🏥 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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Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

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Select Year: Choose a specific year OR "All Years" to search across all data
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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Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

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

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

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

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Showing 24,851 to 24,900 of 34,052 reports (Page 498 of 682)

« First ‹ Prev 1 ... 495 496 497 498 499 500 501 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥
2833549	62	M	WA	03/27/2025	YF	SANOFI PASTEUR	UK124AB	Incorrect route of product administration Incorrect route of product administration	I have given the vaccine to patient via IM route instead of Subcutaneous route. I have given the vaccine to patient via IM route instead of Subcutaneous route.
2833550	0.33	M	AZ	03/27/2025	DTPPVHBHPB PNC20 RV5	MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC.		Erythema; Erythema; Erythema Erythema; Erythema; Erythema	Immediately after his shots the lower part of his lower legs turned red. No difficulty breathing, it... Immediately after his shots the lower part of his lower legs turned red. No difficulty breathing, it resolved on its own within minutes. More
2833551	55	M	NV	03/27/2025	RAB	NOVARTIS VACCINES AND DIAGNOSTICS	FDP00595	Arthralgia, Sciatica Arthralgia, Sciatica	February 2nd- Left hip pain that progressed to excruciating pain. Sciatica.. given pain meds and mus... February 2nd- Left hip pain that progressed to excruciating pain. Sciatica.. given pain meds and muscle relaxers, More
2833552	0.58	F	CA	03/27/2025	DTPPVHBHPB PNC20 RV5	MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC.	2CA53C1 LX4483 Y014317	Urticaria; Urticaria; Urticaria Urticaria; Urticaria; Urticaria	Hives to bilateral thighs Hives to bilateral thighs
2833553	70	F	TX	03/27/2025	PNC20	PFIZER\WYETH	LK6655	Injection site erythema Injection site erythema	Developed 13x7 cm erythematous patch oat injection site. Treated with antibiotics (cephalexin starte... Developed 13x7 cm erythematous patch oat injection site. Treated with antibiotics (cephalexin started 3-20-25). Symptoms resolved a few days later. More
2833554	28	M	MD	03/27/2025	COVID19 FLU3	PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS	LN0589 PG52S	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More	Patient was given Flu and Covid vaccine on 3/21/25 and he had already received both of those on 10/1... Patient was given Flu and Covid vaccine on 3/21/25 and he had already received both of those on 10/18/24. Patient had no adverse effects from this- More
2833555	62	F	CA	03/27/2025	PNC20 PNC20	PFIZER\WYETH PFIZER\WYETH	LK6651 LK6651	Discomfort, Erythema, Pyrexia, Skin warm, Swelling; Tenderness Discomfort, Erythema, Pyrexia, Skin warm, Swelling; Tenderness	Patient started noticing discomfort that evening. On Saturday patient with redness, swelling, tender... Patient started noticing discomfort that evening. On Saturday patient with redness, swelling, tenderness and fever (102). Came to clinic on 3/24/25 with redness, swelling, tenderness and warm to touch. Patient was given antibiotic and treated for possible cellulitis. More
2835938	70	F	FL	03/27/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration, Influenza like illness, Pain, ... Inappropriate schedule of product administration, Influenza like illness, Pain, Vaccine positive rechallenge More	flu like symptoms; aches and pains; first dose of shingrix in 2022 and second dose of shingrix on 8 ... flu like symptoms; aches and pains; first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in 2022 with aches and pains and pain at the injection site). Concomitant products included lisinopril, rosuvastatin calcium (Crestor), pantoprazole, prednisone, levothyroxine, ipratropium bromide, salbutamol sulfate (Duoneb), sodium chloride, fluticasone propionate;salmeterol xinafoate and tiotropium bromide monohydrate (Spiriva). On 08-MAR-2025, the patient received the 2nd dose of Shingrix .5 ml. On 08-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.). On 09-MAR-2025, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms) and pain (Verbatim: aches and pains). Rechallenge with Shingrix was positive. On 10-MAR-2025, the outcome of the influenza-like symptoms and pain were resolved (duration 1 day). The outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms and pain to be related to Shingrix. Linked case(s) involving the same patient: US2025029169 Additional Information: GSK Receipt Date: 10-MAR-2025 I had Shingrix dose in 2022 and again 08-March-2025, the patient did not go back for the second vaccine within the recommended schedule time, which led to lengthening of vaccination schedule. The reporter asked was a third dose recommended due to the time lag in between doses. Recently her physician notified her that to start Nucala she would have to receive the second dose of Shingrix. The patient has not started Nucala yet. The patient had her second dose of Shingrix. After the second dose of Shingrix the patient did have the same flu-like symptoms with aches and pains one day after the resolved the next day. Medications listed in this report were medication that patient was taking in 2025 during second dose of suspect vaccine.; Sender's Comments: US-GSK-US2025029169: More
2833164		F	CA	03/26/2025	PPV	MERCK & CO. INC.	X027348	Accident at work, Skin laceration, Syringe issue Accident at work, Skin laceration, Syringe issue	Medical Assistant was cut by a PNEUMOVAX 23 pfs; Is the syringe broken into 2 or more pieces? YES---... Medical Assistant was cut by a PNEUMOVAX 23 pfs; Is the syringe broken into 2 or more pieces? YES---THE OTHER PIECE IS MISSING; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Medical Assistant was cut by a PNEUMOVAX 23 pfs; This spontaneous report was received from a medical assistant and refers to herself, a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Mar-2025, the patient was cut by a glass of a broken finger flange of a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #X027348, expiration date: 24-Jan-2026) 0.5 mL (Skin laceration) syringe (Injury associated with device). The syringe was broken into 2 or more pieces (Syringe issue). The injury occurred after removing the syringe from the tray, while trying to attach the needle to the syringe. The syringe tray was intact and undamaged on receipt. The product was exposed to patient's bodily fluids (Accidental exposure to product). The vaccine was not administered. A the time of reporting, the outcome of the event was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was related. More
2833165			TX	03/26/2025	HPV9	MERCK & CO. INC.		Incomplete course of vaccination Incomplete course of vaccination	Caller states a 27 year old patient missed their second dose. The first dose was administered on 11/... Caller states a 27 year old patient missed their second dose. The first dose was administered on 11/07/2024 and they have not received their second dose as of yet.; No other AE; This spontaneous report was received from a pharmacist and refers to a 27-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 07-NOV-2024, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) administered as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) It was reported that the patient did not received he second dose of the previous mention vaccine as of yet (Inappropriate schedule of product administration). No other adverse event (No adverse event). More
2833166		M	MI	03/26/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		Acquired factor V deficiency, Activated partial thromboplastin time, Blood bilir... Acquired factor V deficiency, Activated partial thromboplastin time, Blood bilirubin, Blood fibrinogen, Blood folate; Blood iron, Blood lactate dehydrogenase, Coagulation factor V level, Coagulation factor VII level, Coagulation factor X level; Coagulation factor inhibitor assay, Fibrin D dimer, HIV test, Haemoglobin, Haptoglobin; Hepatic enzyme, Hepatitis viral test, International normalised ratio, Platelet count, Prothrombin time; Smear test, Thrombin time, Ultrasound scan, Unevaluable investigation, Vital signs measurement; Vitamin B12, Vitamin K deficiency More	Acquired FV inhibitor; Partial vitamin k deficiency; This is a literature report from the Regulatory... Acquired FV inhibitor; Partial vitamin k deficiency; This is a literature report from the Regulatory Agency for the following literature source(s): Other Case identifier(s): PI450028-00060, PI450028-00089, PI450028-00317, US-MLMSERVICE-20250318-PI450028-00053-1. This case was detected in the medical literature by the Regulatory Agency. Acquired factor V inhibitor treated with rituximab. On 14 Mar 2025 This spontaneous case was reported in the medical literature by a physician and concerns a male patient in 50's (06 decades) who experienced serious adverse drug reaction of acquired FV inhibitor associated with tozinameran, ceftriaxone, azithromycin, ampicillin, tobramycin and partial vitamin k deficiency associated with ceftriaxone, azithromycin, ampicillin and tobramycin. The patient in his 50s presented to the hospital from a skilled nursing facility for behavioural and psychiatric issues. He had a complex medical history including chronic obstructive pulmonary disease, hypertension, type II diabetes mellitus, schizoaffective disorder and a severe COVID-19 infection 2 years prior resulting in tracheostomy and gastrostomy tube dependence. On admission, the patient had stable vital signs and appeared cachectic, with no signs of active bleeding or pallor on examination. His hospital course consisted of treatment for multiple multidrug-resistant urinary tract and pulmonary infections. On hospital day 16, the patient developed oozing at the peripheral IV and tracheostomy sites and was found to have markedly abnormal coagulation findings. He had an elevated activated partial thromboplastin time (aPTT) greater than 200s, an elevated prothrombin time (PT) of 58.0s, an elevated international normalised ratio of 6.7, haemoglobin of 90g/L, elevated fibrinogen at 595mg/dL, D-dimer 0.42 ug/mL and platelets 240x10^9 /L. The patient's previous coagulation studies approximately 1 year prior showed a normal aPTT of 30.1s and PT of 12.3s. Investigations: A 1:1 mixing study of the patient's plasma and normal pooled plasma did not correct the aPTT immediately, aPTT 59s, or after 60min of incubation, aPTT 63.7s, indicating the presence of a circulating fast-acting inhibitor. The thrombin time was normal 17.4s, indicating normal factor II function and excluding the presence of a thrombin inhibitor. Specific factor assays showed an FVII level of 39%, a factor X level of 51% and an FV level of < 1%. The FV inhibitor was present at an activity level of 184 Bethesda units/mL. Differential diagnosis: The results of liver studies, including ultrasonography and liver enzymes, were normal. HIV and viral hepatitis serologies were negative. There was no laboratory evidence of haemolysis as noted by haptoglobin, lactate dehydrogenase and total bilirubin within normal ranges along with the absence of schistocytes on peripheral smear. The iron panel was consistent with anaemia of chronic disease. The vitamin B12 and folate levels were within normal limits. Vitamin K was administered because of concerns regarding antibiotic-related deficiencies. Prophylactic low-molecular-weight heparin was discontinued. Despite these interventions, the patient continued to have prolonged aPTT and PT, with ongoing mucosal bleeding. Treatment: The patient was administered packed red blood cells, fresh frozen plasma (FFP) and platelets, along with immunosuppressive therapy initially with glucocorticoids (methylprednisolone 40mg daily) and intravenous immunoglobulin (IVIG) at 1g/kg/ day for 2days. Tranexamic acid was also administered intermittently over the next 3days to control acute mucosal bleeding episodes due to concerns regarding airway compromise. The patient's coagulopathy was still not corrected with these interventions. Author followed standard hospital protocol to discuss risk, benefits and alternatives with the patient and his family regarding rituximab use. Following this discussion and obtaining his consent, rituximab was started (375mg/m2 once weekly for 4weeks) and methylprednisolone was continued. His coagulapathy improved with the aPTT and PT trending down slowly. Outcome And Follow-Up : After 4weeks of treatment with rituximab and glucocorticoids, the author observed that the FV level increased from <1% to 15 % and the FV inhibitor level decreased from 184 BU/mL to 2.9 BU/mL The PT decreased from 58.0 s to 27.4 s and the aPTT decreased from >200.0s to 64.9s. By the end of his hospital course on day 65, there was a clear improvement in his overall labs. He was discharged with a prednisone taper, instructions to repeat future labs and close outpatient follow-up. Unfortunately, the patient did not show up to any of his future appointments and was ultimately lost to follow-up even after countless calls. Author stated that patient developed acquired factor V (FV) inhibitor during treatment with tozinameran for COVID-19 immunisation, ceftriaxone, azithromycin, ampicillin and tobramycin and partial vitamin k deficiency during treatment with ceftriaxone, azithromycin, ampicillin and tobramycin for enterococcus faecalis urinary tract infection and pseudomonas aeruginosa pulmonary infection. Additionally, he exhibited lack of efficacy during treatment with vitamin-k for partial vitamin k deficiency. Before admission, he had received 3 doses of tozinameran [pfizer-bioNTech-COVID-19-vaccine] for COVID-19 immunisation. Upon admission, he had stable vital signs and appeared cachectic. He was receiving ceftriaxone, azithromycin, ampicillin and tobramycin for enterococcus faecalis urinary tract infection and pseudomonas aeruginosa pulmonary infection. During hospitalization, he developed oozing at the peripheral and tracheostomy sites and had abnormal coagulation tests. His laboratory investigations revealed an elevated activated partial thromboplastin time (aPTT), an elevated prothrombin time (PT) of 58.0s, an elevated international normalised ratio of 6.7, haemoglobin of 90 g/L, elevated fibrinogen 595 mg/dL, fibrin D dimer 0.42 ug/mL and platelets 240x10^9 /L. Additionally, coagulation factor VII level was 39%, coagulation factor X level of 51% and coagulation factor V level of < 1%. He experienced anaemia of chronic disease. Thus, acquired FV inhibitor secondary to tozinameran, ceftriaxone, azithromycin, ampicillin and tobramycin and partial vitamin k deficiency secondary to ceftriaxone, azithromycin, ampicillin and tobramycin was confirmed. Subsequently, vitamin K was administered for partial vitamin k deficiency. His treatment with unspecified low-molecular-weight-heparins was discontinued. Despite treatment with vitamin K, he continued to had prolonged aPTT and PT, with ongoing mucosal bleeding (lack of efficacy). Thus, he required packed red blood cells, fresh frozen plasma and platelets. Additionally, methylprednisolone, immune-globulin and tranexamic-acid was administered for acquired FV inhibitor. However, he showed mild improvement and partial response. Thus, he started on off label use with rituximab 375 mg/m2 once weekly for 4 weeks and methylprednisolone was continued. His condition improved. After completion of treatment with rituximab and methylprednisolone, he had clear improvement. Subsequently, he was discharged with a prednisone. However, he lost to follow-up. The patient had a severe COVID-19 infection 1.5 years prior, which is unlikely to be causally related to the current presentation. However, he received three subsequent doses of Pfizer-BioNTech COVID-19 vaccines including the booster vaccine approximately 128 days before the diagnosis of his coagulopathy. Follow-up information has been requested. No follow-up attempts are possible.; Sender's Comments: Based on available information, the possible contributory role of suspect products cannot be excluded for the event acquired factor V deficiency. Conversely, it appears unlikely that the event Vitamin K deficiency was related to the BNT162b2 (COMIRNATY) therapy. Use of other co-suspect products may be a confounder. Case will be reassessed should additional information become available. 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		✓
2833167	0.5	M	MI	03/26/2025	DTAP DTAP DTAPHEPBIP DTAPHEPBIP FLU3 FLU3 FLU3 FLU3 FLU4 FLU4 HEPA HEPA HEPA HEPA HIBV HIBV PNC13 PNC13 RV5 RV5 DTAP DTAP FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 HEP HEP HEPA HEPA HEPA HEPA HIBV HIBV PNC13 PNC13 RV5 RV5	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC.	FX6077 FX6077 FX6077 FX6077 FX6077 FX6077	Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death... Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age; Autopsy, Death, Inappropriate schedule of product administration; Autopsy, Death, Product administered to patient of inappropriate age More	This 2 year old boy passed away while napping; Dose 2 administered on 29Dec2022 and dose 3 on 02Mar2... This 2 year old boy passed away while napping; Dose 2 administered on 29Dec2022 and dose 3 on 02Mar2023 (after 9 weeks); This is a spontaneous report received from a Consumer or other non HCP. A 2-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 02Mar2023 as dose 3, single (Lot number: FX6077) at the age of 6 months for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), on 02Mar2023 as dose number unknown, single) for immunisation; influenza vaccine inact split 3v (FLULAVAL), on 02Mar2023 as dose number unknown, single) for immunisation; influenza vaccine inact split 3v (FLUARIX), on 02Mar2023 as dose number unknown, single) for immunisation; fluconazole (FLUZONE [FLUCONAZOLE]), on 02Mar2023 as dose number unknown, single) for immunisation; hib vaccine conj (ompc) (PEDVAXHIB), on 02Mar2023 as dose number unknown, single) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), on 02Mar2023 as dose number unknown, single) for immunisation; hepatitis a vaccine inact (VAQTA), on 02Mar2023 as dose number unknown, single) for immunisation; hepatitis a vaccine inact (HAVRIX), on 02Mar2023 as dose number unknown, single) for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), on 02Mar2023 as dose number unknown, single (Lot number: FX6077) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: prevnar 13 (Dose 1, single, Lot Number: FN5555), administration date: 03Nov2022, when the patient was 2-month-old, for Immunization; prevnar 13 (Dose 2, single, Lot Number: FN5555), administration date: 29Dec2022, when the patient was 4-month-old, for Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Mar2023, outcome "unknown", described as "Dose 2 administered on 29Dec2022 and dose 3 on 02Mar2023 (after 9 weeks)"; DEATH (death, medically significant) with onset 09Mar2025, outcome "fatal", described as "This 2 year old boy passed away while napping". The patient date of death was 09Mar2025. The reported cause of death was unknown. Clinical course: Dose 1, 2 and dose 3 received on Doctor's office/urgent care. No other vaccine in four weeks. Unknown if other medications in two weeks. This 2 year old boy passed away while napping with no previous conditions and an autopsy was pending. Autopsy performed, autopsy remarks as pending. No known allergies. No treatment received for event-as reported.; Reported Cause(s) of Death: Unknown cause of death More	✓
2833168		M		03/26/2025	COVID19	PFIZER\BIONTECH		Allergy to vaccine Allergy to vaccine	they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous repor... they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Peg 3350, reaction(s): "Allergy: PEG 3350", notes: PEG, 3350 or something; Miralax, reaction(s): "allergy to Miralax". Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine". Additional information: The patient received 3 doses. The patient had an allergy to ingredient in COVID-19 vaccine, clarified a PEG 3350 or something allergy, an allergy to MiraLAX (said the ingredient in Miralax was also in the vaccine). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833169		F	NC	03/26/2025	COVID19	PFIZER\BIONTECH		Cardiac disorder Cardiac disorder	heart problems; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-o... heart problems; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problems". Clinical details: the reporter (patient's father) stated his wife, daughter (patient) and he all got the Pfizer mRNA shots. All now have heart problems. Pfizer owes compensation to all of them who have suffered so severely. The patient will undergo an ablation on Thursday, 20Mar2025. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2833201		F		03/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; I had the shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; I had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date : 20-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that the side effects were not worth it and he/she had the shingles. 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 vaccine Shingrix. More
2833202			AL	03/26/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	4N222	Incorrect route of product administration Incorrect route of product administration	patient that accidentally received IM versus subcutaneous; This non-serious case was reported by a p... patient that accidentally received IM versus subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 14-MAR-2025, the patient received Priorix (intramuscular). On 14-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient that accidentally received IM versus subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAR-2025 Pharmacist reported they changed to the Priorix, the MMR-II, and did not realize that Priorix is preferred to be subcutaneously administration versus IM, which is the other manufacturer. So, they wanted to see if there was any risk that they need to be aware of, for they have a patient that accidentally received IM versus subcutaneous. The vaccine which is preferred to be subcutaneously administered to the patient intramuscularly, which led to subcutaneous injection formulation administered by other route. More
2833217			FL	03/26/2025	RV5	MERCK & CO. INC.		Infantile vomiting Infantile vomiting	HBP called and placed Medical Assistant on the line who reported an infant who vomited a dose of ROT... HBP called and placed Medical Assistant on the line who reported an infant who vomited a dose of ROTATEQ about 5 minutes after administration. No patient demographics were known at the time of call. No additional information was known by reporter. No; infant who vomited a dose of ROTATEQ about 5 minutes after administration; This spontaneous report was received from a Consumer or other non-health professional and refers to a(n) Infant patient of unknown exact 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 an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), administered by oral route (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date (about 5 minutes after administration), the patient experienced infantile vomiting. The patient vomited a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (accidental underdose). At the reporting time, the outcome of infantile vomiting was unknown. The causal relationship between the event of i infantile vomiting n and Rotavirus Vaccine, Live, Oral, Pentavalent was unknown/not reported/not provided. More
2833218			VA	03/26/2025	PNC15	MERCK & CO. INC.	Y010032	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No adverse event; Medical Assistant calling to report inadvertently administering a dose of VAXNEUVA... No adverse event; Medical Assistant calling to report inadvertently administering a dose of VAXNEUVANCE to a 1 month and 4-day old child. Caller stated patient has not experienced any symptoms. Permission to contact HCP was granted. No additional information provided.; This spontaneous report was received from a medical assistant concerning a 1 month and 4-day-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-MAR-2025, the patient was inadvertently vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (lot #Y010032, expiration date: 17-FEB-2027) administered for Prophylaxis (Inappropriate age at vaccine administration) (Dose, route and anatomical location were not reported). No adverse event was reported. More
2833219			CA	03/26/2025	HPV9	MERCK & CO. INC.	X014788	Expired product administered, No adverse event Expired product administered, No adverse event	No symptomatic events.; administration of expired GARDASIL-9.; a T/E that had previously occurred; T... No symptomatic events.; administration of expired GARDASIL-9.; a T/E that had previously occurred; This spontaneous report was received from an other health professional and refers 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 24-Aug-2024, the vaccine Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) had temperature excursion of 51F for 1 hours 12 minutes 0 seconds. There was no previous excursion. On 21-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (0.5 ml, lot #X014788 has been verified to be a valid lot number, expiration date: 07-Mar-2025; strength was not provided) by intramuscular route for prophylaxis (expired product administered, product storage error). No symptomatic events were reported (no adverse event). More
2833220	38			03/26/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.		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 More	No additional AE; patient received their first dose of GARDASIL 9 on April 1, 2024, and the second d... No additional AE; patient received their first dose of GARDASIL 9 on April 1, 2024, and the second dose on March 24, 2025.; This spontaneous report was received from a Pharmacist and refers to a 39-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-Apr-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 1, 0.5 mL (lot #, expiration date, anatomical location, and route of administration date were not reported) for prophylaxis. On 24-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 2, 0.5 mL (lot #, expiration date, anatomical location, and route of administration date were not reported) for prophylaxis (Inappropriate schedule of product administration). Reporter asked about alternative dosing schedules for the suspect vaccine. No adverse effects were reported; no additional adverse event (AE) (no adverse event). Additional information is not expected. More
2833221			MD	03/26/2025	VARCEL	MERCK & CO. INC.	Y011712	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; T/E for VARIVAX on 1/29/2025. HBP reported that vaccines were administered to pati... No additional AE; T/E for VARIVAX on 1/29/2025. HBP reported that vaccines were administered to patients; This spontaneous report was received from regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 29-JAN-2025, a temperature excursion (TE) occurred for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), at 14.65 degree Fahrenheit (F) for 13 hours and 15 minutes, with no previous TE. On 28-FEB-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 ml, administered as prophylaxis (lot number Y011712 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 02-Jul-2026) (Product storage error). No additional adverse event was reported for the patient. This is one of several reports from the same reporter. More
2833222	1		KS	03/26/2025	MMR MMR	MERCK & CO. INC. MERCK & CO. INC.	X011441	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to u... No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to unknown amount of patients. HCP is unable to provide patient information or dates of administration at this time.; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 13-JAN-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (Lot No. X011441 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 19-APR-2025 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error); that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (Lot N., expiration date, route and anatomical location of administration were not provided), after a temperature excursion of 10.9 degree Celsius (C) during a time frame of 1 hour with 37 minutes. No previous temperature excursion was reported. No additional adverse event (AE) was reported. (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : X011441 GF , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : More
2833223	1	M	TN	03/26/2025	DTAPIPV MMR	GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER	5G23D UNK	Incorrect dose administered, Product administered to patient of inappropriate ag... Incorrect dose administered, Product administered to patient of inappropriate age, Syringe issue; Incorrect dose administered, Product administered to patient of inappropriate age, Syringe issue More	she does not know which vaccine of the three administered it was, was leaking out of the syringe ont... she does not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination; her 1 year old son, who is a male patient and a minor infant, received Kinrix yesterday; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 31-AUG-2026) for prophylaxis. Co-suspect products included MMR (MMR vaccine) for prophylaxis. Concomitant products included Varicella zoster vaccine (Varicella vaccine). On 11-MAR-2025, the patient received Kinrix (intramuscular, left thigh) .5 ml and MMR vaccine (left thigh). On 11-MAR-2025, an unknown time after receiving Kinrix and MMR vaccine, the patient experienced incomplete dose administered (Verbatim: she does not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination) and inappropriate age at vaccine administration (Verbatim: her 1 year old son, who is a male patient and a minor infant, received Kinrix yesterday). The outcome of the incomplete dose administered and inappropriate age at vaccine administration were 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 12-MAR-2025 The reporter was the mother called to report that her 1-year-old son, who was a patient and a minor infant, received Kinrix yesterday (day before reporting), which led to an inappropriate age at vaccine administration. The reporter had reported this event to VAERS. The patient also received his MMR vaccine and Varicella vaccine (on right thigh) yesterday on 11-MAR-2025. All three vaccines were administered for the patient's routine vaccinations. The reporter also reported that one of the syringes, and she did not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination, which led to an incomplete dose administered. No other condition was reported. The reporter had reported all that was provided about these adverse events. More
2833224		F	FL	03/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Pain, Pruritus, Vaccination failure Herpes zoster, Pain, Pruritus, Vaccination failure	Suspected vaccination failure/lack of drug effect; Shingles; This serious case was reported by a con... Suspected vaccination failure/lack of drug effect; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure/lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with menthol, zinc oxide (Gold Bond Medicated), calamine, cortisone, lidocaine and aesculus hippocastanum seed, butyl aminobenzoate, halibut-liver oil, yeast dried (Preparation H). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAR-2025 The reporter called, stating that the only medication that had worked for the itching was gold bond medicated powder. The reporter stated that the following list of medications had not worked for the itching, Calamine lotion, Cortisone 10 cream, Lidocaine cream, or Preparation H. The reporter stated that the itching and pain the patient had experienced with shingles after having received Shingrix was horrendous and relentless. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR022743, reported by same reporter.; 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 vaccine Shingrix. US-GSK-US2025AMR022743:same reporter More
2833225	81	M	PA	03/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Injection site erythema Injection site erythema	redness at the injection site after receiving the first dose of Shingrix; This non-serious case was ... redness at the injection site after receiving the first dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood cholesterol increased. Concomitant products included simvastatin. On 10-MAR-2025, the patient received the 1st dose of Shingrix. On 15-MAR-2025, 5 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection site after receiving the first dose of Shingrix). The outcome of the injection site erythema was resolving. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site erythema to be related to Shingrix. Additional Information: GSK receipt date: 19-MAR-2025 Customer reported developing redness at the injection site after receiving the first dose of Shingrix. Vaccine was administered on 10th March 2025, redness developed on 15th March 2025. More
2833226				03/26/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	forgot 2nd dose; This non-serious case was reported by a consumer via interactive digital media and ... forgot 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 15th march 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient self-reported this case for himself/herself. patient had taken Shingrix on 15th March 2024 but had forgotten the second dose and was asking for the best course of action. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2833227				03/26/2025	VARZOS VARZOS VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK	Facial pain, Herpes zoster, Pruritus, Swelling face, Swelling of eyelid; Vaccina... Facial pain, Herpes zoster, Pruritus, Swelling face, Swelling of eyelid; Vaccination failure; Facial pain, Herpes zoster, Pruritus, Swelling face, Swelling of eyelid; Vaccination failure More	Suspected Vaccination failure; Got shingles January 28, right side of face swelled and right eye was... Suspected Vaccination failure; Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches; 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 28-JAN-2025, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the two shot vaccine about 2 years ago and got shingles on 28th January and the right side of face swelled and right eye was almost shut and still hurts and itches. This case was considered as suspected vaccination failure since the details regarding the 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2833228				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Feeling abnormal Feeling abnormal	feel like crap; This non-serious case was reported by a consumer via interactive digital media and d... feel like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: feel like crap). The outcome of the feeling abnormal was not reported. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the second shot made him/her feel like crap the next day, though he/she did not miss work because of it. Get the shot, but not the day before something important. More
2833229				03/26/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspeceted vaccination failure; still got shingles; This serious case was reported by a consumer via... Suspeceted vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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. In FEB-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The reporter was patient. The reporter reported that got the 2 part vaccine and still got shingles, 6 weeks now and counting. The reporter asked who was having fun now. This case was considered as suspected vaccination failure as details regarding time to onset for shingles 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2833230				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Pain, Stress, Vaccination failure, Varicella Herpes zoster, Pain, Stress, Vaccination failure, Varicella	Suspected vaccination failure; I have them right now my sixth time; Chickenpox; This serious case wa... Suspected vaccination failure; I have them right now my sixth time; Chickenpox; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 61-year-old 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: I have them right now my sixth time) and chickenpox (Verbatim: Chickenpox). The outcome of the vaccination failure and chickenpox were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and chickenpox 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 and chickenpox to be related to Shingles vaccine. Additional Information: GSK receipt date: 19-MAR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she was 61 year old and had vaccine by a pain doctor bad choice on his/her part. Patient had them right now sixth time and this was the worst ever and they said stress was what bring them out Gabapion was the only thing stop pain been through every opioid there was Chicken pox and if you ever did lsd aka acid stayed in base of spinal cord rest of life could not get a good trip back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2833231				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; have had shingles twice; This serious case was reported by a consumer... Suspected vaccination failure; have had shingles twice; 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: have had shingles twice). 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: 18-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she has had the shot, and have had shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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 vaccine Shingles vaccine. More
2833232				03/26/2025	VARCEL VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More	Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... 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 VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox when he/she was little). On an unknown date, the patient received Shingles vaccine and VARICELLA 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: 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. 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: 19-MAR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had chickenpox when he/she was a child, and in his/her case, it was really bad. Later, he/she got the vaccine but still ended up with shingles, which were very painful. It felt like neither the chickenpox vaccine nor the shingles vaccine made much of a difference for him/her. It was unknown if the reporter considered shingles to be related to varicella vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2833233		F		03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise Malaise	feel sick; This non-serious case was reported by a consumer via interactive digital media and descri... feel sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female 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 feeling unwell (Verbatim: feel sick). The outcome of the feeling unwell was not reported. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated that hubby and she got the vaccine. The patient watched her strong mother beg for morphine from shingles pain. The vaccine made patient feel sick, but it was nothing compared to what she saw her mother go through. More
2833234				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	bad case of shingles; This non-serious case was reported by a consumer via interactive digital media... bad case of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: bad case of shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had received one, he/she had not known he/she was supposed to get two, and he/she ended up with a bad case of shingles. More
2833235				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter knows someone that got the shingles shot 3 years ago and got shingles 2 weeks later and it still lingers some. More
2833236				03/26/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Post herpetic neuralgia Herpes zoster, Post herpetic neuralgia	shingles/had a mild case; am still dealing with neuropathy pain in my right hand; This non-serious c... shingles/had a mild case; am still dealing with neuropathy pain in my right hand; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 85-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In NOV-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles/had a mild case) and post herpetic neuralgia (Verbatim: am still dealing with neuropathy pain in my right hand). The outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK receipt date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the first shingles shot, never went back for the 2nd dose. The patient reported that he/she had shingles the first part of November 2024, he/she still dealing with neuropathy pain in his/her right hand. The reporter reported that he/she had a mild case. They requested get the vaccine both of them. More
2833237				03/26/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS		Incorrect route of product administration Incorrect route of product administration	Priorix probable intramuscular administration; This non-serious case was reported by a other health ... Priorix probable intramuscular administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix probable intramuscular administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-MAR-2025 A pharmacist wanted to know what would happen if Priorix was administered intramuscularly. The agent asked if this administration had already occurred, which led subcutaneous injection formulation administered by other route but the health care provider only commented that he did not have confirmation till the time of reporting and therefore could not provide the adverse event data. More
2833238	4	F	TN	03/26/2025	DTAP DTAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	49TM3 UNK	Incomplete course of vaccination, Product administered to patient of inappropria... Incomplete course of vaccination, Product administered to patient of inappropriate age; Incomplete course of vaccination, Product administered to patient of inappropriate age More	booster was not administered; received on 15-SEP-2021; This non-serious case was reported by a nurse... booster was not administered; received on 15-SEP-2021; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number 49TM3, expiry date 28-MAY-2022) for prophylaxis. Concurrent medical conditions included immunocompromised and multiple allergies. On an unknown date, the patient did not received the 2nd dose of Infanrix. On 15-SEP-2021, the patient received the 1st dose of Infanrix. On 15-SEP-2021, not applicable after receiving Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received on 15-SEP-2021). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: booster was not administered). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were 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: 17-MAR-2025 The nurse reported that a patient who was in here for her well check and she was immunocompromised and allergies had drawn titers and recommended she had have another DTAP, now she was out of the age range and asked for provided multiple times if this was the vaccine that we should give and they said yes but they just wanted to make sure that this would, that she was still within the parameters for that vaccine. The health care professional confirmed that the patient completed the Infanrix schedule. The heath care professional did not have dates or lot numbers of all the vaccines administered but provided the first one administered on September 15th, 2021. Patient was immunocompromised and the booster was not administered. Till the time of reporting, the patient did not receive 2nd dose of Infanrix, which led to incomplete course of vaccination. The patient received a dose of Infanrix at an inappropriate age, which led to inappropriate age at vaccine administration. More
2833239	19	M	NY	03/26/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	3D72S	Product preparation issue Product preparation issue	they were only given the diluent, it wasn't reconstituted with the antigen component; Only dilu... they were only given the diluent, it wasn't reconstituted with the antigen component; Only diluent 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 19-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On 14-MAR-2025, the patient received Priorix. On 14-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: they were only given the diluent, it wasn't reconstituted with the antigen component) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 18-MAR-2025 A nurse called to informed that they have a patient that was given the MMR vaccine, Priorix, and they were only given the diluent, it was not reconstituted with the antigen component, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. More
2833240	63	F		03/26/2025	COVID19	MODERNA		Giant cell arteritis, Pain in extremity, Polymyalgia rheumatica, Suspected COVID... Giant cell arteritis, Pain in extremity, Polymyalgia rheumatica, Suspected COVID-19 More	polymyalgia rheumatica/stiff shoulders / everything was stiff; Patient reported the temporal arterit... polymyalgia rheumatica/stiff shoulders / everything was stiff; Patient reported the temporal arteritis and GCA they are all the same field; felt like Covid; legs hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field). In 2021, the patient experienced SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt). The patient was treated with Tocilizumab (Actemra) at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff), GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field), SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient reported that it had all started after getting the Covid shot on 11-Jan-2021 (Moderna), with the second one on 08-Feb-2021 (Moderna), before taking Actemra. The patient reported that she hadn't been taking anything and had been perfectly healthy, but within 6 months of getting the second Moderna Covid shot, her shoulders and legs had become stiff, everything had felt stiff, and it had felt like Covid.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report. More
2833241	17	M	MI	03/26/2025	MEN	UNKNOWN MANUFACTURER	U8369BA	Product storage error Product storage error	Menquadfi was administered post temperature excursion with no reported adverse event; Initial inform... Menquadfi was administered post temperature excursion with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post temperature excursion 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 HPV VACCINE (HPV VACCINE) for Immunisation; and MENINGOCOCCAL VACCINE B (MENB) for Immunisation. On 19-Mar-2025, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot U8369BA and expiry date- 31-MAR-2028) via intramuscular route in the right arm for Immunisation post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Max/low temperature reached: lowest temp of negative 0.6�C and max temp of 6.3�CDuration: 25 hrs Previous Excursion- NONE, Human error- Unknown, Administered- YES, Does extended stability data cover the excursion- NO. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for both the events. 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.; Sender's Comments: US-SA-2025SA086554:02460337 US-SA-2025SA087172:02460523 More
2833242	60	M	VA	03/26/2025	TD	SANOFI PASTEUR	U7679AA	Expired product administered, No adverse event Expired product administered, No adverse event	60 year old patient received an expired dose of TENIVAC today with no reported adverse event; Initia... 60 year old patient received an expired dose of TENIVAC today with no reported adverse event; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On 25-Mar-2025, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) lot U7679AA, Expiry date : 21-Mar-2025 (expired product administered) via intramuscular route in the right deltoid for Immunization with no reported adverse event (strength was unknown) (latency : same day). Reportedly, Caller requested information regarding any detrimental effects to the patient for administration of TENIVAC 4 days post expiration date. The caller was not aware of any adverse reactions at the time of the call. 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
2833258			GA	03/26/2025	MMR	MERCK & CO. INC.		Viral titre decreased Viral titre decreased	Pharmacist inquiring if a 45-year-old patient with low titers can receive a booster of MMRII.; This ... Pharmacist inquiring if a 45-year-old patient with low titers can receive a booster of MMRII.; This spontaneous report was received from a pharmacist and refers to a 45-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, vaccination site, route of administration, lot # and expiration date were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On an unknown date, the patient had low titers (antibody test negative). The pharmacist was inquiring if a 45-year-old patient with low titers can receive a booster of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The caller stated that the patient would like a booster shot. It was unknown if the dose was administered. No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was reported. At the reporting time, the outcome of the adverse event was not provided. The causal relationship between the adverse event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. Lot # is being requested and will be submitted if received. More
2833260		F		03/26/2025	PNC21	MERCK & CO. INC.		Erythema, Peripheral swelling, Product use in unapproved indication, Skin warm, ... Erythema, Peripheral swelling, Product use in unapproved indication, Skin warm, Tenderness More	CAPVAXIVE Provider treated patient for cellulitis; Patient presented arm that was swollen, ,doubled ... CAPVAXIVE Provider treated patient for cellulitis; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; This spontaneous report was received from a 60s female patient via company representative referred to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route, anatomical site, dose form, lot # and expiration date were not reported) for cellulitis (product use in unapproved indication). On 12-Mar-2025, the patient experienced side effect with arm that was swollen, doubled in size, and was red, hot, and tender (peripheral swelling, erythema, feeling hot, pain in extremity). It was reported that treatment was given for the events. The outcome of all events was not reported. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The reporter considered the events of peripheral swelling, erythema, feeling hot and pain in extremity to be medically significant. Lot # is being requested and will be submitted if received. More
2833261		M	NC	03/26/2025	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER		COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products,... COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test; COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test; COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test More	two originally then a couple of boosters/one of the boosters be the other guy's or something; h... two originally then a couple of boosters/one of the boosters be the other guy's or something; had covid several times/This will be the third time I got COVID; had covid several times/This will be the third time I got COVID; had covid several times/This will be the third time I got COVID; The initial case was missing the following minimum criteria: specified product. Upon receipt of follow-up information on 19Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single) 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 2023, outcome "recovered" and all described as "had covid several times/This will be the third time I got COVID"; DISEASE RECURRENCE (medically significant), outcome "recovered", described as "had covid several times/This will be the third time I got COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "two originally then a couple of boosters/one of the boosters be the other guy's or something". The event "had covid several times/this will be the third time i got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Mar2025) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient had COVID several times and he took the vaccine as well. He was now going to be taking Paxlovid and he took Paxlovid previously as well. The patient had tested positive for COVID today (19Mar2025), he was sick as a dog and his primary physician had called in a prescription for Paxlovid to the pharmacy and they were trying to get that perfected so to speak so that patient's son could pick the prescription up and delivered it immediately upon finding patient had COVID he had kind of quarantined himself from everybody and everything. The patient just wanted to shorten this COVID thing up as much as he could. This would be the third time he got COVID, all in the last two years and the first time or the second time his doctor did prescribe Paxlovid, and they did think it shortened up the sickness period. Patient did not know about contagious wise but as far as being sick it seemed to be a four- or five-day thing instead of being much more drawn out. The last time was much worse on him physically then the first time. Patient had trouble breathing one night and he thought it was the third night in, and he thought, if he woke up tomorrow morning and if he still had trouble breathing, he was going to the hospital. So, neither of the prior ones were hospitalized. The patient had all the original shots except for the last one that came out and three of those were Pfizer's and then they suggested one of the boosters be the other guy's or something. Patient thought even Pfizer even suggested for that particular one to switch to the other one so to speak but he could not remember how many. The patient wanted to say two originally then a couple of boosters. There had been a more recent booster, but he hadn't taken that one. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2833262		F		03/26/2025	COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		Death; Death; Death; Death Death; Death; Death; Death	died after taking the vaccines; This is a spontaneous report received from a Consumer or other non H... died after taking the vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "died after taking the vaccines". The cause of death on her death certificate also says it was the vaccine that killed her. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death More	✓
2833263		F	FL	03/26/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-Co... COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-CoV-2 test More	Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A... Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 89-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, in 2025 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 Mar2025, outcome "unknown" and all described as "Covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2025) Positive. The caller just had a six month appointment with her doctor today (20Mar2025), and she hasn't been feeling well this week, and the doctor took the test and she had Covid. All her Covid shots were Pfizer. When she had her last Booster, well they didn't give her a booster they just gave her a shot this year a couple of weeks ago, they gave it to her, and all of a sudden now she got Covid. While the caller mentioned all their COVID shots were Pfizer, they were not sure if the last shot was Pfizer or not. More
2833264	16	M	MI	03/26/2025	MEN	UNKNOWN MANUFACTURER	U8369BA	No adverse event, Product storage error No adverse event, Product storage error	Administered MENQUADFI post temperature excursion with no reported AE; Max/low temperature reached a... Administered MENQUADFI post temperature excursion with no reported AE; Max/low temperature reached at lowest temp of negative 0.6�C and max temp of 6.3�C for 25 hrs with no adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with US-SA-2025SA086720 and US-SA-2025SA086554. This case involves a 16 years old male patient where for the Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reporter reported max/low temperature reached at lowest temp of negative 0.6�c and max temp of 6.3�c for 25 hrs with no adverse event and vaccine was administered post temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Mar-2025, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot U8369BA and expiry date- 31-MAR-2028) via intramuscular route in the right arm for Immunisation post temperature excursion with no reported ae (poor quality product administered) (latency- same day). On an unknown date in 2025 the reporter reported max/low temperature reached at lowest temp of negative 0.6�c and max temp of 6.3�c for 25 hrs with no adverse event (product storage error) (unknown latency). Reportedly, Previous Excursion- NONE, Human error- Unknown, Administered- YES, Does extended stability data cover the excursion- NO. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for both the events. 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.; Sender's Comments: US-SA-2025SA086720:02460523 US-SA-2025SA086554:02460337 More
2833281	4		KS	03/26/2025	MMR MMR	MERCK & CO. INC. MERCK & CO. INC.	X011441	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to u... No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to unknown amount of patients. HCP is unable to provide patient information or dates of administration at this time.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 04-NOV-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (Lot No. X011441 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 19-APR-2025 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error); that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (Lot N., expiration date, route and anatomical location of administration were not provided), after a temperature excursion of 9.2 degree Celsius (C) during a time frame of 13 minutes. No previous temperature excursion was reported. No additional adverse event (AE) was reported. (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : X011441 HL , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : More
2833282		F	MS	03/26/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected Vaccination failure; breakout of shingles to forehead, face and around the eyes; This seri... Suspected Vaccination failure; breakout of shingles to forehead, face and around the eyes; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (about 15 years ago). In AUG-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, the patient received the 1st dose of Shingrix. On 19-FEB-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: breakout of shingles to forehead, face and around the eyes). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure and facial herpes zoster to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the 1st vaccine of Shingrix in June 2024 and 2nd vaccine in August 2024, was unsure of exact date. Patient stated that she had a breakout of shingles that had improved and breakout was to forehead, face and around the eyes. Had to see eye doctor too. This case was considered as suspected vaccination failure as details of 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix. More

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