🏥 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

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Select Year: Choose a specific year OR "All Years" to search across all data
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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 4,101 to 4,150 of 34,052 reports (Page 83 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	⚠️
2866076	82	M	OK	10/15/2025	COVID19	PFIZER\BIONTECH	NA0589	Extra dose administered Extra dose administered	Patient received two doses of the Comirnaty vaccination on 10/15/25 Patient received two doses of the Comirnaty vaccination on 10/15/25
2866077	22	F	ID	10/15/2025	FLU3	SANOFI PASTEUR	u8883ba	Fall, Joint injury, Seizure Fall, Joint injury, Seizure	Patient had witnessed seizure and fell into floor about 30 seconds after administration. Injured ank... Patient had witnessed seizure and fell into floor about 30 seconds after administration. Injured ankle after falling. More
2866078	52	M	FL	10/15/2025	FLU3	SANOFI PASTEUR	u8823aa	Injected limb mobility decreased, Injection site bruising, Injection site pain Injected limb mobility decreased, Injection site bruising, Injection site pain	Patient is reporting a bruise, tenderness and limited range of motion at the injection site to this ... Patient is reporting a bruise, tenderness and limited range of motion at the injection site to this day. More
2866079	65	F	NC	10/15/2025	PNC21 RSV	MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS	Z007870 7HZ93	Injection site pain, Product administered at inappropriate site; Injection site ... Injection site pain, Product administered at inappropriate site; Injection site pain, Product administered at inappropriate site More	On October 15, 2025, I received two intramuscular vaccines (RSV and Pneumococcal) in the right arm. ... On October 15, 2025, I received two intramuscular vaccines (RSV and Pneumococcal) in the right arm. Before the first injection, my husband (a Registered Nurse) observed the injection site placement and immediately stated aloud that it was too low anatomically ? below the CDC-recommended deltoid injection zone. The administering healthcare worker disregarded his warning and proceeded with both injections in the same low position. At the time of injection, I experienced noticeably sharper and more immediate pain than with the two previous vaccines I received two weeks earlier in the opposite arm, administered properly by a different provider. Those earlier injections caused no pain at the time, only normal post-vaccine muscle soreness the following day. As of 4 hours post-injection: * No tingling, numbness, radiating pain, or weakness * Full range of motion preserved * Initial pain resolved within hours However, due to improper injection site, I remain concerned about: * Possible nerve or fascial contact * Potential suboptimal immune response due to incorrect depth or location * Violation of standard clinical procedure despite on-site correction attempt If my trusted diagnostic partner had been present (name withheld), he would have either prevented the injection outright or advised me to leave the facility immediately. This report is submitted to support future patient safety and reinforce respect for anatomical standards. Notably, I experienced a similar improperly placed vaccine at a (name withheld) pharmacy in (city, state withheld) approximately 8 years ago, which resulted in lasting shoulder pain and loss of range of motion that persisted for nearly a year. I was an active swimmer at the time and was unable to swim properly due to the injury. That injury was never formally reported. Given the similarities in pain and misplacement, I am submitting this event to prevent a recurrence of long-term complications ? for myself and others. Additionally, upon entering the current clinic, I had an immediate instinctual hesitation. Something felt wrong, as though the staff were disorganized or untrained. I now believe this instinct was accurate and should have been honored. More
2866080	47	M	ID	10/15/2025	FLU3	SANOFI PASTEUR		Injected limb mobility decreased, Injection site discomfort, Injection site pain... Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain More	I had some discomfort at the injection site initially (tenderness). Pain persisted and evolved over ... I had some discomfort at the injection site initially (tenderness). Pain persisted and evolved over 24 hours, and started to limit range of motion. tenderness went away and now discomfort is kind of hard to pin point, but abducting my arm causes significant pain More
2866081	78	F	AL	10/15/2025	FLU3 PNC21	SANOFI PASTEUR MERCK & CO. INC.	U876DB Z009681	Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling	REDNESS, SWELLING, AND WARM REDNESS, SWELLING, AND WARM
2866082	67	F	CA	10/15/2025	COVID19	MODERNA	3052732	Peripheral swelling, Tenderness Peripheral swelling, Tenderness	Adverse Event- Occured the day after her covid vaccination. She got her covid vaccination on 10-12... Adverse Event- Occured the day after her covid vaccination. She got her covid vaccination on 10-12-25 and got adverse reaction on 10-13-25. Symptoms are: Swelling on right side- she stated "It looks like I got hit by a baseball on that arm." No itching, just tender." Treatment- she sought no medical treatment from her primary md. She just took OTC ibuprofen. Outcome- she is fine now, no more swelling. More
2866083	31	F	NY	10/15/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION	948203	Dyspnoea, Urticaria Dyspnoea, Urticaria	received the second dose of HEP B vaccine in the office around 1 pm. Shortly after, around 2 pm, the... received the second dose of HEP B vaccine in the office around 1 pm. Shortly after, around 2 pm, the student returned to the clinic to inform us that she was experiencing hives and difficulty breathing. The student was promptly triaged and assessed, with notable hives on the bilateral arms, neck, and face, and was visibly experiencing breathing difficulty. VS stable (135/84, HR 88, sats 100%). The student informed us that she took Benadryl PO 30 minutes prior, which helped slightly with her hives. EMS called on site and took the student to the ED. More
2866084	44	M	TX	10/15/2025	COVID19	MODERNA		Antibody test positive Antibody test positive	Spike protein levels are now @ 15,300+. Spike protein levels are now @ 15,300+.		✓
2866085	50	F	WA	10/15/2025	COVID19 FLU3	MODERNA SEQIRUS, INC.	8146367 948409	Injection site bruising, Injection site swelling; Injection site bruising, Injec... Injection site bruising, Injection site swelling; Injection site bruising, Injection site swelling More	injection site reaction. severe arm swelling and bruising around deltoid and tricep area injection site reaction. severe arm swelling and bruising around deltoid and tricep area
2866087	10	F	TX	10/15/2025	FLU3	SANOFI PASTEUR	UT8817MA	Musculoskeletal stiffness, Pallor, Staring, Unresponsive to stimuli Musculoskeletal stiffness, Pallor, Staring, Unresponsive to stimuli	Pt was loading into her car outside and was unresponsive to mom, staring and stiff, mentioned arms w... Pt was loading into her car outside and was unresponsive to mom, staring and stiff, mentioned arms were pulled up against chest but not witnessed by provider--EMS called Parents were carrying her out of the car on MD arrival Brought to room 1, she had pallor, was unresponsive estimated 30 seconds, no jerking movements noted, normal tone Placed 2 L Ox by NC for comfort and helped her slow breathing No desats, poc glucose was 100 Mild pink rash noted upper left arm superior to bandaid from today's blood draw Pt stated she felt weird -denied blacking out Mom said pt had a similar reaction about 3 years ago but could not explain -no hx vaccine reactions-received Fluzone today RD EMS arrived and transporting to (withheld ER name) for further observation, post ictal vs vasovagal reaction More
2866088	51	F	UT	10/15/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	CY53G2026-06-30	Chest discomfort, Pharyngeal swelling, Throat irritation Chest discomfort, Pharyngeal swelling, Throat irritation	Began having itchy and irritated throat and throat swelling about 2 hours after receiving the shot. ... Began having itchy and irritated throat and throat swelling about 2 hours after receiving the shot. Chest tightness about 30 min after the throat swelling started. More
2866089	96	F	ME	10/15/2025	COVID19	PFIZER\BIONTECH	NA0590	Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus	Patient reported to her primary care physician with erythema, itching, redness and swelling in her a... Patient reported to her primary care physician with erythema, itching, redness and swelling in her arm with slow improvement in swelling. More
2866091	30	F	MI	10/15/2025	FLU3	SEQIRUS, INC.	406986	Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity	patient feels pain in her left arm when moving but does have full range of motion patient feels pain in her left arm when moving but does have full range of motion
2866094		F	NM	10/15/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Injection site pain; Injection site pain; Injection site pain Injection site pain; Injection site pain; Injection site pain	injections hurts; injections hurts; injections hurts; This spontaneous report was received from a me... injections hurts; injections hurts; injections hurts; This spontaneous report was received from a medical assistant via a company employee. Medical assistant was referring to herself, a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, the patient was vaccinated with a total of 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), Suspension for injection, (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. This was a 3 dose series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) vaccinations. The medical assistant reported, that the injections hurt. She said the 1st and 2nd dose hurt more than the 3rd. Date of adverse event was not provided. The patient recovered from all events on an unspecified date. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) was reported as dose not changed (reported as therapy not withdrawn). The causal relationship was not provided. Batch/Lot number is being requested and will be submitted if received. More
2866095	15	M	CA	10/15/2025	HPV9	MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	No additional AE; male patient who was 15 years old when he received his first dose of GARDASIL 9 an... No additional AE; male patient who was 15 years old when he received his first dose of GARDASIL 9 and he received a second dose of GARDASIL 9 yesterday on 10/14/2025 at the age of 25; This spontaneous report was received from a consumer regarding a 25-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 14-OCT-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 1 dosage form administered as prophylaxis (strength, exact dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). It was reported that the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) on an unknown date when he was 15 years old, and he received the second dose at 25 years old (Inappropriate schedule of product administration). No additional adverse events were reported. Lot number is being requested and will be submitted if received. More
2866096	10	F	IN	10/15/2025	HPV9	MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	a patient who received her first dose of GARDASIL 9 in 2022 at 10 years old and is now requesting he... a patient who received her first dose of GARDASIL 9 in 2022 at 10 years old and is now requesting her second dose.; No clinical side effects noted. No additional AE; This spontaneous report was received from a Nurse and refers to an approximately 13-year-old female patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. In 2022 (At the age of 10-year-old), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) (route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis; and at the reporting time, she was requesting her second dose (Inappropriate schedule of product administration). No clinical side effects noted. No additional adverse event (AE). Batch/Lot number is being requested and will be submitted if received. More
2866097	32	F	NC	10/15/2025	UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	37KF3 37KF3 37KF3 37KF3	Anaphylactic reaction, Back pain, Choking sensation, Dizziness, Erythema; Fatigu... Anaphylactic reaction, Back pain, Choking sensation, Dizziness, Erythema; Fatigue, Feeling of body temperature change, Headache, Influenza like illness, Muscular weakness; Pain, Pain in extremity, Paraesthesia, Poor quality sleep, Swelling; Swelling face, Swelling of eyelid, Tremor More	Anaphylaxis; patient did not sleep well that night; patient's entire face was a complete circle... Anaphylaxis; patient did not sleep well that night; patient's entire face was a complete circle (her entire face was swollen); Her upper and lower eye lids were swollen; She was also swollen under her chin and neck; patient felt super tired and felt super dizzy, and was having achiness; Her face started to tingle; felt shaky; patient was also experiencing a choking sensation; had weakness in the left arm and left leg; felt super dizzy; was having achiness; arm began to feel sore; began to turn red; headache; fatigue/patient felt super tired; terrible back pain; flu-like symptoms; Patient took her temperature at 11 pm and it was 100.1 degrees F; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 32-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 37KF3, expiry date 20-JUN-2026) for prophylaxis. The patient's past medical history included asthma (Asthma), postural orthostatic tachycardia syndrome (Postural orthostatic tachycardia syndrome), hydronephrosis (Hydronephrosis of kidney), celiac disease (Celiac disease), hypermobility syndrome and endometriosis. Concurrent medical conditions included anxiety (Anxiety), depression (Depression), sleep disorder, latex allergy (Latex allergy), allergy to animal (Animal allergies), drug allergy (Chlorhexidine Allergy) and drug allergy (Allergy to Naproxen, In past, experienced swelling of face and chin with Naproxen). Concomitant products included fexofenadine hydrochloride (Allegra), desvenlafaxine succinate monohydrate (Pristiq) and trazodone. On 30-SEP-2025 11:30, the patient received the 1st dose of Fluarix 2025-2026 season (intramuscular, left arm) .5 ml. On 30-SEP-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced fever (Verbatim: Patient took her temperature at 11 pm and it was 100.1 degrees F). On 30-SEP-2025 18:00, the patient experienced pain in arm (Verbatim: arm began to feel sore), erythema of extremities (Verbatim: began to turn red), headache (Verbatim: headache), fatigue (Verbatim: fatigue/patient felt super tired), back pain (Verbatim: terrible back pain) and influenza-like symptoms (Verbatim: flu-like symptoms). On 01-OCT-2025, the patient experienced dizziness (Verbatim: felt super dizzy), pain (Verbatim: was having achiness), choking sensation (Verbatim: patient was also experiencing a choking sensation) and weakness of limbs (Verbatim: had weakness in the left arm and left leg). On 01-OCT-2025 09:00, the patient experienced facial swelling (Verbatim: patient's entire face was a complete circle (her entire face was swollen)), swelling of eyelid (Verbatim: Her upper and lower eye lids were swollen), local swelling (Verbatim: She was also swollen under her chin and neck), tiredness (Verbatim: patient felt super tired and felt super dizzy, and was having achiness), tingling (Verbatim: Her face started to tingle) and tremor (Verbatim: felt shaky). On an unknown date, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant) and sleeplessness (Verbatim: patient did not sleep well that night). The patient was treated with ibuprofen, Steroids, diphenhydramine hydrochloride (Benadryl) and prednisone. The outcome of the anaphylaxis, pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation and tremor were resolving and the outcome of the weakness of limbs was not resolved. It was unknown if the reporter considered the anaphylaxis, pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation, weakness of limbs and tremor to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. The company considered the anaphylaxis to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation, weakness of limbs and tremor to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-OCT-2025 The reporter reported that around 6 pm that day on the day of vaccination the patient arm began to feel sore, and began to turn red. She felt hot and cold, and shaky. At 9 am the next day, the patient entire face was a complete circle, her entire face was swollen. Her upper and lower eye lids were swollen, the patient could only see half-way out of her eyes. The patient was also swollen under her chin and neck. The patient took Ibuprofen for the swelling. The patient felt super tired and felt super dizzy, and was having achiness. The patient tried to sleep it off, after she woke up, the patient realized her swollen face was not going down, it was getting worse. The patient began to have weakness in her left arm and left leg. Her face started to tingle. The patient was also experiencing a choking sensation. Around 4:30 pm, the patient went to an urgent care center where she was told she was exhibiting signs of anaphylaxis. The patient was given injectable steroids, injectable Benadryl, and a nebulizer treatment to treat her symptoms. The patient was subsequently prescribed Prednisone for 5 days, and Benadryl after every 8 hours. On 02nd October 2025, the patient face was a little less swollen and had weakness in the left arm. The patient felt her symptoms were getting better, but were still worrisome. The patient did not take the placebo tablets in the birth control pills, so no periods.; Sender's Comments: A case of Anaphylactic reaction, less than a week after receiving Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and biological plausibility. More
2866098		M	CA	10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	not yet received the second dose; This non-serious case was reported by a consumer via call center r... not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2024). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-OCT-2025 The batch number of first dose was not provided, and we are unable to contact the reporter. More
2866099		F		10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Periarthritis, Product administered at inappropriate site Periarthritis, Product administered at inappropriate site	Frozen shoulder; nurse administered the vaccine too high into the shoulder joint, rather than into t... Frozen shoulder; nurse administered the vaccine too high into the shoulder joint, rather than into the deltoid muscle; This serious case was reported by a consumer via sales rep and described the occurrence of frozen shoulder in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced frozen shoulder (Verbatim: Frozen shoulder) (serious criteria other: Serious as per reporter) and vaccine administered at inappropriate site (Verbatim: nurse administered the vaccine too high into the shoulder joint, rather than into the deltoid muscle). The outcome of the frozen shoulder was resolved and the outcome of the vaccine administered at inappropriate site was not applicable. The reporter considered the frozen shoulder to be unrelated to Shingrix. The company considered the frozen shoulder to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-OCT-2025 The reporter stated that they themselves were the patient, and the nurse administered the vaccine too high into the shoulder joint, rather than into the deltoid muscle. The reporter stated that the event had nothing to do with the product itself, but rather the incorrect administration technique. No other products were received by the patient. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Periarthritis, an unknown time after receiving Shingrix, in an 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
2866100	56	F	MS	10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Condition aggravated, Pain, Pruritus Condition aggravated, Pain, Pruritus	return of severe shingles pain/severe itching; This non-serious case was reported by a consumer via ... return of severe shingles pain/severe itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (in JAN-2023) and pain (pain that never fully resolved). On 06-AUG-2025, the patient received the 1st dose of Shingrix. In AUG-2025, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: return of severe shingles pain/severe itching). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date:09-OCT-2025 The patient received Shingrix and indicated that prior to receiving the shot she had a case of shingles and experienced pain that never fully resolved, it subsided but did not resolve. But then after receiving the Shingrix shot the severe shingles pain returned and also, she experienced severe itching which has not resolved. She made a comment on Instagram which said went to a new doctor got the Shingrix vaccine. Two weeks later a new case of shingles The batch number was not provided, and will contact the reporter for more information More
2866101				10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Product administered to patient of inappropriate age, Product prescribing error Product administered to patient of inappropriate age, Product prescribing error	Under 50, but doctor recommended Shingrix; This non-serious case was reported by a consumer via cal... Under 50, but doctor recommended Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug prescribing error 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 drug prescribing error (Verbatim: Under 50, but doctor recommended Shingrix). The outcome of the drug prescribing error was not applicable. Additional Information: GSK Receipt Date: 25-SEP-2025 This case was reported by a patient via interactive digital media. The physician recommended Shingrix for the patient who was below 50 years of age. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: US-GSK-US2025AMR124610:Original Case Number : US2025AMR124581 US-GSK-US2025AMR124609:Original Case Number : US2025AMR124581 US-GSK-US2025AMR124608:Original Case Number : US2025AMR124581 US-GSK-US2025AMR124581:Original Case Number : US2025AMR124581 US-GSK-US2025AMR124607:Original Case Number : US2025AMR124581 More
2866103		F		10/15/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; I thought I had flea bites on my back. I went to the doctor, and he s... Suspected vaccination failure; I thought I had flea bites on my back. I went to the doctor, and he said it was shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Family history included shingles (patient's parents suffered from shingles). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I thought I had flea bites on my back. I went to the doctor, and he said it was shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by the patient via interactive digital media. The patient stated that one year her husband told her to get a shingle shot since both her parents have had them. The next year they said they had changed it to two shots a few months apart and the patient had those. A few months ago (from the date of reporting) she thought she had flea bites on her back and went to the physician, and he said it was shingles. The patient said but she had her shots, and the physician said it would have been so much worse if she would not have had her shots. A few days of medicines and it was gone. The patient's husband got his shots. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, 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
2866104		F		10/15/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Loss of visual contrast sensitivity, Ophthalmic herpes zoster, Pa... Herpes zoster, Loss of visual contrast sensitivity, Ophthalmic herpes zoster, Pain, Pruritus; Vaccination failure, Vision blurred More	Suspected vaccination failure; Shingles into my eye; Shingles top of my head; This serious case was ... Suspected vaccination failure; Shingles into my eye; Shingles top of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles into my eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles top of my head). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that she had shingles on the top of her head into her eye. It had been two years now and patient was still having pain, itching, loss of sensitivity in her eye and blurred vision. The batch number was not provided, and we are unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles and ophthalmic herpes zoster were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, a3 months after receiving Shingles vaccine, 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
2866105				10/15/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	UNK	Injection site pruritus, Injection site rash Injection site pruritus, Injection site rash	itchiness and some localized rash at the site of the injection; itchiness and some localized rash at... itchiness and some localized rash at the site of the injection; itchiness and some localized rash at the site of the injection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, 3 days after receiving Arexvy, the patient experienced injection site itching (Verbatim: itchiness and some localized rash at the site of the injection) and injection site rash (Verbatim: itchiness and some localized rash at the site of the injection). The outcome of the injection site itching and injection site rash were not reported. It was unknown if the reporter considered the injection site itching and injection site rash to be related to Arexvy. It was unknown if the company considered the injection site itching and injection site rash to be related to Arexvy. Additional Information: GSK Receipt Date: 05-OCT-2025 The patient developed itchiness and some localized rash at the site of the injection three days after the Arexvy vaccine. The patient was ask could get the delay reaction. More
2866106				10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; but got shingles; This serious case was reported by a consumer via in... Suspected vaccination failure; but got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: but got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 08-OCT-2025 This case was reported by a patient via interactive digital media. Patient got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, 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
2866107				10/15/2025	RVX	UNKNOWN MANUFACTURER	UNK	Autoimmune disorder, Sepsis Autoimmune disorder, Sepsis	sepsis; it activated an autoimmune system issue; This serious case was reported by a consumer via in... sepsis; it activated an autoimmune system issue; This serious case was reported by a consumer via interactive digital media and described the occurrence of sepsis 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 sepsis (Verbatim: sepsis) (serious criteria GSK medically significant) and autoimmune disorder (Verbatim: it activated an autoimmune system issue) (serious criteria GSK medically significant). The outcome of the sepsis and autoimmune disorder were not reported. The reporter considered the sepsis and autoimmune disorder to be related to RSV vaccine. The company considered the sepsis and autoimmune disorder to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 12-OCT-2025 This case was reported by a patient via interactive digital media. Patient had a horrible reaction to RSV vaccine as it activated an autoimmune system issue that led to sepsis. The reporter mentioned that not for him/her but what did they consider helpful. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Sepsis and Autoimmune disorder, an 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
2866108				10/15/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; I got both shots and 2 years later I got shingles lasted for 2 months... Suspected vaccination failure; I got both shots and 2 years later I got shingles lasted for 2 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and 2 years later I got shingles lasted for 2 months). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 2 months). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-OCT-2025 This case was reported by a patient via interactive digital media. Patient said that having shingles was not fun at all. This case was considered as suspected vaccination failure as details of 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, 2 years after receiving Shingles vaccine (dose2) and more than 2 years after receiving Shingles vaccine (dose 1), 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
2866109		F	TN	10/15/2025	UNK	UNKNOWN MANUFACTURER	9CC9K	Incorrect route of product administration Incorrect route of product administration	patient had received a dose of Fluarix via IV; This non-serious case was reported by a other health ... patient had received a dose of Fluarix via IV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 9CC9K, expiry date 30-JUN-2026) for prophylaxis. On 21-SEP-2025, the patient received Fluarix 2025-2026 season (intravenous). On 21-SEP-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced intramuscular formulation administered by other route (Verbatim: patient had received a dose of Fluarix via IV). The outcome of the intramuscular 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: 22-SEP-2025 No further details were provided. More
2866111	54	M	KS	10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	55KB9	Product preparation issue Product preparation issue	administered only adjuvant portion of Shingrix; administered only adjuvant portion of Shingrix; This... administered only adjuvant portion of Shingrix; administered only adjuvant portion of Shingrix; 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 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 55KB9, expiry date 26-APR-2027) for prophylaxis. On 22-SEP-2025, the patient received Shingrix. On 22-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered only adjuvant portion of Shingrix) and inappropriate preparation of medication (Verbatim: administered only adjuvant portion of Shingrix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 The nurse explained they administered only adjuvant portion of Shingrix to a patient on 22nd September 2025. More
2866112		M	NY	10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 19-JUL-2023). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:10-OCT-2025 The patient who received one dose of Shingrix back in 2023, and he just wanna to see if the patient had to restart the series. The vaccine administration facility was the same as Primary Reporter. More
2866113		M	TN	10/15/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	UNK	Seizure Seizure	patient presented seizures/convulsions after getting flu shot; This serious case was reported by a p... patient presented seizures/convulsions after getting flu shot; This serious case was reported by a pharmacist via call center representative and described the occurrence of seizure in a elderly male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced seizure (Verbatim: patient presented seizures/convulsions after getting flu shot) (serious criteria GSK medically significant). The outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the seizure to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 10-OCT-2025 Reporter asked regarding the Arexvy vaccine and a possible adverse reaction. According to the reporter, an adult patient was suggested by his Physician to get the Arexvy vaccine, but the patient presented seizures /convulsions after getting a flu vaccine (not specified) in the past (unknown date). The patient wanted to know if there was a possibility of having these adverse reactions after getting the shot of Arexvy.; Sender's Comments: A case of Seizure, unknown time after receiving a dose of Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE in a male subject. 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
2866114		M	IL	10/15/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Second dose missing; This non-serious case was reported by a pharmacist via call center representati... Second dose missing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2 years ago, batch number: N547S and expiry date:27-OCT-2026). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Second dose missing). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:10-OCT-2025 The patient who received 1 dose of Shingrix two years ago and asked if he start should again with 2 doses or complete the series with 1 dose. He received 1st dose 2 years ago did not remember the date. More
2866115	69	F		10/15/2025	COVID19	MODERNA		Illness, Pain, Pain in extremity, Pyrexia Illness, Pain, Pain in extremity, Pyrexia	Ill; Achy; low grade temp; it was just slightly sore in the arm; This spontaneous case was reported ... Ill; Achy; low grade temp; it was just slightly sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was just slightly sore in the arm), ILLNESS (Ill), PAIN (Achy) and PYREXIA (low grade temp) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot on 12-Sep-2025. Past adverse reactions to the above products included No adverse effect with Flu shot. Concomitant products included Paracetamol (Tylenol) and Ibuprofen for an unknown indication. On 03-Oct-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 03-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced PAIN IN EXTREMITY (it was just slightly sore in the arm). On 04-Oct-2025, the patient experienced PAIN (Achy) and PYREXIA (low grade temp). On 06-Oct-2025, the patient experienced ILLNESS (Ill). On 04-Oct-2025, PAIN IN EXTREMITY (it was just slightly sore in the arm) had resolved. At the time of the report, ILLNESS (Ill), PAIN (Achy) and PYREXIA (low grade temp) outcome was unknown. The patient didn't feel any side effects right after getting the vaccine and was surprised by that. Later, at night of vaccination had slightly sore in the arm and next day patient was fine. On 06-Oct-2025 she got ill. Patient also had low grade temperature and was achy. She was unsure about when she could safely take Ibuprofen or Tylenol again. She also felt she wasn't given enough information about the vaccine type and dose. Despite this, she gave positive feedback and appreciated the lower dose. Treatment medication was not reported. This case was linked to MOD-2025-789983, MOD-2025-789984 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live non-significant follow-up received: Reference numbers added On 06-Oct-2025: Live significant follow-up received includes new events like Illness, Ache, Low grade fever and concomitant medications Tylenol and ibuprofen were added. On 06-Oct-2025: Live non-significant follow-up received. Reference numbers were added. On 07-Oct-2025: Live non-significant follow-up received. Reference numbers added More
2866116				10/15/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3046714	Oropharyngeal pain; Oropharyngeal pain Oropharyngeal pain; Oropharyngeal pain	Sometimes feel had a sore throat/oropharyngeal pain (sore throat); This spontaneous case was reporte... Sometimes feel had a sore throat/oropharyngeal pain (sore throat); This spontaneous case was reported by a non-health professional and describes the occurrence of OROPHARYNGEAL PAIN (Sometimes feel had a sore throat/oropharyngeal pain (sore throat)) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046714) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for Prophylactic vaccination. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (It was reported that patient's all previous vaccines shots were Moderna.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 22-Aug-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In 2025, the patient experienced OROPHARYNGEAL PAIN (Sometimes feel had a sore throat/oropharyngeal pain (sore throat)). At the time of the report, OROPHARYNGEAL PAIN (Sometimes feel had a sore throat/oropharyngeal pain (sore throat)) had not resolved. Concomitant medications were not reported. The patient sometimes felt a sore throat/oropharyngeal pain (sore throat) after receiving the Influenza USP Trival A-B high dose subvirion vaccine, suspension for injection in a pre-filled syringe [Fluzone high dose] and Spikevax 2024-2025 Formula. The patient's past medical treatments and family history were not provided. Information on the batch number was requested corresponding to the one at the time of event occurrence. The event latency was reported as a few days approximately. The patient did not have an effect like this before. It was the first time the patient had a negative effect to the extent that the patient was in bed all day the following day and did not know if it was the flu shot or the extra COVID shot. Regarding whether the patient was still experiencing symptoms, it was reported that it was probably a phantom thing. The patient was so upset about it. The patient sometimes felt a sore throat, when it was probably just normal. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment for the event. More
2866117		F	AZ	10/15/2025	COVID19	MODERNA		Vaccination site pain Vaccination site pain	Arm injection site soreness for a day or two; This spontaneous case was reported by a consumer and d... Arm injection site soreness for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm injection site soreness for a day or two) 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 VACCINATION SITE PAIN (Arm injection site soreness for a day or two). At the time of the report, VACCINATION SITE PAIN (Arm injection site soreness for a day or two) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. The current age of the patient was reported as 69-year-old. The patient never had any reactions to COVID vaccinations since late 2020, except for annual arm injection site soreness for a day or two. The patient had no medical history, concomitant diseases, or risk factors. There were no lab data/results available. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-789998 (Patient Link). More
2866118	76	F		10/15/2025	COVID19 COVID19	MODERNA MODERNA	026L20A 026L20A	Aneurysm, Blood cholesterol increased, Coronary artery disease, Fall, Gait distu... Aneurysm, Blood cholesterol increased, Coronary artery disease, Fall, Gait disturbance; Rash More	fell; hobbling; Zetia did not bring down her cholesterol enough; coronary artery disease; an aneurys... fell; hobbling; Zetia did not bring down her cholesterol enough; coronary artery disease; an aneurysm; Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (coronary artery disease), ANEURYSM (an aneurysm), FALL (fell), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A, 939676 and 056M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced CORONARY ARTERY DISEASE (coronary artery disease) and ANEURYSM (an aneurysm). On an unknown date, the patient experienced FALL (fell), GAIT DISTURBANCE (hobbling), BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash). The patient was treated with Ezetimibe (Zetia) for High cholesterol, at an unspecified dose and frequency and Evolocumab (Repatha) for High cholesterol, at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY DISEASE (coronary artery disease), ANEURYSM (an aneurysm), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) outcome was unknown and FALL (fell) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash) had resolved. Concomitant medications were not reported. Date of administration of Fourth dose was reported as either 25-Apr-2022 or 25-Nov-2022. Patient was diagnosed two years ago with coronary artery disease and an aneurysm. Patient was trying to diet and she took Zetia, which she was still on. Zetia did not bring down her cholesterol enough, so they put her on Repatha too. She was currently on Repatha and her next dose would be her 3rd shot. It was reported that in the past she was not on Repatha so she has never had a COVID vaccine at the same time as her Repatha. It was reported that after every vaccine, patient experienced the Moderna arm. Patient would get the rash but no big side effects, just the rash and it got extended to the elbow (it would go from her shoulder to her elbow). It was a big rash and guesses that it was called the COVID rash or something. It was reported that the rash has gotten smaller every time patient had gotten the shot. Patient's last year shot, it was much smaller in reaction. Patient had the first rash which was the worst, and it was just "like crazy" and went away in one week. This case was linked to MOD-2025-790020 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2025: Live non-significant follow-up received. Reporter's email address and reference numbers added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2866119	78	F		10/15/2025	COVID19-2 COVID19-2	MODERNA MODERNA	046H22A 046H22A	Aneurysm, Blood cholesterol increased, Coronary artery disease, Fall, Gait distu... Aneurysm, Blood cholesterol increased, Coronary artery disease, Fall, Gait disturbance; Rash More	Fell; hobbling; Zetia did not bring down her cholesterol enough; Moderna arm/She would get the rash/... Fell; hobbling; Zetia did not bring down her cholesterol enough; Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash; Coronary artery disease; an aneurysm; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (Coronary artery disease), ANEURYSM (an aneurysm), FALL (Fell), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4 and Batch no. - 056M21A) in 2022. Past adverse reactions to the above products included Aneurysm with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Coronary artery disease with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Fall with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; High cholesterol with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Rash with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; and Walking difficulty with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine. In 2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced CORONARY ARTERY DISEASE (Coronary artery disease) and ANEURYSM (an aneurysm). On an unknown date, the patient experienced FALL (Fell), GAIT DISTURBANCE (hobbling), BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash). The patient was treated with Ezetimibe (Zetia) for High cholesterol, at an unspecified dose and frequency and Evolocumab (Repatha) ongoing since an unknown date for High cholesterol, at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY DISEASE (Coronary artery disease), ANEURYSM (an aneurysm), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) outcome was unknown and FALL (Fell) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash) had resolved. No concomitant medications were reported. Patient was trying to diet and she took Zetia, which she was still on. Zetia did not bring down her cholesterol enough, so they put her on Repatha too. She was currently on Repatha. It was reported that in the past she was not on Repatha so she has never had a COVID vaccine at the same time as her Repatha. It was reported that after every vaccine, patient experienced the Moderna arm. Patient would get the rash but no big side effects, just the rash and it got extended to the elbow (it would go from her shoulder to her elbow). It was a big rash and guesses that it was called the COVID rash or something. It was reported that the rash had gotten smaller every time patient had gotten the shot. This case was linked to MOD-2025-790020 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2025: Live non-significant follow-up received. Reporter's email address and reference numbers added. More
2866120	75	M		10/15/2025	COVID19	MODERNA		COVID-19, Immunisation reaction, SARS-CoV-2 test COVID-19, Immunisation reaction, SARS-CoV-2 test	Diagnosed with Covid-19 in late August 2025; Patient always seems to react to things a little bit mo... Diagnosed with Covid-19 in late August 2025; Patient always seems to react to things a little bit more; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19 in late August 2025) and IMMUNISATION REACTION (Patient always seems to react to things a little bit more) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with Flu vaccine. In May 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced IMMUNISATION REACTION (Patient always seems to react to things a little bit more). In August 2025, the patient experienced COVID-19 (Diagnosed with Covid-19 in late August 2025). At the time of the report, COVID-19 (Diagnosed with Covid-19 in late August 2025) and IMMUNISATION REACTION (Patient always seems to react to things a little bit more) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2025, SARS-CoV-2 test: Positive. Concomitant medication use information was not provided by reporter. It was reported that, patient reacted a lot to previous Moderna vaccines. Patient got the latest vaccine in May 2025 which had least reaction of all of them. With each one, any kind of little reaction has gotten better. Patient was diagnosed with Covid-19 in late August 2025. No hospitalization required. It was just that the patient reacted to the flu shot the same way, always seeming to react to things a little bit more. It was reported that years ago, for the shingles shot, the patient had a reaction to it. It was nothing alarming, so it was not a big deal. 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 US-MODERNATX, INC.-MOD-2025-790046 (E2B Linked Report). This case was linked to MOD-2025-790049, MOD-2025-790048 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790046:Patient 01 More
2866121		F		10/15/2025	COVID19	MODERNA		Illness Illness	she got the Moderna Covid-19 Vaccine and got sick from it; This spontaneous case was reported by a c... she got the Moderna Covid-19 Vaccine and got sick from it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got the Moderna Covid-19 Vaccine and got sick from it) 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 ILLNESS (she got the Moderna Covid-19 Vaccine and got sick from it). At the time of the report, ILLNESS (she got the Moderna Covid-19 Vaccine and got sick from it) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. More
2866122	81	M		10/15/2025	COVID19	MODERNA		Pain Pain	aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PA... aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains) in an 81-year-old male patient 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 PAIN (aches and pains). At the time of the report, PAIN (aches and pains) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received the Spikevax vaccine last September (2024), and that he had been getting Spikevax every year. He mentioned that each time he received the vaccine, he experienced side effects. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-790151 (Patient Link). Reporter did not allow further contact More
2866123	44	F	CA	10/15/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Diabetes mellitus, Underdose; Diabetes mellitus, Underdose Diabetes mellitus, Underdose; Diabetes mellitus, Underdose	this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems ... this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose; was diagnosed with diabetes; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (was diagnosed with diabetes) in a 44-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. Concurrent medical conditions included Undifferentiated connective tissue disease (autoimmune condition - undifferentiated connective tissue disease) and Obesity. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In July 2024, the patient experienced DIABETES MELLITUS (was diagnosed with diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced UNDERDOSE (this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose). At the time of the report, DIABETES MELLITUS (was diagnosed with diabetes) had not resolved and UNDERDOSE (this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that the patient had received mNEXSPIKE and unspecified Flu vaccine on 30-Sep-2025. The patient's first COVID vaccine was the first one that Moderna ever created. The patient was used to get standard Spikevax every 6 months and only received Moderna vaccine as a COVID vaccine. The patient never had any issues, and it was always super well tolerated. The patient was diagnosed with diabetes last July. It was stated, Initially, patient was doing it yearly because patient wasn't going anywhere. When patient moved to every 6 months and patient felt a little bit better about going into public spaces. It was stated that this was a lower dose than the standard, number one, so that patient got a little worried. Also, it seemed like it's a tailored dose. It was unknown if the patient experienced any additional symptoms or events. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up received: Reference ids added On 06-Oct-2025: Live non-significant follow-up received: Reference ids added; Reporter's Comments: Co-suspect product Influenza vaccine, Concurrent medical conditions autoimmune disease and Obesity are confounders for the event. The benefit-risk relationship of product is not affected by this report. More
2866124	81	M		10/15/2025	COVID19	MODERNA		Colonoscopy, Crohn's disease, Therapeutic product effect incomplete Colonoscopy, Crohn's disease, Therapeutic product effect incomplete	has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and ... has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case; was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) in an 81-year-old male 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 Ustekinumab (Stelara) for Crohn's disease. Concurrent medical conditions included Crohn's (diagnosed from before the vaccines (when he was 76 years old)) since 2020. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and Ustekinumab (Stelara) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) (seriousness criterion medically significant) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving). The patient was treated with Risankizumab rzaa (Skyrizi) at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) had not resolved and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: while Stelara was improving most of the colon there was one section that was not improving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, HCP recommended the patient to take Covid vaccine every 6 months - off label usage. He had Crohn's disease, diagnosed from before the vaccines (when he was 76 years old) and was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that was not improving and so his HCP switched him to Skyrizi. On 05-May-2025, he received Spikevax 2024-2025 (Lot number: 3046731) at a dose of 0.5 ml. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2866125	79	F		10/15/2025	COVID19	MODERNA	8057965	Blood cholesterol increased, Fall, Gait disturbance, Rash Blood cholesterol increased, Fall, Gait disturbance, Rash	Fell; hobbling; Zetia did not bring down her cholesterol enough; Moderna arm/She would get the rash/... Fell; hobbling; Zetia did not bring down her cholesterol enough; Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell), GAIT DISTURBANCE (hobbling), BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057965) for COVID-19 prophylaxis. Concurrent medical conditions included Coronary artery disease since 2023 and Aneurysm since 2023. In 2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FALL (Fell), GAIT DISTURBANCE (hobbling), BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash). The patient was treated with Ezetimibe (ZETIA) for Blood cholesterol increased, at an unspecified dose and frequency and Evolocumab (Repatha) at an unspecified dose and frequency. At the time of the report, FALL (Fell) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash) had resolved and GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) outcome was unknown. Concomitant medications were not reported. Date of administration of sixth dose was reported as either 07-Feb-2024 or 17-Oct-2024 at pharmacy. Patient was trying to diet and she took Zetia, which she was still on. Zetia did not bring down her cholesterol enough, so they put her on Repatha too. She was currently on Repatha and her next dose would be her 3rd shot. It was reported that in the past she was not on Repatha so she has never had a COVID vaccine at the same time as her Repatha. It was reported that after every vaccine, patient experienced the Moderna arm. Patient would get the rash but no big side effects, just the rash and it got extended to the elbow (it would go from her shoulder to her elbow). It was a big rash and guesses that it was called the COVID rash or something. It was reported that the rash has gotten smaller every time patient had gotten the shot. Patient's last years shot, it was much smaller in reaction. Patient had the first rash which was the worst, and it was just "like crazy" and went away in one week. For her last shot, patient hardly, didn't had much at all, and it went away pretty quickly. It lasted for 2 days after her last shot. This case was linked to US-MODERNATX, INC.-MOD-2025-790025 (E2B Linked Report). This case was linked to MOD-2025-790023, MOD-2025-790024 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2025: Live non-significant follow-up received. Reporter's email address and reference numbers added.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790025:Invalid case for multiple people More
2866126		F	MA	10/15/2025	COVID19	MODERNA	3032264	Fatigue, Feeling abnormal, Pulmonary embolism Fatigue, Feeling abnormal, Pulmonary embolism	saddle pulmonary embolism/she couldn't step up and she couldn't stand; very tired; felt we... saddle pulmonary embolism/she couldn't step up and she couldn't stand; very tired; felt weird after; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) (seriousness criteria hospitalization, medically significant and life threatening) and FEELING ABNORMAL (felt weird after). On an unknown date, the patient experienced FATIGUE (very tired). The patient was hospitalized on sometime in 2023 due to PULMONARY EMBOLISM. The patient was treated with Surgery (Operation for a saddle pulmonary embolism) for Pulmonary embolism. At the time of the report, PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) and FATIGUE (very tired) was resolving and FEELING ABNORMAL (felt weird after) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. Patient felt weird after the vaccine administration, but the pharmacy said that it was normal. Patient ended up going by ambulance to the hospital to have an operation for a saddle pulmonary embolism. Patient was in the ICU for quite a while. On 01-Nov-2023 patient had the big surgery at hospital. It was reported that patient had done a lot of tests and exams to exclude that the side effects are from blood disease or cancer, so she was sure that the AE was because of the Moderna vaccine. Patient started feeling weird a couple of days after she got the vaccine, it was probably like flu. Patient got scared as she felt very tired, she couldn't step up and she couldn't stand. Patient got a surgery, and she was told that was the biggest embolism that the doctors had seen. Patient was better now, she can walk and people can understand her when she talks. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790097 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2025: Live follow-up received contains significant information. New events were added, narrative was updated and reference was added.; Reporter's Comments: All events have been assessed as related to suspected vaccine due to close temporal association, however additional information has been requested. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790097:Other patient case More	✓	✓
2866127		F	FL	10/15/2025	COVID19	MODERNA		Dizziness, Ear discomfort, Headache, Vestibular disorder, Visual impairment Dizziness, Ear discomfort, Headache, Vestibular disorder, Visual impairment	ear pressure; affected vision; vestibular issues; dizziness; headache; This spontaneous case was rep... ear pressure; affected vision; vestibular issues; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (ear pressure), VISUAL IMPAIRMENT (affected vision), VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizziness) and HEADACHE (headache) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Neck discomfort. 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 EAR DISCOMFORT (ear pressure), VISUAL IMPAIRMENT (affected vision), VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, EAR DISCOMFORT (ear pressure), VISUAL IMPAIRMENT (affected vision), VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizziness) and HEADACHE (headache) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient did not receive any other vaccines within the past 4 weeks. It was reported that the patient experienced numerous negative effects after receiving Spikevax NOS when it initially became available. Patient had ongoing symptoms such as dizziness, headache, ear pressure, affected vision, and vestibular issues. It was also noted that she was suffering and had consulted numerous specialists without success. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2866128				10/15/2025	COVID19	PFIZER\BIONTECH		Myocardial infarction Myocardial infarction	heart attack; This is a spontaneous report received from a Consumer or other non HCP. A patient (ag... heart attack; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Clinical course: It was reported that Shots (Pfizer Covid-19 shots) gave me a heart attack. Outcome of reaction/event at the time of last observation reported as Unknown. Patient was actually calling to see if you could give me the email address to your legal department. Concern included Consumer stated, your shots gave me a heart attack (Clarified as Pfizer Covid-19 shots). Consumer Stated, patient had already talked with somebody at length and patient left a lot of information. So, patient was just hoping patient could get an email address, but patient would try to fax this. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2866129			MD	10/15/2025	PNC20	PFIZER\WYETH	MA2502	Product container issue Product container issue	Prevnar-20 Pediatric vial broke upon removing it from the box in preparation for administration; Thi... Prevnar-20 Pediatric vial broke upon removing it from the box in preparation for administration; This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2502, Expiration Date: 31Oct2026) for immunisation, Device Lot Number: MA2502, Device Expiration Date: 31Oct2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Prevnar-20 Pediatric vial broke upon removing it from the box in preparation for administration". The reporter considered "prevnar-20 pediatric vial broke upon removing it from the box in preparation for administration" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "prevnar-20 pediatric vial broke upon removing it from the box in preparation for administration" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2866130			NC	10/15/2025	RSV	PFIZER\WYETH	LL8391	Occupational exposure to product, Product container issue Occupational exposure to product, Product container issue	Upon attempting to puncture the jar it shattered in pharmacist hands; Upon attempting to puncture th... Upon attempting to puncture the jar it shattered in pharmacist hands; Upon attempting to puncture the jar it shattered in pharmacist hands; This is a spontaneous report received from a Pharmacist from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), PRODUCT CONTAINER ISSUE (non-serious) and all described as "Upon attempting to puncture the jar it shattered in pharmacist hands". Additional information: The pharmacist was reporting a defective Abrysvo vaccine. The product was completely lost and spilt everywhere. Causality for "upon attempting to puncture the jar it shattered in pharmacist hands" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). More
2866131		F	NY	10/15/2025	COVID19 COVID19	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	0315M100FC 0315M100FC	Chills, Pyrexia, Tremor, Vaccination site erythema, Vaccination site induration;... Chills, Pyrexia, Tremor, Vaccination site erythema, Vaccination site induration; Vaccination site pruritus, Vaccination site swelling More	woke up with shake and chills; 103 fever; woke up with shake and chills; the entire area became rais... woke up with shake and chills; 103 fever; woke up with shake and chills; the entire area became raised and hard; injection site was brick red; got like a COVID arm itching; the entire area became raised and hard; Initial information received on 29-Sep-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 78 years old female patient (161.29 cm and 68.04 kg) who experienced woke up with shake and chills, the entire area became raised and hard, 103 fever, injection site was brick red, got like a covid arm itching after receiving NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past vaccination(s) included MODERNA COVID-19 VACCINE (Fever ; site injection discomfort including redness and pain), COVID-19 VACCINE (Fever ; site injection discomfort including redness and pain) and NUVAXOVID in 2024 with irritation at the injection site, but nothing really horrible. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Immunisation. On 26-Sep-2025, the patient received 0.5 ml dose (dose 1) of suspect NVX-COV2373 (original) adjuvanted vaccine , Injection (lot 0315M100FC and expiry date: 31-DEC-2025) via intramuscular route in the left arm for Prophylactic vaccination. On 27-Sep-2025 the patient woke up with shake and chills (tremor) (chills) and 103 fever (pyrexia) (latency: 1 day). On unknown date In Sep-2025 the patient reported that the entire area became raised and hard (vaccination site induration) (vaccination site swelling) , injection site was brick red (vaccination site erythema) and got like a covid arm itching (vaccination site pruritus) (few days: latency). It was reported that "Patient had the Novavax vaccine last year and without incident maybe a little, you know, it's an irritation at the injection site, but nothing really horrible, you know, just very mild, no problem. I went ahead and I had the shot again this year on Friday, this past Friday. Saturday night,I would say, or early Sunday morning, actually, it was like around 1 a.m. I woke up with shake and chills, 103 fever. The injection site was brick red and I got like a COVID arm itching and it was similar to what I had with Moderna, which is why I didn't take Moderna. last night, my husband took me to the (Emergency Room) ER in with the fever continuing. And they advised me to possibly take Keflex 500 milligrams four times a day for five days. The fever broke and I am afebrile now but the itching, the redeness, it's still there. It's still on my arm not as red and not as large an area, but itching, you know, at the injection concentrated on the injection site. When this started, the entire area became raised and hard. Now the raised section is much less but I'm reporting that it happened. Yeah, I guess you don't, you wouldn't have medical information for, you know, your position at the company is, you know, to get, gather information. But I don't understand the difference between last year's shot and this year's shot reaction. In other words, felt comfortable getting it this year and I actually ran once I found out they had it. We were going to go someplace on Saturday so I wanted to make sure to get my shot before. I wasn't worried at all because the year before when I had it it was like a big nothing burger, you know al little bit but no fever no horrible reaction just a little slight irritation which is okay. This was not okay, this was quite different. I read all the descriptions, you know, that were available on the web of possible reactions, but when I was fine last year without any really bad reaction and this year I end up in an ER. So, what do I do now: I can't take the Moderna and I can't take the Pfizer, I have a major reaction and so now the Novavax was my ace in the whole so to speak and now what do I do: if they change, they must have changed something in terms of what they're either an additive that they changed, either to cheapen it or whatever they did. They should know that this is what's happening. So, I am reporting it now. My husband had the same thing and he didn't have a reaction. What I went through was very, very similar to what I had been through with the Moderna. With the Moderna I had 103 plus fever but it lasted longer. I remember I was very ill with the Moderna. I had COVID arm on the whole upper part of my arm, not just a large round circle, the whole upper arm, all the way down to the elbow and that lasted for a couple of weeks, that was the Moderna. Well, my husband's a physician, but he saw this, he was afraid I was getting an access and it was raised so, he took me to the ER and drove me all the way to the best ER here. I am on KeFlex, cephalexin is the generic I am on 500mg four times a day for five days. My husband was afraid that I was developing cellulitis and that's why he took me to the ER. I woke up with a high fever. You know, when you have high fever, if I can't think straight, it's always very high, shaking chills, and, you know, and even with two Motrin and then next hour, two Tylenols, I never got under 100 and almost 101. In other words it went all the way up to almost 103 and then even with the Tylenol and the Motrin, I couldn't get it below 100 and almost 101. I was thinking, what did they do to change it: I don't know if taking it two days after or three days after the flu shot mattered. But my husband didn't have this reaction." Action taken: Not applicable. The patient was treated with Cefalexin (Keflex), Paracetamol (Tylenol) and Ibuprofen (Motrin) for Pyrexia. At time of reporting, the outcome was Recovering / Resolving for the event the entire area became raised and hard, was Unknown for the event (tremor, chills, vaccination site pruritus and vaccination site induration, vaccination site swelling), was Recovered / Resolved on an unknown date for the event 103 fever, was Not Recovered / Not Resolved for the event vaccination site erythema. More

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