🏥 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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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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Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

⚠️ 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 14,801 to 14,850 of 34,052 reports (Page 297 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿
2850392	58	F	FL	07/19/2025	PNC20	PFIZER\WYETH	LN4929	Cellulitis Cellulitis	Cellulitis on their arms; This is a spontaneous report received from a Consumer or other non HCP. A... Cellulitis on their arms; This is a spontaneous report received from a Consumer or other non HCP. A 58-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jul2025 as dose number unknown, single (Lot number: LN4929, Expiration Date: 31Jul2026) at the age of 58 years intramuscular for pneumonia. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis on their arms". Therapeutic measures were taken as a result of cellulitis. Additional information: Five days after was given the vaccine, was given antibiotics, a cream and a medication for allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500144941 Same reporter/vaccine/event, different patients; More
2850393		F		07/19/2025	PNC20	PFIZER\WYETH		Rash Rash	She had a large rash on her back that persisted for approximately one week; This is a spontaneous re... She had a large rash on her back that persisted for approximately one week; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Mar2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Mar2023. The following information was reported: RASH (non-serious) with onset Mar2023, outcome "recovered" (Mar2023), described as "She had a large rash on her back that persisted for approximately one week". Therapeutic measures were not taken as a result of rash. Additional information: Patient received Prevnar 20 from doctor's office on same day as starting Singulair. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2850394			FL	07/19/2025	PNC13 PNC13	PFIZER\WYETH PFIZER\WYETH		Erythema, Impaired work ability, Malaise, Muscle swelling, Myalgia; Pain in extr... Erythema, Impaired work ability, Malaise, Muscle swelling, Myalgia; Pain in extremity, Pyrexia More	arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red,... arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red/arm will swell up or turn this angry red; my arm started hurting a lot/arm/deltoids is still painful; fever of 101 to 102; arm will swell up; sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Jul2025 at 09:30 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), RASH (non-serious) all with onset 07Jul2025 at 16:00, outcome "unknown" and all described as "arm/deltoids is still painful and very red, like a rash"; ERYTHEMA (non-serious) with onset 07Jul2025 at 16:00, outcome "not recovered", described as "arm/deltoids is still painful and very red/arm will swell up or turn this angry red"; VACCINATION SITE PAIN (non-serious) with onset 07Jul2025 at 16:00, outcome "unknown", described as "my arm started hurting a lot/arm/deltoids is still painful"; PERIPHERAL SWELLING (non-serious) with onset Jul2025, outcome "not recovered", described as "arm will swell up"; PYREXIA (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "fever of 101 to 102"; ILLNESS (non-serious) with onset Jul2025, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient received Prevnar shot last 07Jul2025 at 9:30 AM. Patient was fine until around 4 pm when arm started hurting a lot. Patient had fever of 101 to 102F for almost two days. Missed work. On 10Jul2025, arm/deltoids was still painful and very red, like a rash. Patient wasn't told that arm will swell up or turn this angry red. On 12Jul2025, it was still the same. The vaccine made the patient sick. More
2850395				07/19/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	Patient got Covid three months ago; Patient got Covid three months ago; This is a spontaneous report... Patient got Covid three months ago; Patient got Covid three months ago; This is a spontaneous report received from a Consumer or other non HCP. 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "Patient got Covid three months ago". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2850396		F		07/19/2025	COVID19	PFIZER\BIONTECH		Asthma, Malaise Asthma, Malaise	increase frequency of humlra due to frequent flare ups; not feeling well; This is a spontaneous repo... increase frequency of humlra due to frequent flare ups; not feeling well; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020032 (BioNTech). This case involves elderly female patient who was not feeling well and increase frequency of Humira due to frequent flare ups while being treated with DUPILUMAB [DUPIXENT] delivered via Single dose Pre-Filled Pen and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In Sep2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for Injection at a strength and dose of 300 mg QOW subcutaneously delivered via Single dose Pre-Filled Pen for Asthma. On an unknown date, the patient started taking COVID-19 VACCINE with unknown strength, dose, frequency, route and indication. On an unknown date, the patient developed a non-serious event "not feeling well" (malaise) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. On an unknown date, the patient developed a non-serious event "increase frequency of Humira due to frequent flare ups" (asthma) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. Information regarding batch number and expiration date corresponding to the one at the time of event occurrence was requested. It was reported "The patient (pt) reports had covid vaccines yesterday and not feeling well. Md (medical doctor) Is aware and md Is working to increase frequency of Humira due to frequent flare ups. Unknown If md aware. Action taken with DUPILUMAB: No action taken for both events. Action taken with COVID-19 VACCINE was unknown for both events. The patient was treated with ADALIMUMAB (HUMIRA) for Asthma and was not reported for malaise. At time of reporting, the outcome was Unknown for both events. BNT162b2 is under agreement with BIONTECH SE. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2850406	34	F	RI	07/19/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		Abortion spontaneous, Anti-thyroid antibody increased, Autoimmune thyroiditis, B... Abortion spontaneous, Anti-thyroid antibody increased, Autoimmune thyroiditis, Blood aluminium increased, Blood lead increased; Blood mercury abnormal, Goitre, Thyroglobulin increased More	Goiter, Elevated thyroglobulin and thyroperoxidase antibodies, elevated levels of mercury, aluminum,... Goiter, Elevated thyroglobulin and thyroperoxidase antibodies, elevated levels of mercury, aluminum, and lead. Two miscarriages due to chromosomal abnormalities. Diagnoses of hashimotos thyroiditis. After a spike protein detox and heavy metal detox, ovaries are perfect. Overall health has improved immensely. Energy improved. Digestion improved. Goiter has gone away. More
2850407	55	F	VA	07/19/2025	PNC21	MERCK & CO. INC.	Y011819	Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity	Patient reported arm soreness post administration - has continued to have arm soreness/pain and limi... Patient reported arm soreness post administration - has continued to have arm soreness/pain and limited range of motion for the last 6 months in arm at site of administration. More
2850408	0.33	F	VT	07/19/2025	DTPPVHBHPB PNC20 RV1	MSP VACCINE COMPANY PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS		Haematemesis, Laboratory test normal, White blood cell count increased; Haematem... Haematemesis, Laboratory test normal, White blood cell count increased; Haematemesis, Laboratory test normal, White blood cell count increased; Haematemesis, Laboratory test normal, White blood cell count increased More	hospital admission with vomiting blood. hospital admission with vomiting blood.
2850409	65	M	AL	07/19/2025	PNC20	PFIZER\WYETH	LK6650	Extra dose administered Extra dose administered	PATIENT WAS OVERVACCINATED. PATIENT HAD ALREADY RECEIVED A PREVNAR 20 VACCINE ON 10/23/2023. AND R... PATIENT WAS OVERVACCINATED. PATIENT HAD ALREADY RECEIVED A PREVNAR 20 VACCINE ON 10/23/2023. AND RECEIVED A SECOND DOSE ON 7/19/2025 More
2850410	71	F	NJ	07/19/2025	PNC21 RSV	MERCK & CO. INC. PFIZER\WYETH	Y019158 LN5486	Injection site pruritus, Injection site swelling; Injection site pruritus, Injec... Injection site pruritus, Injection site swelling; Injection site pruritus, Injection site swelling More	Patient called today stating that shortly after she received her RSV vaccine on her left arm the sit... Patient called today stating that shortly after she received her RSV vaccine on her left arm the site of the injection got swollen to the size of a golf ball. Patient then stated that the swollen arm subsided but the site of the injection is still itchy. The patient did not try to treat the reaction in any way and stated she decided to inform the pharmacy about the reaction today. The patient also stated they had no reaction on their right arm where they received the Pneumonia vaccine. More
2850411	68	F	AZ	07/19/2025	RSV RSV RSV RSV RSV RSV	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	PS2CK PS2CK PS2CK PS2CK PS2CK PS2CK	Arthralgia, Cerebral small vessel ischaemic disease, Coccidioidomycosis, Conditi... Arthralgia, Cerebral small vessel ischaemic disease, Coccidioidomycosis, Condition aggravated, Cough; Dyspnoea, Ear pain, Gait disturbance, Headache, Hyperhidrosis; Inflammation, Injection site erythema, Joint swelling, Lacrimation increased, Lymphadenopathy; Magnetic resonance imaging head abnormal, Malaise, Night sweats, Ophthalmic migraine, Peripheral swelling; Rash, Retinal haemorrhage, Scan with contrast abnormal, Sinus disorder, Sinusitis; Ultrasound Doppler, Ultrasound lymph nodes, White matter lesion More	2-5-24 dry cough, has not been resolved; 3 inch diameter bright red spot on right arm where vaccinat... 2-5-24 dry cough, has not been resolved; 3 inch diameter bright red spot on right arm where vaccination was received and rash on both arms (disappeared within 48 hours); lymph node in right armpit swollen to size of racquetball; lymph node in left armpit swollen to size of golf ball; lymph nodes in neck and groin area also swollen; as of today lymph nodes are all still swollen, armpit nodes have decreased to golf ball size on right armpit and marble size on left armpit; lymph node on left groin area has increased to egg size; severe inflammation and swelling especially in legs and ankles; severity has decreased, but some days the swelling returns; 2-5-24 thru 2-10-24 headaches 2-5-24 thru 3-5-24 night sweats of the same intensity of valley fever night sweats (i.e. I woke up in middle of night drenched from head to toe and had to change clothes) 2-19-24 sinus issues, watery eyes, but did not develop into respiratory illness and resolved within about two weeks; severe hip pain for two days making it hard to walk; this symptom was identical to known side effect of disseminated valley fever case where I could hardly walk from July-October 2014; I also had hip pain when I became allergic to Macrobid; allergies to antibiotics are also a result of having valley fever 7-8-24 had six night sweats about one per hour 9-19-24 ocular event which my eye doctor diagnosed as an ocular migraine without the migraine; he scheduled me for a return visit to monitor on 11-4-24; (Dr. had dealt with severe infections of my eyes due to valley fever which began in October 2024) 12-5-24 Was called by provider and told that I needed to immediately start doing nasal rinses to resolve sinusitis; she was extremely concerned because sinus infections in valley fever are dangerous 12-5-24 thru 12-17-24 sinus rinses were not effective until 12-17-24 when massive amounts of blood and green mucus were finally released; I became so ill that I called to make appt with PCP, but she was out of town; by 12-21-24 the severe earaches and headaches and difficulty breathing sent me to an urgent care center where I was given only a 7-day prescription of Amox-Clav when it should have been a 14-day prescription 1-2-25 saw provider and she was alarmed that I had not been given a 14 day treatment of antibiotics; she prescribed me another 7 day prescription 12-17-24 thru 6-17-25 had nightly sweats; during this period it was difficult to exert myself, exercise or take a walk of any distance due to breathing difficulties and dry coughing fits; 6-13-25 ? I learned from a friend and paralegal that she was involved in legal cases addressing the fact that the RSV vaccine should never be given to valley fever survivors; evidently all the adverse events I have suffered have also occurred to other valley fever patients; to my knowledge the medical profession has not been informed of this information 7-15-25 ? scheduled appt. with PCP to get an inhaler and was prescribed Albuterol and given a sample of AirSupra which is not covered by my insurance company More			✓
2850412	31	F	MN	07/19/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	HH3221 HH3221 FJ6369 FJ6369 FJ5682	Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unev... Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event More	I had a rare side effects from the covid vaccine. I applied for insurance back in May and unfortunat... I had a rare side effects from the covid vaccine. I applied for insurance back in May and unfortunately they did not hurry and approve my application and now I am still suffering from unusual side effects and can?t get medical care. This feels like neglect as many are aware of this and I did notify a doctor. A pediatrician during a office visit, Please contact me right away as this is an ongoing issue, I?m even having a housing crisis. More
2850413	60	F		07/19/2025	PNC21	MERCK & CO. INC.	y019157	Headache, Injection site erythema, Injection site rash, Malaise, Pyrexia Headache, Injection site erythema, Injection site rash, Malaise, Pyrexia	severe malaise, fever, headache. redness at the injection site, rash at the injection site. severe malaise, fever, headache. redness at the injection site, rash at the injection site.
2850414	11	F	MI	07/19/2025	HPV9 MNQ TDAP	MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS	2018414 amvb064a 7kd5b	Dysstasia, Loss of consciousness, Pallor, Paraesthesia; Dysstasia, Loss of consc... Dysstasia, Loss of consciousness, Pallor, Paraesthesia; Dysstasia, Loss of consciousness, Pallor, Paraesthesia; Dysstasia, Loss of consciousness, Pallor, Paraesthesia More	Patient passed out and face turned white along with lips had tingling in hands and feet and could no... Patient passed out and face turned white along with lips had tingling in hands and feet and could not stand for 10 minutes was able to stand after but kept them at pharmacy sitting down for an extra 20 minutes to observe. More
2850415	62	F	UT	07/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	332L4	Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling	redness and swelling that feels warm at injection site that is worsening after four days. No pain or... redness and swelling that feels warm at injection site that is worsening after four days. No pain or fever associated. More
2850416	76	F	PA	07/19/2025	COVID19	PFIZER\BIONTECH	me6072	Cardiac arrest, Death Cardiac arrest, Death	Cardiac arrest and death Cardiac arrest and death	✓
2850417	19	F	KS	07/19/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Vaccination error Vaccination error	Given in error Given in error
2850418	62	M	IL	07/19/2025	FLU3	SEQIRUS, INC.	946614	Injected limb mobility decreased Injected limb mobility decreased	symptoms: pain of needle like needle is still in his body and cant lift arm and its on right arm symptoms: pain of needle like needle is still in his body and cant lift arm and its on right arm
2850419	80	M	WA	07/19/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	dl326	Limb discomfort, Mobility decreased, Pain in extremity Limb discomfort, Mobility decreased, Pain in extremity	Severe arm pain. Heaviness in arms and legs. Could not get out of bed for 2 days. Severe arm pain. Heaviness in arms and legs. Could not get out of bed for 2 days.
2850211	66	F	MA	07/18/2025	MMR	MERCK & CO. INC.		Antibody test negative Antibody test negative	Consumer calling to report that prior to getting MMR II vaccine, they had the negative titer test. O... Consumer calling to report that prior to getting MMR II vaccine, they had the negative titer test. Once vaccine was received, there was no change in negative titer results. Consumer did not report any side effect. Permission to contact HCP was not gi; This spontaneous report was received from a 66 years-old female patient, referring on herself. The patient's concurrent conditions included Collagen Disorder. Medical history and concomitant therapies were not reported. On an unknown date, prior to getting the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), she had the negative titer test. On 27-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) diluted with a sterile diluent (MERCK STERILE DILUENT), administered by Intramuscular route (lot numbers and expiration dates were not reported) as MMR II Vaccine (prophylaxis). On an unspecified date in 2025 (reported as "Once vaccine was received"), the patient stated that there was no change in negative titer results. At the reporting time, the outcome negative titer results was unknown. The causal relationship between the event of negative titer results and the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. Lot # is being requested and will be submitted if received. More
2850213	74	F	NJ	07/18/2025	PNC21 PNC21 PNC21 PNC21 PNC21 PNC21	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Z004302 Z004302 Z004302 z004302 z004302 z004302	Immediate post-injection reaction, Injection site erythema, Peripheral swelling,... Immediate post-injection reaction, Injection site erythema, Peripheral swelling, Pruritus; Chills, Erythema, Injection site bruising, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Paraesthesia, Sleep disorder; Immediate post-injection reaction, Injection site erythema, Peripheral swelling, Pruritus; Chills, Erythema, Injection site bruising, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Paraesthesia, Sleep disorder More	The caller stated that right away, her arm hurt at the injection site.; the pharmacist will not be g... The caller stated that right away, her arm hurt at the injection site.; the pharmacist will not be giving her any more doses of CAPVAXIVE because they believe she has an allergy to one of the ingredients; The caller stated that by 07/06/2025, her left arm was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm was itchy, swollen, and red.; This spontaneous report was received from a 74-year-old female patient and referred to herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z004302, expiration date: 04-Sep-2026) for prophylaxis. On 04-Jul-2025, right away, her arm hurt at the injection site. By 06-Jul-2025, her left arm was itchy, swollen, and red. The patient stated that her left arm was red from the injection site down to her elbow and that her left arm was"double the size" of her right arm.The patient stated that the pharmacist would not be giving her any more doses of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) because they believe she had an allergy to one of the ingredients. At the reporting time, the patient had not recovered from all the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as withdrawn. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The causal relationship between Allergy to vaccine and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was default to be related. More
2850215	24	F	PA	07/18/2025	HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Abdominal pain, Autoimmune thyroiditis, Blood testosterone increased, Decreased ... Abdominal pain, Autoimmune thyroiditis, Blood testosterone increased, Decreased appetite, Dry skin; Fatigue, Gastrointestinal disorder, Headache, Inflammatory marker increased, Oligomenorrhoea; Pelvic discomfort, Peripheral coldness, Temperature intolerance, Vomiting, Weight increased; Abdominal pain, Autoimmune thyroiditis, Blood testosterone increased, Decreased appetite, Dry skin; Fatigue, Gastrointestinal disorder, Headache, Inflammatory marker increased, Oligomenorrhoea; Pelvic discomfort, Peripheral coldness, Temperature intolerance, Vomiting, Weight increased; Abdominal pain, Autoimmune thyroiditis, Blood testosterone increased, Decreased appetite, Dry skin; Fatigue, Gastrointestinal disorder, Headache, Inflammatory marker increased, Oligomenorrhoea; Pelvic discomfort, Peripheral coldness, Temperature intolerance, Vomiting, Weight increased More	headaches; abdominal pain/ gastrointestinal issues; loss of appetite/ gastrointestinal issues; vomit... headaches; abdominal pain/ gastrointestinal issues; loss of appetite/ gastrointestinal issues; vomiting/ gastrointestinal issues; pelvic discomfort; prolonged menstrual cycles; tested positive for elevated testosterone level; tested positive for elevated inflammatory markers; neurological injuries; Hashmioto's disease/ autoimmune injury/ dry skin and scalp/ increased sensitivity to cold (particularly in her hands and feet)/ fatigue/ weight gain/ persistent cold sensation traveling up to shaft of her leg; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female adult patient of unknown exact age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, at the age of 24 years old, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prevention of cervical cancer, as recommended by nurse practitioner. The patient contended her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries and a constellation of adverse symptoms, complications, injuries, and other adverse events which were caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorders. The patient sustained serious autoimmune injuries as a result of her vaccination. On an unknown date, a few days following the administration of her first Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection, the patient began to experience a range of symptoms, including headaches, dry skin and scalp, increased sensitivity to cold (particularly in her hands and feet), fatigue, and abdominal pain. After receiving the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection on an unknown date, these symptoms intensified. Additionally, she began to experience a loss of appetite, vomiting, pelvic discomfort, prolonged menstrual cycles, weight gain, and tested positive for elevated testosterone levels and inflammatory markers. She had no reason to believe her symptoms were caused by the vaccine, so she received her third dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) on an unknown date. After third Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection, her symptoms continued to persist and worsen, with new developments including gastrointestinal issues and a persistent cold sensation traveling up the shaft of her leg. On an unknown date in September 2022, the patient was diagnosed with Hashimoto's disease. She had since sought treatment from a variety of medical specialists, including a hematologist, dermatologist, and gastroenterologist, to manage her condition. At the time of the report, the patient was required to take medication to control her systems associated with Hashimoto's disease. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, she was diagnosed with various medical conditions, including but not limited to Hashimoto's disease. The patient contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to Hashimoto's disease, resulting in experiencing headaches, dry skin and scalp, increased sensitivity to cold (particularly in her hands and feet), fatigue, and abdominal pain, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, she suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and they will continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. Upon internal review, the event of Hashmioto's disease was determined to be medically significant. The reporter considered the events of Hashmioto's disease, headaches abdominal pain, loss of appetite, neurological injuries, vomiting, pelvic discomfort, prolonged menstrual cycles, tested positive for elevated testosterone level and tested positive for elevated inflammatory markers to be disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-15 , MNSC number : , CLIC number : , ESTAR number : LEGCLACHN , IRMS number : 68941 , Central date : 2025-07-14 , Classification : DMC, Attachment description : Legal , Safety case number : More			✓
2850216	65	M	IL	07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Extra dose administered Extra dose administered	Extra dose administered; This non-serious case was reported by a consumer via call center representa... Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in 2019) and Shingrix (Received 2nd dose of Shingrix vaccine in 2019). On 14-JUL-2025, the patient received the 3rd dose of Shingrix (left deltoid). On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 14-JUL-2025 The patient had already received both doses of the Shingrix vaccine in 2019 and mistakenly got the vaccine again today which led to extra dose administered. More
2850217				07/18/2025	COVID19	PFIZER\BIONTECH		Vaccination site pain, Vaccination site swelling, Wrong product administered Vaccination site pain, Vaccination site swelling, Wrong product administered	swelling/pain at sites; swelling/pain at sites; asked if the vaccine he had in the syringe was Novav... swelling/pain at sites; swelling/pain at sites; asked if the vaccine he had in the syringe was Novavax. He nodded "yes."/was told I was given Pfizer.; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Feb2025 as dose 1 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete), for covid-19 immunization, reaction(s): "hypersensitivity". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 22Feb2025, outcome "unknown", described as "asked if the vaccine he had in the syringe was Novavax. He nodded "yes."/was told I was given Pfizer."; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling/pain at sites". Batch/lot number is not provided, and it cannot be obtained. More
2850218			KY	07/18/2025	HIBV	SANOFI PASTEUR	UK227AC	No adverse event, Product preparation error No adverse event, Product preparation error	a dose of ACTHIB was reconstituted with a sterile diluent and administered to a patient with no repo... a dose of ACTHIB was reconstituted with a sterile diluent and administered to a patient with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] was reconstituted with a sterile diluent with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength) with lot UK227AC and expiry date 30-Jun-2026 via unknown route in unknown administration site for Immunization that was reconstituted with a sterile diluent and administered to a patient with no reported adverse event (product preparation error) (latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850223	75	M	NV	07/18/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	G22GH	Expired product administered Expired product administered	expired vaccine administered; This non-serious case was reported by a pharmacist via call center rep... expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, expiry date 01-JUL-2025) for prophylaxis. On 13-JUL-2025, the patient received Arexvy (intramuscular, left arm). On 13-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: expired vaccine administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 14-JUL-2025 The pharmacist calling on behalf patient stated that they administered a dose of Arexvy to the patient day before reporting and the vaccine expired which led to, expired vaccine used. The reporter stated she did file a report of the incident in VAERS. More
2850224	23	F	AZ	07/18/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	57H54	Incorrect route of product administration Incorrect route of product administration	Menveo, it was administered subcutaneously instead of intramuscularly; This non-serious case was rep... Menveo, it was administered subcutaneously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 23-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for an unknown indication. On 03-JUL-2025, the patient received Menveo (subcutaneous). On 03-JUL-2025, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: Menveo, it was administered subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 08-JUL-2025 The pharmacist reported that a patient who was administered one of vaccines, the Menveo, it was administered subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route The Vaccine Administration Facility was the same as Primary Reporter More
2850225	16	M	IL	07/18/2025	MENB MENB MNQ MNQ	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	ZK9P4 EK7DG	Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More	Double dose on same day; This non-serious case was reported by a nurse via call center representativ... Double dose on same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ZK9P4) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number EK7DG) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis. On 23-JUN-2025, the patient received Bexsero, Menveo, Bexsero and Menveo. On 23-JUN-2025, an unknown time after receiving Bexsero, Menveo, Bexsero and Menveo, the patient experienced accidental overdose (Verbatim: Double dose on same day). The outcome of the accidental overdose was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 09-JUL-2025 and 11-JUL-2025 The reporter had a patient that, on the date of the visit, inadvertently received the Menveo 1 vial, they received 2 doses on the same day. They also received the Bexsero. So, on that day, they received a double, 2 of each on the same day. The healthcare professional informed that on the same day on 23rd June 2025 the patient received 2 doses of Menveo (1 vial) and 2 doses of Bexsero, in total, the patient received 4 doses which led to accidental overdose. More
2850226	17	M	MS	07/18/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	E4A39	Expired product administered Expired product administered	expired dose administered; This non-serious case was reported by a nurse via call center representat... expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 11-JUL-2025, the patient received Menveo. On 11-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 11-JUL-2025 The nurse manager explained that they administered an expired dose of Menveo (1-vial) to the patient which led to, expired vaccine used. More
2850278	37		SC	07/18/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y014059	Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	no additional AE; Second dose on 3/31/2025, and Third dose administered today, 6/25/2025; This spont... no additional AE; Second dose on 3/31/2025, and Third dose administered today, 6/25/2025; This spontaneous report was received from a Pharmacist and refers to a 37-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. The patient received 3 dose series of vaccination with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection � dose 1 on 26-FEB-2025 (dose, lot#, expiration date, route and site of vaccination were not provided), dose 2 on 31-MAR-2025 (dose, lot#, expiration date, route and site of vaccination were not provided), and dose 3 on 25-JUN-2025 (inappropriate schedule of vaccine administered) (lot #Y014059, expiration date: 01-Nov-2026), 0.5 mL (route and site of administration were not provide). No additional adverse event was reported. More
2850279		M	NV	07/18/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Skin papilloma; Skin papilloma; Skin papilloma Skin papilloma; Skin papilloma; Skin papilloma	They had a 9 year old patient who had severe warts on his entire body, they explained it as the wors... They had a 9 year old patient who had severe warts on his entire body, they explained it as the worst they had seen. After being vaccinated with 3 doses of GARDASIL 9 his symptoms resolved completely.; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 2, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 3, administered by unknown route (indication, expiration date, and lot # were not reported). On an unspecified date, after being vaccinated with 3 doses of the suspect vaccine, the patient's severe warts on his entire body (described as "the worst they had seen") resolved completely (Therapeutic response unexpected). At the reporting time, the outcome of event was not known. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not applicable. More
2850280		F	KS	07/18/2025	HPV9	MERCK & CO. INC.	X019862	Expired product administered, No adverse event Expired product administered, No adverse event	Confirmed no symptomatic adverse events; Inbound call from nurse calling to report administration of... Confirmed no symptomatic adverse events; Inbound call from nurse calling to report administration of expired GARDASIL-9 to a patient on 18-MAR-2025. Caller states that they discovered that the dose was administered expired after the patient came in recently for the next dose. Confirmed no; This spontaneous report was received from a nurse and refers to a 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #X019862, expiration date: 14-Feb-2025) (0.5 ml / once), for prophylaxis, administration of expired vaccine (expired product administered). The nurse reported that it was discovered that the dose was administered expired after the patient came in recently for the next dose. Confirmed no symptomatic adverse events (no adverse event). More
2850281	23	F	MO	07/18/2025	HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Abdominal distension, Cervical dysplasia, Cough, Dizziness, Fatigue; Heart rate ... Abdominal distension, Cervical dysplasia, Cough, Dizziness, Fatigue; Heart rate increased, Hyperhidrosis, Hypersensitivity, Joint stiffness, Laboratory test; Loss of personal independence in daily activities, Menstrual disorder, Muscle fatigue, Pain, Somnolence; Thirst, Weight increased, Wheezing; Abdominal distension, Cervical dysplasia, Cough, Dizziness, Fatigue; Heart rate increased, Hyperhidrosis, Hypersensitivity, Joint stiffness, Laboratory test; Loss of personal independence in daily activities, Menstrual disorder, Muscle fatigue, Pain, Somnolence; Thirst, Weight increased, Wheezing; Abdominal distension, Cervical dysplasia, Cough, Dizziness, Fatigue; Heart rate increased, Hyperhidrosis, Hypersensitivity, Joint stiffness, Laboratory test; Loss of personal independence in daily activities, Menstrual disorder, Muscle fatigue, Pain, Somnolence; Thirst, Weight increased, Wheezing More	POTS-like symptoms, rapid heart beat, chronic&daily fatigue, abnormal perspiration without exerc... POTS-like symptoms, rapid heart beat, chronic&daily fatigue, abnormal perspiration without exercise&excessive sweating,dizziness,abdominal bloating,autonomic&neurological injuries,excessive daytime sleepiness,daily pain,muscle fatigue; inhaler which she used five to ten times a day, but with little to no relief; extreme thirst; joint stiffness; extreme allergies, acute allergies (which can develop after changes in the immune system); Autoimmune injuries; abnormal menstruation, menstrual injuries; weight gain; daily coughing; wheezing; epithelial cell abnormality, atypical squamous cell of undetermined significance (abnormal cells in the tissue that lines the outer part of the cervix); Information was received from a lawyer regarding a case in litigation and refers to an adult female patient (pt). The pt's concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, at the age 23 years old, the pt was vaccinated with the first and the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported). On an unspecified date, at the age of 24 years old, the patient received the third dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). All doses were administered for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's consent and the pt's physician (referred to as a doctor and also as a health care provider) recommendation. On an unknown date, following third human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced an onset of extreme allergies, rapid heart rate, fatigue, abnormal perspiration without exercise, constant sweating, extreme thirst, joint stiffness, abnormal menstruation, muscle fatigue, weight gain, dizziness, and daily coughing and wheezing. She was prescribed an inhaler (name was not provided) which she used five to ten times a day, but with little to no relief. Her daily fatigue caused excessive sleeping during the day. After multiple tests and appointments, the pt was diagnosed with chronic fatigue and acute allergies (which could develop after changes in the immune system). The pt was later diagnosed with epithelial cell abnormality, atypical squamous cell of undetermined significance (abnormal cells in the tissue that lines the outer part of the cervix). She was experiencing daily pain, fatigue, joint stiffness, and abdominal bloating. As a result of her post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in activities that a normal young person would enjoy. The pt's symptoms were ongoing and would require treatment for the foreseeable future and possibly the rest of her life. Based upon her chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to, chronic fatigue, acute allergies, epithelial cell abnormality, atypical squamous cell of undetermined significance, and postural orthostatic tachycardia syndrome (POTS)-like symptoms. The pt contended that her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, menstrual, and neurological injuries, including but not limited to chronic fatigue, acute allergies, and POTS-like symptoms, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered/not resolved. The causality assessment between therapeutic product effect incomplete and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided. The reporter considered the other events to be related to the suspect vaccine. The reporter considered all events to be disabling. More			✓
2850282		M	CA	07/18/2025	HPVX HPVX	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Decreased appetite, Dizziness, Educational problem, Fatigue, Headache; Heart rat... Decreased appetite, Dizziness, Educational problem, Fatigue, Headache; Heart rate increased, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Weight decreased More	Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; Susta... Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; POTS, weight loss and loss of appetite, headaches, rapid heart rate, and dizziness; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 19-year-old male patient (pt). The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date, the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for prophylaxis. It was reported that on an unknown date (reported as following receipt of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience headaches, rapid heart rate and dizziness, causing him to visit his primary care doctor. Prior to receiving his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt was a happy, healthy, physically active young person. He enjoyed playing sports, exercising, and hanging out with friends. The months following his first and only dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt experienced weight loss and loss of appetite, in addition to the headaches, rapid heart rate, and dizziness. The pt was ultimately diagnosed with Postural Tachycardia Syndrome (POTS) and was told his condition was something that would not go away and that he would have to deal with it for the rest of his life. In approximately September 2022, the pt was informed by his doctor that the HPV vaccination might be the cause of his POTS. Prior to this date, the pt had no reason to suspect that his illness was caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a result of his post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, he had been unable to engage in activities that a teenager and young adult his age would normally enjoy. As a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)- induced injuries, he was unable to continue his participation in the varsity football team and recreational basketball. ln addition, the pt was no longer able to exercise or play sports without feeling extremely dizzy and fatigued. He was forced to make small and calculated physical movements to avoid the symptoms. Furthermore. Pt's plans to travel after high school, attend an out of state. university, and live an active life were necessarily altered due to his illness. While attending his first year of college, the pt experienced daily fatigue, dizziness, headaches and loss of appetite due to his POTS symptoms. Due to the severity of the symptoms, pt's academic performance was adversely affected and he was forced to move back home to continue his education online. Based on his chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above and the tests performed by a number of me.die.al providers, pt had been diagnosed with POTS, the pt contended that his injection of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused him to develop serious and debilitating injuries, including bm not limited, POTS as well as a constellation of adverse symptoms, complications and injuries, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and omission and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. PT also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced Injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he would continue to incur these losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events POTS, autoimmune disorder and neurological disorder, were considered disabling by the reporter. More			✓
2850283		M	IA	07/18/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION	945660	Extra dose administered Extra dose administered	Extra Dose Administered; Gave HEPLISAV-B Series Two Doses 28 Days Apart, Rechecked Titer and He is N... Extra Dose Administered; Gave HEPLISAV-B Series Two Doses 28 Days Apart, Rechecked Titer and He is Non-Reactive; Initial report received on 07-Jul-2025. A nurse reported that a 33-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer lab test which showed that he is non-reactive. No concomitant medications or medical history was reported. On 07-Apr-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945660 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid. On 12-May-2025, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number 945664 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid. On 24-Jun-2025, 44 days after receiving the second dose of HEPLISAV-B, the patient had a qualitative hepatitis B surface antibody titer test performed. The test result showed non-reactive (not immune to hepatitis B virus infection). On 09-Jul-2025, 59 days after receiving the second dose of HEPLISAV-B, the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number 946060 and expiration date 05-May-2027; NDC number not available) intramuscularly in the left deltoid. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule. More
2850285		M	CA	07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Rash Rash	developed a rash/ general rash on chest; This non-serious case was reported by a other health profes... developed a rash/ general rash on chest; This non-serious case was reported by a other health professional via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: developed a rash/ general rash on chest). The outcome of the rash was resolved. The reporter considered the rash to be related to Shingrix. The company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JUL-2025 The physician assistant that they had a patient who developed a rash after the 1st dose of Shingrix injection and was general rash on chest that lasted a few weeks. More
2850286				07/18/2025	RVX	UNKNOWN MANUFACTURER	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	rsv's infections/suspected vaccination failure; rsv's infections; This serious case was re... rsv's infections/suspected vaccination failure; rsv's infections; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: rsv's infections/suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv's infections). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a consumer via interactive digital media. After the RSV shot, he/she had stopped taking any vaccines. That's how bad rsv's infections were to his/her body that he/she had to check in emergency room and it was happened first time in his/her life. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming Respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2850287				07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Dehydration, Malaise, Pyrexia, Vomiting Dehydration, Malaise, Pyrexia, Vomiting	running a fever; I had my first shot and I was so sick for 4-5 days; throwing up dehydrated; This no... running a fever; I had my first shot and I was so sick for 4-5 days; throwing up dehydrated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fever (Verbatim: running a fever), sickness (Verbatim: I had my first shot and I was so sick for 4-5 days) and dehydration (Verbatim: throwing up dehydrated). The outcome of the fever and dehydration were not reported and the outcome of the sickness was resolved. It was unknown if the reporter considered the fever, sickness and dehydration to be related to Shingrix. It was unknown if the company considered the fever, sickness and dehydration to be related to Shingrix. Additional Information: GSK Receipt Date: -8-JUL-2025 This case was reported by a patient via interactive digital media. The had my first shot and was so sick for 4-5 days. The smell of food made sick. The patient was throwing up dehydrated, running a fever. It all started within 3 hours after had the shot, patient refuse the second shot because friends of mine that had the shots got really sick off of the second one. This case is linked with US2025AMR088832, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR088832:friend case More
2850288		F		07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Injection site erythema, Injection site swelling, Injection site warmth, Paraest... Injection site erythema, Injection site swelling, Injection site warmth, Paraesthesia, Peripheral swelling More	raised injection site; red area (a few square inches) at injection site; hot to touch the injection ... raised injection site; red area (a few square inches) at injection site; hot to touch the injection site; she is still tired; swollen fingers/ arm; tingling fingers; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: raised injection site), injection site erythema (Verbatim: red area (a few square inches) at injection site), injection site warmth (Verbatim: hot to touch the injection site), tiredness (Verbatim: she is still tired), peripheral swelling (Verbatim: swollen fingers/ arm) and tingling of extremity (Verbatim: tingling fingers). The outcome of the injection site swelling, injection site erythema, injection site warmth and peripheral swelling were resolving and the outcome of the tiredness was not resolved and the outcome of the tingling of extremity was resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix. Additional Information: GSK receipt date: 08-JUL-2025 The subject was the reporter, a physician, and the patient. She was a personal friend who shared that she received Shingrix the day before. In the arm where she received the injection, she had a raised, red area (a few square inches) that it was hot to the touch. She noted her fingers were swollen and tingling due to the swelling in that same arm. She had put cool compresses on the area which have helped. She had not taken any medication for this yet but planned to take Tylenol before bed. The reporter followed up with her this morning and she said the swelling was down, finger tingling was gone. She noted that she was still tired (which she did not mention originally). Overall, she said she was improved. More
2850289	51	F		07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	2HJ99	Product preparation issue Product preparation issue	Shingrix + Adjuvant administration only; Incorrect dose administered; This non-serious case was repo... Shingrix + Adjuvant administration only; Incorrect dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HJ99, expiry date 04-APR-2027) for prophylaxis. On 07-JUL-2025, the patient received Shingrix. On 07-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix + Adjuvant administration only) and inappropriate dose of vaccine administered (Verbatim: Incorrect dose administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 07-JUL-2025 Nurse reported that a patient received the Adjuvant portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. More
2850290	72	F		07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Extra dose administered Extra dose administered	Shingrix Third dose given; This non-serious case was reported by a physician via call center represe... Shingrix Third dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date) and Shingrix (received second dose of Shingrix on an unknown date). On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix Third dose given). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 09-JUL-2025 The healthcare professional mentioned that a patient received two doses of Shingrix and the by mistake a third dose was administered which led to extra dose administered. No further details were provided. More
2850291	2	F	VA	07/18/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	943Y2	Expired product administered Expired product administered	received an expired dose of Havrix today; This non-serious case was reported by a nurse via call cen... received an expired dose of Havrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix 720) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis. On 11-JUL-2025, the patient received Havrix 720. On 11-JUL-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix today). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-JUL-2025 A Registered Nurse reported a two year old received an expired dose of Havrix today which led to expired vaccine used. More
2850292		F		07/18/2025	COVID19	MODERNA	056A22A	Influenza like illness, Injection site reaction Influenza like illness, Injection site reaction	flu like feeling; little injection site reaction limited to a localized area in the arm; This sponta... flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) in 2022 at an unspecified dose and frequency. In 2022, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to MOD-2025-788129 (Patient Link). More
2850293		F		07/18/2025	COVID19-2	MODERNA	AS7164B	Influenza like illness, Injection site reaction Influenza like illness, Injection site reaction	flu like feeling; little injection site reaction limited to a localized area in the arm; This sponta... flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7164B and AS7170B) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 30-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 03-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) 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. Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to MOD-2025-788129 (Patient Link). More
2850294	65	F		07/18/2025	COVID19	MODERNA		COVID-19, Injection site reaction COVID-19, Injection site reaction	little injection site reaction limited to a localized area in the arm; Covid infection in 14-Feb-202... little injection site reaction limited to a localized area in the arm; Covid infection in 14-Feb-2024 and has experienced very mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 02-Dec-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 27-Apr-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2024, the patient experienced COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms). On an unknown date, the patient experienced INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. Patient had a Covid infection in 14-Feb-2024 and had experienced very mild symptoms. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to MOD-2025-788129 (Patient Link). More
2850295		F		07/18/2025	COVID19	MODERNA		Pain Pain	By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.; This spontane... By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 15-Sep-2024, the patient received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. By the 9th dose of vaccine taken, she hardly had any side effects, just some soreness with no fever or aches. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to MOD-2025-788129 (Patient Link). More
2850296	66	M		07/18/2025	COVID19	MODERNA		Brain herniation, Cerebrovascular accident, Transient ischaemic attack, Weight d... Brain herniation, Cerebrovascular accident, Transient ischaemic attack, Weight decreased More	big stroke/ died from a stroke; His death certificate states he died of a brain herniation; mini str... big stroke/ died from a stroke; His death certificate states he died of a brain herniation; mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out; losing weight and having a lot of problems; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (big stroke/ died from a stroke), BRAIN HERNIATION (His death certificate states he died of a brain herniation) and TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis in April 2020. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In March 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) (seriousness criterion medically significant) and WEIGHT DECREASED (losing weight and having a lot of problems). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (big stroke/ died from a stroke) (seriousness criteria death, hospitalization and medically significant) and BRAIN HERNIATION (His death certificate states he died of a brain herniation) (seriousness criteria death and medically significant). The patient died on 07-Jan-2022. The reported cause of death was stroke due brain herniation and big stroke/ died from a stroke. It is unknown if an autopsy was performed. At the time of death, TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) had not resolved and WEIGHT DECREASED (losing weight and having a lot of problems) outcome was unknown. Concomitant medications were not reported. The reporter stated that the patient had received the Moderna COVID shot in Mar-2021, and patient immediately had mini strokes, little TIAs which patient thought it was eyes so went to the optometrist for new glasses. The reporter stated that after the vaccine, patient immediately started losing weight and having a lot of problems. The reporter states that patient complained about his eyes, his head, being dizzy, blanking out and had a big stroke at the house. The reporter states that the patient died from a stroke that must have pushed a clot up into his brain. Patient's death certificate reported that he died of a brain herniation. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Patient�s underlying condition of Rheumatoid arthritis is a risk factor for vascular events. Brain herniation is assessed as not related as is more likely to be secondary to the big stroke. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Stroke due brain herniation; big stroke/ died from a stroke More	✓	✓
2850297		F		07/18/2025	COVID19	MODERNA	011A21A	Influenza like illness, Injection site reaction Influenza like illness, Injection site reaction	flu like feeling; little injection site reaction limited to a localized area in the arm; This sponta... flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 007B21A and 076C21A) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to US-MODERNATX, INC.-MOD-2025-788167 (E2B Linked Report). This case was linked to MOD-2025-788134, MOD-2025-788137, MOD-2025-788138, MOD-2025-788141 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788167:Husband's case More
2850298	69	M	NJ	07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	55th4	Joint injury Joint injury	Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
2850299	83	M	MA	07/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	99d52	Injection site erythema, Injection site pain, Injection site swelling, Pruritus,... Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash More	Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild More

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