🏥 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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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
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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 1,901 to 1,950 of 34,052 reports (Page 39 of 682)

« First ‹ Prev 1 ... 36 37 38 39 40 41 42 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥
2869808	26	F	CA	10/31/2025	COVID19	PFIZER\BIONTECH	NA0739	Urticaria Urticaria	Severe hives all over the body. Pt went to emergency room and was given steroids for the ongoing con... Severe hives all over the body. Pt went to emergency room and was given steroids for the ongoing condition. More
2869809	55	F	WA	10/31/2025	FLU3	SEQIRUS, INC.	948402	Musculoskeletal stiffness, Pain Musculoskeletal stiffness, Pain	Flu shot was given on 10/8 and as of today 10/31 I am still having pain in my left shoulder with upw... Flu shot was given on 10/8 and as of today 10/31 I am still having pain in my left shoulder with upward range of motion. Stiffness and slight pain when lifting my arm up over head or to reach up and out above my shoulders. More
2869811	34	F	NY	10/31/2025	FLU3	SEQIRUS, INC.	948401	Arthritis, Tenderness, X-ray limb abnormal Arthritis, Tenderness, X-ray limb abnormal	patient reports severe tenderness in the shoulder joint since vaccination patient reports severe tenderness in the shoulder joint since vaccination
2869812	38	M	CA	10/31/2025	FLU3 FLU3	SANOFI PASTEUR SANOFI PASTEUR	UT8836KA UT8836KA	Arthralgia, Back pain, Injected limb mobility decreased, Neck pain, Pain; Pain i... Arthralgia, Back pain, Injected limb mobility decreased, Neck pain, Pain; Pain in extremity More	Pt described pain in left arm within 1-2 hours after vaccination. This persisted and the arm continu... Pt described pain in left arm within 1-2 hours after vaccination. This persisted and the arm continued to hurt. Left shoulder pain and radiating to the back of the shoulder and back of neck on the left side he is unable to lift his arm overhead due to the discomfort. Has discomfort when he lies down. He has been unable to lie down on the bed, as the back of shoulder /blade discomfort++, so he is lying down on the floor. More
2869813	8	F	HI	10/31/2025	FLU3	SANOFI PASTEUR	U8883AA	Refusal of vaccination Refusal of vaccination	Vaccine given by mistake. The parent completed and signed the consent form sent home by the school, ... Vaccine given by mistake. The parent completed and signed the consent form sent home by the school, but did not actually want their child to receive the influenza vaccine. The parent reported to our clinic and the child's school upon receipt of the VIS, which we sent home with the child. More
2869814	64	F	AK	10/31/2025	FLU3	SANOFI PASTEUR	UT8806NA	Pruritus, Rash Pruritus, Rash	I got it in my arm and i was feeling fine that day and then saturday my back was itching i thought m... I got it in my arm and i was feeling fine that day and then saturday my back was itching i thought my skin was dry and i saw a rash on my back and then it spread to my shoulders and chest and stomach and arm. It got bad. And i went ER they gave me a steriod and claratin More
2869815	30	F	OH	10/31/2025	COVID19 COVID19 FLU3 FLU3	PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC.	00069-2528-10 00069-2528-10 70461-0655-03 70461-0655-03	Burning sensation, Herpes zoster, Neuralgia, Pain, Rash; Rash erythematous, Rash... Burning sensation, Herpes zoster, Neuralgia, Pain, Rash; Rash erythematous, Rash pruritic; Burning sensation, Herpes zoster, Neuralgia, Pain, Rash; Rash erythematous, Rash pruritic More	That evening after receiving my vaccines, I started feeling an itchy feeling on my right side of my ... That evening after receiving my vaccines, I started feeling an itchy feeling on my right side of my torso. Over the past 5 days, I have developed a very painful rash on my right side and under my right breast. The rash is red, itchy, has nerve pain, and has a shooting pain that burns as well. I have talked to several doctors who have heard of my symptoms and seen pictures of my developing rash and believe I have Shingles. More
2869816	54	M	NY	10/31/2025	COVID19 COVID19 FLU3 FLU3	MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR	3052550 3052550 TFAA2546 TFAA2546	Chest discomfort, Computerised tomogram abdomen, Dyspnoea, Electrocardiogram nor... Chest discomfort, Computerised tomogram abdomen, Dyspnoea, Electrocardiogram normal, Hyperventilation; Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Troponin normal; Chest discomfort, Computerised tomogram abdomen, Dyspnoea, Electrocardiogram normal, Hyperventilation; Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Troponin normal More	Shortly after dinner, patient experienced chest tightening and difficulty breathing while at home. T... Shortly after dinner, patient experienced chest tightening and difficulty breathing while at home. The symptoms progressed over the course of an hour, causing the patient to hyperventilate. When the patient's hands became numb, they decided to go to the ER. On the way to the hospital, the patient's hands began to clamp down and stiffen, making it difficult to move them. No nausea, no abd pain. Patient was given fluids, mylanta, famotidine, toradol at ER and discharged home feeling better. Had follow-up w PCP 10/30/25 and currently without symptoms of GAD, labs pending. We are awaiting records from ED. Of note, it appears that patient had only received Pfizer vaccines prior to getting Moderna on 10/17/25. More
2869817	10	F	MI	10/31/2025	COVID19	MODERNA	3052668	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	pt received 12 & up & should have received 6month to 11 yrs dose pt received 12 & up & should have received 6month to 11 yrs dose
2869819	73	M	MI	10/31/2025	FLU3	SEQIRUS, INC.	407981	Extra dose administered, No adverse event Extra dose administered, No adverse event	Patient was administered a flu shot today when he already received one on 10/27/25. This was an err... Patient was administered a flu shot today when he already received one on 10/27/25. This was an error because he was really asking for his covid vaccine. No adverse effects as of yet. More
2869821	75	F	PA	10/31/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3052734 UT8763EA	Back pain, Pain in extremity; Back pain, Pain in extremity Back pain, Pain in extremity; Back pain, Pain in extremity	EXTREME PAIN ON THE RIGHT ARM SINCE THE COVID SHOT GIVEN. THE PAIN IS ROTATING TO HER BACK AND WHOLE... EXTREME PAIN ON THE RIGHT ARM SINCE THE COVID SHOT GIVEN. THE PAIN IS ROTATING TO HER BACK AND WHOLE ARM More
2869841	3	M	IN	10/31/2025	PPV	MERCK & CO. INC.	Z004034	Injection site abscess sterile, Injection site pain, Injection site swelling, Py... Injection site abscess sterile, Injection site pain, Injection site swelling, Pyrexia More	reached a fever of 102 overnight from 10/1/2025 to 10/2/2025; sterile abscess; swelling at the inje... reached a fever of 102 overnight from 10/1/2025 to 10/2/2025; sterile abscess; swelling at the injection site; pain at the injection site/he is still experiencing mild pain at the injection site; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's medical history included febrile seizures. The patient's concurrent conditions included allergy to cephalosporin. Concomitant therapies were not reported. On 30-Sep-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, 0.5 ml, lot #Z004034, expiration date: 19-Jan-2027, administered by intramuscular route in the left thigh (dose number was not provided), for prophylaxis. On the same date (reported as "that evening"), the patient became symptomatic and he experienced pain and swelling at the injection site. The patient reached a fever of 102 (unit not provided) overnight from 01-Oct-2025 to 02-Oct-2025. The patient's mother alternated paracetamol (TYLENOL) and ibuprofen (MOTRIN) for symptom relief and he was also provided with a cold compress which did not help the symptoms. The patient's mom brought him to his primary care physician (PCP) who advised him to be seen at an unspecified hospital where he was diagnosed with a "sterile abscess". The patient was not admitted and was sent home with instructions to continue paracetamol (TYLENOL) and ibuprofen (MOTRIN) as needed for pain and fever. On an unknown day in October, the patient's fever resolved however he was still experiencing mild pain at the injection site and was "still favoring the left leg." The outcome of swelling at injection site and sterile abscess was not provided. At the reporting time, the patient did not recover from pain at injection site. The action taken with the suspect vaccine regarding events was considered as not applicable. The causal relationship between events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. More
2869843				10/31/2025	PPV	MERCK & CO. INC.		Pneumonia Pneumonia	she received PNEUMOVAX 23 on 09/18/2025, then got pneumonia a month later.; This spontaneous report ... she received PNEUMOVAX 23 on 09/18/2025, then got pneumonia a month later.; This spontaneous report was received from a consumer reporting on themselves and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Sep-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. In approximately October 2025 (reported as "a month later"), the patient experienced pneumonia. The outcome of the event was not reported. The action taken with the suspect vaccine regarding the event was not reported but assessed as not applicable. The causal relationship between pneumonia and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. Upon internal review, the event of pneumonia was determined to be medically significant. More
2869844			TX	10/31/2025	HEPA	MERCK & CO. INC.	Z005472	No adverse event, Product storage error No adverse event, Product storage error	No symptoms reported. No additional AE/no PQC reported.; a dose of VAQTA which was improperly stored... No symptoms reported. No additional AE/no PQC reported.; a dose of VAQTA which was improperly stored was administered; This spontaneous report was received from a medical assistant on 27-Oct-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-Oct-2025, the patient was administered a dose of hepatitis A vaccine, inactivated (VAQTA) injection, 25/0.5 (unit not provided), lot #Z005472, expiration date: 08-Jul-2026, 0.5 mL (dose number, route and anatomical site of administration were not provided) for prophylaxis, which was administered after a temperature excursion at 48F for 6 hours 36 minutes 0 seconds, there was no previous temperature excursion (Product storage error). No additional adverse event (AE)/product quality compliance (PQC) provided (No adverse event). More
2869845		F	PA	10/31/2025	RAB	NOVARTIS VACCINES AND DIAGNOSTICS	Unknown	Antibody test abnormal, Drug ineffective Antibody test abnormal, Drug ineffective	Rabies titers continue to be persistently low, potential lack of efficacy; Rabies titers continue to... Rabies titers continue to be persistently low, potential lack of efficacy; Rabies titers continue to be persistently low, potential lack of efficacy; Case reference number US-BN-2025-001687 is a spontaneous case initially received from physician via Bavarian-Nordic (reference number: CASE-000303) on 16-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported, the patient received all the doses of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, route, and site of administration for unknown indication. On an unspecified date, the patient received all the doses of HRIG (immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route, site of administration for an unknown indication. On an unspecified date, unknown time after vaccination with RabAvert the patient's rabies titers continue to be persistently low and had potential lack of efficacy. At the time of the initial report, it was unknown if the patient recovered from the event of 'antibody result abnormal' and 'lack of drug effect'. The reporter did not provide seriousness and causality assessment for the events of 'lack of drug effect' and 'antibody result abnormal', however the event of 'lack of drug effect' was assessed as serious due to the criteria of medical significance. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced a serious event of drug ineffective (medical significance), and a non-serious event of antibody test abnormal on an unspecified date, unknown time after the patient received all the doses of RabAvert vaccine for unknown indication, as the patient's rabies titers continued to be persistently low and the patient had potential lack of efficacy. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI, and drug ineffective is considered as listed per company convention. The outcome was unknown. The patient's medical history, concurrent diseases and concomitant medication details were not provided. There was no information on similar events in the context of or independent from previous immunizations. There is no information on temporal relationship between immunization and events, nor of the presence of confounding factors or alternative explanations. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable.; Sender's Comments: A female patient of unspecified age experienced a serious event of drug ineffective (medical significance), and a non-serious event of antibody test abnormal on an unspecified date, unknown time after the patient received all the doses of RabAvert vaccine for unknown indication, as the patient's rabies titers continued to be persistently low and the patient had potential lack of efficacy. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI, and drug ineffective is considered as listed per company convention. The outcome was unknown. The patient's medical history, concurrent diseases and concomitant medication details were not provided. There was no information on similar events in the context of or independent from previous immunizations. There is no information on temporal relationship between immunization and events, nor of the presence of confounding factors or alternative explanations. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable. More
2869846		F	NJ	10/31/2025	RAB	NOVARTIS VACCINES AND DIAGNOSTICS	Unknown	Antibody test abnormal Antibody test abnormal	Gone through the vaccine procedure twice, but her titers has been coming back at 0.1 iu/mL, below t... Gone through the vaccine procedure twice, but her titers has been coming back at 0.1 iu/mL, below the required 0.5 iu/mL; Case reference number US-BN-2025-001723 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000420) on 23-Oct-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, a couple of months ago, the patient was bitten by bat. On an unspecified date, unknown of time after bat bite, as reported the patient gone through the procedure twice with RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, route, and site of administration, for indication post-exposure vaccination. On an unspecified date, the patient's titers had been coming back at 0.1 iu/mL, below the required 0.5 iu/mL. At the time of the initial report, it was unknown if the patient recovered from the event of 'antibody result abnormal'. The reporter assessed the event of 'antibody result abnormal' as non-serious, however the event is assessed as serious due to seriousness criteria of other medically important condition, and the causality was not reported. No further information provided.; Reporter's Comments: A female patient of unknown age had a serious event of antibody test abnormal (other medically important condition) on an unspecified date, an unknown amount of time after patient gone through the procedure twice with RabAvert vaccine for indication post-exposure vaccination. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable.; Sender's Comments: A female patient of unknown age had a serious event of antibody test abnormal (other medically important condition) on an unspecified date, an unknown amount of time after patient gone through the procedure twice with RabAvert vaccine for indication post-exposure vaccination. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable. More
2869847		F		10/31/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Condition aggravated, Osteoarthritis, Pain, Rheumatoid arthritis Condition aggravated, Osteoarthritis, Pain, Rheumatoid arthritis	Rheumatoid arthritis; Osteoarthritis; This serious case was reported by a consumer via other manufac... Rheumatoid arthritis; Osteoarthritis; This serious case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis, osteoarthritis, penicillin allergy, sulfonamide allergy, food allergy and drug allergy (Codeine allergy). Additional patient notes included No additional vaccines were administered on the same day or within four weeks The patient denied any recent lab work within two weeks of the event and reported no other medications.. Concomitant products included tofacitinib citrate (Xeljanz Xr) and methotrexate. In AUG-2025, the patient received Shingrix (left arm). On an unknown date, less than a week after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant) and osteoarthritis flare up (Verbatim: Osteoarthritis) (serious criteria GSK medically significant). The patient was treated with paracetamol (Tylenol Arthritis). The outcome of the rheumatoid arthritis flare up and osteoarthritis flare up were not resolved. The reporter considered the rheumatoid arthritis flare up and osteoarthritis flare up to be related to Shingrix. The company considered the rheumatoid arthritis flare up and osteoarthritis flare up to be unrelated to Shingrix. Additional Information: GSK receipt date 16 Oct 2025: The patient had a flare up since she was off the medication (Xeljanz XR) due to a Shingles shot (Shingrix) and she was still in a flare-up. The patient's rheumatologist told her to stop the medication for one week, because he said it wouldn't absorb okay and eventually it was taking a quite a while to get. The patient still waking up achy in the morning which she had not been for years because she was on Xeljanz for many years and not had any flare-up like this. would suspect It was reported that within 3 days after receiving shot, my medication for about three or four days and then started flare-up. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Rheumatoid arthritis flare up and Osteoarthritis flare up, less than a week after receiving a dose of Shingrix in a 76-year-old female subject. Report is inconsistent with causal relation to the vaccine product, absence of biological plausibility and alternative risk factors (underlying rheumatoid arthritis and osteoarthritis and patient stopped her medication for a week). More
2869848		F		10/31/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Limb operation, Monoplegia Limb operation, Monoplegia	Arm was paralyzed/now she has to have surgery on her arm; This serious case was reported by a consum... Arm was paralyzed/now she has to have surgery on her arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of arm paralysis in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced arm paralysis (Verbatim: Arm was paralyzed/now she has to have surgery on her arm) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the arm paralysis was resolved (duration 8 months). It was unknown if the reporter considered the arm paralysis to be related to Shingrix. The company considered the arm paralysis to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 22-OCT-2025 This case was reported by a patient's neighbor via interactive digital media. The patient said vaccines were a myth. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Monoplegia, unknown time after receiving Shingrix in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2869849	18	M	CA	10/31/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS	UNK	Eyelid operation, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise Eyelid operation, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise	Guillain Barre syndrome; Eyelid operation; Lumbar puncture abnormal; Malaise; This serious case was... Guillain Barre syndrome; Eyelid operation; Lumbar puncture abnormal; Malaise; This serious case was reported by a pharmacist via regulatory authority and described the occurrence of guillain barre syndrome in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. On 14-AUG-2016, the patient received the 1st dose of Bexsero. On an unknown date, several weeks after receiving Bexsero, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), eyelid operation (Verbatim: Eyelid operation) (serious criteria clinically significant/intervention required), lumbar puncture abnormal (Verbatim: Lumbar puncture abnormal) and malaise (Verbatim: Malaise). The outcome of the guillain barre syndrome, eyelid operation, lumbar puncture abnormal and malaise were unknown. The reporter considered the guillain barre syndrome to be probably related to Bexsero. It was unknown if the reporter considered the eyelid operation, lumbar puncture abnormal and malaise to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the guillain barre syndrome to be related to Bexsero Pre-Filled Syringe Device. The company considered the guillain barre syndrome, eyelid operation, lumbar puncture abnormal and malaise to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 18 years. The patient never received the second dose of Bexsero. The patient became sick within a few weeks after the first dose. The guillain barre syndrome was confirmed with a lumbar puncture and the patient required eyelid surgery. Follow up information received on 22-OCT-2025 Summary of changes: Reporter information and event tab updated.; Sender's Comments: A case of Guillain-Barre syndrome, Eyelid operation, Lumbar puncture abnormal and Malaise, Several weeks after receiving 1st dose of Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE, in a 18-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2869850		F	TX	10/31/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	2T543	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	four-month-old patient that was administered a Flulaval vaccine; This non-serious case was reported ... four-month-old patient that was administered a Flulaval vaccine; 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 4-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 2T543, expiry date 30-JUN-2026) for prophylaxis. On 03-OCT-2025, the patient received FluLaval 2025-2026 season. On 03-OCT-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced inappropriate age at vaccine administration (Verbatim: four-month-old patient that was administered a Flulaval vaccine). The outcome of the inappropriate age at vaccine administration 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. More
2869853		F		10/31/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Product administered to patient of inappropriate age, Vaccination... Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure More	Suspected vaccination failure; HZ breakthrough case; Vaccine administered to patient under recommend... Suspected vaccination failure; HZ breakthrough case; Vaccine administered to patient under recommended age; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: HZ breakthrough case) (serious criteria other: serious as per reporter) and inappropriate age at vaccine administration (Verbatim: Vaccine administered to patient under recommended age). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. The reporter considered the vaccination failure and herpes zoster to be unrelated to Shingrix. The company considered the vaccination failure and herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 28-OCT-2025 This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster, unknown time after receiving Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2869863				10/31/2025	RVX	UNKNOWN MANUFACTURER	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	suspected vaccination failure; RSV; This serious case was reported by a other health professional vi... suspected vaccination failure; RSV; This serious case was reported by a other health professional via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of RSV vaccine. On an unknown date, less than a year after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 23-OCT-2025 This case was reported by a patient via interactive digital media. Patient took the vaccine last year in 2024 for the first time and got RSV (respiratory syncytial virus infection) that year for the first time and it was not a fun. Patient stated that he/she was in medical field for 30 years but never got either. The patient thought he/she would sit it out this year (2025). The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details of laboratory confirmation regarding respiratory syncytial virus infection was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, less than a year after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2869865				10/31/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date 28 Oct 2025: This case was reported by a consumer via interactive digital media. This case was considered as suspected vaccination failure since the details regarding completion of priamry vaccination failure, time to onset and laboratory confirmation of shingles was not reported. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2869867				10/31/2025	RVX	UNKNOWN MANUFACTURER	UNK	Feeling abnormal, Respiratory syncytial virus infection, Vaccination failure Feeling abnormal, Respiratory syncytial virus infection, Vaccination failure	I had RSV a year ago. Was in the hospital 6 days; I really felt awful; Suspected vaccination failure... I had RSV a year ago. Was in the hospital 6 days; I really felt awful; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included allergy (Im allergic to the RSV vaccine). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I had RSV a year ago. Was in the hospital 6 days) (serious criteria hospitalization) and feels awful (Verbatim: I really felt awful). The outcome of the vaccination failure, respiratory syncytial virus infection and feels awful were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and feels awful to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. It was unknown if the company considered the feels awful to be related to RSV vaccine. Additional Information: GSK receipt date:27-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that had respiratory syncytial virus infection year ago. The reporter mentioned was in the hospital 6 days. The reporter mentioned he/she was allergic to the RSV vaccine and was really felt awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, unknown time after receiving RSV vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More	✓
2869868				10/31/2025	RVX	UNKNOWN MANUFACTURER	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	Suspected vaccination failure; got the vaccine and still got Respiratory syncytial virus; This serio... Suspected vaccination failure; got the vaccine and still got Respiratory syncytial virus; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got the vaccine and still got Respiratory syncytial virus). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 25-OCT-2025 This case was reported by a patient via interactive digital media. The batch number was not provided and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus and laboratory confirmation regarding respiratory syncytial virus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2869869				10/31/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination Failure; now years later I have them again; This serious case was reported by ... Suspected Vaccination Failure; now years later I have them again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had the shingles many years ago). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: now years later I have them again). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-OCT-2025 This case was reported by a patient via interactive digital media. The patient had the shingles many years ago, so decided to get the Shingles shot, now years later he/she have them again. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2869871		F	CA	10/31/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	DJ22N	Expired product administered Expired product administered	Expired Product Used - Maladministration of an expired dose; This non-serious case was reported by a... Expired Product Used - Maladministration of an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis. On 07-OCT-2025, the patient received FluLaval 2024-2025 season. On 07-OCT-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: Expired Product Used - Maladministration of an expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-OCT-2025 A Registered Nurse had called to seek advice regarding the maladministration of an expired vaccine. The vaccine had expired on 13th June 2025, and was administered on 7th October 2025. More
2869872	1.25	F		10/31/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS		Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered	Kinrix instead of DTaP administration in a 15 months-old patient; Kinrix instead of DTaP administrat... Kinrix instead of DTaP administration in a 15 months-old patient; Kinrix instead of DTaP administration in a 15 months-old patient; received Kinrix instead of DTaP (as a 4th dose in the schedule); This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included DTPa (DTPa vaccine) for prophylaxis. On 09-OCT-2025, the patient received the 4th dose of Kinrix. The patient did not receive DTPa vaccine. On 09-OCT-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of DTaP administration in a 15 months-old patient), inappropriate age at vaccine administration (Verbatim: Kinrix instead of DTaP administration in a 15 months-old patient) and inappropriate schedule of vaccine administered (Verbatim: received Kinrix instead of DTaP (as a 4th dose in the schedule)). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-OCT-2025 A physician asked how to proceed. The vaccine administration facility was the same as primary reporter. Patients, initials, date of birth, vaccine lot and expiration date were unknown by the reporter. The batch number was not provided upon follow- up with the reporter. More
2869873			KS	10/31/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	7745R	Expired product administered Expired product administered	maladministration of an expired dose of Kinrix; This non-serious case was reported by a pharmacist ... maladministration of an expired dose of Kinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis. On 09-OCT-2025, the patient received Kinrix. On 09-OCT-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: maladministration of an expired dose of Kinrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-OCT-2025 A registered pharmacist had called to seek advice regarding the maladministration of an expired dose of Kinrix. More
2869874	13	F	PA	10/31/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	J245K	Expired product administered Expired product administered	Flulaval expired dose; This non-serious case was reported by a other health professional via call ce... Flulaval expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number J245K, expiry date 05-JUN-2025) for prophylaxis. On 10-OCT-2025, the patient received FluLaval 2025-2026 season. On 10-OCT-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced expired vaccine used (Verbatim: Flulaval expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-OCT-2025 A medical assistant called on 10th October 2025, to report that a dose of Flulaval with an expiration date of 5th June 2025, had been administered. More
2869875	11	M	FL	10/31/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	Y49BZ	Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered	Maladministration on an eleven-year-old patient (instead of a BOOSTRIX vaccine); This non-serious ca... Maladministration on an eleven-year-old patient (instead of a BOOSTRIX vaccine); This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 13-OCT-2025, the patient received Kinrix. The patient did not receive Boostrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration on an eleven-year-old patient (instead of a BOOSTRIX vaccine)). The outcome of the wrong vaccine administered 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-OCT-2025 The Clinical Manager had called to report that an eleven-year-old male patient had been maladministered with a Kinrix vaccine instead of Boostrix. More
2869876	64	F	KS	10/31/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	K4JH7	Underdose Underdose	administered a pediatric dose of Engerix-B to an adult; administered a pediatric dose of Engerix-B t... administered a pediatric dose of Engerix-B to an adult; administered a pediatric dose of Engerix-B to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 64-year-old female patient who received HBV (Engerix B Junior) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 13-OCT-2025, the patient received Engerix B Junior. On 13-OCT-2025, an unknown time after receiving Engerix B Junior, the patient experienced adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to an adult) and underdose (Verbatim: administered a pediatric dose of Engerix-B to an adult). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-OCT-2025 Medical assistant reported she administered a pediatric dose of Engerix-B to an adult today (date of reporting). More
2869877		M	NJ	10/31/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	3D72S	Expired product administered, Inappropriate schedule of product administration Expired product administered, Inappropriate schedule of product administration	Maladministration after the expiration date; Inappropriate Schedule of Vaccine (administration on a ... Maladministration after the expiration date; Inappropriate Schedule of Vaccine (administration on a sixteen-month-old patient); This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-month-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On 09-OCT-2025, the patient received Priorix. On 09-OCT-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Maladministration after the expiration date) and inappropriate age at vaccine administration (Verbatim: Inappropriate Schedule of Vaccine (administration on a sixteen-month-old patient)). The outcome of the expired vaccine used and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date:14-OCT-2025 The reporter stated the maladministration after the expiration date of a Priorix vaccine. More
2869879			IL	10/31/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS		Product preparation issue Product preparation issue	a vial of the MMR (Priorix) vaccine in the box without its corresponding sterile diluent.; Inappropr... a vial of the MMR (Priorix) vaccine in the box without its corresponding sterile diluent.; Inappropriate dose of vaccine administered; 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 patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: a vial of the MMR (Priorix) vaccine in the box without its corresponding sterile diluent.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-OCT-2025 The reporter worked for a doctor office. The reporter had a question regarding Priorix. They discovered a vial of the MMR (Priorix) vaccine in the box without its corresponding sterile diluent. The reporter reported that prior to being discovered, two patients received the Priorix vaccine, however, they were unable to determine which patient received the properly reconstituted vaccine and which may have received the one without the diluent. The reporter did not have patient information with by hand. The reporter knew product name was Priorix not a new box. The reporter was reaching out to ask the manufacture for guidance on what should be the next step. More
2869880			IL	10/31/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS		Product preparation issue Product preparation issue	unaccompanied diluent used; have received the one without the diluent; This non-serious case was rep... unaccompanied diluent used; have received the one without the diluent; 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 patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: unaccompanied diluent used) and inappropriate dose of vaccine administered (Verbatim: have received the one without the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-OCT-2025 The reporter had a question regarding Priorix. They discovered a vial of the MMR (Priorix) vaccine in the box without its corresponding sterile diluent. Prior to being discovered, two patients received the Priorix vaccine; however, they were unable to determine which patient received the properly reconstituted vaccine and which might have received the one without the diluent. The reporter did not have patient information and wanted to know the manufacture for guidance on what should be the next step. No other Information available. The batch number was not provided and a request for this information has been made. More
2869882	0.25		CT	10/31/2025	RV1	GLAXOSMITHKLINE BIOLOGICALS	J757K	Inappropriate schedule of product administration Inappropriate schedule of product administration	given his second dose dose of Rotarix twenty days after his first dose; This non-serious case was re... given his second dose dose of Rotarix twenty days after his first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 3-month-old patient who received Rota (Rotarix liquid formulation) (batch number J757K, expiry date 05-DEC-2026) for prophylaxis. Concomitant products included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX). On 16-OCT-2025, the patient received the 2nd dose of Rotarix liquid formulation. On 16-OCT-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced drug dose administration interval too short (Verbatim: given his second dose dose of Rotarix twenty days after his first 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: 16-OCT-2025 Pediatrician stated that they had a three-month-old who was inadvertently given his second dose dose of Rotarix twenty days after his first dose. Obviously, this was invalid. The reporter asked that they should give a third dose in one month. Vaccination date, vaccine detail and patient demographics were obtained in this call. The vaccine administration facility was the same as primary reporter. More
2869884	59	F	OR	10/31/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	7F299	Product storage error Product storage error	Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 59-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 7F299, expiry date 01-JUN-2026) for prophylaxis. On 15-OCT-2025, the patient received FluLaval 2025-2026 season. On an unknown date, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-OCT-2025 Nurse reported had an excursion and the vaccine was given to patient. Conditions of the excursion temperature was minus 7 degree Celsius for 1 hour and 55 minutes. Vaccine not supported by extended stability data. The reporter consented to follow up. More
2869885			OH	10/31/2025	DTAPIPV MENB TDAP	GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS		Product storage error; Product storage error; Product storage error Product storage error; Product storage error; Product storage error	Vaccine stored outside recommended conditions and administered to patient; This non-serious case wa... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Bexsero, Boostrix and Kinrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-OCT-2025 The registered nurse and clinical manager had reported that they experienced a temperature excursion on one of their units on 8 Oct 2025. The vaccines in that fridge had been out of temperature for 45 minutes, reaching a low of negative two degrees Celsius. As per audits, they were required to call the manufacturers. The reporter had enquired whether the vaccines Kinrix, Men B, and Boostrix, if they had been used, would need to be repeated. The batch number was not provided upon follow- up with the reporter. More
2869886			TN	10/31/2025	FLU3 FLUX	GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER		Expired product administered; Expired product administered Expired product administered; Expired product administered	Expired dose given; This non-serious case was reported by a physician via call center representative... Expired dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 1-year-old patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received FluLaval 2024-2025 season and Influenza vaccine. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season and Influenza vaccine, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-OCT-2025 The physician contacted through a field representative, requesting data after an expired dose was given to a 1 year old patient. Only Flulaval season 2024-2025 could be selected in the listing. The CRM is as follows: The patient also received expired flu vaccine. The reporter was trying to find out how long the patients need to wait before coming back in to receive in date flu vaccine. The vaccine administration facility was the same as primary reporter. The batch number was not provided upon follow up with the reporter. More
2869888		F	CA	10/31/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	72AB2	Incorrect route of product administration Incorrect route of product administration	Inappropriate Route of Administration; This non-serious case was reported by a nurse via call center... Inappropriate Route of Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 72AB2, expiry date 10-DEC-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Inappropriate Route of Administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 20-OCT-2025 Reporter stated an intramuscular administration of Priorix vaccine to a patient. Reporter wanted guidance on this topic. Vaccination date, vaccine detail and patient demographics were obtained. More
2869889	25	F	SC	10/31/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	72742	Exposure during pregnancy, Product use issue, Wrong product administered Exposure during pregnancy, Product use issue, Wrong product administered	pregnant patient received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; received Ar... pregnant patient received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; 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 25-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 23-SEP-2025, the patient received Arexvy. The patient did not receive Abrysvo. On 23-SEP-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: received Arexvy instead of Abrysvo) and product use in unapproved population (Verbatim: received Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): To mother in third trimester Estimated Delivery/Due date: 18-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 The nurse had reported that a pregnant patient had received Arexvy instead of Abrysvo.; Sender's Comments: US-GSK-US2025137800:SAME REPORTER US-GSK-US2025137805:SAME REPORTER US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137807:SAME REPORTER More
2869890	79	F		10/31/2025	COVID19	MODERNA		COVID-19 COVID-19	got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19... got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy to antibiotic (The patient was allergic to antibiotics, since when the patient was a child, so in distant past.) and Arthritis (20 years ago). In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (got Covid). At the time of the report, COVID-19 (got Covid) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient was fairly healthy. No treatment medications were reported. This case was linked to MOD-2025-790447 (Patient Link). More
2869891	69	M	KY	10/31/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	UT8409CA	Rash, Urticaria; Rash, Urticaria Rash, Urticaria; Rash, Urticaria	Developed a severe case or rash; Developed a severe case or rash and hives which lasted for more tha... Developed a severe case or rash; Developed a severe case or rash and hives which lasted for more than 4 months; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunization. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for Influenza immunization. Previously administered products included for Prophylactic vaccination: Fluzone HD in 2020, Fluzone HD in 2021 and Fluzone HD in 2023; for COVID-19 immunization: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse effect with Fluzone HD, Fluzone HD, Fluzone HD and Moderna COVID-19 Vaccine. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In 2024, the patient experienced RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months). At the time of the report, RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months) had resolved. Concomitant medication use information was not provided by reporter. In 2024, the patient received FLUZONE HD (high dose) (Influenza USP trivalent A-B high dose subvirion vaccine suspension for injection in a pre-filled syringe) and Moderna COVID vaccines but developed a severe case of rash and hives which lasted for more than 4 months. The reporter wanted to know if the patient would still receive FLUZONE HD this year. The reporter was not sure if it was really caused by FLUZONE HD because the patient also received the Moderna COVID vaccine, which they had been able to use before. The reporter wanted to know if the ingredients of FLUZONE HD this year had changed from the last year. It was not reported if the patient received corrective treatment for the events. More
2869892		F		10/31/2025	COVID19	MODERNA		Immunisation reaction, Pain Immunisation reaction, Pain	Little soreness; Knocked on butt; This spontaneous case was reported by a consumer and describes the... Little soreness; Knocked on butt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little soreness) and IMMUNISATION REACTION (Knocked on butt) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (Little soreness) and IMMUNISATION REACTION (Knocked on butt). At the time of the report, PAIN (Little soreness) and IMMUNISATION REACTION (Knocked on butt) outcome was unknown. Concomitant medication use information was not provided by reporter. All previously received boosters were fine and never had a problem other than a little soreness. It was reported that the first set of vaccines "knocked on the butt" like many people, but the patient had a booster every year since, so this was surprising. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790512 (Patient Link). More
2869893	44	F	MA	10/31/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Nausea, Poor quality sleep; Nausea, Poor quality sleep Nausea, Poor quality sleep; Nausea, Poor quality sleep	Bad sleep; nauseous; This spontaneous case was reported by a consumer and describes the occurrence o... Bad sleep; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Bad sleep) and NAUSEA (nauseous) in a 44-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In 2023, the patient experienced POOR QUALITY SLEEP (Bad sleep) and NAUSEA (nauseous). At the time of the report, POOR QUALITY SLEEP (Bad sleep) and NAUSEA (nauseous) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The patient height was reported as 66. The patient was receiving unspecified concomitant ongoing medication via oral route. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789942 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789942:the same patient, different product More
2869894	66	F		10/31/2025	COVID19	MODERNA		Paraesthesia, Vaccination site pain Paraesthesia, Vaccination site pain	tingling/tingling was intermittent; very sore injection site; This spontaneous case was reported by ... tingling/tingling was intermittent; very sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling/tingling was intermittent) and VACCINATION SITE PAIN (very sore injection site) in a 66-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 03-Oct-2025, the patient received fourth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced PARAESTHESIA (tingling/tingling was intermittent) and VACCINATION SITE PAIN (very sore injection site). In October 2025, VACCINATION SITE PAIN (very sore injection site) had resolved. At the time of the report, PARAESTHESIA (tingling/tingling was intermittent) had not resolved. No concomitant medications were provided. The patient had injection on 03-Oct-2025. Initially the patient had a very sore injection site for 4 days but then the tingling started and was still happening. This was 4th Moderna vaccine, but this was a new reaction. The patient was currently 66 years old with no other health issues. The tingling was intermittent and lasted about 10 seconds. No pain or other symptoms. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790376 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790376:Same patient different product More
2869895		F		10/31/2025	COVID19	MODERNA		COVID-19, Herpes zoster COVID-19, Herpes zoster	shingles; Covid; This spontaneous case was reported by a consumer and describes the occurrence of HE... shingles; Covid; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and COVID-19 (Covid) in an adult female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Breast cancer in 2023, Splenectomy (No spleen) and Pancreatectomy (No spleen and 1/2 pancreas). In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and COVID-19 (Covid). At the time of the report, HERPES ZOSTER (shingles) had resolved and COVID-19 (Covid) outcome was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2869896	61	F	MN	10/31/2025	COVID19 COVID19	MODERNA MODERNA		Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesth... Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia; Ophthalmic migraine More	had 2 ocular migraines in one day; felt a little bit dizzy too; this time it was kind of more from t... had 2 ocular migraines in one day; felt a little bit dizzy too; this time it was kind of more from the area where got the vaccine down; right foot and my right calf got numb/not getting any more numbness in my foot or my calf; upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb; That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again; very bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb), OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day), DIZZINESS (felt a little bit dizzy too), INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down) and HEADACHE (very bad headaches) in a 61-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Tick bite (20 years ago) in 2005. Concurrent medical conditions included Blood pressure high and Autoimmune disorder (Autoimmune illness" due to a tick bite 20 years ago leaving with "MS-like symptoms." in a state of hyper-reactivity.) since 2005. On 25-Sep-2025 at 1:00 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Sep-2025, the patient experienced HEADACHE (very bad headaches). 25-Sep-2025, the patient experienced HYPOAESTHESIA (That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again). On 28-Sep-2025, the patient experienced HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb) and HYPOAESTHESIA (right foot and my right calf got numb/not getting any more numbness in my foot or my calf). 28-Sep-2025, the patient experienced DIZZINESS (felt a little bit dizzy too). 28-Sep-2025, the patient experienced INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down). In October 2025, the patient experienced OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency; Loratadine (Claritin) at an unspecified dose and frequency and Dexamethasone sodium succinate (Dexamethasone) at a dose of for a few days. At the time of the report, HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb), OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day), DIZZINESS (felt a little bit dizzy too) and HYPOAESTHESIA (That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again) had not resolved and INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down), HEADACHE (very bad headaches) and HYPOAESTHESIA (right foot and my right calf got numb/not getting any more numbness in my foot or my calf) was resolving. No concomitant medication was reported. Patient had a COVID booster about a month ago and this year patient had some kind of alarming reactions to it "That evening, patient right arm went numb from elbow all the way down to fingertips, like when laying on arm and it felt asleep. that lasted about 30 seconds to a minute. And patient thought, well, that was really weird. It felt like, so numb, like, when felt asleep on arm and before the pins and needles set in, where kind of were just like super numb. It did not last very long. So that was Thursday night after the shot. Friday and Saturday, nothing happened. Sunday, at about 11 in the morning, right arm went numb again. But this time it was kind of more from the area where patient got the vaccine down and it did not go away. And patient felt a little bit dizzy too. So, at that point, she got a little bit alarmed, and she took a Tylenol and took Claritin and got off the heating pad and going to lay down on the couch for a while and see if it goes away. When she lay down on the couch, upper right lip got numb, right foot and right calf got numb. At that point, this was a little more than normal, patient thought. she went up to urgent care. The only thing they really could did they offered to patient a brain MRI which patient didn't want to get one. Patient had many and she did not want to get; she did not want to do that. There were no signs of having a stroke or anything like that. So, they put patient on dexamethasone for a few days. That gave terrible side effects, so patient stopped taking it and she did not know that it helped at all. If it did, it helped just slightly. She was also having very bad headaches, and those have kind of died off a little bit. did not know if it was an allergy thing, but this felt different. This did not feel like normal headache. That was kind of gotten better, but the other alarming thing that happened was maybe 2 weeks ago or a week ago, maybe 10 days ago. Patient had 2 ocular migraines in one day. had 4 in life and patient had not had one for years, but she had 2 in 1 day." "And basically, this just kind of persisted. This Thursday, it was 4 weeks. It started as upper lip, but then it kind of became more lower lip that was numb. It was reported that patient lower lip felt just slightly numb now. Patient was not getting any more numbness in foot or calf. Patient right arm, the numbness has gotten better, but right hand was still numb. When it first started, it was kind of thumb that ended up being the worst. Now, patient thumb feels ok now. It was more like last, 4th and 5th finger that felt kinda numb, and the palm of hand was very numb. It was more the palm of hand and the back of hand. The headaches have gotten better. patient had gotten better. Every once in a while, though, they would come and go now, but at first it was really kind of persistent. lower lip had gotten better, but this morning, Actually, the reason as today was patient just felt a little worse today and patient lower lip was a little bit numb again. This case was linked to MOD-2023-744170 (Patient Link). More
2869897	63	F		10/31/2025	COVID19 COVID19 FLUX FLUX	MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Antibody test, COVID-19, Cerebral small vessel ischaemic disease, Eye pain, Feel... Antibody test, COVID-19, Cerebral small vessel ischaemic disease, Eye pain, Feeling abnormal; Magnetic resonance imaging head, Scan brain; Antibody test, COVID-19, Cerebral small vessel ischaemic disease, Eye pain, Feeling abnormal; Magnetic resonance imaging head, Scan brain More	things floating around in body from taking the COVID and the booster; woke up after her flu shot wit... things floating around in body from taking the COVID and the booster; woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse; COVID; Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 21-Feb-2024, the patient experienced CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change) (seriousness criterion medically significant). In September 2024, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced FEELING ABNORMAL (things floating around in body from taking the COVID and the booster) and EYE PAIN (woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse). At the time of the report, CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change), FEELING ABNORMAL (things floating around in body from taking the COVID and the booster), EYE PAIN (woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse) and COVID-19 (COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2024, Magnetic resonance imaging head: A small hyper handing focus of vessel was in the high left frontal cerebrum. With a drainage information and overlaying cortical vein, several small patchy paraventricular subcortical and deep white matter flare. Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change. No abnormal post contrast enhancement of these lesions. Results of chronic small blood related damage. On an unknown date, Antibody test: before the vaccines they tested their antibodies and tested again in 2 weeks, and their antibodies were always up and off the scale. On an unknown date, Scan brain: everything was ok. No concomitant medication was reported. The patient did not have a shot in a long time, probably since this time last year. The patient had one small reaction from the Moderna COVID vaccine. She had only received the Moderna COVID vaccine, one in 2023 and in Sep-2024. The patient woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot, and the eye pain got worse. The pain was in the region behind left eye. The patient went to the ophthalmologist who advised her that it was not her vision, as her vision had not been affected. The patient was then sent to a specialist in ophthalmology where they conducted a brain scan and everything was ok. Every now and then she would feel it and that she would feel that her left eye was weaker. The patient was unsure if she had too much medication at once, things floating around in her body from taking the COVID and the booster. Even though she took the testing to understand that she was fully protected and her antibodies were off the chart, every time she took the booster, and went back and checked it and her antibodies were lower so the patient did not know if she still had some and then she got the flu shot and then it was just too much for her body. The patient also stated that she had COVID for the first time in Sep-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790492 (E2B Linked Report).; Reporter's Comments: Flu vaccine remains as a co-supect drug. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790492:Husband case More
2869898	70	F	TX	10/31/2025	COVID19	MODERNA		Hypokinesia, Vaccination site pain Hypokinesia, Vaccination site pain	Extreme pain to entire left arm where the injection was done. Inability to move my arm because of th... Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain; Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain) and HYPOKINESIA (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain) in a 70-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 17-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced VACCINATION SITE PAIN (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain) and HYPOKINESIA (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain). At the time of the report, VACCINATION SITE PAIN (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain) and HYPOKINESIA (Extreme pain to entire left arm where the injection was done. Inability to move my arm because of the extreme muscle pain) was resolving. No concomitant medication was reported. It was reported that patient had extreme pain to entire left arm where the injection was done. She was unable to move her arm because of the extreme muscle pain. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More

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