🏥 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

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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 6,251 to 6,300 of 34,052 reports (Page 126 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥
2863053	54	M		10/03/2025	FLU3	SANOFI PASTEUR		Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered	Pt is 54 and was supposed to get flublock. Technician accidentally pulled and administered fluzone H... Pt is 54 and was supposed to get flublock. Technician accidentally pulled and administered fluzone HD. More
2863054	29	F	MT	10/03/2025	FLU3	SANOFI PASTEUR	U8863AA	Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered	Patient received annual flu shot on 9/22/25. This recorded dose is a repeat dose. Patient is curren... Patient received annual flu shot on 9/22/25. This recorded dose is a repeat dose. Patient is currently 34 weeks 3 days pregnant when she received the repeat dose. Expected due date 11/10/2025 More
2863055	72	F	IL	10/03/2025	FLU3 RSV VARZOS	SEQIRUS, INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS		Condition aggravated, Polymyalgia rheumatica; Condition aggravated, Polymyalgia ... Condition aggravated, Polymyalgia rheumatica; Condition aggravated, Polymyalgia rheumatica; Condition aggravated, Polymyalgia rheumatica More	Flair of my pmr neck, shoulders, hips, back ,leg pain. I have increased prednisone to 15 mg. No rel... Flair of my pmr neck, shoulders, hips, back ,leg pain. I have increased prednisone to 15 mg. No relief yet. More
2863056	7	F	CA	10/03/2025	COVID19	MODERNA	8146670	Incorrect dose administered Incorrect dose administered	RN gave higher dose of COVID vaccine to a pediatric patient. Provider on site notified parental guar... RN gave higher dose of COVID vaccine to a pediatric patient. Provider on site notified parental guardian of patient. Sharp medication error protocols were followed and completed. More
2863057	68	F	KS	10/03/2025	FLU3	SANOFI PASTEUR	UT8781BA	Pyrexia, Rash Pyrexia, Rash	2 days after the patient received the vaccine, a rash started and had a high fever resulting in a tr... 2 days after the patient received the vaccine, a rash started and had a high fever resulting in a trip to the Emergency Department More
2863062	22	F	WA	10/03/2025	FLU3	SEQIRUS, INC.	407003	Dizziness, Injection site reaction, Urticaria, Vomiting Dizziness, Injection site reaction, Urticaria, Vomiting	hives on bilateral shoulders, neck, and face. vomiting, dizzy, and welt at injection site hives on bilateral shoulders, neck, and face. vomiting, dizzy, and welt at injection site
2863063	61	F	NC	10/03/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	2HJ99	Injection site erythema, Injection site oedema, Injection site warmth Injection site erythema, Injection site oedema, Injection site warmth	large erythematous patch with irregular borders, warmth, and edema to left upper arm consistent with... large erythematous patch with irregular borders, warmth, and edema to left upper arm consistent with cellulitis More
2863064	79	F		10/03/2025	COVID19	MODERNA		Pain in extremity Pain in extremity	just a slightly sore arm; This spontaneous case was reported by a consumer and describes the occurre... just a slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a slightly sore arm) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In September 2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced PAIN IN EXTREMITY (just a slightly sore arm). At the time of the report, PAIN IN EXTREMITY (just a slightly sore arm) outcome was unknown. No concomitant medication was reported. It was stated patient developed reactions after getting a dose from Moderna COVID-19 vaccines. It was stated patient received Moderna COVID-19 vaccine since 2021. It was stated that the reaction on her first dose in February 2021 was a "minor rash" which was stated that was not so bad." In contrast to her 2nd dose in March 2021 which was stated to be a "major reaction". It was stated that in March 2021, patient got a whole torso body rash" and described the rash as "major rash" which lasted for 1 week. It was also added along with the rash that patient had sore arm, chills, and a low-grade fever. It was also narrated that she also received a dose in November 2021 which stated to experienced low grade fever that lasted for few hours and a minor rash for a couple of days. It was added that she also received a dose in September 2023 wherein she experienced 2 days of general lethargy, achy legs, and a rash that stayed for about a week. Lastly, the patient also received a dose in September 2024 wherein she experienced just a slightly sore arm. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case was linked to MOD-2025-789700 (Patient Link). More
2863065	83	F	FL	10/03/2025	COVID19	PFIZER\BIONTECH	my9550	Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth	Rash and warm around injection site Rash and warm around injection site
2863066	22	F	WI	10/03/2025	COVID19	PFIZER\BIONTECH	MY9548	Confusional state, Dyskinesia, Loss of consciousness Confusional state, Dyskinesia, Loss of consciousness	Patient passed out then upper and lower extremities began flailing about. Patient was confused when ... Patient passed out then upper and lower extremities began flailing about. Patient was confused when she became conscious and did not know where she was or what happened. More
2863068	81	F	AL	10/03/2025	COVID19	PFIZER\BIONTECH	na0587	Extra dose administered, No adverse event Extra dose administered, No adverse event	No adverse reaction but patient was administered 2 doses of covid 25-26 pfizer in the same visit one... No adverse reaction but patient was administered 2 doses of covid 25-26 pfizer in the same visit one in each arm More
2863069	79	F	CO	10/03/2025	FLU3	SANOFI PASTEUR	U8800DA	Eye inflammation, Ocular hyperaemia Eye inflammation, Ocular hyperaemia	THREE DAYS AFTER VACCINE ADMINISTRATION PATIENT DEVELOPED EYE INFLAMMATION WITH EYE REDDNESS/RED DOT... THREE DAYS AFTER VACCINE ADMINISTRATION PATIENT DEVELOPED EYE INFLAMMATION WITH EYE REDDNESS/RED DOTS IN EYES. PATIENT RECEVIED CIPROFLOXACIN 0.3% OPHTHALMIC SOLN 1 DROP INTO AFFECTED EYE (S) TWICE DAILY STARTED ON 9/14/25. PATIENT GOT A REFILL ON 9/30/25 DUE TO STILL HAVING SYMPTOMS. SPOKE TO PATIENT AND SHE SAID SHE IS DOING BETTER AS OF TODAY 10/3/25 More
2863070	78	M	IL	10/03/2025	COVID19 COVID19 FLU3 FLU3 PNC20 PNC20	MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. PFIZER\WYETH PFIZER\WYETH	3052734 3052734 AX4605A AX4605A MA2519 MA2519	Asthenia, Culture urine negative, Full blood count normal, Loss of personal inde... Asthenia, Culture urine negative, Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal; Urine analysis normal; Asthenia, Culture urine negative, Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal; Urine analysis normal; Asthenia, Culture urine negative, Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal; Urine analysis normal More	Patient received PCV 20 on 9/24, Afluria on 9/26, and Moderna vaccine on 10/1. Reported weakness an... Patient received PCV 20 on 9/24, Afluria on 9/26, and Moderna vaccine on 10/1. Reported weakness and functional decline during therapy and needing more assistance overall. UA/CS and CBC/CMP completed were unremarkable. Resident evaluated by Physiatrist and sent out for evaluation to hospital. Suspicion for either vaccine related illness or neurological illness. More	✓
2863071	2	M	MN	10/03/2025	COVID19	MODERNA	8146545	Incorrect dose administered Incorrect dose administered	Child was ordered to be given age-appropriate dose of medication. Clinic staff accidentally gave the... Child was ordered to be given age-appropriate dose of medication. Clinic staff accidentally gave the dose appropriate for 12+. Patient was stable and alert in clinic and family was notified over what occurred. More
2863073	58	F	NY	10/03/2025	FLU3 PNC21	SANOFI PASTEUR MERCK & CO. INC.	tfaa2503 z010761	Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More	redness and minor swelling extending halfway down upper arm feeling warm to the touch. Symptoms hav... redness and minor swelling extending halfway down upper arm feeling warm to the touch. Symptoms have not gotten worse since the patient noticed on 10/2. More
2863074	32	M	TN	10/03/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR		Herpes zoster, Rash; Herpes zoster, Rash Herpes zoster, Rash; Herpes zoster, Rash	Rash attributable to shingles emerged ~36 hours after receiving these two vaccines together Rash attributable to shingles emerged ~36 hours after receiving these two vaccines together
2863075	76	F	FL	10/03/2025	COVID19 FLU3 FLU3	MODERNA SANOFI PASTEUR SANOFI PASTEUR	3052732 u8832aa u8763ea	Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More	technician took vaccines out for a family of 4 to give them around 5:25p on 10/3/25. the patient rec... technician took vaccines out for a family of 4 to give them around 5:25p on 10/3/25. the patient received their fluzone hd and was supposed to received mnexspike as well. patient was incorrectly given a flublok intended for another family member in the party instead. patient was counseled by pharmacist on duty and was then administered the correct mnextspike vaccine. patient was not upset during or when leaving the pharmacy More
2863076	78	F	CA	10/03/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	NDC:00069-2528- NDC:00069-2528-	Blood test, Chest X-ray, Chills, Echocardiogram, Electrocardiogram; Loss of cons... Blood test, Chest X-ray, Chills, Echocardiogram, Electrocardiogram; Loss of consciousness, Myalgia, Nausea, Urine analysis More	Around 10:00 PM I started having the usual sore muscles chills. Then at around 3:00 Am I found mysel... Around 10:00 PM I started having the usual sore muscles chills. Then at around 3:00 Am I found myself on the bathroom floor without knowing how I got there. Then I was sitting on my couch and blacked out two more times. My son said I was non responsive. I called my primary doctor and he told me to go to the emergency room. Since I was also nauseous and couldn?t eat or drink the ER hydrated me took blood work and admitted me. Afterwards I was able to eat and the next day I was discharged Thursday October 2, 2025. More
2863078		F		10/03/2025	COVID19-2	MODERNA	AS7146B	Condition aggravated, Immunisation reaction, Vaccination site erythema, Vaccinat... Condition aggravated, Immunisation reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth More	she gets a reaction every time she has a booster; the first time it was really warm; She gets concer... she gets a reaction every time she has a booster; the first time it was really warm; She gets concerned every time she gets it because she has had something worse than others; the localized red, itchy symptoms; the localized red, itchy symptoms; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: sulfa and penicillin. Past adverse reactions to the above products included Allergy with penicillin and sulfa. Concurrent medical conditions included Allergy to antibiotic (she had a serious, though not anaphylactic, hemolytic reaction one time with cephalosporin. She just wants to be sure that it is not an allergy because she keeps getting the vaccine), Hypertension (She is healthy except that she sees a cardiologist, her hypertension is controlled), Hemolytic reaction, Mitral valve prolapse, Penicillin allergy and Sulfonamide allergy. On 20-Sep-2022, 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. On an unknown date, the patient experienced IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms). At the time of the report, IMMUNISATION REACTION (she gets a reaction every time she has a booster) and CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others) outcome was unknown and VACCINATION SITE WARMTH (the first time it was really warm), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms) had resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was stated that Patient had COVID arm. she was not on blood thinners and did not have any other conditions. She got concerned every time she got it because she had something worse than others. It was stated that she got a reaction every time she had a booster. Sometimes her reaction was more than others, the localized red, itchy symptoms. It was stated it was not dreadful, but she was concerned as to what was causing it. It was stated that it was warm sometimes, the first time it was really warm and then it just subsided. She took the antihistamines, and it was fine, "the next day it was a little bad". She did not want to take Benadryl again because she did not want to be tired. It was stated that her arm symptoms only last a couple of days. It was stated that she was pretty sure there was a time where her reaction was "really, really minimal" but the first time she got the vaccine it seemed to be the worst. It was stated there was another time, she did not remember exactly, might be the third one, that she had a pretty big reaction again. It was stated that there were always like something, so patient was careful." It was stated she'll get her flu shot first and then wait a month because she often reacted to the flu too with mild symptoms, no flu vaccine brand was mentioned. Patient had triple antibiotic allergies and once she had a serious hemolytic reaction to cephalosporin. It was stated this was a long time ago but that her immune system likes to overreact. She did not want to put herself at risk and wants the protection. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2021-008609, MOD-2023-741990, MOD-2025-789715 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live Significant Follow-up information received: New event Condition worsened was added. Patient's historical condition was updated, and narrative was updated. More
2863079		F		10/03/2025	COVID19	MODERNA		Condition aggravated, Immunisation reaction, Vaccination site erythema, Vaccinat... Condition aggravated, Immunisation reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth More	she gets a reaction every time she has a booster; it is warm sometimes-the first time it was really ... she gets a reaction every time she has a booster; it is warm sometimes-the first time it was really warm; She gets concerned every time she gets it because she has had something worse than others; the localized red, itchy symptoms; the localized red, itchy symptoms; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (it is warm sometimes-the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: penicillin. Past adverse reactions to the above products included Allergy with penicillin. Concurrent medical conditions included Hypertension, Hemolytic reaction (she had a serious, though not anaphylactic, hemolytic reaction one time with cephalosporin. She just wants to be sure that it is not an allergy because she keeps getting the vaccine), Penicillin allergy (penicillin), Sulfonamide allergy (sulfa), Allergy to antibiotic (cephalosporin) and Mitral valve prolapse. On 30-Sep-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (it is warm sometimes-the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (she gets a reaction every time she has a booster) and CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others) outcome was unknown and VACCINATION SITE WARMTH (it is warm sometimes-the first time it was really warm), VACCINATION SITE PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was stated that she was a person who had COVID arm. She had a reaction every time she had a booster. Sometimes her reaction was more than others, the localized red, itchy symptoms. She states it was not dreadful, but she was concerned as to what was causing it. It was stated that it was warm sometimes the first time it was really warm and then it just subsided. She took the antihistamines, and it was fine- the next day it was a little bad. She didn't want to take Benadryl again because she didn't want to be tired. Her arm symptoms only last a couple of days. It was stated that she was pretty sure there was a time where her reaction was really, minimal but the first time she got the vaccine it seemed to be the worst. There was another time, she didn't remember exactly, maybe the third one, that she had a pretty big reaction again. There was always something, so she was careful. Patient will get her flu shot first and then wait a month because she often reacts to the flu too with mild symptoms - no flu vaccine brand was mentioned. She states that she has triple antibiotic allergies and once she had a serious hemolytic reaction to cephalosporin. She states this was a long time ago but that her immune system likes to overreact. She was healthy except when she saw a cardiologist, her hypertension was controlled. Other than that, she was not on blood thinners and didn't have any other conditions. She gets concerned every time she gets it because she has had something worse than others. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2021-008609, US-MODERNATX, INC.-MOD-2023-741990, US-MODERNATX, INC.-MOD-2025-789714 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live Significant Follow-up information received: New event Condition worsened was added. Patient's historical condition, and narrative was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-008609:Monovalent Dose US-MODERNATX, INC.-MOD-2023-741990:2023-2024 PFS Case (Dose 6) US-MODERNATX, INC.-MOD-2025-789714:Bivalent Dose (Dose 5) More
2863080		M		10/03/2025	COVID19	MODERNA		Illness Illness	ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) ... ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The patient's past medical history included Liver transplantation. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2024, the patient experienced ILLNESS (ill). At the time of the report, ILLNESS (ill) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that the patient had received the COVID-19 vaccine doses with Moderna since 2020 except for last year due to illness. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789732 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789732:Master case More
2863081	78	F		10/03/2025	COVID19	MODERNA		Bronchiectasis, Organising pneumonia Bronchiectasis, Organising pneumonia	had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia; had 2 lung issues ... had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia; had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIECTASIS (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) and ORGANISING PNEUMONIA (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BRONCHIECTASIS (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) (seriousness criterion medically significant) and ORGANISING PNEUMONIA (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) (seriousness criterion medically significant). At the time of the report, BRONCHIECTASIS (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) and ORGANISING PNEUMONIA (had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia) outcome was unknown. No concomitant medications were reported. It was reported that, she had 2 lung issues which were bronchiectasis and cryptogenic organizing pneumonia which were not specified if those occurred before or after the vaccination. She had read online that she should get a booster but the pharmacist or physician or whoever gave her the shot did not mention it. She confirmed that both her pulmonologist and primary health care provider urged her to get Spikevax, so she had gotten it. She just did not know if she needs a second booster or not. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2863082	65	F		10/03/2025	COVID19 COVID19	MODERNA MODERNA	3052030 3052030	Anxiety, Photopsia, Vaccination site bruising, Vaccination site haemorrhage, Vac... Anxiety, Photopsia, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site mass; Vaccination site swelling More	swelling and a large lump at the injection site/swelling at the injection site on her left arm; She ... swelling and a large lump at the injection site/swelling at the injection site on her left arm; She had a little bleeding/she had a little bit of blood on the injection site following administration; has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed; swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin; she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.; She expressed apprehension that the injection might not have been administered correctly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm), VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin) and PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna in 2021, Spikevax NOS in 2022, Spikevax NOS in 2023 and Spikevax 2024-2025 formula on 01-Oct-2024. Past adverse reactions to the above products included No adverse effect with Moderna, Spikevax 2024-2025 formula, Spikevax NOS and Spikevax NOS. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 22-Sep-2025, the patient experienced VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm), VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin), PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) and ANXIETY (She expressed apprehension that the injection might not have been administered correctly). At the time of the report, VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm) was resolving, VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin), PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) and ANXIETY (She expressed apprehension that the injection might not have been administered correctly) outcome was unknown and VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed) had not resolved. The patient's age was reported as 65-and-a-half-years-old. The patient had not received any other vaccines in the past 4 weeks. She did not have life threatening medical condition and not on any prescription meds. No concomitant medications were reported. Immediately after receiving the injection, the patient noticed swelling at the injection site, which was unusual since she had never experienced such reactions from previous vaccines, including COVID-19 vaccines. She had received the Moderna COVID-19 vaccine every year since it first became available in 2021. She never had any reactions, swelling, or bruising from any vaccine in the past. The healthcare provider who administered the vaccine remarked that the swelling was strange and mentioned accidentally hitting a "fat pocket", raising her suspicion that the vaccine was not injected intramuscularly as intended. She was informed that she had a little bit of blood on the injection site following administration. After receiving the vaccine, she was nearly in tears as she recounted the experience to her husband. She expressed apprehension that the injection might not have been administered correctly, had a concern. Although she could not definitively say she felt lightheaded, she experienced seeing "stars," described as little flashes of light. That led to some worry, as she feared she might pass out, prompting her to sit down on the floor for a few minutes until the sensation subsided. Fortunately, she did not pass out or faint and felt fine afterward, aside from having seen the stars. That occurred within half an hour of receiving the injection. While she could not be certain if those symptoms were a reaction to the Moderna product, her suspicion was that the injection was not administered correctly and felt it was not done properly. Due to the mishap with how her injection was administered, she was asking how soon she should be re-vaccinated, or had there been studies done on re-vaccination for a patient in such a situation. Concerned about the competency of the pharmacy staff, she decided against returning there for a planned flu shot. Her most recent Moderna COVID-19 vaccination was administered at the same pharmacy on 01-Oct-2024. While she has primarily been vaccinated with Moderna, she might have also received a Pfizer vaccine on one occasion. Her pharmacist mentioned that if she received the vaccine, she would need to wait for 2 months. If it were a different vaccine, she would have to wait 3 months. She wanted to know if she could be re-vaccinated, and how long people were waiting between injections when getting re-vaccinated. She now had a bruise there, which was initially a large, goose egg-like bump, but the swelling had since gone down. She was very concerned about the level of protection. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live significant follow-up received included reporter's mail address updated, patient's DOB added, historical vaccine added, dose details of suspect (dose and anatomical location) updated, verbatim of events, narrative updated, and reference numbers were added. More
2863083	78	F		10/03/2025	COVID19	MODERNA		COVID-19, Illness, SARS-CoV-2 test COVID-19, Illness, SARS-CoV-2 test	she had COVID in early August; I got sick; This spontaneous case was reported by a consumer and desc... she had COVID in early August; I got sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she had COVID in early August) and ILLNESS (I got sick) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (in the past she always had Pfizer). Past adverse reactions to the above products included No adverse effect with Pfizer. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In August 2025, the patient experienced COVID-19 (she had COVID in early August) and ILLNESS (I got sick). At the time of the report, COVID-19 (she had COVID in early August) and ILLNESS (I got sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2025, SARS-CoV-2 test: Negative. Concomitant medications details were not reported by the reporter. Patient mentioned during a call that she had COVID in early August and that she had tested negative somewhere around the 18th. She added that "in August, both her husband and she got sick and neither one of us had had a second dose for 2024-2025. She asked if they'd had Moderna COVID vaccines in the past and she said "no, in the past they always had Pfizer. It was unknown if the patient experienced any additional symptoms/events. Treatment details were not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789716 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789716:patient husband case More
2863084	77	M	FL	10/03/2025	COVID19 COVID19 PNC	MODERNA PFIZER\BIONTECH PFIZER\WYETH		COVID-19, SARS-CoV-2 test, Shoulder injury related to vaccine administration; CO... COVID-19, SARS-CoV-2 test, Shoulder injury related to vaccine administration; COVID-19, SARS-CoV-2 test, Shoulder injury related to vaccine administration; COVID-19, SARS-CoV-2 test, Shoulder injury related to vaccine administration More	he got covid; SIRVA; This spontaneous case was reported by a consumer and describes the occurrence o... he got covid; SIRVA; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got covid) and SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for Prevention. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (3 weeks apart in Fall of 2020) in 2020, Moderna COVID-19 vaccine in 2021, Spikevax NOS in 2022 and Spikevax NOS in 2023. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Spikevax NOS and Spikevax NOS. On 05-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In March 2025, the patient started Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of Pneumococcal vaccine conj 7v (CRM197) (Prevnar) (unknown route) 1 dosage form. In March 2025, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA). On 01-Jun-2025, the patient experienced COVID-19 (he got covid). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in June 2025 for COVID-19, at an unspecified dose and frequency. In May 2025, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) had resolved. On 06-Jun-2025, COVID-19 (he got covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2025, SARS-CoV-2 test: home kit that showed positive for COVID, he did it twice. He continued testing himself during the week until it was clear. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. No concomitant medications were reported. The patient received Moderna as the first vaccine and was stuck by it. Because he was 65 and older he was recommended that he get another one in 6 months, he took the Pfizer vaccine in March 2025. His Pfizer vaccine was an old strain, the fall shot that they gave him again in March, he was told to take it as a booster. The extra Pfizer shot did not work. He caught covid on 01-Jun-2025, and he got better on 05-Jun-2025. He took Paxlovid right away, it was only a day and a half delay until he started Paxlovid. He was sure it protected him somewhat because he did not get very sick. He had a home kit that showed positive for COVID, he did it twice. He continued testing himself during the week until it was clear. It took 5 days to be clear. Sick on Monday, completely over it by Friday. He had a slight cough, runny nose, typical cold symptoms but he was a little more severe than that. A little bit of a fever, not much, but a little bit. Every year he took the Moderna shot. Two weeks after he had the Pfizer booster in March, he got the new Pneumonia 21 valent shot as per his doctor's recommendation. 4 days later, his arm started to hurt so bad it felt like it was falling off, and it got worse, the pain did not go away for 3 months. They thought the pharmacist misdirected the injection; they called it SIRVA - something about injury during vaccine administration. It went away eventually. The pharmacist aimed too high and injected his bursa or something like that. It caused nerve damage too it seemed, but it all went away. It took 3 months. They did not give him the shot right, that was what happened. It was reported that he told the pharmacist had injured his arm. He got hurt in March, he was in pain since March, that went away in the middle of May, that finally dissipated. That was an injury. He went to his doctor. It was not the covid shot, it was the pneumonia shot. He took his Spikevax 2025-2026 shot, Lot/Batch Number: 3052549, Expiration Date: 08-May-2026, with dose of 0.5 ml on 24-Sep-2025 in his right arm, and took his flu shot in the left arm, just to make sure not to injure his arm too much. It was unknown if the patient experienced any additional symptoms/events. More
2863085	79	F		10/03/2025	COVID19	MODERNA	031L20A	Chills, Pain in extremity, Pyrexia, Rash Chills, Pain in extremity, Pyrexia, Rash	sore arm; minor rash/got a whole torso body rash; chills; low-grade fever; This spontaneous case was... sore arm; minor rash/got a whole torso body rash; chills; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (minor rash/got a whole torso body rash), CHILLS (chills) and PYREXIA (low-grade fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 001B21A, 013F21A and 051B22A) for COVID-19 prophylaxis. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (minor rash/got a whole torso body rash), CHILLS (chills) and PYREXIA (low-grade fever). In 2021, RASH (minor rash/got a whole torso body rash) and PYREXIA (low-grade fever) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (chills) outcome was unknown. No concomitant medication was reported. It was stated patient developed reactions after getting a dose from Moderna COVID-19 vaccines. It was stated patient received Moderna COVID-19 vaccine since 2021. It was stated that the reaction on her first dose in February 2021 was a "minor rash" which was stated that was not so bad." In contrast to her 2nd dose in March 2021 which was stated to be a "major reaction". It was stated that in March 2021, patient got a whole torso body rash" and described the rash as "major rash" which lasted for 1 week. It was also added along with the rash that patient had sore arm, chills, and a low-grade fever. It was also narrated that she also received a dose in November 2021 which stated to experienced low grade fever that lasted for few hours and a minor rash for a couple of days. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case was linked to MOD-2025-789705, MOD-2025-789706, MOD-2025-789707 (Patient Link). More
2863086		F		10/03/2025	COVID19	MODERNA	3042914	Gallbladder disorder Gallbladder disorder	Gall bladder surgery; This spontaneous case was reported by a pharmacist and describes the occurrenc... Gall bladder surgery; This spontaneous case was reported by a pharmacist and describes the occurrence of GALLBLADDER DISORDER (Gall bladder surgery) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (patient probably received more COVID-19 vaccines in 2023 but this was the only information.) in 2023. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced GALLBLADDER DISORDER (Gall bladder surgery). At the time of the report, GALLBLADDER DISORDER (Gall bladder surgery) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter asked if there was any contraindication to a patient who had just undergone gall bladder surgery a week ago. The reporter mentioned that it had been over 3 months already since the patient had her last COVID-19 vaccine. No treatment medications were reported. More
2863087	55	M	FL	10/03/2025	COVID19 COVID19 FLUX FLUX	MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Dizziness, Eye pain, Fatigue, Headache, Hyperacusis; Ocular discomfort; Dizzines... Dizziness, Eye pain, Fatigue, Headache, Hyperacusis; Ocular discomfort; Dizziness, Eye pain, Fatigue, Headache, Hyperacusis; Ocular discomfort More	severe eye pain with intense pressure; severe eye pain with intense pressure; sound sensitivity; diz... severe eye pain with intense pressure; severe eye pain with intense pressure; sound sensitivity; dizziness when I walk; relentless headache; overwhelming fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (severe eye pain with intense pressure), OCULAR DISCOMFORT (severe eye pain with intense pressure), HYPERACUSIS (sound sensitivity), DIZZINESS (dizziness when I walk) and HEADACHE (relentless headache) in a 55-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Concurrent medical conditions included Diabetes, Psoriatic arthritis and Hypothyroidism. Concomitant products included Meloxicam and Paracetamol (Tylenol) for an unknown indication. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In September 2025, the patient experienced EYE PAIN (severe eye pain with intense pressure), OCULAR DISCOMFORT (severe eye pain with intense pressure), HYPERACUSIS (sound sensitivity), DIZZINESS (dizziness when I walk), HEADACHE (relentless headache) and FATIGUE (overwhelming fatigue). At the time of the report, EYE PAIN (severe eye pain with intense pressure), OCULAR DISCOMFORT (severe eye pain with intense pressure), DIZZINESS (dizziness when I walk), HEADACHE (relentless headache) and FATIGUE (overwhelming fatigue) had not resolved and HYPERACUSIS (sound sensitivity) outcome was unknown. The patient received the Moderna COVID vaccine two days ago and experienced alarming symptoms. He had severe eye pain with intense pressure, a relentless headache, sound sensitivity, overwhelming fatigue, and dizziness when he walked. Sitting or lying down helped slightly to him, but the eye pressure remained intense and concerning. If it did not improve very soon, he planned to seek immediate medical care. The patient did not experience any additional symptoms or events. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data or results available. The treatment medication was not reported by the reporter. More
2863088	70	F		10/03/2025	COVID19	MODERNA		Food allergy Food allergy	was recently diagnosed with Alpha-Gal; This spontaneous case was reported by a pharmacist and descri... was recently diagnosed with Alpha-Gal; This spontaneous case was reported by a pharmacist and describes the occurrence of FOOD ALLERGY (was recently diagnosed with Alpha-Gal) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna COVID19 vaccine. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In May 2025, the patient experienced FOOD ALLERGY (was recently diagnosed with Alpha-Gal). At the time of the report, FOOD ALLERGY (was recently diagnosed with Alpha-Gal) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Patient date of birth year reported. The concomitant medication was not reported by the reporter. The patient who always received Moderna COVID-19 vaccines was recently diagnosed with Alpha-Gal in May 2025. The pharmacy did not have records of other Moderna COVID-19 vaccines. No additional information was provided. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2863089			ID	10/03/2025	PNC20	PFIZER\WYETH	LP4947	Needle issue Needle issue	when nurse went to close safety needle, caller states she is not sure which part, but the part of th... when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut; when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 19Sep2025, this case now contains all required information to be considered valid. This is a spontaneous report received from an Other HCP 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: LP4947, Expiration Date: Aug2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut". Additional information: A nurse was administering the vaccine and when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut. States this occurred right after administering it to the patient and caller confirms the patient did get the appropriate dose. It occurred when trying to cap the needle. She does not have patient details to provide stating she does not know who the patient was. States the needle is still attached to part of it and asking if requested by quality department, should the needle be removed before sending back. The sample is available to be returned. Causality for "when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2863090	68	M	CA	10/03/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective, Investigation COVID-19, Drug ineffective, Investigation	covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old... covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 3, single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma, Diagnosed about 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29Sep2025, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: Covid test: (29Sep2025) Positive, notes: Unit: Not Provided. Clinical course: Warm transfer from (Withheld) calling from (Withheld). Patient stated that he went to take the Covid-19 vaccine on Friday and reported that he had body aches that hit him like a freight train, he could not swallow, and he was feeling whoozy. He went to (Withheld) and was diagnosed with Covid and was prescribed Paxlovid. Caller reported that he never had that issue before and he has had 2 previous doses of the covid-19 vaccine.The caller verified the information provided by the transferring agent. Caller clarified that the previous 2 doses were the Pfizer Covid 19 vaccines as well.Lot/expiry: Does not remember the Pharmacy giving them any paperwork. Caller said that his wife was going to reach out to the pharmacy to get the product details. Description of Product Complaint: Description of complaint: he went to take the Covid-19 vaccine on Friday. He went to (Withheld) and was diagnosed with Covid 29Sep2025. Lot/expiry: Does not remember the Pharmacy giving them any paperwork. Caller said that his wife was going to reach out to the pharmacy to get the product details. The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] has been requested and will be submitted if and when received. More
2863091	48	M		10/03/2025	COVID19	PFIZER\BIONTECH		Chills, Headache, Pain Chills, Headache, Pain	Body aches; Headache; Chills; This is a spontaneous report received from a Consumer or other non HCP... Body aches; Headache; Chills; This is a spontaneous report received from a Consumer or other non HCP. A 48-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 as dose 1, single (left shoulder) (Batch/Lot number: unknown) at the age of 48 years for COVID-19 immunisation. The patient's relevant medical history included: "Anxiety, ADHD" (unspecified if ongoing); "Anxiety, ADHD" (unspecified if ongoing). Concomitant medication(s) included: LISDEXAMFETAMINE, start date: 09Sep2025; ESCITALOPRAM, start date: 04Sep2023. The patient had no allergy. The vaccine was administered in Workplace Clinic. The patient did not receive any other vaccines on the same date as COMIRNATY and did not receive any other vaccines within 4 weeks prior COMIRNATY. The following information was reported: PAIN (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering"; HEADACHE (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering". Therapeutic measures were taken as a result of pain, headache, chills which included Tylenol. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863092	54	F	CT	10/03/2025	COVID19	PFIZER\BIONTECH		Chills, Nausea, Pain Chills, Nausea, Pain	chills; body aches; nausea; This is a spontaneous report received from a Consumer or other non HCP. ... chills; body aches; nausea; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Oesophageal achalasia" (unspecified if ongoing); "allergy to herbal tea" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 24Sep2025 as right arm; AZELASTINE HYDROCHLORIDE; BUDESONIDE; B12-VITAMIIN; D3; ELDERBERRY [SAMBUCUS NIGRA]; MAGNESIUM; WOMEN'S MULTIVITAMIN & MINERAL; WOMEN'S MICROFLORA PROBIOTIC; VITAMIN E [VITAMIN E NOS]. Past drug history included: Benadryl, reaction(s): "allergy"; Levaquin, reaction(s): "allergy". The following information was reported: PAIN (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025), described as "body aches"; CHILLS (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025); NAUSEA (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025). Therapeutic measures were not taken as a result of chills, pain, nausea. Additional information: Facility where vaccine was administered was workplace clinic. The patient did not receive any other vaccines on the same date as the covid-19 vaccine. The patient was taking any other medications within 2 weeks of the event starting. Approx 10 hours after receiving the vaccination, chills, body aches and nausea symptoms started. These symptoms lasted approximately 12 hours and then resolved. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863093	67	F		10/03/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		Chills, Diarrhoea, Fatigue, Nausea, Pain; Pyrexia Chills, Diarrhoea, Fatigue, Nausea, Pain; Pyrexia	Fever 100.4F; aches; chills; nausea; diarrhea; fatigue; This is a spontaneous report received from a... Fever 100.4F; aches; chills; nausea; diarrhea; fatigue; This is a spontaneous report received from an Other HCP. A 67-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 as dose number unknown, single (arm) (Batch/Lot number: unknown) at the age of 67 years for COVID-19 immunisation. The patient's relevant medical history included: "CT contrast dye" (unspecified if ongoing). There were no concomitant medications.The vaccine was administered in a Pharmacy or Drug Store. The patient did not receive any other vaccines on the same date as Comirnaty. The patient receive any other vaccines within 4 weeks prior to Comirnaty. The following information was reported: PYREXIA (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered", described as "Fever 100.4F"; PAIN (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered", described as "aches"; CHILLS (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered"; DIARRHOEA (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered"; NAUSEA (non-serious) with onset 30Sep2025 at 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, pain, chills, nausea, diarrhoea, fatigue. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863094				10/03/2025	COVID19	PFIZER\BIONTECH		Abdominal pain upper Abdominal pain upper	stomach ache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. ... stomach ache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache". Additional information: Patient reported that, It's a stomach ache a side effect of Covid vaccine and asked for what are common side effects associated with recent vaccinations. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863095	32	F	MI	10/03/2025	COVID19 FLUX HEPA	PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Feeling cold, Feeling hot, Insomnia, Pain in extremity; Feeling cold, Feeling ho... Feeling cold, Feeling hot, Insomnia, Pain in extremity; Feeling cold, Feeling hot, Insomnia, Pain in extremity; Feeling cold, Feeling hot, Insomnia, Pain in extremity More	Couldn't sleep; Excessive pain in left arm; Feeling really cold and warm throughout the night; ... Couldn't sleep; Excessive pain in left arm; Feeling really cold and warm throughout the night; Feeling really cold and warm throughout the night; This is a spontaneous report received from a Consumer or other non HCP. A 32-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; hepatitis a vaccine (HEPATITIS A), on 01Oct2025 as dose 2, single, in right arm for hepatitis a immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2025 as dose number unknown, single, in left arm for influenza immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ABILIFY, start date: 01Oct2025; BUSPIRONE, start date: 01Oct2025; EFFEXOR, start date: 01Oct2025. Past drug history included: Imitrex, reaction: "Drug allergy". Vaccination history included: Hepatitis a (dose 1, single), for Hepatitis A immunisation. The following information was reported: INSOMNIA (non-serious) with onset 02Oct2025, outcome "recovering", described as "Couldn't sleep"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2025, outcome "recovering", described as "Excessive pain in left arm"; FEELING COLD (non-serious), FEELING HOT (non-serious) all with onset 02Oct2025, outcome "recovering" and all described as "Feeling really cold and warm throughout the night". Therapeutic measures were not taken as a result of insomnia, pain in extremity, feeling cold, feeling hot. Additional information: The suspected vaccines were administered at a pharmacy or drug store. The patient didn't receive any other vaccines with 4 weeks prior to the suspected vaccines. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863096	58	F		10/03/2025	COVID19 FLUX	PFIZER\BIONTECH UNKNOWN MANUFACTURER		Arthralgia, Mobility decreased; Arthralgia, Mobility decreased Arthralgia, Mobility decreased; Arthralgia, Mobility decreased	Significant shoulder pain and movement restriction within a couple of hours of receiving vaccine; Si... Significant shoulder pain and movement restriction within a couple of hours of receiving vaccine; Significant shoulder pain and movement restriction within a couple of hours of receiving vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 58-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2025 at 11:00 as dose number unknown, single for influenza immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious), MOBILITY DECREASED (non-serious) all with onset 01Oct2025 at 12:00, outcome "not recovered" and all described as "Significant shoulder pain and movement restriction within a couple of hours of receiving vaccine". Therapeutic measures were taken as a result of arthralgia, mobility decreased. Additional information: The suspected vaccines were administered at a workplace clinic. The patient didn't receive any other vaccines with 4 weeks prior to the suspected vaccines. Treatment received for the adverse event included ice and Tylenol. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863097				10/03/2025	COVID19	PFIZER\BIONTECH		Anaphylactic reaction Anaphylactic reaction	got an anaphylactic reaction to this initial MRNA vaccine; This is a spontaneous report received fro... got an anaphylactic reaction to this initial MRNA vaccine; This is a spontaneous report received from a Physician. Other Case identifier(s): NOV25-00837 (NOVAVAX). An adult patient received BNT162b2 (BNT162B2), 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "got an anaphylactic reaction to this initial MRNA vaccine". Clinical course: It was reported that when the Pfizer vaccine first came out for Covid-19 and it received emergency authorization, the patient received two doses. The patient got an anaphylactic reaction to this initial MRNA vaccine. After the first dose, the reaction was somewhat mild. With the second dose, the reaction was quite stronger. The patient was told by Pfizer and the CDC that patient should not have another MRNA based vaccination. The patient had never had a reaction to any other vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile. ,Linked Report(s) : US-PFIZER INC-202500192354 same reporter/patient/AE, different doses; More
2863098				10/03/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test	COVID infection; COVID infection; This is a spontaneous report received from a Consumer or other non... COVID infection; COVID infection; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier: MOD-2025-789684 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "recovering" and all described as "COVID infection". Clinical course: The reporter wanted to know what is Moderna's recommendations for the waiting time between having a COVID infection and the next COVID vaccine. The reporter mentioned that the patient was infected in early Aug2025. Last vaccine administered was a Pfizer vaccine in Sep2024. They were told by an HCP to wait 4 months since the patient has tested negative on 18Aug2025, but the patient doesn't want to wait so long because of the coming Thanksgiving and Christmas family parties. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2025) Negative. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863099	69	F	NY	10/03/2025	RSV	PFIZER\WYETH	LG9829	Lymphadenopathy, Pharyngeal hypoaesthesia, Swelling face Lymphadenopathy, Pharyngeal hypoaesthesia, Swelling face	numbness in the throat; facial swelling / swelling in her face was in her right jaw; enlarged lymph ... numbness in the throat; facial swelling / swelling in her face was in her right jaw; enlarged lymph node; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 26Jan2025 as dose 1, single (Lot number: LG9829) at the age of 69 years, in right deltoid for immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: diagnosed about 20 years ago and it ws contained; "sulfa drugs" (unspecified if ongoing); "thyroid nodules", start date: 2017 (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE oral (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2025, outcome "recovered" (2025), described as "enlarged lymph node"; SWELLING FACE (non-serious) with onset 26Jan2025, outcome "recovering", described as "facial swelling / swelling in her face was in her right jaw"; PHARYNGEAL HYPOAESTHESIA (non-serious) with onset 26Jan2025, outcome "recovered" (2025), described as "numbness in the throat". The event "enlarged lymph node" required physician office visit. The event "facial swelling / swelling in her face was in her right jaw" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy. Therapeutic measures were taken as a result of swelling face. Additional information: The patient has never had an allergic reaction. On 26Jan2025 she got Abrysvo and about 5 or 6 minutes later her left side felt as if she was injecting with NOVOCAIN (procaine). She experienced numbness in the throat and took about 90 days for it to go away. She went back to the pharmacy and the agent at the counter said it could not be the Abrysvo shot, she reminded them that she had walked in fine. On 27Jan2025 her right side was swollen, and she went to the hospital where she got prednisone, she was not admitted, and she was in the emergency room for about 4 hours. The swelling in her face was in her right jaw which started on 26Jan2025, only took about 24 hours to go down, the swelling went down progressively for three months. She had an enlarged lymph node and she was not aware of it until she went to the doctor about a week later after receiving Abrysvo. Her lymph node was enlarged due to the Abrysvo shot, and was recovered completely about several months later, it took about 90 days to recover. She had a biopsy done on 07Apr2025 at Hospital and they were not successfully able to biopsy the lymph node since it was close to an artery. She had thyroid nodules which she was previously aware of. Clarifies she was diagnosed with thyroid nodules back in 2017 and the biopsy she had was on her thyroid nodules. The biopsy of the thyroid nodules that were non-cancerous and that is why they felt the lymph node was also non-cancerous. The patient did not receive any other vaccines on the same date as the Pfizer vaccine and, to her knowledge, had not received any other vaccines within four weeks prior to the first administration of the suspect vaccine. More
2863100	80	M		10/03/2025	FLUX	UNKNOWN MANUFACTURER		Chills, Cough, Influenza like illness, Night sweats, Productive cough Chills, Cough, Influenza like illness, Night sweats, Productive cough	experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like ... experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; experienced flu like symptoms such as cough, chills, night sweats, and phlegm; his left arm, the injection site is red, swollen and hot to the touch; his left arm, the injection site is red, swollen and hot to the touch; his left arm, the injection site is red, swollen and hot to the touch; has a cough again; injection site reactions such as swelling, itching, and pain for 2-3 days after dupixent administration; injection site reactions such as swelling, itching, and pain for 2-3 days after dupixent administration; Initial information received on 20-Aug-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 80 years old male patient who had a cough again, his left arm, the injection site was red, swollen and hot to the touch, experienced flu like symptoms such as cough, chills, night sweats, and phlegm, injection site reactions such as swelling, itching, and pain for 2-3 days after DUPILUMAB [DUPIXENT] administration via prefilled syringe and after receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2025, the patient started taking DUPILUMAB Solution for injection in prefilled syringe (strength 300mg/2ml) at dose 600 mg once as loading dose followed by maintenance dose 300mg QOW subcutaneously for Chronic obstructive pulmonary disease. On 20-AUG-2025 the patient developed a non-serious his left arm, the injection site is red, swollen and hot to the touch (injection site erythema) (injection site swelling), (injection site warmth) (latency 5 months 2 days) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB. On 16-Sep-2025, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. In SEP-2025 the patient developed a non-serious event "experienced flu like symptoms such as cough, chills, night sweats, and phlegm" (influenza like illness) (chills) (night sweats) (productive cough) (approximately 6 months latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and (unknown latency) after the administration of INFLUENZA VACCINE. In 2025 the patient developed a non-serious event "has a cough again" (cough) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB. In 2025 the patient developed a non-serious event "injection site reactions such as swelling, itching, and pain for 2-3 days after Dupixent administration" (injection site pruritus) (injection site pain) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and (unknown latency) after the administration of INFLUENZA VACCINE. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "that has a cough again (onset unknown) symptom that has been improving, but continues occasionally, unknown if md is aware. patient indicated that his doctor injected the medication yesterday 19-Aug-2025 in his left arm and today 20-Aug-2025 the injection site is red, swollen and hot to the touch, md (Doctor of Medicine) not aware. Patient reports that after receiving the influenza vaccine (16-Sep-2025), has experienced flu-like symptoms such as cough, chills, night sweats, and phlegm that is improving. patient reports that he is having injection site reactions such as swelling, itching, and pain for 2-3 days after Dupixent administration, are resolved, and the md is not aware. no further information was provided." Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken with dupilumab: Unknown for all events; However, therapy was ongoing. Action taken with influenza vaccine: Not applicable for all events. It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Recovered / Resolved in 2025 for injection site pruritus, injection site pain, injection site swelling, Recovering / Resolving for cough and influenza like illness along with symptoms and unknown for other events. Additional information was received on 23-Sep-2025 from patient: new events injection site pruritus, injection site pain and influenza like illness along with symptoms chills, night sweats and productive cough added, new suspect influenza vaccine added, clinical course updated, and text amended accordingly. More
2863101	65	F	GA	10/03/2025	FLUX	UNKNOWN MANUFACTURER		Malaise, Stress Malaise, Stress	Stressed; Feeling sick; Infusion site came out twice this month; Initial information received on 26-... Stressed; Feeling sick; Infusion site came out twice this month; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 65 years old female patient (63 kg) who had stressed, feeling sick and infusion site came out twice this month after receiving Influenza Vaccine and treated with Treprostinil sodium. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Omeprazole, Cetirizine hydrochloride (Zyrtec); Furosemide, Mycophenolate mofetil, Sodium chloride (Saline nasal spray); Paracetamol (Tylenol); Macitentan (Opsumit); Magnesium chelate (Magnesium); Ketamine hydrochloride (Ketamine HCL); Glycine max extract (Lecithin); Apixaban (Eliquis); Fluticasone propionate (Flonase allergy relief); Cod-liver oil (Cod liver oil); Clonidine, Ketoprofen, Ascorbic acid, Biotin, Calcium pantothenate, Cyanocobalamin, Ergocalciferol, Iron, Nicotinamide, Pyridoxine hydrochloride, Retinol, Riboflavin, Thiamine hydrochloride, Tocopheryl acetate (Centrum); Calcium, Oxygen, Montelukast sodium, Lidocaine hydrochloride (Lidocaine HCL); Amitriptyline hydrochloride (Amitriptyline); Gabapentin, Poloxamer and Ondansetron hydrochloride (Ondansetron HCL). On 18-Sep-2025, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, formulation, expiry date and strength not reported) via unknown route in unknown administration site for Flu vaccination (Influenza immunization). On an unknown date, the patient started taking Treprostinil sodium (0.044 �g/kg, formulation and expiry date unknown) subcutaneous for Pulmonary arterial hypertension. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date in Sep-2025, the patient developed stressed (stress), feeling sick (malaise) and infusion site came out twice this month (device dislocation) (latency approximately few days) following intake of Treprostinil sodium and administration of Influenza Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2863102				10/03/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	8080473 UT8409CA	COVID-19, Urticaria; COVID-19, Urticaria COVID-19, Urticaria; COVID-19, Urticaria	covid; urticaria; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-se... covid; urticaria; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(non-healthcare professional). This case involves a patient with unknown age and gender who had covid and urticaria after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and treated with Elasomeran [Spikevax]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2024, the patient received 1DF (dosage form) of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot UT8409CA) via unknown route in unknown administration site for product used for unknown indication and Spikevax (Elasomeran) (0.5 mL, frequency once, lot 8080473, formulation unknown) intramuscular for COVID-19 (expiry date not reported for both). On an unknown date in 2024, the patient developed covid (covid-19), urticaria (latency approximately few months) following intake of Elasomeran and administration of Influenza Quadrival A-B Multidose Vaccine Preserved. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for the event (covid-19) and was Recovered / Resolved on an unknown date for the event (urticaria). More
2863103		F		10/03/2025	FLU3 FLU3	SANOFI PASTEUR SANOFI PASTEUR	VT8770JA VT8770JA	Asthenia, Dizziness, Feeling of body temperature change, Hyperhidrosis, Impaired... Asthenia, Dizziness, Feeling of body temperature change, Hyperhidrosis, Impaired work ability; Vomiting projectile More	think it was a virus.; projectile vomiting for 6 plus hours; whole body was on fire but i was cold a... think it was a virus.; projectile vomiting for 6 plus hours; whole body was on fire but i was cold at the same time; sweating all over; felt dizzy; drained; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves an unknown age female patient who reported that they think it was a virus, projectile vomiting for 6 plus hours, whole body was on fire but i was cold at the same time, sweating all over, felt dizzy and drained after receiving influenza USP Trival A-B subvirion no preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2025, the patient received unknown dose of suspect influenza USP Trival A-B subvirion no preservative vaccine, Suspension for injection (strength and expiry date not reported) (lot VT8770JA) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date in Sep-2025 patient developed projectile vomiting for 6 plus hours (vomiting projectile), upon ER (emergency room) visit they said they think it was a virus (viral infection) on same day after vaccination and also reported her whole body was on fire but she was cold at the same time (feeling of body temperature change), sweating all over (hyperhidrosis), felt dizzy (dizziness) and drained (fatigue) (unknown latency). It was reported that she was not coming down with anything before the flu shot and she do not have any flu/cold symptoms as of today. She had to take off Thursday and came in late on Friday. Her whole body was on fire but she was cold at the same time and sweating all over the place all while vomiting. It stopped Friday morning but she was at that point drained and felt dizzy and like and said, almost wasn't sure she should come in to work. She did not have any of my usual flu shot reactions (pain in the arm where the shot was given, body aches, feeling like she is coming down with something, fever) Is it possible to exchange for a different log number, the log numbers for Fluzone on site now are: VT8770JA-used up and staff have problem with this lot U8863DA-still have some, but i pulled this log number to a different fridge U8883BA-The New Stock Action taken: Not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for the event (vomiting projectile, dizziness, viral infection and fatigue) and was Recovered / Resolved on an unknown date for the event (feeling of body temperature change and hyperhidrosis). More
2863107		F	LA	10/03/2025	UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	No batch number No batch number No batch number	Dysstasia, Erythema, Hypoaesthesia, Injection site discolouration, Injection sit... Dysstasia, Erythema, Hypoaesthesia, Injection site discolouration, Injection site mass; Injection site swelling, Injection site warmth, Muscle tightness, Muscular weakness, Neck mass; Skin warm, Swelling More	My arm is swollen above the right elbow/There's a big brown spot and huge knot that's hot ... My arm is swollen above the right elbow/There's a big brown spot and huge knot that's hot that's near the injection site; My wrist and hand are numb; I'm little horse too; The doctor said it might infected; My legs were so weak and I could barely get up; My right arm is red and feels hot; My right arm is red; There's a big brown spot that's near the injection site; There is a huge knot that's hot that's near the injection site; My neck on the same side has a knot; My neck is really tight and swollen; This spontaneous case from United States, initially received on 21-Sep-2025, was reported by a non-health professional and concerns an adult female patient. Past medical history included autoimmune issues- thyroid (reports she has no thyroid), mentioned she had an oncologist, said she had shingles before. Administration of company suspect drug: On 10-Sep-2025, the patient received Flucelvax (TIV) for Flu prevention, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2025, the patient experienced My arm is swollen above the right elbow/There's a big brown spot and huge knot that's hot that's near the injection site (outcome: Not recovered / Not resolved), My wrist and hand are numb (outcome: Not recovered / Not resolved), I'm little horse too (outcome: Not recovered / Not resolved), The doctor said it might infected (outcome: Not recovered / Not resolved), My legs were so weak and I could barely get up (outcome: Not recovered / Not resolved), My right arm is red and feels hot (outcome: Not recovered / Not resolved), My right arm is red (outcome: Not recovered / Not resolved), There's a big brown spot that's near the injection site (outcome: Not recovered / Not resolved), There is a huge knot that's hot that's near the injection site (outcome: Not recovered / Not resolved), My neck on the same side has a knot (outcome: Not recovered / Not resolved), My neck is really tight and swollen (outcome: Not recovered / Not resolved). The adult patient says: She got Flucelvax on 10-Sep-2025. Her right arm was red and felt hot. Her wrist and hand were numb, and it was driving her crazy. Her arm was swollen above the right elbow. There was a big brown spot and huge knot that was hot that's near the injection site but not at the injection site. Her neck on the same side had a knot and was really tight and swollen. The doctor said it might infected. Her doctor gave her steroid cream. All of this has been going on since the evening she got the flu shot. She was a little horse too. Two different doctors told her not to get the flu shot again. She went to the Emergency room (ER) first three or four days after getting the shot because her legs were so weak and she could barely get up. She thought she must have fallen or something but she didn't fall. After that, she went to another doctor. She has follow up with her doctor in October, but she may have to go to urgent care if this numbness doesn't get better soon. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Mupirocin, Steroid cream, Antibiotics Reporter's assessment: The reporter assessed events as non-serious and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes More
2863108		M		10/03/2025	FLUX	UNKNOWN MANUFACTURER	No batch number	Liquid product physical issue Liquid product physical issue	Product is the one administered to patient; Looked milky white, instead of clear; This spontaneous c... Product is the one administered to patient; Looked milky white, instead of clear; This spontaneous case, initially received on 22-Sep-2025 (Including additional information received on 23-Sep-2025), was reported by a non-health professional and concerns an adult male patient. Relevant History and concomitant medication were reported as unknown. The patient was not immunocompromised. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Indication not reported, Dose regimen: not reported, Anatomical Location: not reported, Route of administration: not reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the Product is the one administered to patient (outcome: Unknown), Looked milky white, instead of clear (outcome: Unknown). Reporter mentioned that her father sent her a photo of a Seqirus vaccine. In the photo, the reporter noticed, it said for 3 years and older. It also looked milky white, instead of clear. The defect had been discovered after use. The batch number had not been reported, and follow-up was required. The dose had been administered, but it was unknown whether a full dose had been given. It was also unknown whether the complaint sample was available. Regarding the packaging, it was unknown whether it appeared damaged. The storage conditions of the product were also unknown, including whether it had been stored in its original packaging, blister trays removed from the box, or individual syringes stored separately. The temperature conditions under which the product had been stored, such as refrigerator, freezer, or room temperature were not reported. For the particle complaint, the number of visible particles was unknown, and it was unknown when the particles had been noticed. The particle had been described as having a milky white appearance. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter did not provide a seriousness or causality assessment for events.; Reporter's Comments: The events were assessed as not related due to nature of events (special situation). More
2863109		F		10/03/2025	COVID19 UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	No batch number 406981	Fatigue, Pyrexia; Fatigue, Pyrexia Fatigue, Pyrexia; Fatigue, Pyrexia	Fever; Fatigue; This spontaneous case, initially received on 25-Sep-2025, was reported by a non heal... Fever; Fatigue; This spontaneous case, initially received on 25-Sep-2025, was reported by a non health professional and concerns an adult female patient. Administration of company suspect drug: On 22-Sep-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: 406981. Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine) Adverse reactions/events and outcomes: On 24-Sep-2025, the patient experienced Fever (outcome: Unknown), Fatigue (outcome: Unknown). The non health professional reporter reported that Flucelvax was given to patient on 22-Sep-2025 shown adverse reactions as fever and fatigue on 24-Sep-2025 and not sure it was related or not and also received a COVID vaccine on the same day as the Flu vaccine on 22-Sep-2025 Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide causality assessment and seriousness was unknown; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events considered related for reporting purposes More
2863110				10/03/2025	FLUX RVX UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	No batch number No Batch number No batch number	Drug ineffective, Malaise, Product label issue; Drug ineffective, Malaise, Produ... Drug ineffective, Malaise, Product label issue; Drug ineffective, Malaise, Product label issue; Drug ineffective, Malaise, Product label issue More	Flucelvax package insert was hard to read; Last year was not that effective; Very sick, very very si... Flucelvax package insert was hard to read; Last year was not that effective; Very sick, very very sick; This spontaneous case, initially received on 24-Sep-2025, was reported by a health professional and concerns an elderly patient. Administration of company suspect drugs: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication not reported, Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available and would not be requested as the reporter did not provide consent for follow-up. On an unknown date in 2024, the patient received Flucelvax (TIV) for indication not reported, Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available and would not be requested as the reporter did not provide consent for follow-up No additional suspect drugs. On an unknown date in 2024, the patient received Flucelvax (TIV) for RSV vaccine (RSV vaccine), Indication: Not reported. Dosage regimen: not reported, Route of administration: not reported, Lot number: No batch number available Adverse reactions/events and outcomes: On an unknown date in 2024, the patient experienced last year was not that effective (Medically Significant, outcome: Not Reported), Very sick, very very sick (outcome: Not Reported). On an unknown date, the patient experienced Flucelvax package insert was hard to read (outcome: Not Reported). Pharmacist stated, It was very confusing because nurses in different areas were putting out pamphlets that said it was quadrivalent. Reporter followed this very closely; last year (2024) it was not that effective. Reporter hoped that it would be effective this year 2025. Also, the Flucelvax package insert was hard to read. Reporter liked the flu vaccine. Reporter thought reporter was going to get the COVID vaccine also. Last year (2024) he got RSV and the doctors did not pay much attention. Reporter was very sick, very very sick. Patient could not get an appointment with the doctor in the country unless patient was dying, so it was kind of sad, not that summer, but last year 2024. Patient was 87 at home, and they did not pay attention. INN Flu Vaccine Seasonal action taken: Not Applicable Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: INN Flu vaccine seasonal- Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug/vaccine product as a 100% success rate cannot be reasonably assumed in every patient treated. However, further information required on exact etiology (whether due to Flu vaccines or any other suspect product), temporality, onset latency, etc. for meaningful causal assessment. The event illness is probably attributed to RSV vaccine administered. Flucelvax (TIV)- Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug/vaccine product as a 100% success rate cannot be reasonably assumed in every patient treated. However, further information required on exact etiology (whether due to Flu vaccines or any other suspect product), temporality, onset latency, etc. for meaningful causal assessment. The event illness is probably attributed to RSV vaccine administered. More
2863111	3	M	CA	10/03/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	7JZ2R	Immediate post-injection reaction, Injection site discolouration, Injection site... Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling More	Immediately after injecting vaccine, a blue, purple discoloration appeared at injection site. A blue... Immediately after injecting vaccine, a blue, purple discoloration appeared at injection site. A blue purple line traveled lateral to injection site. The blue purple line was raised with surrounding erythema. The surrounding area around injection site was red and swollen. 2 days later, the injection area is red and tender. More
2863113	55	F	CA	10/03/2025	FLU3	SANOFI PASTEUR	U8764DB	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	high dose given to patient under 65 years old high dose given to patient under 65 years old

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