to convince me that I was making up all these symptoms in my head, including my husband. I contacted my doctor concerning my medical files dating back to 2010, as proof that I was diagnosed with RA Vasculitis. Once I received the record showing when, where, I was diagnosed, and I took it straight up to my doctor. I demanded to see her immediately and they took me back. I went in and slammed the document on the exam desk. I was mad that I tracked down my medical record to prove to her that I had RA Vasculitis. She gasped and looked at me and stated, We need to get you checked for Multiple sclerosis (MS) and several other things. All of my labs and tests have always come back normal. I have been seeing numerus doctors for 3 years, and they still cannot tell me what is going on. I am having serve nerve pain, continuous headaches every day, very tired all the time, no energy, my whole left side hurts severely, my left foot hurts, my fingers tingle, and my legs shake. More		✓
2827406	5	F	MT	02/20/2025	HEPA IPV TDAP	MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR	Y011643 W1B511M U7905AA	Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More	Patient was given TDAP when due for DTAP. Mom notified of administration of incorrect vaccine and ve... Patient was given TDAP when due for DTAP. Mom notified of administration of incorrect vaccine and verbalizes understanding. Will administer DTAP at 6 year well child check. More
2827407	2	M	NY	02/20/2025	DTAP	SANOFI PASTEUR	49281-256-58	Febrile convulsion, Influenza A virus test positive, Pyrexia Febrile convulsion, Influenza A virus test positive, Pyrexia	onset of high fever 2/15/25 febrile seizure 2/17/25, tested positive for influenza A onset of high fever 2/15/25 febrile seizure 2/17/25, tested positive for influenza A			✓
2827408	4	M	UT	02/20/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	5G23D	Abdominal pain Abdominal pain	Abdominal pain approx 15 mins after receiving vaccine. Abdominal pain approx 15 mins after receiving vaccine.
2827409	18	F	KS	02/20/2025	RSV	PFIZER\WYETH	KD0161	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	None reported. None reported.
2827421	32	M	CO	02/20/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	PG52S	Cough, Pneumonia, Pyrexia, Respiratory tract congestion Cough, Pneumonia, Pyrexia, Respiratory tract congestion	cough fever congestion. cough fever congestion.
2826946		M	NY	02/19/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.		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 More	No additional adverse event; HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP repor... No additional adverse event; HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that an 19 year old male patient received his first dose of the vaccine on 12/21/2023 at 17 years of age. HCP stated that the patient received his second dose of the vaccine o; This spontaneous report has been received from a pharmacist, regarding to a 19-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-DEC-2023, the patient was vaccinated with the first dose (at the age of 17-years old) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) suspension for injection as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On 10-FEB-2025, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) suspension for injection as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the pharmacist did not know the reason for the delay between the first and second doses of the mention vaccine. (Inappropriate schedule of product administration). No additional adverse events were reported (No adverse event). More
2826947		U		02/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pain in extremity Pain in extremity	My arm got really sore; This non-serious case was reported by a consumer via interactive digital med... My arm got really sore; 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 (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 in arm (Verbatim: My arm got really sore). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-JAN-2025 This case was reported by a patient via interactive digital media. The patient just had his/her first shot of Shingles vaccine and his/her arm got really sore but patient would go and get the second shot in 2 months. More
2826948		U	NC	02/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Product preparation issue Product preparation issue	administration of only the diluent portion; administration of only the diluent portion; This non-ser... administration of only the diluent portion; administration of only the diluent portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received 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: administration of only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: administration of only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 28-JAN-2025 The pharmacist asked if it was problematic to administer only the diluent portion of Shingrix. The pharmacist was administered only diluent portion of Shingrix which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist was not sure if a patient received the diluent portion without the lyophilized component. More
2826957	67	M		02/19/2025	FLU3 FLU3	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Blood test normal, Computerised tomogram normal, Magnetic resonance imaging norm... Blood test normal, Computerised tomogram normal, Magnetic resonance imaging normal, Neurological symptom, Paralysis; X-ray normal More	Pt present 3 weeks post vaccination to ER with Guillen-Barre like symptoms. Paralysis to waist. Pt r... Pt present 3 weeks post vaccination to ER with Guillen-Barre like symptoms. Paralysis to waist. Pt reuiring continued IV immunotherapy and rehab. No prior medical history More		✓
2826962		F	TX	02/19/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More	interval between first dose and second dose was too short; vesicles; This non-serious case was repor... interval between first dose and second dose was too short; vesicles; This non-serious case was reported by a other health professional and described the occurrence of vesicles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 17-DEC-2024, the patient received the 1st dose of Shingrix. On 28-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-DEC-2024, 7 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vesicles (Verbatim: vesicles). On 28-JAN-2025, the patient experienced drug dose administration interval too short (Verbatim: interval between first dose and second dose was too short). On 28-JAN-2025, the outcome of the vesicles was resolved (duration 1 month 4 days). The outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the vesicles to be related to Shingrix and Shingrix. It was unknown if the company considered the vesicles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 03-FEB-2025 The reporter reported that the patient had received Shingrix vaccine and experienced autoimmune disease diagnosed (Vesicles). The reporter mentioned that the expiry date of Shingrix was unknown. The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. More
2826963		U		02/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Feeling abnormal Feeling abnormal	felt bad on bath shots; This non-serious case was reported by a consumer via interactive digital med... felt bad on bath shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad (Verbatim: felt bad on bath shots). The outcome of the feeling bad was resolved. It was unknown if the reporter considered the feeling bad to be related to Shingrix. It was unknown if the company considered the feeling bad to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR013535 Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by patient itself. The patient felt bad upon receiving Shingrix vaccine.. More
2826964		F	SC	02/19/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination, Injection site erythema, Injection site swelli... Incomplete course of vaccination, Injection site erythema, Injection site swelling; Incomplete course of vaccination, Injection site erythema, Injection site swelling More	She still has not received Shingrix dose 2; red injection site; and swollen injection site; This non... She still has not received Shingrix dose 2; red injection site; and swollen injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In MAY-2024, the patient received the 1st dose of Shingrix. In MAY-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red injection site) and injection site swelling (Verbatim: and swollen injection site). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: She still has not received Shingrix dose 2). The outcome of the injection site erythema and injection site swelling were resolved (duration 10 days) and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix. It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter stated that she received dose 1 Shingrix in May 2024. She stated that within 24 hours her arm was red and swollen. That lasted 10 days and then resolved. The reporter stated that as per her PCP and her neurologist had different ideas on getting dose 2. The patient still had not received Shingrix dose 2 and will speak to her HCP again. Information provided per content. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2826965		F	MO	02/19/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Herpes zoster, Rash pruritic, Vaccination failure; Herpes zoster, Rash pruritic,... Herpes zoster, Rash pruritic, Vaccination failure; Herpes zoster, Rash pruritic, Vaccination failure More	Suspected vaccination failure; shingles; developed a rash on her right side yesterday; This serious ... Suspected vaccination failure; shingles; developed a rash on her right side yesterday; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 57-year-old female 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. In FEB-2022, the patient received the 1st dose of Shingrix. On 04-FEB-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and itchy rash (Verbatim: developed a rash on her right side yesterday). The patient was treated with triamcinolone and valaciclovir. The outcome of the vaccination failure and itchy rash were not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and itchy rash to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 The patient who received 2 doses of Shingrix in 2022 and she thought she got her first dose in February 2022 and her second dose 6 months later. She developed a rash on her right side and one day before the reporting day that itches and went to the doctor. The doctor thought she had shingles and prescribed triamcinolone cream and valacyclovir. This case was considered as suspected vaccination failure as details regarding 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix. Rash pruritic is a listed event which, due to the following criteria (concurrent herpes zoster) is considered unrelated to GSK vaccine Shingrix. More
2826966	0.6	F	NY	02/19/2025	DTAPHEPBIP IPV PNC20	GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH	X9EP5 X1C891M HL3889	Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered	Patient was given extra ipol vaccine at visit on 2/18/2025. Patient was given extra ipol vaccine at visit on 2/18/2025.
2826967	54	M	NC	02/19/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	XG9AF	Chills, Cough, Pyrexia, Vomiting Chills, Cough, Pyrexia, Vomiting	cough, fever, chills, vomiting cough, fever, chills, vomiting

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