🏥 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.
No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
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Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
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Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
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Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
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⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

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

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Showing 151 to 200 of 34,052 reports (Page 4 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿	⚠️
2874574	26	F	NY	11/24/2025	FLUC4 FLUC4	SEQIRUS, INC. SEQIRUS, INC.	410515 410515	Injection site bruising, Injection site injury, Injection site pain, Injection s... Injection site bruising, Injection site injury, Injection site pain, Injection site swelling, Joint injury; Pain More	Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje... Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Additional Details: Patient came into the store on 11/20/25 (13 days after vaccination) complaining about injection site injury. She still has a bruise around injection site. She's experiencing radiating pain on her arm and worried if there's any nerve damage. She took ibuprofen/tylenol OTC but it's not helping. More
2874577	80	M	IA	11/24/2025	COVID19	MODERNA	8146751	Death Death	Resident passed away Resident passed away	✓
2874584	4	F	NJ	11/24/2025	FLU3	SANOFI PASTEUR	73BN2	Cellulitis, Erythema, Local reaction, Pruritus, Swelling Cellulitis, Erythema, Local reaction, Pruritus, Swelling	RED LOCAL REACTION, itchy and swollen RED LOCAL REACTION, itchy and swollen
2874585	71	M	KY	11/24/2025	COVID19 COVID19	MODERNA MODERNA	3051995 3051995	Asthenia, Computerised tomogram head, Computerised tomogram neck, Computerised t... Asthenia, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Electrocardiogram; Full blood count, Hyperhidrosis, Mental status changes, Urine analysis More	On 11/22/25 at approximately 1126 resident had altered mental status compared to baseline and was un... On 11/22/25 at approximately 1126 resident had altered mental status compared to baseline and was unable to follow commands. Diaphoresis as well as weakness was present at that time. The resident was sent out to the hospital directly after the event and is currently continues in the hospital for observation. More		✓
2874588	74	M	GA	11/24/2025	COVID19	PFIZER\BIONTECH	na4457	Atrial flutter, Electrocardiogram abnormal Atrial flutter, Electrocardiogram abnormal	Patient did not have any symptoms until he went in 11/7/25 and after EKG patient was told to go to c... Patient did not have any symptoms until he went in 11/7/25 and after EKG patient was told to go to cardiologist for further checkup. diagnosis was Atrial flutter in the Right atrium. 25 days until he was diagnosed. More
2874590	7	F	IL	11/24/2025	COVID19 FLU3	MODERNA GLAXOSMITHKLINE BIOLOGICALS	3053667 P2P9T	Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia... Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia More	Had Low grade fever now resolved yesterday with red, hot shoulder in location of vaccinations. Feve... Had Low grade fever now resolved yesterday with red, hot shoulder in location of vaccinations. Fever is resolved today but arm swelling persisting. 3 x 6 cm of erythema and calor around injection site. She is able to move her arm. No other rash, limp/tongue swelling, vomiting or persistent cough. C/W localized, non-allergic reaction to vaccination. Recommended symptomatic care with ibuprofen now. More
2874593	80	M	NH	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	305 3824 8862 AA	Refusal of vaccination; Refusal of vaccination Refusal of vaccination; Refusal of vaccination	Resident did not have consent for Covid vaccine. Flu vaccine was the only vaccine that consent was g... Resident did not have consent for Covid vaccine. Flu vaccine was the only vaccine that consent was given for. Pharmacy technician administered Covid vaccine in error at today's vaccine clinic. More
2874603	71	F	OH	11/24/2025	COVID19	MODERNA		Arthralgia, Injection site haemorrhage, Injection site mass, Pain, Pain in extre... Arthralgia, Injection site haemorrhage, Injection site mass, Pain, Pain in extremity More	Patient stated she received a vaccine at this location. Patient reported blood running down arm at ... Patient stated she received a vaccine at this location. Patient reported blood running down arm at time of injection, ongoing nagging pain down arm and across shoulder, and a knot at the injection site. 'knot went away since then' Patient requested guidance. Advised patient that radiating arm/shoulder pain requires evaluation by a medical provider and recommended she be seen by her doctor. More
2874607	64	F	IA	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3052741 U8854AA	Cellulitis, Pain in extremity; Cellulitis, Pain in extremity Cellulitis, Pain in extremity; Cellulitis, Pain in extremity	Pt states she awoke with sore left arm that felt as if it were broken. Pt states she awoke with sore left arm that felt as if it were broken.
2874609	59	F	UT	11/24/2025	COVID19	MODERNA	3051995	Mobility decreased, Myalgia Mobility decreased, Myalgia	Patient said MNexSpike caused her muscle aches, so much so that she couldn't get out of bed. S... Patient said MNexSpike caused her muscle aches, so much so that she couldn't get out of bed. She also said that if she touched her face, it lit up. More
2874612	64	F	WI	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3053483 U8823BA	Dizziness, Faeces discoloured, Vomiting; Dizziness, Faeces discoloured, Vomiting Dizziness, Faeces discoloured, Vomiting; Dizziness, Faeces discoloured, Vomiting	Patient reported feeling very dizzy, blacking out and vomiting. They called an ambulance but did not... Patient reported feeling very dizzy, blacking out and vomiting. They called an ambulance but did not get taken to hospitals. Ambulance said vitals were normal. More
2874613	60	F	LA	11/24/2025	FLU3 UNK	SEQIRUS, INC. UNKNOWN MANUFACTURER	410515 NM35M	Myalgia, Peripheral swelling, Pruritus, Pyrexia; Myalgia, Peripheral swelling, P... Myalgia, Peripheral swelling, Pruritus, Pyrexia; Myalgia, Peripheral swelling, Pruritus, Pyrexia More	3 days later I still have a swollen right arm, itching, muscle pain, fever. 3 days later I still have a swollen right arm, itching, muscle pain, fever.
2874615	39	F	NY	11/24/2025	COVID19	PFIZER\BIONTECH	NA0739	Dizziness Dizziness	The patient received the COVID vaccine and a couple of minutes later was lightheaded and needed to s... The patient received the COVID vaccine and a couple of minutes later was lightheaded and needed to sit down. Water was given and EMS was called for patient safety. More
2874629	8	M	TX	11/24/2025	COVID19	PFIZER\BIONTECH	NA4459	No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More	Moderna Spikevax ordered, but Covid-19 (Pfizer12+yr) inadvertently administered instead. No advers... Moderna Spikevax ordered, but Covid-19 (Pfizer12+yr) inadvertently administered instead. No adverse reaction while in the office. More
2874632	66	M		11/24/2025	FLU3	SANOFI PASTEUR		Cerebrovascular accident Cerebrovascular accident	Stroke, hospitalization, resolved Stroke, hospitalization, resolved		✓		✓
2874633	78	M	MI	11/24/2025	COVID19 FLU3	MODERNA SEQIRUS, INC.	3053483 3053483	Shoulder injury related to vaccine administration; Shoulder injury related to va... Shoulder injury related to vaccine administration; Shoulder injury related to vaccine administration More	Patient stated that they were diagnosed with SIRVA shoulder within days of the vaccine Patient stated that they were diagnosed with SIRVA shoulder within days of the vaccine
2874634	77	M	IL	11/24/2025	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	NA0507 NA0507 NA0507	Asthenia, Biopsy bone marrow normal, Blood pressure decreased, Blood test abnorm... Asthenia, Biopsy bone marrow normal, Blood pressure decreased, Blood test abnormal, Brain fog; Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram thorax normal, Dizziness, Dyspnoea; Echocardiogram normal, Haemoglobin decreased More	Extreme dizziness, weakness, breathing difficulties, brain fog, severe drop in hemoglobin and blood ... Extreme dizziness, weakness, breathing difficulties, brain fog, severe drop in hemoglobin and blood pressure, worsening over several days. More		✓		✓
2874636	77	F	MT	11/24/2025	COVID19	MODERNA	3052734	Glossodynia, Taste disorder, Tongue discomfort Glossodynia, Taste disorder, Tongue discomfort	Sore tongue with symptoms of burning, stinging, and altered taste. Sore tongue with symptoms of burning, stinging, and altered taste.			✓
2874641	37	F	PA	11/24/2025	COVID19	MODERNA		Blepharospasm, Influenza like illness Blepharospasm, Influenza like illness	This was my first time receiving the Moderna Covid vaccine; I've received the Pfizer in the pas... This was my first time receiving the Moderna Covid vaccine; I've received the Pfizer in the past at least 2-3 times. I noticed normal, flu-like symptoms the next day, but the adverse event was an additional symptom which included subtle eye twitching in my left eye that has persisted daily since the day after I received the vaccine (beginning on 11/5/25). My left eye was initially twitching over approximately 30 times per day, and now as of 11/24, is twitching approximately 15-20 times per day; the twitching is not noticeable to others but is felt by me. I have not yet received medical attention, but did schedule an annual eye exam with a Doctor of Optometry on 12/6/25 and will review this issue if it continues to persist. More
2874645	7	F	CO	11/24/2025	COVID19 FLU3	PFIZER\BIONTECH SEQIRUS, INC.	NA4457 409415	Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More	Flu shot clinic was being operated at a local mall. Patient received a flu and covid vaccine. After ... Flu shot clinic was being operated at a local mall. Patient received a flu and covid vaccine. After the clinic, vaccines were being processed at the pharmacy store, and it was realized the patient received the COVID 12+ instead of the 3-11 year old dose. The pharmacy attempted to call the parent many times, and left multiple voicemails to inform them and find out if they had any adverse reactions. We were never able to speak to the parent. The patient's doctor office was notified so this incident could be in the patient's chart. More
2874649	43	F	IA	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR		Contusion; Contusion Contusion; Contusion	Very large bruise Very large bruise
2874650	70	F	CA	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3052859 UT8794DA	Underdose; Underdose Underdose; Underdose	Wrong covid vaccine dose. Pt is an adult who received the Pediatric dose Covid Moderna. Wrong covid vaccine dose. Pt is an adult who received the Pediatric dose Covid Moderna.
2874683	50	F	MD	11/24/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Syphilis, Syphilis test positive Syphilis, Syphilis test positive	after the administration of Shingrix she tested positive for syphilis.; This serious case was report... after the administration of Shingrix she tested positive for syphilis.; This serious case was reported by a pharmacist via call center representative and described the occurrence of syphilis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-SEP-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced syphilis (Verbatim: after the administration of Shingrix she tested positive for syphilis.) (serious criteria GSK medically significant). The outcome of the syphilis was not resolved. It was unknown if the reporter considered the syphilis to be related to Shingrix. The company considered the syphilis to be unrelated to Shingrix. Additional Information: GSK receipt date: 20-NOV-2025 The Pharmacist reported that she had not been sexually active for over a year. No further information was provided/obtained. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Syphilis, an unknown time after receiving 1st dose of Shingrix, in a 50-year-old female patient. Causal association is indeterminate. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2874684		M	MO	11/24/2025	VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK UNK UNK UNK UNK UNK	Arthralgia, Basophil percentage, Biopsy skin abnormal, Blister, Drug level thera... Arthralgia, Basophil percentage, Biopsy skin abnormal, Blister, Drug level therapeutic; Endoscopy upper gastrointestinal tract abnormal, Eosinophil percentage, Erythema, Furuncle, Gastritis erosive; Haemoglobin decreased, Herpes simplex test negative, Hypersensitivity, Inflammation, International normalised ratio increased; Lymphocyte percentage decreased, Melaena, Monocyte percentage decreased, Mouth ulceration, Mucocutaneous toxicity; Mucosal inflammation, Mucosal ulceration, Neutrophil percentage increased, Neutrophilic dermatosis, Pain; Pancytopenia, Papule, Platelet count decreased, Red blood cell sedimentation rate increased, Skin hyperplasia; Skin lesion, Skin necrosis, Tenderness, White blood cell count decreased More	Recombinant adjuvant zoster vaccine-associated acute mucocutaneous toxicity/; progressivelyworsening... Recombinant adjuvant zoster vaccine-associated acute mucocutaneous toxicity/; progressivelyworsening polyarthralgia; pancytopenia; This serious case was reported in a literature article and described the occurrence of mucocutaneous toxicity in a 37-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference:. The patient's past medical history included heart disease congenital and aortic valve replacement. Concurrent medical conditions included psoriatic arthritis and immunocompromised. Concomitant products included warfarin, methotrexate and adalimumab. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced mucocutaneous toxicity (Verbatim: Recombinant adjuvant zoster vaccine-associated acute mucocutaneous toxicity/) (serious criteria hospitalization and GSK medically significant), polyarthralgia (Verbatim: progressivelyworsening polyarthralgia) (serious criteria hospitalization) and pancytopenia (Verbatim: pancytopenia) (serious criteria hospitalization and GSK medically significant). The patient was treated with methylprednisolone, Corticosteroids and prednisone. The outcome of the mucocutaneous toxicity, polyarthralgia and pancytopenia were resolved. The reporter considered the mucocutaneous toxicity, polyarthralgia and pancytopenia to be related to Shingrix. The company considered the mucocutaneous toxicity, polyarthralgia and pancytopenia to be unrelated to Shingrix. GSK receipt date: 14-NOV-2025 A patient with a past medical history of con-genital heart disease status following prosthetic aortic valve replacement on chronic warfarin therapy, and psoriatic arthritis managed with methotrexate and adalimumab, presented with a 10 day history of progressively worsening polyarthralgia, melaena, and painful, erythematous skin lesions. Patient also reported new-onset oral and perineal mucosal ulcerations. Notably, these symptoms developed 4 days after receiving his first dose of the recombinant zoster vaccine (RZV) (Shingrix).On admission, physical examination revealed numerous tender, erythematous papules and vesicles with central necrosis distributed across the trunk and bilateral lower extremities, along with oral mucosal ulcers and perineal mucositis. Laboratory testing demonstrated new-onset pancytopenia with a White blood cell count of 3300/�L, leucocyte differential of 81 percent neutrophils, 13.9 percent lymphocytes, 1.4 percent monocytes,3.2 percent eosinophils, and 0.5 percent basophils, haemoglobin of11.7 g/dL, and platelet count of 92 000/�L. Patient inter-national normalized ratio was supratherapeutic, and the erythrocyte sedimentation rate was elevated at 38 mm/h. Upper endoscopic evaluation revealed diffuse erosive gastritis, probably the cause of melaena. Given the timing of symptom onset following RZV administration, lack of evidence for active infection, and the patient's previously stable course on long-standing immunosuppressive therapy, a hypersensitivity reaction to RZV was suspected. Methotrexate was held, and intra-venous methylprednisolone was initiated. A dermatology consultation was obtained, and a skin biopsy was performed. Histopathological examination showed erosive folliculitis with neutrophilic inflammation, squamous hyperplasia, increased mitotic activity, and perifollicular abscess formation, findings consistent with a vaccine-induced inflammatory reaction. Further immunological evaluation was unremarkable, and serum methotrexate levels remained within normal limits, making drug toxicity unlikely. A broad infectious work-up, including testing for herpesvirus reactivation, was negative. The patient demonstrated marked clinical improvement within days of corticosteroid therapy. The mucocutaneous lesions began to resolve, and patient was discharged after 1 week on a tapering regimen of oral prednisone. The patient experienced gradual resolution of skin lesions over the next few weeks, pancytopenia resolved, and patient was successfully reinitiated on methotrexate and adalimumab. This case underscores a rare but clinically significant mucocutaneous hypersensitivity reaction to RZV in an immunocompromised host, highlighting important considerations for vaccination in patients with autoimmune disease on chronic immunosuppressive therapy.; Sender's Comments: A case of Mucocutaneous toxicity, Arthralgia and Pancytopenia, 4 days after receiving Shingrix in a 37-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (h/o heart disease congenital, concurrent psoriatic arthritis and immunocompromised). More		✓
2874693		M	FL	11/24/2025	MMR MMR	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Blindness transient, Blindness unilateral, Headache, Laboratory test normal, Mag... Blindness transient, Blindness unilateral, Headache, Laboratory test normal, Magnetic resonance imaging head abnormal; Optic perineuritis More	Optic perineuritis; This serious case was reported in a literature article and described the occurre... Optic perineuritis; This serious case was reported in a literature article and described the occurrence of optic perineuritis in a 70-year-old male patient who received MMR (MMR vaccine) for prophylaxis. Literature Reference: On an unknown date, the patient received the 1st dose of MMR vaccine. On an unknown date, 9 weeks after receiving MMR vaccine, the patient experienced optic perineuritis (Verbatim: Optic perineuritis) (serious criteria GSK medically significant). The patient was treated with steroids. The outcome of the optic perineuritis was resolved. The reporter considered the optic perineuritis to be related to MMR vaccine. The company considered the optic perineuritis to be unrelated to MMR vaccine. Additional Information: GSK Receipt Date: 10-NOV-2025 Author reports a case of a 70-year-old male who presented to the Hospital after two episodes of self-resolving acute painless vision loss in the right eye (OD) and headaches 9?weeks after receiving the first dose of the measles, mumps, and rubella (MMR) vaccination. Magnetic resonance imaging (MRI) performed at an outside institution showed enhancement of the right optic nerve sheath suggesting optic perineuritis (OPN). Extensive laboratory investigations were negative for common infectious and inflammatory etiologies. The patient received IV steroids followed by a taper, with no recurrence. Author utilized the Bradford Hill criteria for causality to evaluate the evidence for a causal relationship between MMR vaccination and OPN, supporting post-vaccination autoimmunity as the most plausible etiology. This case highlights a rare presentation of OPN, potentially attributable to immunization at an unusual age. This article is not available for regulatory reporting due to copyright restriction.; Sender's Comments: A case of Optic perineuritis, 9 weeks after receiving MMR vaccine, in a 70-year-old male patient. Case lacks further information on medical history, concurrent conditions and concomitant medications. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2874695		F	CA	11/24/2025	COVID19 FLUX VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration, Musculoskeletal stiffness; Ina... Inappropriate schedule of product administration, Musculoskeletal stiffness; Inappropriate schedule of product administration, Musculoskeletal stiffness; Inappropriate schedule of product administration, Musculoskeletal stiffness; Inappropriate schedule of product administration, Musculoskeletal stiffness More	Reaction after the first one (Stiff fingers); Late second dose; This non-serious case was reported b... Reaction after the first one (Stiff fingers); Late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of stiff fingers in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis. On 03-AUG-2021, the patient received the 1st dose of Shingrix. On 18-NOV-2025, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Flu vaccine and COVID-19 vaccine. On 18-NOV-2025, not applicable after receiving Shingrix and Flu vaccine, an unknown time after receiving Shingrix, not applicable after receiving Shingrix and Flu vaccine and an unknown time after receiving COVID-19 vaccine, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On an unknown date, the patient experienced stiff fingers (Verbatim: Reaction after the first one (Stiff fingers)). The outcome of the stiff fingers was unknown and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the stiff fingers to be related to Shingrix and Flu vaccine. It was unknown if the company considered the stiff fingers to be related to Shingrix and Flu vaccine. Additional Information: GSK Receipt Date: 18-NOV-2025 The patient (Member of the Public) called to enquire whether to receive a second shot for Shingrix vaccine The patient had received both the shots of the vaccine. The patient mentioned that after the first dose had experienced stiff fingers and wanted to know if it was related to the vaccine The patient received both flu and COVID vaccines during this The batch number was not provided upon follow- up with the reporter. More
2874702		F		11/24/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Illness; Illness Illness; Illness	got really sick; This spontaneous case was reported by a consumer and describes the occurrence of IL... got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Concurrent medical conditions included Migraine (her migraines were from "years before"). Concomitant products included Paracetamol (Tylenol) and Sumatriptan succinate (Sumatriptan) for Migraine. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) had resolved. The patient's current age was 65 years old. It was reported that the patient only took medications (Tylenol and sumatriptan) for her migraines. She had a lot of vaccines and there had only been one time where she got really sick, it was when she got the influenza and Moderna all at once. She got pretty sick for a little bit there but that was a couple of years ago. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-791399 (Patient Link). More
2874703	67	F		11/24/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Chills, Fatigue, Headache, Myalgia; Chills, Fatigue, Headache, Myalgia Chills, Fatigue, Headache, Myalgia; Chills, Fatigue, Headache, Myalgia	Body aches; Severe fatigue; Headaches; Chills; This spontaneous case was reported by a consumer and ... Body aches; Severe fatigue; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Severe fatigue), HEADACHE (Headaches) and CHILLS (Chills) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches), FATIGUE (Severe fatigue), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches), FATIGUE (Severe fatigue), HEADACHE (Headaches) and CHILLS (Chills) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. It was reported that 10 to 12 hours after taking the vaccine patient experienced severe fatigue, body aches, headaches and chills but did not experience fever. Patient had always experienced these symptoms after Spikevax in all 6 previous years. Patient had described them as not debilitating and that fatigue was the worst of it. It was reported that the patient had always spaced the Covid vaccine and Flu vaccine to know the side effects are due to which vaccine and patient knows that the reactions are due to Spikevax. It was reported that the symptoms go away after 24 hours. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-791487 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791487:Master Case More
2874704		F	SC	11/24/2025	COVID19	MODERNA		Pyrexia Pyrexia	slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREX... slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Pneumonia (twice since 2018) in 2018 and Sepsis (twice since 2018) in 2018. Concurrent medical conditions included Hypertension and Herpes genital. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever). At the time of the report, PYREXIA (slight fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient did not have any additional medical history, concomitant disease or risk factor. Since the first Covid Vaccines, the patient had been vaccinated regularly. The usual reaction was a slight fever, and it resolved in 24 hours. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case was linked to MOD-2025-791431 (Patient Link). More
2874705	65	F		11/24/2025	COVID19	MODERNA		Nasal congestion, Rash pruritic Nasal congestion, Rash pruritic	rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps... rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy; congestion; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) and NASAL CONGESTION (congestion) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Hand tendon injury (tendons were severed way bac) and Hand repair operation (3rd surgery but the patient was not on any medication for it) in July 2025. Concurrent medical conditions included Migraine (years before). Concomitant products included Paracetamol (Tylenol) and Sumatriptan succinate (Sumatriptan) for Migraine, Influenza vaccine (Influenza trivalent vaccine) for an unknown indication. On 22-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) and NASAL CONGESTION (congestion). In October 2025, NASAL CONGESTION (congestion) had resolved. At the time of the report, RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) had not resolved. The patient did not have rash before from the vaccine. It was reported that the patient got the mNEXSPIKE and after that the patient dealt with a back rash that looked like a COVID rash. The patient did not report that when the rash was started, since she never had this before, but it might have been a number of days after she got the vaccine. It was reported that the rash plus very small things were on her back, like little bumps. The patient bought over the counter antihistamines treatment medication and the patient has been taking one of those for the last number of days now. At first, she was looking to see if the rash was caused by her bed or if it was fleas; she researched everything, and it was none of that. She checked for bedbugs too and there were no bedbugs. In future the patient will have a dermatologist visit for the symptom of rash. It was reported that for the patient the rash was red little things, plus it was itchy. It was reported that the patient had a little bit of congestion as well and for moments that were hard, but now the patient was fine. This case was linked to MOD-2025-791595 (Patient Link).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2874706	79	F		11/24/2025	COVID19 COVID19	MODERNA MODERNA		Abdominal discomfort, Asthenia, Dizziness, Fatigue, Nausea; Pyrexia Abdominal discomfort, Asthenia, Dizziness, Fatigue, Nausea; Pyrexia	Stomach upset; Nausea; Low grade fever; Exhaustion; Dizziness; Feeling weak and unable to get up wit... Stomach upset; Nausea; Low grade fever; Exhaustion; Dizziness; Feeling weak and unable to get up without assistance; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak and unable to get up without assistance), ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever) and FATIGUE (Exhaustion) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: RSV vaccine and Flu vaccine. Past adverse reactions to the above products included No adverse effect with Flu vaccine and RSV vaccine. Concurrent medical conditions included Leukemia and Immunocompromised. Concomitant products included Pemivibart (Pemgarda) for Prevention. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced ASTHENIA (Feeling weak and unable to get up without assistance). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever), FATIGUE (Exhaustion) and DIZZINESS (Dizziness). In October 2025, ASTHENIA (Feeling weak and unable to get up without assistance) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever), FATIGUE (Exhaustion) and DIZZINESS (Dizziness) had resolved. Due to patient's underlying medical conditions, doctor recommended Pemgarda, a preventive measure that was not a vaccine, it was an infusion administered every three months, in addition to continuing with the vaccine. Historically, patient had not received the Tdap vaccine. It was reported that patient had always received the Moderna vaccine. Being an older person, patient got a booster last year. Every time patient had received the vaccine, experienced a reaction which is not life-threatening or alarming, but it resulted in about four days in bed with nausea and other symptoms, after which patient was fine. Patient had compromised immune system and the doctor strongly advised that patient should continue with the vaccinations. This has been the case for the past four or five years. Each time patient had received the Moderna vaccine, had a reaction, which the doctor doesn't considered an adverse effect, but it might be categorized as such for record-keeping purposes. It was reported that typically, the first few times, patient experienced a low-grade fever, exhaustion, dizziness, and stomach upset. For instance, last month, patient was essentially bedridden for three days, feeling weak and unable to get up without assistance. After three or four days, patient recovered, and the doctor was not concerned about it. The usual response was that it was a good sign, indicating the vaccine was working. Treatment medication was not reported. It was unknown if the patient experienced any additional symptoms/events. More
2874707		F		11/24/2025	COVID19	MODERNA		Immunisation reaction, Product availability issue Immunisation reaction, Product availability issue	having previously received six doses without major side effects, though patient experienced mild sym... having previously received six doses without major side effects, though patient experienced mild symptoms after second shot; expressed frustration over her inability to find the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (having previously received six doses without major side effects, though patient experienced mild symptoms after second shot) and PRODUCT AVAILABILITY ISSUE (expressed frustration over her inability to find the Moderna vaccine) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma chronic (chronic asthmatic). On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (having previously received six doses without major side effects, though patient experienced mild symptoms after second shot) and PRODUCT AVAILABILITY ISSUE (expressed frustration over her inability to find the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (having previously received six doses without major side effects, though patient experienced mild symptoms after second shot) and PRODUCT AVAILABILITY ISSUE (expressed frustration over her inability to find the Moderna vaccine) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient received total six dose without major side effects, though she experienced mild symptoms after her second shot. The patient expressed frustration over her inability to find the Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789335 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789335:Original's reporter case More
2874708		M		11/24/2025	COVID19	MODERNA		Tinnitus Tinnitus	ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of... ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Weight gain. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced TINNITUS (ringing in the ear). At the time of the report, TINNITUS (ringing in the ear) had resolved. Concomitant medication was not provided. Patient did not receive any other vaccines 4 weeks prior. It was reported that the patient had a history of bone-on-bone condition in both knees for about ten years. It was reported that the previous year, one of the times the patient had received the vaccine in her left arm, on her left shoulder, she had experienced ringing in her left ear. It had lasted for quite a while, but eventually it had gone away. She added that this year, she had received Moderna in her right arm and had not had any side effects, not even ringing in the ear. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. More
2874709	66	F	NC	11/24/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Injection site pain, Therapeutic response unexpected; Injection site pain, Thera... Injection site pain, Therapeutic response unexpected; Injection site pain, Therapeutic response unexpected More	I have so much energy; little bit of soreness at the injection site for the flu; This spontaneous ca... I have so much energy; little bit of soreness at the injection site for the flu; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy) and INJECTION SITE PAIN (little bit of soreness at the injection site for the flu) in a 66-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. The patient's past medical history included Dengue fever (she believed it was related to a prior dengue fever infection in 2014.) in 2014. Previously administered products included for Drug use for unknown indication: HYDROXYCHLOROQUINE (She had previously tried infusions and hydroxychloroquine but had not found an effective treatment.), ORENCIA (Patient had also tried Orencia, which knocked her down for 4 days.), SIMPONI (Patient had tried Simponi for 4 months, which did not improve her condition.), SIMPONI (made her feel worse.), ORENCIA (was nauseated throughout.), ORENCIA (Her arm and back would not stop hurting.), ORENCIA and ORENCIA (She could not eat during that time.). Past adverse reactions to the above products included Back pain with ORENCIA; Bedridden with ORENCIA; Condition aggravated with SIMPONI; Drug ineffective with HYDROXYCHLOROQUINE and SIMPONI; Nausea with ORENCIA; Pain in arm with ORENCIA; and Unable to eat with ORENCIA. Concurrent medical conditions included Arthritis (It was reported that the patient had been struggling with inflammation and swelling in her feet since last July and that her physicians were unsure whether it was rheumatoid or psoriatic arthritis.). On 08-Nov-2025, the patient received fifth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2025, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site for the flu). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy) and INJECTION SITE PAIN (little bit of soreness at the injection site for the flu) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received 4 Moderna COVID-19 vaccines and experienced a significant increase in energy each time. She mentioned that she had ongoing inflammation and that her healthcare providers were still uncertain about how to treat her condition. The patient wanted to know how often she could receive a COVID-19 vaccine and whether it could be used off-label for arthritis. The reporter indicated that patient had consulted two rheumatologists without resolution. She had previously tried infusions and hydroxychloroquine but had not found an effective treatment. She expressed that it would be ideal if the vaccine could resolve her symptoms and prevent further suffering. According to the patient, after receiving the Moderna COVID-19 vaccine, her inflammation decreased and her energy level improved the following day. She also noted that she had received a flu vaccine at the same time as the COVID-19 vaccine and experienced only mild soreness at the flu injection site, which did not limit her activity. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-791554 (Patient Link). More
2874710		F		11/24/2025	COVID19	PFIZER\BIONTECH		Bone pain, Chills, Pain, Pyrexia Bone pain, Chills, Pain, Pyrexia	fever, chills, bone pain and aches; fever, chills, bone pain and aches; fever, chills, bone pain and... fever, chills, bone pain and aches; fever, chills, bone pain and aches; fever, chills, bone pain and aches; fever, chills, bone pain and aches; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 20Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3(BOOSTER), SINGLE), administration date: Oct2022, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Bone pain", "Chills", "felt so awful", "had Stomach Cancer", "Headache", "really sick", "Lung cancer", "muscles aches all over her body/muscle pain", "Body hurt when she even tried to lay down/General body pain/ached", "fever of 101.9"; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), administration date: Oct2023, when the patient was 75 years old, for Covid-19 Immunization, reaction(s): "allergic to Covid vaccine", "bone pain", "did get COVID even after having a vaccine", "chills", "did get COVID even after having a vaccine", "Headache", "sick", "Muscles aches all over my body", "ached", "fever". The following information was reported: BONE PAIN (non-serious), PAIN (non-serious), PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "fever, chills, bone pain and aches". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2874711			AL	11/24/2025	RSV	PFIZER\WYETH	LL8391	Device connection issue, Syringe issue Device connection issue, Syringe issue	attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the ... attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side; liquid from syringe leaked out/liquid from the syringe goes out the side; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 13Oct2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation, Device Lot Number: J591, Device Expiration Date: 29Nov2028. The following information was reported: DEVICE DIFFICULT TO USE (non-serious), outcome "unknown", described as "attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "liquid from syringe leaked out/liquid from the syringe goes out the side". The reporter considered "attempted to administer two vaccines, the abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side" and "liquid from syringe leaked out/liquid from the syringe goes out the side" not related to rsv vaccine prot.subunit pref 2v. Causality for "attempted to administer two vaccines, the abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side" and "liquid from syringe leaked out/liquid from the syringe goes out the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The reporter has attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side. When clarified error happened with two Abrysvo, reporter stated yes and they did one and then they try it again on another thinking it was just like a fluke or they put too much pressure, but then it happened again. There was no administration to any patient, and it was they could not get the liquid in there. Samples were available. These details are provided for the second kit: Abrysvo Carton: NDC: 00069034401, LOT: LL8391, EXP: May2026, Abrysvo Antigen Powder Vial: NDC: 00069020701, LOT: LL8391, EXP: May2026, Abrysvo Diluent Syringe: NDC: 00069025001, LOT: HT4720, EXP: Dec2026, Abrysvo Vial Adapter: NDC: Unknown, LOT: J591, EXP: 29Nov2028. More
2874712		M		11/24/2025	COVID19 FLUX	PFIZER\BIONTECH UNKNOWN MANUFACTURER		Oxygen saturation, Oxygen saturation decreased; Oxygen saturation, Oxygen satura... Oxygen saturation, Oxygen saturation decreased; Oxygen saturation, Oxygen saturation decreased More	my oxygen level to be 89; This is a spontaneous report received from a Consumer or other non HCP, Pr... my oxygen level to be 89; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "my oxygen level to be 89". Relevant laboratory tests and procedures are available in the appropriate section. Clinical course: Patient age group was reported as elderly (65+ Years). Patient was asking how long does rsv last? Chat questions, what causes her oxygen level to be 89? Can COVID and flu vaccines cause low respiratory rate? What if this person got the vaccines, but has cirrhosis? The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2874714	80	F	FL	11/24/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		Body temperature increased, Feeling abnormal, Headache, Hypertension, Illness; I... Body temperature increased, Feeling abnormal, Headache, Hypertension, Illness; Insomnia, Lymphadenopathy, Oropharyngeal pain, Peripheral swelling, Pyrexia More	sick/has been sick ever since/She's been sick with the covid-19 before, but the shot was 200 ti... sick/has been sick ever since/She's been sick with the covid-19 before, but the shot was 200 times worse; high temperature/very high fever; couldn't sleep; Just could not believe how bad she felt; her lymph nodes are both swelling up/Lymph nodes swollen; feels like there is a lemon under her arm, the swelling under her arm; sore throat; blood pressure was up in the morning; headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 80-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Nov2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 12Nov2025, outcome "unknown", described as "couldn't sleep"; PYREXIA (non-serious) with onset 12Nov2025, outcome "unknown", described as "high temperature/very high fever"; ILLNESS (non-serious) with onset 12Nov2025, outcome "not recovered", described as "sick/has been sick ever since/She's been sick with the covid-19 before, but the shot was 200 times worse"; FEELING ABNORMAL (non-serious) with onset Nov2025, outcome "unknown", described as "Just could not believe how bad she felt"; HYPERTENSION (non-serious) with onset Nov2025, outcome "unknown", described as "blood pressure was up in the morning"; PERIPHERAL SWELLING (non-serious) with onset Nov2025, outcome "unknown", described as "feels like there is a lemon under her arm, the swelling under her arm"; HEADACHE (non-serious) with onset Nov2025, outcome "unknown"; LYMPHADENOPATHY (non-serious) with onset Nov2025, outcome "not recovered", described as "her lymph nodes are both swelling up/Lymph nodes swollen"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2025, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, oropharyngeal pain, headache, pyrexia, lymphadenopathy. Additional information: Patient went last week and she got the Covid-19 shot. Caller said that she's been sick ever since. She's been sick with the covid-19 before, but the shot was 200 times worse. The whole night, she was so sick. She's had headache, sore throat, high temperature when she woke up in the morning, her lymph nodes are both swelling up. So she went to the doctor today, they told her to take Tylenol and put some ice. Caller said that the night she got the shot, she couldn't sleep. First she went to her doctor, after her shot last week and and this is her second time to her shot today, and she saw her doctor and she still don't understand what kind of shot they were given. Caller said that she had a very high fever and her blood pressure was up in the morning. All of that happened since Wednesday night when she got the shot. Thursday and Friday gone by and she went to the doctor again after that and then today, she went to the doctor again and her Lymph nodes are still swelling up. It looks like she got a lemon under her arm. The arms are swelling down but underneath her lymph nodes are swollen. It looks like a lemon. Underneath her armpit is like a size of a small lemon. She was told to wait for 2 to 3 weeks for the swelling to go down. Caller is extremely upset and she said that she won't wait for 2 to 3 weeks. Caller is asking, how long is that going to take me? until holiday. Has been sick ever since then. Today is Tuesday, nobody called her back yesterday. Lymph nodes swelled up. Went to doctor twice since then, still not happy. Clarified, she called yesterday, already reported with Pfizer Drug Safety, has been 24 hours. Waiting on call back, is miserable. When clarifying if there was something specific she was waiting for call back for, caller states, are they going to send her a check, like for pain and suffering.When clarifying if caller seeking compensation, she states, she needs to tell something. Is 80 years old. Had Covid shots since when they had to wait all down the highway. Never had Covid shot like this one she had last Wednesday. When caller asked if caller has a reference number from report filed yesterday with Pfizer Drug Safety, she states, she has the name of the shot, Comirnaty. When clarifying if she was given a reference number or report number from yesterday's report, she states, they just gave her number, told her someone would call her back. Clarified, caller waiting for someone to call her back regarding this report. Caller advised, it would be noted in this follow up report that, She stated that she had been waiting for someone to contact her regarding yesterday's report. Nobody has called her, has been miserable for a whole month. Wants to talk to somebody. Clarified Covid shot she has been referring to is, Pfizer Covid shot, gave the name earlier, Comirnaty. One thing she wanted to add is, the first day she went to doctor, had fever, was temperature of 101 or something, or 102, head hurt all night long. Just could not believe how bad she felt. Went to doctor the next day, went to doctor yesterday. Both lymph nodes were swollen way up, which is why she went back. Clarified, the fever with temperature of 101 or 102, was recorded in original report. Had temperature all night long, got up in morning, went to doctor was so sick. With Covid, head hurts so bad, could not even think. Doctor told her, Pfizer gave her a very bad, dirty shot and to not take anymore Pfizer shots. Will not take any Pfizer shots again. Clarified, was last Wednesday, 12Nov2025, caller had fever. Lymph nodes swollen: Clarified, lymph nodes being swollen, was not documented in yesterday's report. Went to doctor yesterday, doctor said, it looks like a small lemon, both of them. There is one, right where she got shot, looks like puffy small lemon, is still there today. Doctor said, to give it 2 weeks and, it should go away. Told by doctor, was given a dirty, bad shot. Agent relays she has a patient on the line that is a bit hysterical about the side effects she has from Pfizer Covid vaccine. Agent relays the caller is an 80 year old female that received the Covid vaccine last week. Caller said she had been sick ever since. Described it as she was sick with Covid before but this is 200 times worse than Covid itself. Had some headache, sore throat, her lymph nodes are swelling up, had very high fever and her blood pressure was up in the morning. She feels like there is a lemon under her arm, the swelling under her arm where the shot was given. She already went to the doctor today and was told to take Tylenol and ice. Caller also mentioned she couldn't sleep. Agent states she informed the caller that she should speak to her healthcare professional if the Tylenol and ice don't work and that she is not able to provide medical advice. Caller states her doctor didn't say to take Tylenol or ice, she said nothing. States she has never had problems with anything from pharmacy. States she went to her doctor today. Moved there 3 years ago. She got the shot Wednesday and went to her doctor the next day, like worst covid like never had covid. Her head, her sleep, her temperature. She couldn't make it to the doctor, she should have gone to the ER that is how bad she felt. Pharmacy gave her the stupid Pfizer Covid shot. She will never take a another Pfizer shot again. Never. Her doctor said she was given a dirty rotten Covid shot. Doctor said she got a dirty shot. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2874717		F	IA	11/24/2025	COVID19	PFIZER\BIONTECH		Cataract, Visual impairment Cataract, Visual impairment	I cannot see I have cataract surgery/She had cataract surgery and can't really see; I cannot se... I cannot see I have cataract surgery/She had cataract surgery and can't really see; I cannot see I have cataract surgery/She had cataract surgery and can't really see; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 14Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: . A 66-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMARIN. The following information was reported: CATARACT (medically significant), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "I cannot see I have cataract surgery/She had cataract surgery and can't really see". Therapeutic measures were taken as a result of cataract. Clinical course: The patient reported that she got something in the mail about Pfizer's follow-up questionnaire that she was a little confused about, and it was over the COVID-shot that she had 4 years ago. She really does not want to go through these questions here. She cannot see as she has cataract surgery and she have got enough paperwork around here to do. The patient was asking about Premarin and asking if there was a way of getting her medication without changing insurance or getting it free from her doctor. She has ongoing issues. A lot of the questions don't pertain or she doesn't have the answers. She was living with it and doesn't want to look up all the information again. She had cataract surgery and can't really see. She stated that she doesn't want to lose contact about Premarin. She wants to get her Premarin through patient assistance still and she declines to report. She stated that unless they send her a settlement and she doesn't have doctor notes or any information. She was confused about payment plan and then she has another call coming through and has to go now. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2874718		M		11/24/2025	COVID19	PFIZER\BIONTECH	5b709A	Loss of consciousness, Pain Loss of consciousness, Pain	had a lot of body pain; it knocked him out for a day or 2; This is a spontaneous report received fro... had a lot of body pain; it knocked him out for a day or 2; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021593 (BioNTech), 2025SA308506 (SANOFI). A 78-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 as dose 1, single (Lot number: 5b709A, Expiration Date: 31Dec2027) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg/2ml at a dose of 300 mg qow (every other week) subcutaneous for neurodermatitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIAMCINOLONE ACETONIDE; ALBUTEROL SULFATE HFA; BUDESONIDE; SYMBICORT; MELATONIN; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; TAMSULOSIN HCL; ATORVASTATIN CALCIUM; METOPROLOL SUCCINATE; ALLOPURINOL; ELIQUIS; OMEPRAZOLE. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Oct2025, outcome "recovering", described as "it knocked him out for a day or 2"; PAIN (non-serious), outcome "recovering", described as "had a lot of body pain". The action taken for dupilumab was unknown. Clinical details: On an unknown date, the patient started taking Dupilumab Solution for injection with the strength of 300 mg/2ml at a dose of 300 mg QOW (every other week) subcutaneously for prurigo nodularis and COVID-19 vaccine (unknown dose, strength, frequency, formulation, indication, route). It was reported patient had the covid vaccine last Thursday and had a horrible reaction to it. It knocked him out for a day or 2 (loss of consciousness) (onset: Oct2025 latency: unknown) but he was feeling better now and last time he took the medication, he had a bad reaction to it. He had a lot of (pain) (onset, latency: unknown) (batch number: 5b709A, expiry date on 31Dec2027 for both the events) but now he was getting better. Company comment: Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Moreover, due to compatible temporal relationship role of covid-19 vaccine cannot be overlooked either. Concomitant medications can be a confounding factor in this case. Case will be reevaluated post further update on medical history, family history, personal history, correctives received and relevant investigations. No follow-up attempts are possible. COMIRNATY (2025-2026 FORMULA) is under agreement with BIONTECH SE. More
2874719				11/24/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	Contracted Covid-19 in 2022 after having received the Pfizer Covid vaccine; Contracted Covid-19 in 2... Contracted Covid-19 in 2022 after having received the Pfizer Covid vaccine; Contracted Covid-19 in 2022 after having received the Pfizer Covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): AE-00243299 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Contracted Covid-19 in 2022 after having received the Pfizer Covid vaccine". Clinical course: Patient reported that they contracted Covid-19 in 2022 after having received the Pfizer Covid vaccine. They believe it was after the Pfizer actually and stated received the Pfizer vaccine in 2021 and contracted Covid in 2022. It was not close to the time received the vaccine at all, so it was just it might have even been in 2022 got it, so know there was some distance between the vaccine and when they got it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2874720		F		11/24/2025	COVID19	PFIZER\BIONTECH		Ear disorder, Ear pain Ear disorder, Ear pain	Ear was hurting the next day (fluid); Ear was hurting the next day (fluid); This is a spontaneous re... Ear was hurting the next day (fluid); Ear was hurting the next day (fluid); This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021594 (BioNTech), 2025SA310818 (Sanofi). An 80-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg every 4 weeks (Lot number: FW0377, Expiration Date: 31Jul2027) subcutaneous for nasal polyps. The patient's relevant medical history included: "Drug hypersensitivity" (ongoing). Concomitant medication(s) included: CARMELLOSE SODIUM; GUAIFENESIN; PARACETAMOL; SODIUM BICARBONATE; SODIUM CHLORIDE; ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; TOCOPHERYL ACETATE; ZINC OXIDE; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHROMIUM NICOTINATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM HYDROXIDE; MANGANESE GLUCONATE; NICOTINAMIDE; PHYTONADIONE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN; SELENOMETHIONINE; SODIUM MOLYBDATE; THIAMINE HYDROCHLORIDE; ZINC GLUCONATE; VITAMIN D3; SALBUTAMOL SULFATE. The following information was reported: EAR PAIN (non-serious), EAR DISORDER (non-serious), outcome "unknown" and all described as "Ear was hurting the next day (fluid)". The action taken for dupilumab was unknown. Additional information: It was not reported if the patient received a corrective treatment for the events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2874721		F	CO	11/24/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Activated partial thromboplastin time, Antineutrophil cytoplasmic antibody, Anti... Activated partial thromboplastin time, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy kidney, Blood creatinine; Blood culture, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein; Chest X-ray, Computerised tomogram abdomen, Computerised tomogram neck, Computerised tomogram thorax, Culture urine; Cytomegalovirus test, Double stranded DNA antibody, Echocardiogram, Epstein-Barr virus test, Fibrin D dimer; Full blood count, Haemoglobin, Heart rate, Inflammatory marker test, Investigation; Laboratory test, Metabolic function test, Ophthalmological examination, Oxygen saturation, Physical examination; Platelet count, Prothrombin time, Red blood cell sedimentation rate, Renal function test, Respiratory pathogen panel; Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Serum ferritin, Specific gravity urine; Streptococcus test, Tubulointerstitial nephritis, Ultrasound bladder, Urine analysis, Urine output; Urine protein/creatinine ratio, Weight, White blood cell count More	Acute tubulointerstitial nephritis; This is a literature report for the following literature source(... Acute tubulointerstitial nephritis; This is a literature report for the following literature source(s). A 12-year-old female patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "strep infections" (unspecified if ongoing); "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (DOSE 1, SINGLE), for COVID-19 immunisation. Twelve-year-old female presented to the hospital with intermittent fevers, dry cough, sore throat, general malaise, decreased appetite, and weight loss for 2 weeks. There was no history of extra-renal losses, and she had normal urine output. Symptoms started 6 days after receiving the second dose of Pfizer COVID-19 vaccine. Previously, the patient was well except for COVID-19 infection 90 days prior to first dose of the vaccine. Before presenting to the hospital, she tested negative for Group A streptococcus, COVID-19 by polymerase chain reaction (PCR), and influenza at her pediatrician's office. She also tested negative for Epstein Barr Virus, cytomegalovirus, and tick-borne diseases pertinent to the area. She did not report decreased urine output, polyuria, vomiting, or diarrhea. The mother reported that patient took only one dose of Tylenol for fever. Otherwise, no antibiotics or medications were given. Past medical history for her was significant for strep infections and tonsillectomy and adenoidectomy. At the hospital, initial blood pressure was 107/63 mmHg, heart rate was 107 beats per minute, respiratory rate 18 per minute, and pulse ox 100% on room air, and temperature 36.8 centigrade. Patient was noted to be pale appearing, no rashes or joint involvement were appreciated, and otherwise physical exam was normal. Initial laboratory values were remarkable for a non-oliguric acute kidney injury (AKI, with a serum creatinine of 1.59 mg/dL). The rest of comprehensive metabolic panel was unremarkable. Serum creatinine did not improve after 2 fluid boluses. Erythrocyte sedimentation rate was elevated to 107 mm/hr and C-reactive protein to 4.2 mg/dL. Complete blood count had hemoglobin that was low to 11.6 g/dL while white blood cell count and platelets were within normal limits. Full Respiratory Pathogen Panel and COVID-19 by PCR upon admission were negative. Initial urinalysis (UA) was negative for nitrites, leukocyte esterase, protein, blood and glucose, had a specific gravity of 1.004, and had 5 white blood cells. Although there was a history of fever, no fever was noted during admission. However, given the history and the elevated inflammatory markers and AKI, work up for multi-system inflammatory syndrome in children (MISC) was initiated. D-dimer was elevated to 420 ng/dL, PT elevated to 14.4 seconds, and ferritin to 168 ng/mL. There was a largely normal CBC and platelets except for mild anemia (hemoglobin 11.6 g/dL). COVID-19 Antibody nucleocapsid immunoglobulin G was positive. The clinical exam, labs and normal echocardiogram did not support a diagnosis of MIS-C. Antinuclear antibody screen, antidouble- stranded DNA and antineutrophil cytoplasmic antibodies were all normal. Initial laboratory findings and inflammatory markers on admission showed Serum creatinine 1.59 mg/dL (reference range: 0.44-0.77 mg/dL); ESR 107 mm/hr (reference range: 0-20 mm/hr); CRP 4.2 mg/dL (reference range: 0-0.5 mg/dL); Urinalysis Negative for nitrites and leukocyte esterase and positive for many bacteria and 5 WBCs per high; powered field (reference range: 0-2); D-dimer 420 DDU ng/mL (reference range: normal low <230 DDU ng/mL); PT 14.4 seconds (reference range: 10-13.6 seconds); aPTT Within normal limits (33 seconds) (reference range: 25.5-38 seconds); Ferritin 168 ng/mL (reference range: 15.0-150.0 ng/mL); ANA screen, anti-double-stranded DNA and ANCA Negative, 4 IU (reference range: normal low <25 IU), 20 (screening titer is 1:20); Hemoglobin 11.6 g/dL (reference range: 12.0-15.4 g/dL); Platelet count 325 K/uL (reference range: 150-350 K/uL); WBC count 6.95 K/uL (reference range: 4.80-10.80 K/uL); SARS-CoV-2 IgG antibody assay (CMIA) Positive. Fevers up to 38.8�C started on the fourth hospital day. A repeat COVID-19 PCR was negative. Renal bladder ultrasound revealed normal sized kidneys with increased echogenicity consistent with medical renal disease. Chest X-ray was normal. Computed tomography scan of the neck, chest, and abdomen without intravenous (IV) contrast were performed for concern for malignancy and all were normal. Blood and urine cultures were negative. Patient had normal urine output throughout her hospital stay. Serum creatinine rose to 3.26 mg/dL. Initial UA was negative for glucose. However, subsequent UAs revealed glucosuria (with 50 mg/dL that later increased to greater than 500 mg/dL). Renal biopsy was performed and revealed diffuse and severe acute TIN predominant with eosinophils and neutrophils. Subsequently the patient received pulse methylprednisolone (30 mg/kg) IV for 3 days after which serum creatinine decreased to 2.67 mg/dL. Subsequently, the patient was treated with oral prednisone 60 mg daily for 6 weeks followed by a slow taper. The patient was also evaluated by ophthalmology while on high dose steroids to rule out uveitis. She had a normal eye exam. Glucosuria resolved after a few weeks on steroids and serum creatinine normalized to 0.7 mg/dL. After discontinuation of steroids, serum creatinine worsened. Treatment was initiated with mycophenolate mofetil (MMF), which has been suggested as a therapy for TIN that is not responsive to steroids. With MMF, serum creatinine has decreased to <0.7 mg/dL. The patient remained on MMF for a year, and afterwards MMF was tapered. One year after MMF was discontinued, UA was persistently negative for both blood and protein, urine protein/creatinine ratio <0.2 mg/dL. Kidney function was also normal one year after MMF discontinuation. The patient currently has been lost to follow-up.; Sender's Comments: The event tubulointerstitial nephritis is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate. More
2874725		F	CA	11/24/2025	MEN	UNKNOWN MANUFACTURER		Adverse reaction, Blood test, Syncope, X-ray Adverse reaction, Blood test, Syncope, X-ray	fainted; After a few minutes of getting the vaccine had some reaction; Initial information received ... fainted; After a few minutes of getting the vaccine had some reaction; Initial information received on 19-Nov-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves an unknown age female patient who had fainted and had some reaction after a few minutes of receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Jun-2025, the patient received 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 30-Jun-2025 the patient had fainted (syncope) and a few minutes of getting the vaccine had some reaction (immunisation reaction) (latency: same day). Reportedly,At the hospital patient went through several checks (triage) and tests like x-ray, blood work etc. She was asked to drink a lot of water. We were told that fortunately she is doing fine and has nothing to worry about her health. She was finally released after a few hours .Patient fortunately didn't have any noticeable issues since then. All the events happened so fast because of the reaction of the vaccine. We followed as guided and before we could realize what was going on, an ambulance was called and she was sent to the Hospital Emergency Room [ER]. We as a family went through an emotional rollercoaster on that day. When she was in the Hospital going through tests, we couldn't' t see her or get any updates about her for hours. 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 Recovered / Resolved on an unknown date in June 2025 for both the events. Seriousness criteria: Medically significant for the event Syncope.; Sender's Comments: Sanofi company comment dated 21-Nov-2025: This case involves an unknown age female patient who had fainted and had some reaction after a few minutes of receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].The time to onset was compatible with the role of vaccine.Furthermore, lack of information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2874728	77	F	HI	11/24/2025	FLU3	SANOFI PASTEUR	U8875BA	Extra dose administered, No adverse event Extra dose administered, No adverse event	2 DOSES OF FLUZONE HD WAS GIVEN TO PATIENT 2 MONTHS APART (ONE DOSE WAS GIVEN ON 9/4/2025 AND A SECO... 2 DOSES OF FLUZONE HD WAS GIVEN TO PATIENT 2 MONTHS APART (ONE DOSE WAS GIVEN ON 9/4/2025 AND A SECOND DOSE WAS GIVEN ON 11/20/2025); PER CAREGIVER, PATIENT DOING WELL WITH NO SIGNS AND SYMTOMS OF ADVERSE REACTIONS AFTER RECIEVING TWO DOSES. More
2874735	80	M	AZ	11/24/2025	COVID19	PFIZER\BIONTECH	NA0590	Injection site swelling, Peripheral swelling Injection site swelling, Peripheral swelling	PATIENT REQUESTS COMIRNATY (PFIZER) COVID VACCINE ON 11/11/2025. AFTER A COUPLE OF DAYS, PATIENT PR... PATIENT REQUESTS COMIRNATY (PFIZER) COVID VACCINE ON 11/11/2025. AFTER A COUPLE OF DAYS, PATIENT PRESENTS BACK TO PHARMACY AND SHOWS PHARMACIST HIS ARM WHERE HE RECEIVED THE VACCINE. PATIENT SIGNS/SYMPTOMS INCLUDED PROFUSE SWELLING RADIATING DOWN FROM THE INJECTION SITE ONTO THE LOWER PART OF HIS ARM UP TO HIS WRIST. PHARMACIST ON DUTY RECOMMENDS PATIENT TO SEE PHYSICIAN FOR FOLLOW UP CARE. PATIENT AS OF 11/24/2025 IS STILL UNDER PHYSICIAN CARE. More
2874760	85	F	GA	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3052733 ut8804ba	Myalgia; Myalgia Myalgia; Myalgia	Pt called today (11/24/25) stating her Right arm is sore all the way down to her elbow and up a litt... Pt called today (11/24/25) stating her Right arm is sore all the way down to her elbow and up a little into her neck. Not a stabbing pain, "more like a muscle pain". It hurts all the time and more when she moves it. More
2874761	14	F	OR	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3053115 U8881AA	Disorientation, Syncope; Disorientation, Syncope Disorientation, Syncope; Disorientation, Syncope	The patient was standing in the consultation room of the pharmacy while her parents and sibling rece... The patient was standing in the consultation room of the pharmacy while her parents and sibling received their vaccines (she went first). She fainted approximately 5 minutes after receiving her vaccines and the immunizing technician called for a pharmacist. The patient was awake and sitting upright in a chair when I entered the room. She appeared slightly disoriented. I could not get a pulse at either of the wrists. The patient's blood pressure was approximately 90/70 mmHg using a standard BP cuff. I could not get a full pulse using the BP cuff but it did not sound tachycardic when assessing her BP. The patient did not appear to have any cutaneous symptoms concerning for anaphylaxis. No angioedema or rash noted. The patient sat in the chair for approximately 20 minutes afterward and did not present any further symptoms. I advised her parents to call their today to notify them of what occurred and schedule a follow-up as soon as possible. I also advised to monitor for further episodes and to seek emergency care if they occur. More
2874767	13	F	CA	11/24/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	8146751 u8855aa	Asthenia, Blood glucose normal, Vision blurred; Asthenia, Blood glucose normal, ... Asthenia, Blood glucose normal, Vision blurred; Asthenia, Blood glucose normal, Vision blurred More	13 year old patient came into pharmacy with younger brother and mother to receive vaccines. patient ... 13 year old patient came into pharmacy with younger brother and mother to receive vaccines. patient received 2 vaccines and then about 5-10 minutes later, after she got up to walk around, patient felt weak and had blurry vision. she sat down and I took her blood pressure. As her blood pressure was loading, 911 was called and patient felt like vomiting. About 1 to 2 minutes after the patient threw up, paramedics arrived shortly after and took her vitals which were all normal. patient felt better after vomiting. Mother, patient and paramedics decided she felt back to normal and felt good enough to go home. More
2874768	23	F	LA	11/24/2025	COVID19 HEPAB	NOVAVAX GLAXOSMITHKLINE BIOLOGICALS		Syncope; Syncope Syncope; Syncope	Patient fainted within minutes after receiving vaccinations. Patient was sitting and head dropped wh... Patient fainted within minutes after receiving vaccinations. Patient was sitting and head dropped while she was sitting. Patient cane to after a couple minutes and was given water. Patient was with a loved one who gave her Gatorade. Patient sat with her head in her lap for a few minutes and started to feel better. Patient was monitored for 40 minutes before she felt fine to stand and leave. More

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