🏥 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:

Data Source & Accuracy

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.
Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

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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
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
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Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
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
Expand text: Click "More" to see full narrative or symptom text
Navigate pages: Use pagination controls at top and bottom of table
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 11,951 to 12,000 of 34,052 reports (Page 240 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿	⚠️
2854727	61	M	CA	08/19/2025	PNC15 PNC15 VARZOS VARZOS	MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	LX2497 LX2497 5Y4TL 5Y4TL	C-reactive protein, Full blood count, Metabolic function test, Pain, Pruritus; R... C-reactive protein, Full blood count, Metabolic function test, Pain, Pruritus; Red blood cell sedimentation rate, Serum ferritin; C-reactive protein, Full blood count, Metabolic function test, Pain, Pruritus; Red blood cell sedimentation rate, Serum ferritin More	Itching of bilateral flank/back that progressed to a burning pain worse with light touch and heat Itching of bilateral flank/back that progressed to a burning pain worse with light touch and heat
2854728	23	F	WA	08/19/2025	HPV9	MERCK & CO. INC.	Y013712	Extra dose administered Extra dose administered	Patient was given an additional HPV immunization on 06/11/2025. Did not have previous records yet. Patient was given an additional HPV immunization on 06/11/2025. Did not have previous records yet.
2854729	44	F	WA	08/19/2025	HPV9	MERCK & CO. INC.	Z005469	Fall, Head injury, Loss of consciousness, Neck pain Fall, Head injury, Loss of consciousness, Neck pain	Vaccine was given at 5:51 pm. Patient advised to remain in clinic for 15 minutes to ensure no reacti... Vaccine was given at 5:51 pm. Patient advised to remain in clinic for 15 minutes to ensure no reaction. Patient declined. Patient used the restroom. After exiting the restroom at 6: 00 pm the patient fell backward, hitting her head on the wall as she fell causing the patient to lose consciousness. ARNP arrived to assess the patient. Patient regained consciousness, vitals were taken, and patient remained in clinic for approximately 10 minutes for observation. ARNP advised the patient to obtain a ride home. On 8/19/25 clinic RN, called to check on patient. Patient reported she feels fine, her neck is a little sore, no vision changes, no further LOC, no head pain. She does not feel any additional follow up is needed. More
2854730	67	F	MD	08/19/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased, Thyr... Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased, Thyroiditis subacute; Angina pectoris, Biopsy, Blood pressure diastolic, Blood pressure increased, Blood pressure measurement; Blood pressure systolic, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Hyperthyroidism, Swelling; Tachycardia, Thyroiditis subacute, Thyroxine, Tri-iodothyronine, Ultrasound scan; Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased, Thyroiditis subacute; Angina pectoris, Biopsy, Blood pressure diastolic, Blood pressure increased, Blood pressure measurement; Blood pressure systolic, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Hyperthyroidism, Swelling; Tachycardia, Thyroiditis subacute, Thyroxine, Tri-iodothyronine, Ultrasound scan More	Suffered side effects beginning October 2024 and on December 27, 2024, TSH level dramatically droppe... Suffered side effects beginning October 2024 and on December 27, 2024, TSH level dramatically dropped to 0.09. (Note: After 4 previous shots with no noted side effects from the Pfizer vaccine, it is worth noting the FDA approved and updated the mRNA formula for Covid-19 vaccines on August 22, 2024, and nearly one month before I received my 5th Covid-19 vaccine. A vaccine, due to the FDA approved formula change, caused me to experience highly devastating symptoms associated with the condition known as subacute thyroiditis, a rare but potential side effect of the latest and formula-updated Covid-19 vaccine. More
2854731	24	M	TX	08/19/2025	TDAP TDAP	SANOFI PASTEUR SANOFI PASTEUR	U8353BA U8353BA	Asthenia, Cold sweat, Hyperventilation, Nausea, Presyncope; Sensory loss, Wheezi... Asthenia, Cold sweat, Hyperventilation, Nausea, Presyncope; Sensory loss, Wheezing More	Patient reported presyncope symptoms with in 3 minutes of administration. He broke out in a cold sw... Patient reported presyncope symptoms with in 3 minutes of administration. He broke out in a cold sweat, hyperventilation, wheezing, reported weakness, nausea, loss of sensation in hands and fingers. More
2854732	11	F	RI	08/19/2025	TDAP TDAP TDAP TDAP UNK UNK UNK UNK	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	X357E X357E X357E X357E Y000205 Y000205 Y000205 Y000205	Activated partial thromboplastin time, Alpha-1 anti-trypsin, Bilirubin conjugate... Activated partial thromboplastin time, Alpha-1 anti-trypsin, Bilirubin conjugated, Culture urine, Cytomegalovirus test; Differential white blood cell count abnormal, Epstein-Barr virus antibody, Full blood count abnormal, Gamma-glutamyltransferase abnormal, Gastrointestinal pathogen panel; Hepatitis, Hepatitis viral test, Metabolic function test, Ocular icterus, Prothrombin time; Respiratory pathogen panel, Reticulocyte count, Stool analysis, Ultrasound abdomen, Urine analysis; Activated partial thromboplastin time, Alpha-1 anti-trypsin, Bilirubin conjugated, Culture urine, Cytomegalovirus test; Differential white blood cell count abnormal, Epstein-Barr virus antibody, Full blood count abnormal, Gamma-glutamyltransferase abnormal, Gastrointestinal pathogen panel; Hepatitis, Hepatitis viral test, Metabolic function test, Ocular icterus, Prothrombin time; Respiratory pathogen panel, Reticulocyte count, Stool analysis, Ultrasound abdomen, Urine analysis More	subsequent viral hepatitis diagnosed on 11/18/24, patient was evaluated on 11/18/24 for yellow tinge... subsequent viral hepatitis diagnosed on 11/18/24, patient was evaluated on 11/18/24 for yellow tinge to sclera bilaterally. The treating provider ordered labs. PCP spoke to GI on-call fellow who recommended a repeat set of labs in 2 days and also added more lab orders The initial Liver panel and CBC came back with abnormal results. Pt was referred to local hospital for a GI consult, and an abdominal ultrasound was ordered. The GI Provider diagnosed her with Hepatitis on 11/21/24, she recovered at home. More
2854734	17	M	PA	08/19/2025	HEPA	MERCK & CO. INC.	Z006542	Incorrect dose administered Incorrect dose administered	1 mL dose was ordered and given to 17 year old patient 1 mL dose was ordered and given to 17 year old patient
2854735	17	M	MD	08/19/2025	MENB MENB MENB MENB MENB	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	3R33K 3R33K 3R33K 3R33K 3R33K	Blood creatine phosphokinase, Blood magnesium, Chest X-ray, Chills, Culture urin... Blood creatine phosphokinase, Blood magnesium, Chest X-ray, Chills, Culture urine; Differential white blood cell count, Drug screen, Full blood count, Hypersomnia, Influenza A virus test; Influenza B virus test, Laboratory test, Lethargy, Lipase, Metabolic function test; Nausea, Ocular hyperaemia, Petechiae, Prothrombin time, Pyrexia; Rash, Respiratory syncytial virus infection, SARS-CoV-2 test, Urine analysis, Vomiting More	? On Friday, pt developed fever and chills. Saturday - developed nausea with vomiting. Sunday - he d... ? On Friday, pt developed fever and chills. Saturday - developed nausea with vomiting. Sunday - he developed a rash on her abdomen and the white of his eyes were blood shot. Pt had video visit on Sunday night and was advised to monitor symptoms and provider against providing medication as pt just received immunization. ? Monday and Tuesday - fever, chills, nausea resolved. Pt continued with rash on abdomen, white of eyes were blood shot as well as petechiae on face. Pt also lethargic. Sleeping all the time. ? Wednesday pt with same symptoms. Mother contacted dermatology and had appointment today. Provider advised pt/pt mother very concerned about his symptoms and had lab work repeated per dermatologist order. New lab work ordered and collected 40 minutes ago. Dermatologist advised mother to contact PCP and notify of their concerns. ? Per mother, pt continues with same symptoms with exception of fever, nausea/vomiting. Pt sleeps all the time and is lethargic. More
2854736	37	F	MI	08/19/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	H4279	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	The patient stepped on a rusty nail and was told by friends/family to get a tetanus even though she ... The patient stepped on a rusty nail and was told by friends/family to get a tetanus even though she had one in 2021. RPh administered dose but CDC recommendations/our protocol states must be 5 years from last immz. Patient didn't have an adverse reaction to the injection but reporting due to shot given out of schedule. More
2854737	0.83	F	OR	08/19/2025	RV5	MERCK & CO. INC.	1918229	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No adverse event , vaccine administered by mistake outside the recommended age . Patient had no side... No adverse event , vaccine administered by mistake outside the recommended age . Patient had no side effects More
2854738	30	F	NC	08/19/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	EW0183 EW0183	Anaphylactic reaction, Angioedema, Dyspnoea, Eye pruritus, Eyelid margin crustin... Anaphylactic reaction, Angioedema, Dyspnoea, Eye pruritus, Eyelid margin crusting; Hypersensitivity More	A week after the second dose, I began experiencing allergies. Although at the time I was not aware i... A week after the second dose, I began experiencing allergies. Although at the time I was not aware it was allergies due to never having allergies. My eyes began itching really bad. I experienced eye crust, difficulty breathing and angioedema on my face. March 2, 2022 I experienced my anaphylactic reaction, followed by another one March 3, 2022. Ever since March, I've experienced multiple idiopathic anaphylactic reactions. More		✓
2854739	11	F	RI	08/19/2025	HPV9 HPV9 HPV9 HPV9 MNQ MNQ MNQ MNQ	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR	Y009051 Y009051 Y009051 Y009051 U8369AA U8369AA U8369AA U8369AA	Aplastic anaemia, Cellulitis, Chest X-ray normal, Chest pain, Dizziness; Dyspnoe... Aplastic anaemia, Cellulitis, Chest X-ray normal, Chest pain, Dizziness; Dyspnoea, Electrocardiogram, Epistaxis, Febrile neutropenia, Full blood count abnormal; Haematoma, Headache, Laboratory test abnormal, Metabolic function test abnormal, Neutropenia; Orthostatic hypotension, Pancytopenia, Peripheral swelling, Pyrexia, Superficial vein thrombosis; Aplastic anaemia, Cellulitis, Chest X-ray normal, Chest pain, Dizziness; Dyspnoea, Electrocardiogram, Epistaxis, Febrile neutropenia, Full blood count abnormal; Haematoma, Headache, Laboratory test abnormal, Metabolic function test abnormal, Neutropenia; Orthostatic hypotension, Pancytopenia, Peripheral swelling, Pyrexia, Superficial vein thrombosis More	subsequent severe aplastic anemia, suspected associated with virus causing viral hepatitis 5 months ... subsequent severe aplastic anemia, suspected associated with virus causing viral hepatitis 5 months prior presented with epistaxis on 04/09/25, then shortness of breath headache and chest pain the next day. Was noted to have orthostatic hypotension upon exam in the office. CXR and ECG ordered. Presented to ED on 04/14/25 with fever and dizziness. Admitted from ED to Hospital on 04/14/25 for pancytopenia; neutropenia. Consult with Hem/Onc resulted in a diagnsois of Aplastic Anemia. Pt was admitted to hospital on 4/28/25 for planned immunosuppressive therapy and discharged on 05/02/25. Pt was admitted on 05/12/25 for febrile neutropenia, was found to have a cephalic vein thrombus and subsequent cellulitis of the neck, then discharged to home on 05/20/25. Admitted on 06/03/25 for swelling of right leg and subsequently diagnosed with a hematoma of the right leg, she was discharged on 06/06/25. More			✓
2854740	53	F	NV	08/19/2025	FLU3 PNC20	SANOFI PASTEUR PFIZER\WYETH	UT8779KA LX4484	Arthralgia, Injection site reaction, Injection site warmth, Rash erythematous; A... Arthralgia, Injection site reaction, Injection site warmth, Rash erythematous; Arthralgia, Injection site reaction, Injection site warmth, Rash erythematous More	Patient has a red rash on left arm around injection sites about the size of a fist. Patient also rep... Patient has a red rash on left arm around injection sites about the size of a fist. Patient also reports a little warmth on touching rash. Patient has not reported any swelling with rash but does have some shoulder pain associated with it More
2854741	0.5	F	OR	08/19/2025	COVID19 COVID19 MMR MMR	PFIZER\BIONTECH PFIZER\BIONTECH MERCK & CO. INC. MERCK & CO. INC.	LN8272 LN8272 Y017527 Y017527	Immediate post-injection reaction, Infant irritability, Injection site erythema,... Immediate post-injection reaction, Infant irritability, Injection site erythema, Injection site rash, Injection site urticaria; Papule, Rash, Roseola; Immediate post-injection reaction, Infant irritability, Injection site erythema, Injection site rash, Injection site urticaria; Papule, Rash, Roseola More	Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh con... Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh concerning for urticaria, pink papules on right buttocks, red patch on dorsum of left toes. Fussiness and rash improved during observation with pink patch remaining on left inner thigh. Observed in clinic for 20 minutes total. No dyspnea, vomiting, or other symptoms of anaphylaxis. Advised home administration of cetirizine which family administered. I (Dr.) followed up 3 hours later with family via phone, she was doing well, rash improving. She had a separate visit to the ER 8/15/25 for high fever, and on 8/18/25 was diagnosed with Roseola. More
2854742	4	M		08/19/2025	DTAPIPV UNK	SANOFI PASTEUR UNKNOWN MANUFACTURER	Glaxo Smith Kli Y014440	Injection site mass, Injection site warmth, Pain in extremity; Injection site ma... Injection site mass, Injection site warmth, Pain in extremity; Injection site mass, Injection site warmth, Pain in extremity More	Patient's mother contacted clinic that patient's arm was sore, a large lump was noted, and... Patient's mother contacted clinic that patient's arm was sore, a large lump was noted, and warm to the touch. Vaccine route and site were inaccurately documented in the medical record. As of 8/19/2025, patient still has a lump near the vaccine site. More
2854743	13	F	GA	08/19/2025	HPV9	MERCK & CO. INC.	Y013818	Dizziness, Hypoacusis, Visual impairment Dizziness, Hypoacusis, Visual impairment	Patient reported spotty vision, dizziness, and difficulty hearing after standing up and walking, abo... Patient reported spotty vision, dizziness, and difficulty hearing after standing up and walking, about 15 minutes post vaccination. Patient sat down for several minutes and stated she began feeling better. She was transferred into a patient room and let to rest while taking vitals every 5 minutes. Vitals at 1:05 PM were BP: 115/74, HR: 58 O2: 96%. At 1:10 PM: BP: 109/75, HR: 62, O2: 98%. At 1:15 PM: BP: 112/75, HR: 62, O2: 98%. Patient was feeling much better and was able to walk down the hallway without assistance. Patient left with family at 1:16 PM. More
2854744	0.58	M	ID	08/19/2025	IPV	SANOFI PASTEUR	W1C751M	Extra dose administered Extra dose administered	Double dose of polio was administered to patient on 07/03/2025 Double dose of polio was administered to patient on 07/03/2025
2854745	6	M	IA	08/19/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	793PT	Wrong product administered Wrong product administered	Child was given Tdap instead of Dtap due to age . Mom was notified and counseled on potential side e... Child was given Tdap instead of Dtap due to age . Mom was notified and counseled on potential side effects. More
2854746	16	M	FL	08/19/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS	G334J	Dizziness, Malaise, Nausea Dizziness, Malaise, Nausea	Pt idx2, allergies reviewed. Pt was not feeling well after administration, per pt he felt dizzy, lig... Pt idx2, allergies reviewed. Pt was not feeling well after administration, per pt he felt dizzy, light headed, wanted to vomit and poop. Pt voiced he had not eaten any food all day. Pt was advised to wait 15 mins and a candy was given to pt, vitals were done bp 113/72, pulse 50 by machine and 51 manually, resp 18, oral temp 97.4, oxygen 100%. Per MD, pt is stable and was able to leave after 15 mins. More
2854747	16	F	TN	08/19/2025	HEP HEPA TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR	H39Z4 H3N97 3CA30C1	Pallor, Syncope; Pallor, Syncope; Pallor, Syncope Pallor, Syncope; Pallor, Syncope; Pallor, Syncope	Vaccine was administered to patient. Pt was anxious before getting the vaccines. about 2 minutes aft... Vaccine was administered to patient. Pt was anxious before getting the vaccines. about 2 minutes after vaccines were given patient became very pale and fainted. More
2854748	0.33	F	TN	08/19/2025	DTAPIPVHIB	SANOFI PASTEUR		Periorbital swelling, Swelling face, Urticaria Periorbital swelling, Swelling face, Urticaria	Hives and swelling around the left eye, face, and head. Hives and swelling around the left eye, face, and head.
2854759		F	NY	08/19/2025	UNK	UNKNOWN MANUFACTURER		Drug ineffective Drug ineffective	minimal side effects with TICE BCG; This spontaneous report was received from a pharmacist and refer... minimal side effects with TICE BCG; This spontaneous report was received from a pharmacist and refers to his mother, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Bacillus of Calmette and Guerin (TICE BCG LIVE) (dose, frequency, route of administration, indication, expiration date, and lot # were not reported). On an unknown date, the patient experienced minimal side effects with TICE BCG. The reported stated that the patient's next dose of the treatment was coming up, and her healthcare provider was having difficulty obtaining the product. At the reporting time, the outcome of minimal side effects with TICE BCG was unknown. The action taken with TICE BCG was unknown. The reporter considered the event of minimal side effects with TICE BCG to be related to TICE BCG. Additional information is not expected. More
2854760	1		TX	08/19/2025	MMR MMR MMRV VARCEL	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y018703 Y018703 Z005153	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More	No additional AE; HCP calling to report the inadvertent administration of PROQUAD and MMR-II for two... No additional AE; HCP calling to report the inadvertent administration of PROQUAD and MMR-II for two patients today (07/25/25). Both patients have already received their first dose of VARIVAX and MMR-II. The 14-month-old patient for this case received their first dose; The 14-month-old patient for this case received their first doses on 05/29/25 for both vaccines. HCP calling to report the inadvertent administration of PROQUAD and MMR-II for two patients today (07/25/25).; Information has been received from registered nurse on 25-Jul-2025 and refers to 14-months-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported On 29-May-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (valid lot #Y018703, expiration date: 11-Nov-2026) for prophylaxis and with 29-May-2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported), which were both reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not provided). On 25-Jul-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (valid lot #Y018703, expiration date: 11-Nov-2026), dose and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (valid lot #Z005153, expiration date: 25-Aug-2026), which were both reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not provided). The administered vaccines were giving inadvertently on the same date (Accidental overdose and inappropriate schedule of product administered). The patient was no symptomatic and no additional adverse event was reported. No other information provided. This is one of two reports from the same reporter. More
2854761			MI	08/19/2025	HEPA MMRV VARCEL	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	Z007853 Z003767	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More	No additional AE; FBE calling to report AE on behalf of HCP for PROQUAD and VARIVAX. HCP reported bo... No additional AE; FBE calling to report AE on behalf of HCP for PROQUAD and VARIVAX. HCP reported both vaccines were administered on 07/25/2025 in addition to the HAVRIX. Precautionary full AE as caller unable to confirm if patient was symptomatic or not. Patient also; This spontaneous report was received from a physician via Company employee and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Jul-2025, the patient was vaccinated with both Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007853, expiration date: 19-Oct-2026), and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (lot #Z003767, expiration date: 30-Jan-2027) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). The patient also received HAVRIX (indication, expiration date, and lot # were not reported) on the same day (Vaccine overdose). No other information available at this moment. No additional adverse event (AE) (No adverse event). More
2854762		F	FL	08/19/2025	HEP	MERCK & CO. INC.	Unknown	Expired product administered, No adverse event Expired product administered, No adverse event	No symptoms reported; daughter who was administered an expired dose of RECOMBIVAXHB; This spontaneo... No symptoms reported; daughter who was administered an expired dose of RECOMBIVAXHB; This spontaneous report was received from a consumer (patient's parent) and refers to a newborn (0-day-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On the day the patient was born, she was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB INJ) suspension for injection at a dose of 0.5 mL, lot # was reported as 0100300064, however upon internal validation was determined to be invalid (route of administration, anatomical location and expiry date were not reported) for prophylaxis (Expired product administered). No symptoms were reported. Lot# is being requested and will be submitted if received. More
2854763		M		08/19/2025	MMR MMR MMR MMR MMR MMR	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Measles antibody negative, Mumps antibody test negative, Rubella antibody negati... Measles antibody negative, Mumps antibody test negative, Rubella antibody negative; Measles antibody negative, Mumps antibody test negative, Rubella antibody negative; Measles antibody negative, Mumps antibody test negative, Rubella antibody negative; Measles antibody negative, Mumps antibody test negative, Rubella antibody negative; Measles antibody negative, Mumps antibody test negative, Rubella antibody negative; Measles antibody negative, Mumps antibody test negative, Rubella antibody negative More	Nurse then got a booster shot of the MMR II in February and had his titers checked in May 2025 and a... Nurse then got a booster shot of the MMR II in February and had his titers checked in May 2025 and again it showed low protection for Measles but his Mumps and Rubella protection had gone up.; had his titers checked in February 2025 and they showed low in protection for Measles, Mumps and Rubella.; Nurse then got a booster shot of the MMR II in February and had his titers checked in May 2025 and again it showed low protection for Measles but his Mumps and Rubella protection had gone up.; Nurse reports he had his titers checked in 2021 and it showed he did not have the protection for Measles, Mumps and Rubella.; Nurse reports he had his titers checked in 2021 and it showed he did not have the protection for Measles, Mumps and Rubella.; Nurse reports he had his titers checked in 2021 and it showed he did not have the protection for Measles, Mumps and Rubella.; This spontaneous report was received from a Nurse and refers to a 26-year-old male patient. The patient's concurrent conditions included allergic to amoxicillin sodium (+) clavulanate potassium (AUGMENTIN). Historical drugs included amoxicillin sodium (+) clavulanate potassium (AUGMENTIN). Concomitant medications included lisinopril, valacyclovir and emtricitabine (+) tenofovir alafenamide fumarate (DESCOVY). His medical history was not reported. On an unspecified date in 2021, the patient titers showed he did not have the protection for measles, mumps, and rubella (measles antibody negative) (mumps antibody test negative) (rubella antibody negative), following that test, on an unknown date in 2021 (reported as summer of 2021 and given 1 month apart), the patient was vaccinated with the two dose series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) both administered intramuscular as prophylaxis (Lot numbers, expiration dates, exact dose quantity volumes, anatomical locations of administration and vaccination scheme frequency were not provided); both doses were reconstituted with sterile diluent administered intramuscular (Lot No., expiration date and indication were not reported). On an unknown day in February 2025, the patient titers showed low in protection for measles, mumps and rubella (antibody test abnormal). On an unspecified day in February 2025, the patient was vaccinated with the third dose (reported as booster dose) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered intramuscular as prophylaxis (Lot No., expiration date, exact dose quantity volume, anatomical location of administration and vaccination scheme frequency were not provided) (extra dose administered). On an unspecified date in May 2025, the patient titers showed again low protection for measles but his mumps and rubella protection had gone up (antibody test abnormal) At the reporting time, the outcome of all the events was not reported. The causal relationship between the events of measles antibody negative, mumps antibody test negative, rubella antibody negative, antibody test abnormal (first time) and antibody test abnormal (second time) with the suspect vaccine and the sterile diluent was not provided. More
2854764	38	F	CO	08/19/2025	VARCEL VARCEL	MERCK & CO. INC. MERCK & CO. INC.	Z004246	Exposure during pregnancy, No adverse event, Product use issue; Exposure during ... Exposure during pregnancy, No adverse event, Product use issue; Exposure during pregnancy, No adverse event, Product use issue More	No additional AE; Caller reported patient received VARIVAX while pregnant. Caller states patient doe... No additional AE; Caller reported patient received VARIVAX while pregnant. Caller states patient does not currently have a rash or any symptoms. No other information provided; This spontaneous report was received from a nurse practitioner and refers to a 38-year-old female pregnant patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. This was a prospective pregnancy case. On an unknown date reported (approximately on 01-Jul-2025) the patient became pregnant. The last menstrual period (LMP) was (17-Jun-2025) and estimated date of delivery (EDD) was (24-Mar-2026) and with estimated 7 week and 2 days of pregnancy gestation. On 07-Aug-2025, the patient was vaccinated while pregnant with a dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Z004246 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)] expiration date reported, and upon internal validation established as 10-Feb-2027) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent, administered subcutaneously (Lot No, expiration date and indication was not provided (exposure during pregnancy). Additionally, it was stated that the patient did not currently have a rash or any symptoms. No other information provided. No additional adverse event (no adverse event). More
2854765			AZ	08/19/2025	VARCEL	MERCK & CO. INC.	Y019318	No adverse event, Product storage error No adverse event, Product storage error	TE VARVAX administered on 08/13/2025. Confirmed not symptomatic. Supported outcome provided. No addi... TE VARVAX administered on 08/13/2025. Confirmed not symptomatic. Supported outcome provided. No additional AE; TE VARVAX administered on 08/13/2025. Confirmed not symptomatic. Supported outcome provided. No additional AE; This spontaneous report was received from an Other health professional and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Aug-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y019318, expiration date: 21-Nov-2026) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # not reported). It was reported that the suspect vaccine was underwent temperature excursions of minus 11.7 degree Celsius (C) (the time frame was 31 minutes) (product storage error). There were no previous temperature excursions. Confirmed not symptomatic (no adverse event). More
2854766		F	TX	08/19/2025	MMRV	MERCK & CO. INC.	Z009668	Product container issue, Skin laceration Product container issue, Skin laceration	minor cut on her finger; vials that were broken; This spontaneous report was received from a/an Othe... minor cut on her finger; vials that were broken; This spontaneous report was received from a/an Other health professional (physician assistant) referring to herself (unknown age). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Aug-2025, the physician assistant was administering Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #Z009668, expiration date: 29-Nov-2026 (dose, anatomical site, route of administration was not reported) as prophylaxis to a patient. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date was not provided). Physician assistant reported a minor cut on her finger related to opening a carton of the vaccine vials that were broken (product container issue). At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable. The reporter considered the event to be related to Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. The reporter considered the event of minor cut on her finger to be related to sterile diluent. This is one of several reports from the same reporter. More
2854767		M	MD	08/19/2025	PPV PPV PPV	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Antibody test abnormal; Antibody test abnormal; Antibody test abnormal Antibody test abnormal; Antibody test abnormal; Antibody test abnormal	suboptimal pneumococcal titers despite vaccination; This literature marketed report has been receive... suboptimal pneumococcal titers despite vaccination; This literature marketed report has been received from the authors of a published article, and refers to a 9-year-old male patient. The patient's medical history included platelet transfusions, hypercellular marrow with megakaryocytic hypoplasia, recurrent pneumonias, prenatal intrauterine grown restriction, postnatal small size for gestational age, and congenital microcephaly. The patient's concurrent conditions included chromosomal microarray, Fanconi's anaemia, significant B-cell and mild T-cell lymphopenia, normocytic anemia, thrombocytopenia, and undetectable levels of IgA. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE); or Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE); or Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (formulation, lor #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced antibody test abnormal (reported as: suboptimal pneumococcal titers despite vaccination). At the reporting time, the outcome of antibody test abnormal was unknown. The reporter considered the event of antibody test abnormal to be related to Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE); or Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE); or Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). More
2854769	78	F	TX	08/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Blood pressure increased, Fatigue, Flushing, Pain in extremity Blood pressure increased, Fatigue, Flushing, Pain in extremity	she experienced flushing from her neck to waist; Increased blood pressure; sore arm; Tiredness; This... she experienced flushing from her neck to waist; Increased blood pressure; sore arm; Tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of flushing in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included propafenone (Rythmol). On 07-JUL-2025, the patient received the 1st dose of Shingrix. On 09-JUL-2025, 2 days after receiving Shingrix, the patient experienced flushing (Verbatim: she experienced flushing from her neck to waist) (serious criteria hospitalization) and increased blood pressure (Verbatim: Increased blood pressure) (serious criteria hospitalization). In JUL-2025, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: Tiredness). The outcome of the flushing and increased blood pressure were unknown and the outcome of the pain in arm and tiredness were resolved. It was unknown if the reporter considered the flushing, increased blood pressure, pain in arm and tiredness to be related to Shingrix. The company considered the flushing and increased blood pressure to be unrelated to Shingrix. It was unknown if the company considered the pain in arm and tiredness to be related to Shingrix. Additional Information: GSK receipt date: 05-AUG-2025 The reporter was the patient who received her first dose of Shingrix and had a sore arm and felt tired. On Wednesday morning, she woke up with flushing from her neck to waist and an elevated blood pressure of 180/88. She went to the emergency room. She was also admitted to the hospital twice so far for flushing and high blood pressure. The first time was from 14th JUL 2025 to 18th JUL 2025 and the second was from the following Tuesday to Thursday.; Sender's Comments: A case of Blood pressure increased and Flushing, 2 days after receiving Shingrix in a 78-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (age). More	✓
2854770	63	F	CA	08/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Amnesia, Dysstasia, Gait inability, Guillain-Barre syndrome, Loss of personal in... Amnesia, Dysstasia, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities More	Guillain Barre syndrome; There is also a period of time that she does not remember; This serious cas... Guillain Barre syndrome; There is also a period of time that she does not remember; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). On 23-AUG-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant) and memory loss (Verbatim: There is also a period of time that she does not remember). The outcome of the guillain barre syndrome and memory loss were unknown. It was unknown if the reporter considered the guillain barre syndrome and memory loss to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the memory loss to be related to Shingrix. Additional Information: GSK Receipt Date: 12-AUG-2025 Reporter was the patient who received her second dose of Shingrix on 23rd August 2024. She stated that she was hospitalized from October 2024 to November 2024. She was diagnosed with Guillain Barre syndrome. She could not walk and stand at that time. There was also a period that she did not remember. Today (on the day reporting) she still cannot walk, she cannot put on her shoes, and was in a long term care facility.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a 63-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More	✓
2854771	65	F	OR	08/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Papule, Pruritus, Rash, Rash papular Papule, Pruritus, Rash, Rash papular	she has discovered a raised rash "looks like small blisters" over the right shoulder, arm ... she has discovered a raised rash "looks like small blisters" over the right shoulder, arm and right side of chest.; last night she felt some itching on her right shoulder and upper arm/Itching papule; This non-serious case was reported by a consumer via call center representative and described the occurrence of itching papule in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included clotting disorder (Anticoagulant therapy) and indigestion. Concomitant products included rivaroxaban (Xarelto) and aluminium hydroxide gel, dried, magnesium carbonate (Pepcid). On 23-JUL-2025 16:00, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 23-JUL-2025 22:00, 6 hrs after receiving Shingrix, the patient experienced itching papule (Verbatim: last night she felt some itching on her right shoulder and upper arm/Itching papule). On 24-JUL-2025, the patient experienced raised rash (Verbatim: she has discovered a raised rash "looks like small blisters" over the right shoulder, arm and right side of chest.). The outcome of the itching papule and raised rash were not resolved. It was unknown if the reporter considered the itching papule and raised rash to be related to Shingrix. It was unknown if the company considered the itching papule and raised rash to be related to Shingrix. Additional Information: GSK Receipt date: 24-JUL-2025 The patient reported that she received her first Shingrix dose yesterday at 4pm in her left deltoid. No other vaccines were administered. Beginning at 10 pm last night she felt some itching on her right shoulder and upper arm. This morning, she had discovered a raised rash looked like small blisters over the right shoulder, arm and right side of chest. More
2854772				08/19/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Rash vesicular; Vacc... Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Rash vesicular; Vaccination failure More	suspected vaccination failure; still got shingles; phn; nerve damage; This serious case was reported... suspected vaccination failure; still got shingles; phn; nerve damage; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles), post herpetic neuralgia (Verbatim: phn) and nerve damage (Verbatim: nerve damage). The outcome of the vaccination failure, shingles and nerve damage were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the shots, still he/he got shingles and ended up with PHN (post herpetic neuralgia) nerve damage. Two and half years later patient still have the post herpetic neuralgia. The reporter thought he/she had all the blisters come out he/she would not have gotten the post herpetic neuralgia. The patient only had about four blisters on the rash. Had horrible pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK's Shingles vaccine. More
2854773				08/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Headache Headache	Severe headache from Shingrix dose 2 yesterday; This non-serious case was reported by a consumer via... Severe headache from Shingrix dose 2 yesterday; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-AUG-2025, the patient received the 2nd dose of Shingrix. In AUG-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Severe headache from Shingrix dose 2 yesterday). The outcome of the headache was not reported. The reporter considered the headache to be related to Shingrix. The company considered the headache to be related to Shingrix. Additional Information: GSK Receipt Date 02-AUG-2025 This case was reported by a patient via interactive digital media. The patient experienced severe headache from Shingrix dose 2 the day before reporting. More
2854774				08/19/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	suspected vaccination failure; shingles/still get small cluster; This serious case was reported by a... suspected vaccination failure; shingles/still get small cluster; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. Previously administered products included GABAPENTIN and Steroids. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/still get small cluster). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient said that yes it (shingles) was a terrible thing to have, they put him/her on gabapentin also steroid shots. He/she waited six months to get the vaccine then another 6 to finish up still get small cluster (shingles) but not like the first time. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles 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 completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 and Dose 2). More
2854775				08/19/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient asked what was postherpetic neuralgia (PHN) and further stated he/she got both shots and had shingles twice since then. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Doses 1 and 2). More
2854776				08/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; still get it; This serious case was reported by a consumer via intera... Suspected vaccination failure; still get it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The reporter said that put peroxide on it when it first appears, it dries it up and keeps it from spreading. The patient had the shingles shot but still get it but very mild. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2854777		F	CA	08/19/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	late third dose of Engerix-B; This non-serious case was reported by a other health professional via ... late third dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 5-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received 2nd dose on 13-Aug-2020) and Hepatitis B vaccine (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Engerix B. The patient had incomplete course of vaccination (Verbatim: late third dose of Engerix-B). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-AUG-2025 and 09-AUG-2025 The reporter reported that 0n 8th August 2025 a pharmacy intern called to ask about a female patient who was 5 years old and received 2 prior doses of a HepB vaccine but the patient mother did not remember if it was Engerix-B and when did the patient receive this doses. The reporter asked could the patient receive Engerix-B on the day of reporting. The colleague who reported the event called again a provided the following additional information that the last dose of HepB was Engerix-B, healthcare professional informed that the last 2 HepB doses were administered at the doctor primary care facility, but they did not provide the full address Also, the last Engerix-B dose was administered on 13-Aug-2020. Till the time of reporting, the patient did not receive 3rd dose of Engerix B vaccine which led to incomplete course of vaccination. More
2854778	69	M	DC	08/19/2025	COVID19	MODERNA		Allergy to vaccine Allergy to vaccine	proved to be deathly allergic to the COVID shot; This 69-year-old male subject was involved in an ot... proved to be deathly allergic to the COVID shot; This 69-year-old male subject was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot). No Medical History information was reported. On an unknown date, the patient received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. In 2022, the patient experienced ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) (seriousness criterion medically significant). At the time of the report, ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown. DCP-ID was reported as withheld id# with DCP name: 2025 Respiratory ATU Tracking Survey - CONSUMER. No concomitant medication was reported. It was unknown if the subject had allergies to medications, food and other products. Reporter stated that the subject provided a vague note that the subject proved to be allergic to the COVID shot when the subject took it. It was unknown if the event caused the subject to seek medical care. It was unknown if there were any other factors that could have led to the adverse event. It was unknown if the subject had experienced a similar event in the past. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-788495 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788495:Same Report, Different patient More
2854779		M		08/19/2025	COVID19	MODERNA		Cardiac ventricular thrombosis Cardiac ventricular thrombosis	developed a blood clot in his heart caused by the Moderna Covid vaccine; This spontaneous case was r... developed a blood clot in his heart caused by the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) (seriousness criterion medically significant). At the time of the report, CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had developed a blood clot in his heart caused by the Moderna Covid vaccine. He was currently seeing a heart specialist. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2854780		F	GA	08/19/2025	COVID19	MODERNA	013A21A	Lichen planus, Lichen sclerosus Lichen planus, Lichen sclerosus	lichen planus; lichen sclerosis; This spontaneous case was reported by a consumer and describes the ... lichen planus; lichen sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis). At the time of the report, LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) had resolved with sequelae. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. More
2854781			TX	08/19/2025	MENB	PFIZER\WYETH	HJ1517	Product storage error Product storage error	Received outside of temperature recommendation; Received outside of temperature recommendation; This... Received outside of temperature recommendation; Received outside of temperature recommendation; This is a spontaneous report received from an Other HCP from medical information team. A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), (Lot number: HJ1517, Expiration Date: Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) and all described as "Received outside of temperature recommendation". Additional information: Patient received this outside of temperature recommendations. Reporter explained on 18Jul2025, the temperature went to 35.9 degrees Fahrenheit for 5 minutes. More
2854782	0.5	F	MT	08/19/2025	HIBV	SANOFI PASTEUR	UK230AA	Product preparation error Product preparation error	act-hib was reconstituted with sterile water instead of the diluent with no reported adverse event; ... act-hib was reconstituted with sterile water instead of the diluent with no reported adverse event; Initial information received on 14-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient as HIB (PRP/T) Vaccine [ACT-HIB] was reconstituted with sterile water instead of the diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap); Polio vaccine (Polio vaccine); and pneumococcal vaccine for Immunisation. On 14-Aug-2025, the patient received a dose 3 of suspect HIB (PRP/T) Vaccine dose 0.5 ml 1x(once) Powder and solvent for solution for injection (strength unknown) lot UK230AA expiry date-30-Jun-2026 via intramuscular route in the thigh nos(not otherwise specified) for immunization, was reconstituted with sterile water instead of the diluent with no reported adverse event (product preparation error)(latency same day). Action taken- 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
2854783	5	M	NY	08/19/2025	IPV	SANOFI PASTEUR	X1E141M	Extra dose administered, No adverse event Extra dose administered, No adverse event	patient received the ipol twice with no reported adverse event; Initial information received on 15-A... patient received the ipol twice with no reported adverse event; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5-year-old male patient who received the IPV (VERO) [IPOL] twice with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Aug-2025, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection strength: standard frequency: once of lot X1E141M and expiry date: 31-Oct-2026 via subcutaneous route in the left deltoid for Immunization and patient received the ipol twice with no reported adverse event (extra dose administered) (latency: on same day). Reportedly,Caller stated that 3 doses of PENTACEL and 2 doses of IPOL were administered to a patient. Second dose of IPOL was administered on 05-AUG-2025. Caller reports that a patient received an additional IPOL vaccine and requests information regarding potential AE (adverse event) or recommendations on how to proceed. Caller adds that the patient received 3 doses of PENTACEL and the IPOL twice. 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
2854784	59	M	AR	08/19/2025	YF	SANOFI PASTEUR	UK065AB	Expired product administered, No adverse event Expired product administered, No adverse event	patient was given an expired dose of YF-VAX with no reported adverse event; Initial information rece... patient was given an expired dose of YF-VAX with no reported adverse event; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who was given an expired dose of Yellow fever vaccine- [YF-VAX] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation. On 15-Aug-2025, the patient received expired dose of Yellow fever vaccine - dose 0.5 ml, 1x(once) Solution for injection (strength standard) lot UK065AB expiry date- 31-Jul-2025 via subcutaneous route in the left arm for immunization with no reported adverse event (expired product administered) (latency same day). Action taken- 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
2854790	63	F	CT	08/19/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX NOVAVAX	6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012 6024MF012	Adverse event, Eye pain, Eye swelling, Eyelid bleeding, Eyelid cyst; Gait distur... Adverse event, Eye pain, Eye swelling, Eyelid bleeding, Eyelid cyst; Gait disturbance, Headache, Illness, Malaise, Meibomian gland dysfunction; Muscle strain, Ocular hyperaemia, Pain in extremity, Product availability issue; Asthenopia, Chalazion, Extra dose administered, Eye swelling, Eyelid bleeding; Eyelid cyst removal, Eyelid pain, Gait disturbance, Headache, Impaired driving ability; Malaise, Meibomian gland dysfunction, Ocular hyperaemia, Pain in extremity, Swelling of eyelid; Adverse event, Eye pain, Eye swelling, Eyelid bleeding, Eyelid cyst; Gait disturbance, Headache, Illness, Malaise, Meibomian gland dysfunction; Muscle strain, Ocular hyperaemia, Pain in extremity, Product availability issue; Asthenopia, Chalazion, Extra dose administered, Eye swelling, Eyelid bleeding; Eyelid cyst removal, Eyelid pain, Gait disturbance, Headache, Impaired driving ability; Malaise, Meibomian gland dysfunction, Ocular hyperaemia, Pain in extremity, Swelling of eyelid More	Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyel... Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; They felt strained; I handle Novavax better than Moderna or Pfizer; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function..they were closed off and things couldn't. Secrete the way the way they're supposed to; Theswellingwediscussed was so severe and I ended up with a clogged gland in my eyelid/The glands couldn't function. They were closed off and things couldnt. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; Little lumps that formed in my eyelid; This non-serious initial spontaneous report from (withheld) was reported by a Consumer and concerns a female of unspecified age who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-Oct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-Oct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-Oct-2024). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment "cytochrome p enzyme deficiency in liver/ genetic diagnosis". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From "My eyes started swelling/my eyes, they were swollen, red, huge" to "My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling". From "I really have difficulty in walking" to "I really have difficulty in walking"/I couldn't drive my car, couldn't walk". From "Little lumps that formed in my eyelid" to "Little lumps that formed in my eyelid/But then I just got another lump". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced "I handle Novavax better than Moderna or Pfizer" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced "Then I started sort of feeling a little crappy, like a week later" (PT: Malaise), "Didn't feel good and I got so sick" (PT: Illness), "The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function..they were closed off and things couldn't secrete the way they're supposed to" (PT: Meibomian gland dysfunction), and "Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events "Adverse event," Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown.; Sender's Comments: This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible. More
2854791		F	TX	08/19/2025	COVID19	NOVAVAX		Incomplete course of vaccination, Off label use Incomplete course of vaccination, Off label use	She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dos... She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; This non-serious initial spontaneous report from withheld was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00601) and concerns a 47- year-old Female who reported "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Incomplete course of vaccination) and "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 22-Mar-2025. At the time of reporting, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This 47-year-old Female experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Incomplete course of vaccination and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible. More
2854792		F	CA	08/19/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		Angina pectoris, Blood test, Computerised tomogram heart, Ear pain, Hypersensiti... Angina pectoris, Blood test, Computerised tomogram heart, Ear pain, Hypersensitivity; Laboratory test, Neck pain, Physical examination More	my allergic reactions; I had stabbing like knife stabbing in my heart and I had stabbing in both of ... my allergic reactions; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; This is a spontaneous report received from a Nurse from medical information team. A 72-year-old female patient received BNT162b2 (BNT162B2), in Dec2019 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated cholesterol level" (unspecified if ongoing); "elevated calcium levels" (unspecified if ongoing); "food allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Shingrix vaccine (DOSE 1, SINGLE), administration date: 2019, for Immunization, reaction(s): "blisters and a circle around her left lower leg above the ankle"; Shingrix vaccine (DOSE 2, SINGLE), administration date: 2019, for Immunization, reaction(s): "blister in a circle below the shot in her right arm"; Tetanus toxoid, for Immunization, reaction(s): "Allergic". The following information was reported: ANGINA PECTORIS (medically significant), EAR PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2019, latency 20 min after the suspect product(s) administration, outcome "unknown" and all described as "I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "my allergic reactions". The patient underwent the following laboratory tests and procedures: Blood test: (Jul2025) Unknown results; Computerised tomogram heart: (unspecified date) showed that she had calcium deposits,; (unspecified date) showed two of the veins in the heart; Lab work: (2025) Unknown results; physicals: (unspecified date) Unknown results. Therapeutic measures were not taken as a result of angina pectoris, ear pain, neck pain, hypersensitivity. Clinical course: The patient reported an adverse event that she experienced from the Pfizer Covid-19 vaccine last Dec2019. It was during the first release of the vaccine and only people in the hospital can have them. The reporter had a reaction to her first shot. She remembered it happened in the hospital where she works, around 5 o'clock in the afternoon. She had to use the stairs in the hospital, and then within 20 minutes after receiving the shot, while she was on the stairs, she sat down and experienced a stabbing pain in her heart, like a knife stabbing her heart. It felt like a knife was stabbing both her ears, going down her neck, similar to a reaction she gets from food allergies. It was like a jellyfish stung her. The patient provided a brief history about the vaccines she had in the past and the reactions she experienced. One of them was the Shingrix vaccine. She had 2 Shingrix shots. The first time, she had blisters and a circle around her left lower leg above the ankle, and then on her second shot, she had another blister in a circle below the shot in her right arm. She also had a reaction with the tetanus toxoid, so she was not allowed to have any of those; she was allergic to tetanus toxoid. She was just telling about the reactions she had with other vaccines; she clarified that it was not related to the Covid vaccine. The patient said she was terrified to have the shot. She even asked her coworkers why she should have the vaccine. She was told to get it so she wouldn't end up in the ICU or on a respirator, so she said that okay, she'll get it. The one that she had with the Covid vaccine, she first reported to VAERS since her side effects were not on the list on the paperwork. She was referred to call Pfizer. She only had a reaction on the first shot, and in the second shot (booster) that she received around January, they were given Tylenol and she did not experience any side effects. They had a calcium CT scan on her heart and it showed that she had calcium deposits, and her husband and daughter have had the vaccines and they have that too, so they're on statins now and that was like 5 years after the vaccine. She had bloodwork last month, and she has her physicals twice a year with her doctor. The reason for the transfer was she was asked if she wants to know what she should do next if she gets the Covid vaccine, so she said sure, so that's why she was transferred to (withheld), so she can find out what to do. Before, she asked what she could have done when she had the reaction to the shot. She was told to call the rapid response team, but she didn't call anybody. She got away and took care of her babies. The patients HCP had not mention for her to have any more vaccines, she did tell her that she had that but she wanted to make sure that her HCP can check her. When probed if consumer took any Pfizer vaccine on the same date or 4 weeks prior, patient stated, her hospital was offering them and she did not want one. She was terrified to get that vaccine because she did not know, She was allergic to the Tetanus Toxoid and may have had an allergic response which she had this after her other vaccine, but was wondering if she could have, the Shingrix she had before, it was in 2019 and so, she had blisters in a circle around my ankle with that vaccine the first shot, the second shot, had blisters in a circle around my right arm which is where she had the vaccine given both times. When clarified if consumer took Pfizer COVID-19 vaccine and Shingrix, consumer stated, "No, I do not have any, I do not take vaccines together. I give them, I am a pediatric RN in (withheld). Pfizer is the one that she had. I have all the paperwork, it is Pfizer and anyway, that was the one that she had. They did not have the (withheld) one quite yet, her daughter had that one, but she had the Pfizer. That was the only one available when she had it. she have not had the Shingles vaccine a year and a half before approximately, she had the COVID vaccines. Yes, they were giving the vaccines to healthcare workers first she was one of those people. Yes, she had the two. She reacted to the first one with that was not on the list on the paperwork that they gave them with the Pfizer vaccine at the hospital and so, she reported it, but she found out and she called VAERS with her allergic reactions. Other medical conditions and other medication: Consumer stated, "At the time no, she was taking statins now, but was not taking them before. Rosuvastatin, elevated cholesterol level, it has gone way down, but she did have a CT scan of her heart a year and a little about a year and a half ago and it showed two of the veins in the heart, widowmaker, and the other one that she had elevated calcium levels and her daughter has it too and so, and her husband (Further details was not available). Patient not had any lab tests in two weeks but had some about a month ago. Patient did not hd any treatments for the events. Consumer stated, "The blisters were from the Shingles vaccine. The COVID vaccine, she had started with in 20 minutes, she had stabbing like knife stabbing in her heart and she had stabbing in both of her ears radiating down her neck and she received no treatment. I called VAERS because they were not on the list, those reactions were not on the VAERS list for the COVID. So, I called them, but I did not know I needed to call you." Anatomical location or site of administration: Consumer stated, "The right arm, they wanted to give it to her left arm, but she only take vaccine shots in her right arm always." Route of administration: Consumer stated, she cannot remember, she was very paranoid of needles. she did not look and see what either she do not ever watch. It was straight in, she did not do it at an angle, it was straight in. If any adverse event resulted in hospitalization: Consumer stated, "No, she had asked them because she was allergic to the Tetanus Toxoid. So, she asked them since she had that vaccine allergy, what should I do because I was working, I was taking care of premature infants, I had my shot and so, I said what do I do if I react to the shot and he says you call for if you have one." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Considering close temporal association, the event of Angina pectoris is assessed as related to BNT162b2. 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
2854793		F	VA	08/19/2025	COVID19	PFIZER\BIONTECH		Influenza like illness, Lymphadenopathy, Mammogram Influenza like illness, Lymphadenopathy, Mammogram	lymph node enlargement; Generic flu like symptoms; This is a spontaneous report received from a Nurs... lymph node enlargement; Generic flu like symptoms; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 (BNT162B2), in 2021 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: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500165860 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose; More

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📖 Help & Search Guide

Column Icons Legend

How to Search

Understanding the Data

Using the Table

💡 Frequently Asked Questions (FAQ)

What is this site?

What is VAERS?

Is this data HIPAA compliant?

Why does this site exist?

Where does the data come from?

My vaccine lot number matches one with deaths/serious events - should I be worried?

Can I trust VAERS data?

What are "adverse events"?

Why are some lot numbers listed multiple times?

How often is this data updated?

Where can I learn more?