🏥 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

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

Understanding the Data

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

Using the Table

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

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

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

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Showing 29,151 to 29,200 of 34,052 reports (Page 584 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2798869	52	F	MO	10/14/2024	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	LM2215 lm2215 lm2215	Accidental exposure to product, Exposure via skin contact, Syringe issue, Underd... Accidental exposure to product, Exposure via skin contact, Syringe issue, Underdose, Vaccination site pain; Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site pruritus, Injection site reaction; Injection site swelling, Underdose, X-ray More	less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administrat... less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration; less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration; what was in the vial spilled on myself and on my arm; what was in the vial spilled on myself and on my arm; It's really painful where the syringe broke; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 52-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Oct2024 as dose 1, single (Lot number: LM2215, Expiration Date: 24Mar2025) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, on 05Oct2024 as dose 1, single. The patient also took other concomitant therapy. The following information was reported: SYRINGE ISSUE (non-serious), UNDERDOSE (non-serious) all with onset 05Oct2024, outcome "unknown" and all described as "less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 05Oct2024, outcome "unknown" and all described as "what was in the vial spilled on myself and on my arm"; VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "not recovered", described as "It's really painful where the syringe broke". Therapeutic measures were not taken as a result of vaccination site pain, syringe issue, underdose, accidental exposure to product, exposure via skin contact. Additional information: The pharmacist said that she didn't want to give the patient another shot - she didn't know how much went into her arm. Vitamins (unspecified) were reported as other concomitant medication. The patient did not receive other vaccines within four weeks prior to the vaccination with Comirnaty. Causality for "it's really painful where the syringe broke", "less than the recommended dose of comirnaty 12 plus because the syringe broke during the administration" and "what was in the vial spilled on myself and on my arm" was determined associated to device constituent of BNT162b2 omicron (kp.2). More
2689824	56	F	MA	10/03/2023	FLUC4 FLUC4	SEQIRUS, INC. SEQIRUS, INC.	370652 370652	Immediate post-injection reaction, Injection site pain, Loss of personal indepen... Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Shoulder injury related to vaccine administration, Sleep disorder; Joint injury More	The pain started in the upper left arm right after the injection (which I felt was placed unusually ... The pain started in the upper left arm right after the injection (which I felt was placed unusually high in the arm). I waited for it to stop after a couple of days, but 10 days later I was still in pain. It has not subsided ever since. The pain wakes me up several times every night. I can no longer perform normal tasks like looking at my wrist watch or putting my clothes on in a normal way or opening a car door with my shoulder. I can no longer do yoga or dancing. This has affected my health enormously. More
2787677	75	F	FL	08/29/2024	FLUA4 FLUA4 FLUA4 FLUA4 FLUA4 FLUA4	SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC.	371594 371594 371594 371594 371594 371544	Anxiety, Arthralgia, Asthenia, Back pain, Impaired driving ability; Injected lim... Anxiety, Arthralgia, Asthenia, Back pain, Impaired driving ability; Injected limb mobility decreased, Injection site pain, Insomnia, Insurance issue, Loss of personal independence in daily activities; Muscle spasms, Musculoskeletal stiffness, Pain, Pain in extremity, Periarthritis; Physical disability, Product administered at inappropriate site, Shoulder injury related to vaccine administration, Sleep disorder, Tendonitis; Wrong technique in product usage process, X-ray limb abnormal; Joint injury More	On September 23, 2023, I received a Flu vaccine at the pharmacy. I was sitting; my husband was stand... On September 23, 2023, I received a Flu vaccine at the pharmacy. I was sitting; my husband was standing on my left side and the Pharmacist stood at my right as he injected the needle with the Flu vaccine into my shoulder. My husband can verify that the Pharmacist was standing, not sitting as he injected my shoulder. After my husband and I left Pharmacy we went to the grocery store and while shopping my right shoulder started hurting and burning more than I had ever experienced from an injection. By the time we got into the checkout line, over an hour later, my shoulder felt like it was on fire and the pain level was a 9 or 10! I was very anxious to go home to Ice my shoulder and take Tylenol. When we arrived, it had been over 1 1/2 hrs since I had the flu shot. It was the worse pain I remember ever having, I could not sleep at all that night and mostly paced the floor in pain. I continued to experience extreme debilitating pain, a serious lack of sleep and physical limitations in that shoulder so on 11/9/23 I went back to the pharmacy explained my dire situation to the Pharmacist, and showed him where the shot was given. He said that flu shot had been administered too high on my shoulder. He checked his computer and said the Pharmacist on 9/23/23 was a weekend temp not one of their regular Pharmacists and made a note of it on the computer. I learned that what I had was called SIRVA, a shoulder injury related to incorrect vaccine administration. Three months after receiving the flu shot I was still experiencing great pain, throbbing and spasms in my right shoulder which continued to disturb my ability to sleep because my right shoulder would hurt in any position I would try to sleep not just on my right side. The pain also spread to the top of my shoulder and back, down my arm to my elbow and toward my wrist. This inhibited my ability to dress, to comb and wash my hair, brush my teeth, put on shoes and sox, and other normal tasks that involved reaching or lifting. The movement in my right arm and shoulder became so limited so that I was unable to move my arm in any direction, mostly because of the pain, but it just wouldn't move! I wasn't able lift my right arm to apply deodorant. I needed my husbands assistance to dress. I could not raise my right arm to hold onto the steering wheel, or even put my hand into my own pocket. On 3/1/24 I finally saw a Shoulder Specialist, Dr. His diagnosis was Shoulder Adhesive Capsulitis which I had never heard of before. I was hesitant to receive a cortisone injection and opted to be treated with Physical Therapy. The Physical Therapy became on March 4, 2024, and I was Immediately beneficial. They stiffness in my shoulder lessened, but the pain remained, I had a total of therapy sessions over a month. At the end of that time I was told I had "plateaued" that my insurance would no longer pay for any additional sessions and that I would need to continue the exercises on my own. It's been 14 weeks since therapy ended and months since I received the errant flu shot at Pharmacy, So almost a year after my shoulder is still somewhat painful and my arm still won't reach in some directions. A few of my lingering shoulder difficulties and limitations are Pain and limited shoulder range of motion. While doing basic exercises and movements that I used to be able to do easily and freely and without pain before the flu shot injured my shoulder. When I am in the driver's seat and need to reach for something in the back seat with my right arm, that movement hurts my shoulder. My shoulder hurts for awhile if I've slept on my right side for longer than an hour. When I do ballroom dancing, my shoulder will feel a sharp twinge if my right arm is lifted above my shoulder. On August 26, 2024, Dr. stated after examining my right shoulder movement, that I now have 85% functionality which means I have some limitations compared to the range I used to have before the shoulder injury at Pharmacy occurred. He also explained that the lingering shoulder pain is due to tendonitis. He said stiffness to resolve and my shoulder to regain former level of strength and mobility. For me to have a chance if fully regaining my former level of movement, strength, and comfort in my right shoulder, and daily continue doing all the PT shoulder exercises myself, I am told that if I don't continue these PT exercises every day, my shoulder could freeze up again. Sometimes I feel discouraged that more progress has not been made after almost a year now and I wonder if my shoulder will ever be normal again. More		✓
2772885	60	M	MI	06/17/2024	FLUC4 FLUC4	SEQIRUS, INC. SEQIRUS, INC.	370652 UT7695NA	Angina pectoris, Arthralgia, Injection site pain; Joint injury Angina pectoris, Arthralgia, Injection site pain; Joint injury	Site: Pain at Injection Site-Medium, Additional Details: Patient is complaining of pain in back of s... Site: Pain at Injection Site-Medium, Additional Details: Patient is complaining of pain in back of shoulder, left side of heart and shoulder. Patient called Doctor and they send Rx for antibiotics and motrin. More
2773914	70	F	DE	06/17/2024	RSV RSV RSV RSV	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	59k92 59k92 59k92 31498	Blister, Chest discomfort, Chest pain, Dyspnoea, Hypersensitivity; Injected limb... Blister, Chest discomfort, Chest pain, Dyspnoea, Hypersensitivity; Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling; Pain, Pruritus, Rash; Joint injury More	Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: The patient described localized pain with discomfort when moving along with what appeared to be an allergic reaction presenting with SOB, rashes/blisters on the arm and challenges when moving More
2826892		U	TX	02/18/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		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 adverse event, Product storage error More	Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature... Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC. Related AE cases; No adverse event; Information has been received from Business Partner/CRO on 11-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) 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 an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 1, (lot # and expiration date were not reported). On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 3, (lot # and expiration date were not reported). On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 2, (lot # and expiration date were not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of Prophylaxis. On an unknown date, the patient experienced Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC. Related AE cases. On an unknown date, the patient experienced No adverse event. At the reporting time, the outcome of Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC. Related AE cases and No adverse event was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable. More
2826893	0.33	M		02/18/2025	DTAPHEPBIP DTAPHEPBIP HIBV HIBV PNC13 PNC13 RV1 RV1 UNK UNK	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory... Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory syncytial virus test positive, Upper respiratory tract infection; Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory syncytial virus test positive, Upper respiratory tract infection; Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory syncytial virus test positive, Upper respiratory tract infection; Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory syncytial virus test positive, Upper respiratory tract infection; Bronchiolitis, Chest X-ray, Infant irritability, Pneumonia, Pyrexia; Respiratory syncytial virus test positive, Upper respiratory tract infection More	Pneumonia; Bronchiolitis; This 7-month-old male subject was enrolled in a study. The subject receive... Pneumonia; Bronchiolitis; This 7-month-old male subject was enrolled in a study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 24-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 24-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22-AUG-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 24-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 12-DEC-2019, 49 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 112 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 pneumonia (Verbatim: Pneumonia) on 26-DEC-2019 with serious criteria of hospitalization. The subject was treated with amoxicillin. Bexsero vs Placebo was continued with no change. The outcome of bronchiolitis was resolved on 12-JAN-2020. The outcome(s) of the additional event(s) included pneumonia (resolved on 12-JAN-2020). Relevant Tests: On 25 DEC 2019, Respiratory Syncytial Virus was positive. On 27 DEC 2019, Chest X-Ray was and no information available about result. On 29 DEC 2019, Chest X-Ray was and no information available about result.. The investigator considered that there was no reasonable possibility that the bronchiolitis and pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the bronchiolitis and pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt date: 20-FEB-2020 Investigator text Mother called for safety follow up phone call 7 on 19FEB2020. She reported that the baby was hospitalized. Admission date 26DEC2019, Discharge date 28DEC2019. Mother was given call center phone advice for upper respiratory infection and fever starting on 12DEC2019. On 24DEC2019 the subject traveled for a one month family vacation. On 25DEC2019 the subject had an increase in fever and irritability. Baby was taken to a doctor where a test for RSV was done. Baby tested positive for Respiratory Syncytial Virus. Also diagnosed with Pneumonia. On 26DEC2019 the baby was hospitalized for Bronchiolitis. Treated with Amoxicillin antibiotic for 7 days. Mother reports the baby's symptoms resolved/recovered completely on 12JAN2020. SAE will be updated when more information becomes available. Records from Hospital in Brazil are not yet available. Follow up information received on 14-FEB-2025 Summary of changes: Added lab test (chest x-ray). Upon internal review, the case was updated on 17-Feb-2025: Seriousness GSK Medically Significant unticked for events pneumonia and bronchiolitis.; Sender's Comments: A case of Pneumonia and Bronchiolitis 49 days after receiving 3rd dose of Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Prevenar 13 and 112 days after receiving 2nd dose of Rotarix lyophilized formulation in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility and alternative etiology (Respiratory Syncytial Virus was positive) and alternative risk factor (Age). More	✓
2826894		F	PA	02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Chills, Headache, Nausea Chills, Headache, Nausea	headache; nausea; chills; This non-serious case was reported by a nurse via sales rep and described ... headache; nausea; chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache), nausea (Verbatim: nausea) and chills (Verbatim: chills). The outcome of the headache, nausea and chills were resolved. The reporter considered the headache, nausea and chills to be related to Shingrix. The company considered the headache, nausea and chills to be related to Shingrix. Additional Information: GSK receipt date: 23-JAN-2025 The reporter reported that the patient had recived Shingrix vaccine and experienced headache, nausea and chills. The expiry date of 1st dose of Shingrix were unknown. The patient did not want to get second dose and the doctor wants to be advised of next steps. Physician wanted to be advised if the patient should get the second dose even though the patient had the adverse reactions reported. More
2826895		F		02/18/2025	MENB MNQ	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	UNK UNK	Injection site erythema, Injection site warmth, Joint swelling; Injection site e... Injection site erythema, Injection site warmth, Joint swelling; Injection site erythema, Injection site warmth, Joint swelling More	Injection site redness/local reaction of redness at injection site; local reaction of swelling at in... Injection site redness/local reaction of redness at injection site; local reaction of swelling at injection site; local reaction of heat at injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and Menveo (unknown arm). On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced injection site erythema (Verbatim: Injection site redness/local reaction of redness at injection site), injection site swelling (Verbatim: local reaction of swelling at injection site) and injection site warmth (Verbatim: local reaction of heat at injection site). The outcome of the injection site erythema was resolved and the outcome of the injection site swelling and injection site warmth were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. It was unknown if the company considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. 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: 24-JAN-2025 The reporter reported that a patient received Bexsero and Menveo in same arm at different sites during same visit and experienced local reaction of redness, swelling, heat at injection site and returned to clinic to be evaluated by physician. Physician did not think site was infected. Physician advised patient to treat with cold compress. Patient did not return for repeat evaluation. More
2826896		U		02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Palpitations Palpitations	having palpitations; This non-serious case was reported by a consumer via interactive digital media ... having palpitations; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of palpitation in a 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 palpitation (Verbatim: having palpitations). The outcome of the palpitation was not reported. It was unknown if the reporter considered the palpitation to be related to Shingrix. It was unknown if the company considered the palpitation to be related to Shingrix. Additional Information: GSK Receipt Date: 26-JAN-2025 The reporter reported that recieved the shingrix shingles vaccine and had palpitations. More
2826897		U		02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Inappropriate schedule of product administration Inappropriate schedule of product administration	2nd dose 3 year after; This non-serious case was reported by a consumer via interactive digital medi... 2nd dose 3 year after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 4 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose 3 year after). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 29-JAN-2025 The reporter reported that the patient received Shingrix vaccine 1st dose 4 years ago and 2nd dose 3 years after the 1st dose, which led to drug dose administration interval too long. More
2826898		U	CA	02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	7LC49	Incorrect dose administered, Product preparation error Incorrect dose administered, Product preparation error	a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure;... a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 7LC49, expiry date 30-JAN-2027) for prophylaxis. In JAN-2025, the patient received Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure) and inappropriate dose of vaccine administered (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 21-JAN-2025 The reporter requested data on how to proceed with a patient who received Shingrix vaccine dose with an unapproved diluent, maybe from a MMR but unsure which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter reported that Shingrix vaccine was administered between 6th January 2025 and 15th January 2025, exact date unknown. It was unknown which Shingrix vaccine in the series. The reporter stated that all the details will not be known regarding the exact patient until the clinic runs a report. More
2826899	14	F	TX	02/18/2025	MNQ TDAP	NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS	LN75D 2A755	Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More	Menveo in 2022 and another dose of Menveo; Boostrix in 2022 and then received another dose of Boostr... Menveo in 2022 and another dose of Menveo; Boostrix in 2022 and then received another dose of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number LN75D, expiry date 30-SEP-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2A755, expiry date 28-OCT-2025) for prophylaxis. Previously administered products included Boostrix (in 2022) and Menveo (in 2022). On 22-JAN-2025, the patient received Menveo and Boostrix. On 22-JAN-2025, an unknown time after receiving Menveo and not applicable after receiving Boostrix, the patient experienced drug dose administration interval too long (Verbatim: Menveo in 2022 and another dose of Menveo) and drug dose administration interval too short (Verbatim: Boostrix in 2022 and then received another dose of Boostrix). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown. 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: 22-JAN-2025 The patient received a dose of Menveo and Boostrix in 2022 and then received another dose of Menveo and Boostrix today (22-January-2025). The patient received Menveo at longer time than the recommended which led lengthening of vaccination schedule. The patient received Boostrix at shorter time than the recommended which led shortening of vaccination schedule. The reporter consented to follow up. More
2826900		F	MD	02/18/2025	HEPA HEPA	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration, Underdose; Inappropriate sched... Inappropriate schedule of product administration, Underdose; Inappropriate schedule of product administration, Underdose More	Havrix - Pediatric dose to an adult; underdose; Havrix - Pediatric dose to an adult; underdose; drug... Havrix - Pediatric dose to an adult; underdose; Havrix - Pediatric dose to an adult; underdose; drug dose administrartion interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HAV (Havrix pediatric) for prophylaxis. Co-suspect products included HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric and Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric and not applicable after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Havrix - Pediatric dose to an adult), underdose (Verbatim: underdose), adult use of a child product (Verbatim: Havrix - Pediatric dose to an adult), underdose (Verbatim: underdose) and drug dose administration interval too short (Verbatim: drug dose administrartion interval too short). The outcome of the adult use of a child product, underdose, adult use of a child product, underdose and drug dose administration interval too short were unknown. 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: 23-JAN-2025 A medical assistant reported that an adult patient received a Havrix pediatric dose and one month later the patient received another pediatric dose. The medical assistant asked if they should re start the series. The reporter did not provide any information about the 2 pediatric Havrix doses. The adult patient received Havrix pediatric dose, which led to adult use of a child product and underdose. The patient received another dose of Havrix pediatric, earlier than the recommended interval, which led to shortening of vaccinations schedule. More
2826901	0.33	F	CO	02/18/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	34MF9	Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More	Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as ... Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as 2nd IPV dose; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap). On 09-JAN-2025, the patient received Kinrix. On 09-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as a 2nd Dtap dose and as 2nd IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 24-JAN-2025 The reporter reported 4 months old patient, received Kinrix as a 2nd Dtap dose and as 2nd IPV dose, which led inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up. This case was linked with case US2025009565 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025009565:Same reporter,Different patient More
2826902	0.33	F	CO	02/18/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	34MF9	Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More	Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as ... Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as 2nd IPV dose; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Polio vaccine inact (Ipv). On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as a 2nd Dtap dose and as 2nd IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 24-JAN-2025 The reporter reported 4 months old patient, received Kinrix as a 2nd Dtap dose and as 2nd IPV dose, which led inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up. This case was linked with case US2025009559 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025009559:Same reporter,Different patient More
2826903		M	MO	02/18/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	2724L	Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered	gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccin... gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20); This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 61-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2724L, expiry date 20-JUN-2025) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis. Concomitant products included Influenza vaccine inact split 3v (Flulaval). On 24-JAN-2025 14:30, the patient received the 2nd dose of FluLaval 2024-2025 season. On an unknown date, the patient received Prevnar 20. On 24-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20)). The outcome of the wrong vaccine administered was unknown. 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: 24-JAN-2025 The reporter reported that they recently had a gentlemen come in to receive a vaccination, and however he/she gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20) which led to, wrong vaccine administered. However, he recently had a 1st Flu vaccination (Flulaval) in October 2024, but latter the health care professional mentioned that the vaccine was given in 11th November 2024. The reporter also mentioned that the 2nd dose was given at 02:30 pm of 24th January 2025. Both Flulaval vaccines that the patient received were administer in the same place. The Vaccine Administration Facility was the same as Primary Reporter. More
2826904	0.17	F	WI	02/18/2025	DTAPHEPBIP	GLAXOSMITHKLINE BIOLOGICALS	BY247	Expired product administered Expired product administered	patient received an expired dose; This non-serious case was reported by a consumer via call center r... patient received an expired dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17-NOV-2023) for prophylaxis. On 21-DEC-2023, the patient received the 1st dose of Pediarix (intramuscular, left thigh) .5 ml. On 21-DEC-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose). The outcome of the expired vaccine used was unknown. 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: 28-JAN-2025 The reporter states that the patient received her first dose of Pediarix on 21-DEC-2023, and the reporter just found out from the patient's new clinic, that the patient received an expired dose, which led to expired vaccine used. The reporter stated that the nurse that administered the dose no longer works at the clinic. The patient also received her first two month dose on 21-DEC-2023, six days past 8 weeks of age, the second four month dose on 26-FEB-2024, one day past four months of age, and the third six month dose on 26-APR-2024, eleven days past six months of age. More
2826905	36	M	WV	02/18/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	AMVB043A	Product preparation issue Product preparation issue	We mixed it with sterile solution instead of the compound; This non-serious case was reported by a n... We mixed it with sterile solution instead of the compound; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis. On 28-JAN-2025, the patient received Menveo. On 28-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: We mixed it with sterile solution instead of the compound). The outcome of the wrong solution used in drug reconstitution was unknown. Additional Information: GSK Receipt Date: 28-JAN-2025 The nurse reported the following for Menveo 2-vial presentation, mixed it with sterile solution instead of the Compound, which led wrong solution used in drug reconstitution. The reporter consented to follow up. More
2826906	55	M	IL	02/18/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	they did not receive a second dose.; This non-serious case was reported by a pharmacist via call cen... they did not receive a second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix adult (received 1st dose of Twinrix in 26-JAN-2020). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: they did not receive a second dose.). The outcome of the incomplete course of vaccination was unknown. 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: 28-JAN-2025 The pharmacist reported that a patient got a dose of Twinrix back in January 26th 2020 and patient did not remember but seemed that they did not receive a second dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination More
2826907	60	M	KS	02/18/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	M77CC	Inappropriate schedule of product administration Inappropriate schedule of product administration	Patient received a second dose of Boostrix too early; This non-serious case was reported by a nurse ... Patient received a second dose of Boostrix too early; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. Previously administered products included Boostrix (received 1st dose on 13-JAN-2020). On 30-JAN-2025, the patient received the 2nd dose of Boostrix. On 30-JAN-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Patient received a second dose of Boostrix too early). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The patient had received a second dose of Boostrix too early, which led to an extra dose administered. More
2826908	37	F	KS	02/18/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	L5229	Underdose Underdose	approximately half of the volume of a Boostrix dose was administered; This non-serious case was repo... approximately half of the volume of a Boostrix dose was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number L5229, expiry date 19-APR-2027) for prophylaxis. On 04-FEB-2025, the patient received Boostrix. On 04-FEB-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: approximately half of the volume of a Boostrix dose was administered). The outcome of the underdose was unknown. 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: 04-FEB-2025 A Medical assistant reported that a patient received approximately half of the volume of a Boostrix dose which led to underdose. The reporter asked for recommendations on this situation. More
2826909	1	M	GA	02/18/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	4L454	Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered More	instead of Infanrix they administered Kinrix to a 15 month old patient; they administered Kinrix to ... instead of Infanrix they administered Kinrix to a 15 month old patient; they administered Kinrix to a 15 month old patient on January 30th 2025; Inappropriate schedule of vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Pediarix (first dose on December 19th 2023 of batch number: 2227K and expiry date : January 17th 2026), Pediarix (second dose on February 20th 2024 of batch number: 2227K and expiry date: January 17th 2026) and Pediarix (third dose on April 24th 2024 of batch number: X9EP5 and expiry date: March 9th 2026). On 30-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not received Infanrix. On 30-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: instead of Infanrix they administered Kinrix to a 15 month old patient), inappropriate age at vaccine administration (Verbatim: they administered Kinrix to a 15 month old patient on January 30th 2025) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administration). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 06-FEB-2025 Nurse explained that instead of Infanrix they administered Kinrix after 3 doses of Pediarix to a 15-month-old patient, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. More
2826910		F	TN	02/18/2025	HEP HEP HEP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Hepatitis B surface antibody negative; Hepatitis B surface antibody negative; He... Hepatitis B surface antibody negative; Hepatitis B surface antibody negative; Hepatitis B surface antibody negative More	antibodies are low; This non-serious case was reported by a other health professional via call cente... antibodies are low; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: antibodies are low). The outcome of the therapeutic response decreased was unknown. 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: 06-FEB-2025 A surgery manager reported to have one employee who was ready for dental school. They gave her the series of Engerix-B vaccine two years ago in 2023 and the antibodies were low. The reporter enquired if she needs a booster. More
2826911	69	M	MD	02/18/2025	COVID19 FLUX PPV VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccinati... Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Scar, Vaccination failure More	few small scars; Suspected Vaccination failure; developed Shingles again in February 2025; first dos... few small scars; Suspected Vaccination failure; developed Shingles again in February 2025; first dose of Shingrix in October 2023 and second dose in October 2024; in August 2024 diagnosed with Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 vaccine for prophylaxis, Influenza vaccine for prophylaxis, Pneumococcal vaccine for prophylaxis, COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis. In OCT-2024, the patient received the 2nd dose of Shingrix (unknown arm) .5 ml. In OCT-2023, the patient received the 1st dose of Shingrix (unknown arm) .5 ml, COVID-19 vaccine, Influenza vaccine and Pneumococcal vaccine. In OCT-2024, the patient received COVID-19 vaccine and Influenza vaccine. In AUG-2024, not applicable after receiving Shingrix and between 9 and 11 months after receiving Shingrix, the patient experienced shingles (Verbatim: in August 2024 diagnosed with Shingles). In OCT-2024, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in October 2023 and second dose in October 2024). In FEB-2025, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles again in February 2025). On an unknown date, the patient experienced scar (Verbatim: few small scars). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and scar were not reported and the outcome of the shingles was resolved and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles and scar to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and scar to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient self-reported this case. The patient received the first dose of Shingrix vaccine in October 2023 and received three other vaccines at the same time which were Covid, Flu and Pneumonia vaccine and in August 2024 he was diagnosed with shingles and had painful itching bumps on his upper thigh, groin and abdomen all located on the left side. The physician gave him Acyclovir and the shingles resolved leaving a few small scars. The patient received his second dose of Shingrix in October 2024 and received two other vaccines at the same time which were Covid and Flu vaccine and developed shingles again in February 2025 that were not resolved. The patient had second episode of shingles bumps present the same as the first episode and were located center back neck to buttocks and the bumps were thicker near the buttocks area. The reporter did not remembered in what arm the first and second dose was administered and did not had a lot number or National Drug Code (NDC) number for the both doses of Shingrix vaccine. It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Covid-19, Influenza and Pneumococcal vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. 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, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2826912	0.5	M	IA	02/18/2025	HIBV	GLAXOSMITHKLINE BIOLOGICALS	KF25B	Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usa... Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usage process More	needle stayed in the patient's leg; steps were not done correctly; patient received partial dos... needle stayed in the patient's leg; steps were not done correctly; patient received partial dose due to the needle coming off of syringe during administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 6-month-old male patient who received Hib (Hiberix) (batch number KF25B, expiry date 14-JUL-2026) for prophylaxis. On 03-FEB-2025, the patient received the 3rd dose of Hiberix (injection, right thigh). On 03-FEB-2025, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patient received partial dose due to the needle coming off of syringe during administration). On an unknown date, the patient experienced accidental needle stick (Verbatim: needle stayed in the patient's leg) and wrong technique in device usage process (Verbatim: steps were not done correctly). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered and wrong technique in device usage process were unknown. It was unknown if the reporter considered the accidental needle stick to be related to Hiberix. It was unknown if the company considered the accidental needle stick to be related to Hiberix. Additional Information: GSK Receipt Date: 07-FEB-2025 The nurse reported that the product quality complaint ruled out due to incorrect preparation. While reviewing product instructions for use step by step, reporter states that the steps were not done correctly. Instructions for vial and prefilled syringe presentation figure one was align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock, was not performed as per package inset. Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock. Reporter states that patient received partial dose due to the needle coming off of syringe during administration, which led to incomplete dose administered. When nurse attempted to take needle out of patients right upper thigh the needle stayed in the patient's leg. Reporter states that the child's health care professional provider evaluated the partial dose given and determined that enough of the dose was administered and the dose did not need to be repeated. This case is linked with US2025016605, reported by same reporter.; Sender's Comments: US-GSK-US2025016605:Same reporter/Diffrent patient More
2826913	0.5	M	IA	02/18/2025	HIBV	GLAXOSMITHKLINE BIOLOGICALS	3BP72	Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usa... Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usage process More	needle stayed in the patient's leg; Facility nurses were not gently connecting the needle hub i... needle stayed in the patient's leg; Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock; patient received partial dose due to the needle coming off of syringe; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 6-month-old male patient who received Hib (Hiberix) (batch number 3BP72, expiry date 13-JUL-2026) for prophylaxis. On 04-FEB-2025, the patient received the 3rd dose of Hiberix (injection, right thigh). On 04-FEB-2025, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patient received partial dose due to the needle coming off of syringe). On an unknown date, the patient experienced accidental needle stick (Verbatim: needle stayed in the patient's leg) and wrong technique in device usage process (Verbatim: Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock). The outcome of the accidental needle stick was not reported and the outcome of the wrong technique in device usage process and incomplete dose administered were unknown. It was unknown if the reporter considered the accidental needle stick to be related to Hiberix. It was unknown if the company considered the accidental needle stick to be related to Hiberix. Additional Information: GSK Receipt Date: 07-FEB-2025 The nurse reported that the product quality complaint ruled out due to incorrect preparation. While reviewing product instructions for use step by step, reporter states that the steps were not done correctly. Instructions for vial and prefilled syringe presentation figure one was align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock, was not performed as per package inset. Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock. Reporter states that patient received partial dose due to the needle coming off of syringe during administration, which led to incomplete dose administered. When nurse attempted to take needle out of patients right upper thigh the needle stayed in the patient's leg. Reporter states that the child's health care professional provider evaluated the partial dose given and determined that enough of the dose was administered and the dose did not need to be repeated. This case is linked with US2025016608, reported by same reporter.; Sender's Comments: US-GSK-US2025016608:Same reporter/Diffrent patient More
2826914	61	F	NY	02/18/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Abdominal pain upper, Chills, Decreased appetite, Feeling cold, Injection site p... Abdominal pain upper, Chills, Decreased appetite, Feeling cold, Injection site pain; Insomnia, Pain, Somnolence More	she had trouble sleeping; she had pain at injection site; chills; stomach pain; she was cold; body a... she had trouble sleeping; she had pain at injection site; chills; stomach pain; she was cold; body aches; no appetite; been sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-FEB-2025, the patient received the 1st dose of Shingrix (left arm). On 08-FEB-2025, several minutes after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had pain at injection site). On 10-FEB-2025, the patient experienced difficulty sleeping (Verbatim: she had trouble sleeping). In FEB-2025, the patient experienced chills (Verbatim: chills), stomach pain (Verbatim: stomach pain), cold (Verbatim: she was cold), general body pain (Verbatim: body aches), appetite absent (Verbatim: no appetite) and sleepiness (Verbatim: been sleepy). The outcome of the injection site pain, difficulty sleeping, chills, stomach pain, cold and appetite absent were resolved and the outcome of the general body pain was not resolved and the outcome of the sleepiness was resolving. It was unknown if the reporter considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix. It was unknown if the company considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 The patient self-reported this case. The patient received 1st dose of Shingrix dose and within minutes she had pain at injection site that had resolved. On Monday she stated she had trouble sleeping because she had chills, stomach pain and she was cold and had body aches. The patient had been sleepy but stated she was feeling better. More
2826915		F	FL	02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Cheilitis Cheilitis	Rash above lip; This non-serious case was reported by a consumer via call center representative and ... Rash above lip; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (The patient received first dose was on unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced rash (Verbatim: Rash above lip). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 13-FEB-2025 The patient had developing a rash above her lip two months after receiving the second dose of Shingrix. More
2826916		U	CA	02/18/2025	COVID19 COVID19 COVID19	JANSSEN MODERNA PFIZER\BIONTECH		Malaise, Rash, Sensory disturbance, Somnolence; Malaise, Rash, Sensory disturban... Malaise, Rash, Sensory disturbance, Somnolence; Malaise, Rash, Sensory disturbance, Somnolence; Malaise, Rash, Sensory disturbance, Somnolence More	face had a rash all over it; not feel good; sleepy all the time; feel insides moving around by butto... face had a rash all over it; not feel good; sleepy all the time; feel insides moving around by buttocks and around lower area; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. Non-company products included: moderna covid-19 vaccine (form of admin and route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 2, for covid-19 prophylaxis; pfizer biontech covid-19 vaccine (form of admin and route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 3, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced face had a rash all over it, not feel good, sleepy all the time, and feel insides moving around by buttocks and around lower area. It was reported that the patient's face had a rash all over it and wouldn't go away and could also feel insides moving around by buttocks and around my lower area. Patient had over 30 vaccines whole life since 1994. The patient do not feel good all the time and was sleepy all the time as well. Dose series 1. The action taken with janssen covid-19 vaccine, moderna covid-19 vaccine and pfizer biontech covid-19 vaccine was not applicable. The patient had not recovered from face had a rash all over it. The outcome of not feel good, sleepy all the time and feel insides moving around by buttocks and around lower area was not reported. This report was non-serious. More
2826917		F	FL	02/18/2025	COVID19	MODERNA		Pruritus Pruritus	last booster was very itchy, more than ever before; This spontaneous case was reported by a patient ... last booster was very itchy, more than ever before; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (last booster was very itchy, more than ever before) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included HRT. Previously administered products included for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included No adverse effect with Penicillin. Concurrent medical conditions included Asthma (needed to carry an inhaler for a rare use), Penicillin allergy (as a young child), Hypothyroidism (Mild) and Menopause. Concomitant products included Levothyroxine sodium for Hypothyroidism. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (last booster was very itchy, more than ever before). At the time of the report, PRURITUS (last booster was very itchy, more than ever before) outcome was unknown. Patient had to see a pulmonologist annually as he's carrier for Alpha 1. Patient was not allergic to bee stings or any other injections. Patient always had Moderna, and because of asthma he had faithfully gotten his boosters in a timely fashion. The patient stated that he had Moderna injections for every single Covid booster. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2024-779524 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2025: Live significant follow-up received with patient initial, narrative and reference ID was added; Sender's Comments: US-MODERNATX, INC.-MOD-2024-779524:Same patient and different dose More
2826918	72	F		02/18/2025	COVID19	MODERNA		Asthma, Liver disorder, Pneumonia, Respiratory syncytial virus infection Asthma, Liver disorder, Pneumonia, Respiratory syncytial virus infection	developed pneumonia; asthma; liver problems; developed RSV; This spontaneous case was reported by a ... developed pneumonia; asthma; liver problems; developed RSV; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (developed pneumonia) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (developed pneumonia) (seriousness criterion medically significant), ASTHMA (asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV). At the time of the report, PNEUMONIA (developed pneumonia) had not resolved and ASTHMA (asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV) outcome was unknown. Concomitant product use was not provided by the reporter. Patient had 5 doses of Moderna vaccines and had asthma, liver problems, developed RSV, developed pneumonia and it had taken 15 months for lungs but still not fully healed. Reporter causality was not reported. Treatment information was not provided. This case was linked to MOD-2025-782183 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2025: Live significant follow-up received: Patient age, event verbatim and outcome updated and reference ID added.; Reporter's Comments: Company comment: Pneumonia and respiratory syncytial virus infection were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
2826919	75	M	AK	02/18/2025	COVID19	MODERNA		Testicular disorder Testicular disorder	Patient now had 3 testicles.; This spontaneous case was reported by a patient and describes the occu... Patient now had 3 testicles.; This spontaneous case was reported by a patient and describes the occurrence of TESTICULAR DISORDER (Patient now had 3 testicles.) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TESTICULAR DISORDER (Patient now had 3 testicles.). At the time of the report, TESTICULAR DISORDER (Patient now had 3 testicles.) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. More
2826922	65	M	NJ	02/18/2025	PNC20 PNC20 PNC20 PNC20 PNC20	PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH		Blood culture, Blood electrolytes, Blood gases, Blood glucose, Blood test; Chest... Blood culture, Blood electrolytes, Blood gases, Blood glucose, Blood test; Chest X-ray, Computerised tomogram, Cough, Fatigue, Fibrin D dimer; Full blood count, Gait disturbance, Hypersomnia, Infection, Lethargy; Malaise, Peripheral swelling, Rash, Scan with contrast, Stasis dermatitis; Ultrasound scan, Urine analysis, White blood cell count increased More	Venous Stasis Dermatitis; Rash from the inside of his calves around his shins of his leg with a swel... Venous Stasis Dermatitis; Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen; Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen; his feet were completely swollen; Sick; walking at like 25 percent of his capacity because of all the swelling and the rash; couldn't walk properly; Sleeping 12 hours everyday exhausted with a cough; Sleeping 12 hours everyday exhausted with a cough; did not feel well; Lethargic; Sick; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient's relevant medical history included: "pre-diabetic" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RASH (non-serious), SWELLING (non-serious) all with onset 09Feb2025, outcome "recovering" and all described as "Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen"; STASIS DERMATITIS (medically significant) with onset 09Feb2025, outcome "recovering", described as "Venous Stasis Dermatitis"; PERIPHERAL SWELLING (non-serious) with onset 09Feb2025, outcome "recovering", described as "his feet were completely swollen"; INFECTION (medically significant) with onset Feb2025, outcome "recovering", described as "Sick; walking at like 25 percent of his capacity because of all the swelling and the rash"; GAIT INABILITY (non-serious) with onset Feb2025, outcome "recovering", described as "couldn't walk properly"; LETHARGY (non-serious) with onset 2025, outcome "recovering", described as "Lethargic"; ILLNESS (non-serious) with onset 2025, outcome "recovering", described as "Sick"; SOMNOLENCE (non-serious), COUGH (non-serious) all with onset 2025, outcome "recovering" and all described as "Sleeping 12 hours everyday exhausted with a cough"; MALAISE (non-serious) with onset 2025, outcome "recovering", described as "did not feel well". The events "lethargic", "sleeping 12 hours everyday exhausted with a cough", "rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen" and "his feet were completely swollen" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: (Feb2025) Unknown results; Blood gases: (Feb2025) Unknown results; (Feb2025) Unknown results; Blood glucose: (Feb2025) Unknown results; Blood test: (Feb2025) Unknown results; (Feb2025) Unknown results; Chest X-ray: (Feb2025) Unknown results; Computerised tomogram: (Feb2025) Unknown results; Fibrin D dimer: (Feb2025) Unknown results, notes: D-dimer you know to look it the blood clots for the information that she had; Full blood count: (Feb2025) Unknown results; electrolyte: (Feb2025) Unknown results; (Feb2025) Unknown results; Ultrasound scan: (Feb2025) Unknown results; Urine analysis: (Feb2025) Unknown results; White blood cell count: (Feb2025) 113. Therapeutic measures were taken as a result of stasis dermatitis, rash. Additional information: The reporter stated, "Well I am calling to complaint about Prevnar 20. My husband was given or he was stupidly took the pneumonia vaccine (Prevnar 20) on 24Jan2025 and he was never the same since then. He was sleeping 12 hours everyday exhausted with a cough, did not feel well, lethargic. We kept thinking that it was going to pass, we went away to a wedding and all he wanted to do is sleep and then he woke up this past Sunday with a rash from the inside of his calves around his shins of his leg with a swelling. We fly home by the time he got home off the plane his feet were completely swollen. The (Withheld) never ever had a problem. I took him to the ER on Monday, I did take him to a clinic on Sunday and he was diagnosed with Venous Stasis Dermatitis but I had to have him go through many test they said he definitely had an infection, his white blood cell count was 113, he was given a bag of fluid and Zosyn which is a broad spectrum antibiotic. He is currently on antibiotic, he had a chest X-ray." The reporter stated, "Right now he is on Amoxicillin 125 two times a day." The reporter stated, "It's poison, my husband is I had him checked for, I know he is going through all the test and your that company should be paying whatever I paid. I have good insurance I paid deductible at the hospital and I am sure we are going to get hit with some other like rather I am going to get him with some Gigantic bills, these are the test that we are done. His blood gas, Venous blood gas and the blood work that they did I am sure they did a regular CBC but they checked Venous blood gas, electrolyte. They also checked they did blood cultures, chest X-ray, ultrasound of the legs, D-dimer you know to look it the blood clots for the information that she had. He had, they were checking his blood sugar because he is, it's like a pre-diabetic, checking his blood sugar. They did a septic blood work, Urine test, CAT- Scan with contrast. I haven't checked for Lyme disease, mononucleosis. So, basically I just want you guys to know because I am upset and I am going to write letters everywhere so basically I am going to get a bill from the ER doctor. The neurologist, the hospitalist because my husband took a stupid vaccine they got him sick. He is better now, he couldn't walk properly, he is walking at like 25 percent of his capacity because of all the swelling and the rash. I had to buy antibiotics and ointment for his rash. Can I expect somebody to call me because I am going to go on everyone, every platform that I have and believe me I am a loud mouth on whatever you are going to call it. I am going to write a letter. I have a family member who works and I am going to everybody you know what because this and excuse my language all right so that my husband is 65 years old, he doesn't have an ounce of sad on his body doesn't get sick. He has medications that he takes because he took another vaccine and I am going to tell everybody and I expect to get somebody to call me back from Pfizer and left Pfizer pay all my medical bills that I just had to lay out. I didn't lay them out yet because I didn't get the bills because he took a vaccine and injured him temporarily this is all again of money and I also wanted to know how much my doctor, my PCP. I don't know how much money she gets to tell my husband to fix this poison pen." More
2826923		M		02/18/2025	COVID19	PFIZER\BIONTECH		Hypertension, Ventricular tachycardia Hypertension, Ventricular tachycardia	ventricular tachycardia; uncontrollable hypertension; This is a spontaneous report received from a P... ventricular tachycardia; uncontrollable hypertension; This is a spontaneous report received from a Physician 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. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), outcome "unknown"; HYPERTENSION (medically significant), outcome "unknown", described as "uncontrollable hypertension". Therapeutic measures were taken as a result of ventricular tachycardia, hypertension. The patient was the reporter's colleague who had received the COVID-19 vaccine and had similar symptoms...uncontrollable hypertension and ventricular tachycardia. He had a pacemaker placed. Despite that, the patient and reporter both agree that having the vaccine was critical. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes 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
2826924		M		02/18/2025	COVID19	PFIZER\BIONTECH		Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, ... Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, X-ray More	He cannot use his arm/cannot move his right arm; Arm is in continuous pain/From his shoulder to elbo... He cannot use his arm/cannot move his right arm; Arm is in continuous pain/From his shoulder to elbow it hurts like hell; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received 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: JOINT RANGE OF MOTION DECREASED (disability), outcome "unknown", described as "He cannot use his arm/cannot move his right arm"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Arm is in continuous pain/From his shoulder to elbow it hurts like hell". The events "he cannot use his arm/cannot move his right arm" and "arm is in continuous pain/from his shoulder to elbow it hurts like hell" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint range of motion decreased, pain in extremity. Additional information: He cannot use his arm. He was crippled with the covid shot and he cannot use his arm and is in continuous pain. He was angry and from that shot he cannot move his right arm and was having a hard time washing his hair. From his shoulder to elbow, it hurts like hell. He wants the spike protein put in his body to be removed. It was a couple of years ago and he is not sure how old he was. He has been having pain which started a couple weeks later after the covid shot. He thought its like a twisted muscle or something. He thought he perhaps twisted his arm but he didn't and a muscle does not take a couple years to heal. Treatment includes ointment prescribed by doctor and nothing is happening. He is a very healthy individual. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More		✓
2826925		F	KS	02/18/2025	COVID19	PFIZER\BIONTECH		Body temperature, COVID-19, Drug ineffective Body temperature, COVID-19, Drug ineffective	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. A 74-year-old female patient received 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), outcome "unknown" and all described as "COVID". The clinical course was reported as follows: The patient wanted desperately to take the COVID 19 VACCINE, however, every time she got the shot, she got COVID and got terribly sick with a fever of 102, so she had stopped getting the vaccine and stopped getting the FLU shot because the same thing happened to her, she got the flu. The patient wanted to be protected and she was scared to take the shots and vaccine. The patient underwent the following laboratory tests and procedures: Body temperature: 102. More
2826926		F	MI	02/18/2025	COVID19	PFIZER\BIONTECH		Pharyngeal mass Pharyngeal mass	lump in her throat - like on the side of neck; This is a spontaneous report received from a Consumer... lump in her throat - like on the side of neck; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old 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: PHARYNGEAL MASS (non-serious), outcome "unknown", described as "got a lump in my throa--like on the side of my neck". Additional information: The patient took the first injection, the first vaccination, and got a lump in her throat - like on the side of her neck. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500036790 same patient and drug, different dose and event; More
2826927		M	NC	02/18/2025	UNK	UNKNOWN MANUFACTURER	946624	Cough, Influenza, Influenza A virus test positive, Vaccination failure Cough, Influenza, Influenza A virus test positive, Vaccination failure	Vaccination failure; Lingering cough; Tested positive for Flu A; This spontaneous case initially rec... Vaccination failure; Lingering cough; Tested positive for Flu A; This spontaneous case initially received on 03-Feb-2025, was reported by a non health professional and concerns a child male patient. At the time of the event the patient had allergy to Peanuts. No concomitant medications were reported. There was no product complaint associated with this case. Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease, dose and route of administration: not reported, anatomical location: Left Deltoid, Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 31-Jan-2025, the patient experienced Tested positive for Flu A (Medically Significant, outcome: Recovered / Resolved, stop date: 03-Feb-2025). Associated symptoms included: Lingering cough. On an unknown date, the patient experienced Vaccination failure (Medically Significant, outcome: Not Reported). The reporter informed that the vaccination was given on a clinic, flu was verified by nasal swab and the source of infection was school or wrestling. The patient Recovered as of 03-Feb-2025 with lingering cough. Case was upgraded to serious upon company assessment of the reported event (Tested positive for Flu A) clinical significance. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen, Oscillococcinum Reporter assessment: The reporter assessed the event Tested positive for Flu A as non serious and did not provide seriousness for Vaccination failure and did not provide a causality assessment for the events.; Reporter's Comments: Causality: Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible. More
2826928		U	SC	02/18/2025	UNK	UNKNOWN MANUFACTURER	No batch number	Hypersensitivity Hypersensitivity	Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 1... Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 15-Oct-2024, was reported by a non health professional and concerns a patient of unknown age/gender. Concomitant Medications and Medical History was reported as Unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for immunization, Dose regimen: 5 ml, Route of Administration: Not Reported, Lot number: No batch number available, and would not be requested due to no consent for follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Experienced an allergic reaction to the immunization (outcome: Unknown). Reporter stated the individual (patient) experience an allergic reaction to the immunization. Treatment measures associated with event was reported as Unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter provides a seriousness and hospitalization for the event as unknown and causality was reported as related.; Reporter's Comments: The causality of events was assessed related to the administration of Flucelvax TIV More
2826929		U	SC	02/18/2025	UNK	UNKNOWN MANUFACTURER	No batch number	Hypersensitivity Hypersensitivity	Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 1... Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 15-Oct-2024, was reported by a non health professional and concerns a patient of unknown age/gender. Concomitant Medications and Medical History was reported as Unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for immunization, Dose regimen: 5 ml, Route of Administration: Not Reported, Lot number: No batch number available, and would not be requested due to no consent to follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Experienced an allergic reaction to the immunization (outcome: Unknown). Reporter stated the individual (patient) experience an allergic reaction to the immunization. Treatment measures associated with event was reported as Unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter provides a seriousness and hospitalization for the event as unknown and causality was reported as related.; Reporter's Comments: The causality of event was assessed related to the administration of Flucelvax More
2826935		U	SC	02/18/2025	HIBV	MERCK & CO. INC.	Y006392	No adverse event, Product storage error No adverse event, Product storage error	No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored P... No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored PEDVAXHIB on 2/4/2025 that experienced a TE on 1/31/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case; This spontaneous report was received from a nurse referring to a patient, age and gender not provided. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX) injection, 0.5 ml for prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y006392 with and expiration date on 08-NOV-2025). The administered dose of the vaccine experienced a temperature excursion 10.22 degrees Celsius for 22 hours and 50 minutes. It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. More
2826949	73	M	CA	02/18/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3043823 u8507ca	Gait inability, Peripheral swelling; Gait inability, Peripheral swelling Gait inability, Peripheral swelling; Gait inability, Peripheral swelling	leg swelling, unable to walk leg swelling, unable to walk
2826950	11	F	NM	02/18/2025	MNQ TDAP	NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS	X4T99 LX494	Injection site swelling, Injection site warmth; Injection site swelling, Injecti... Injection site swelling, Injection site warmth; Injection site swelling, Injection site warmth More	Patient mother noticed swelling and warm to the touch the next day on both sites. Mother dosed with ... Patient mother noticed swelling and warm to the touch the next day on both sites. Mother dosed with Benadryl with some improvement. mother then called clinic the next day to inform clinic that reaction was twice as big and continued to give Benadryl. Provider did go ahead and prescribe antibiotic to pharmacy. More
2826951	64	M	PA	02/18/2025	PNC20	PFIZER\WYETH	LC1281	Hypoaesthesia Hypoaesthesia	Patient complaints that his fingers on left hand was numbed when he was waking up in the morning aft... Patient complaints that his fingers on left hand was numbed when he was waking up in the morning after he got a shot about 3 days. He said he will go to family doctor for checking it up. More
2826952	74	F	MO	02/18/2025	FLU3 PNC20	SANOFI PASTEUR PFIZER\WYETH	ut8473aa lj5280	Pain in extremity, Product administered at inappropriate site; Pain in extremity... Pain in extremity, Product administered at inappropriate site; Pain in extremity, Product administered at inappropriate site More	Patient states her arm was still sore days after her injections. She presented to her MD, and MD to... Patient states her arm was still sore days after her injections. She presented to her MD, and MD told her it was due to vaccine being administered in the incorrect location. Pharmacist states the vaccine was administered according to protocol in the correct location and that MD is speculating since they would not be able to see the injection site days after the injection. Patient states that she has needed physical therapy after her injections. More
2826953	50	F	PA	02/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Chills, Fatigue, Headache Chills, Fatigue, Headache	Chills, fatigue and headache, lasting 36 hrs Chills, fatigue and headache, lasting 36 hrs
2826954	27	F	WA	02/18/2025	RSV	PFIZER\WYETH		Autopsy, Exposure during pregnancy, Foetal heart rate abnormal, Premature delive... Autopsy, Exposure during pregnancy, Foetal heart rate abnormal, Premature delivery, Stillbirth More	Two days after shot baby had no heartbeat. Baby was born 24 hours later stillborn. 4lbs13oz. her nam... Two days after shot baby had no heartbeat. Baby was born 24 hours later stillborn. 4lbs13oz. her name on birth cert. Born at hospital. More	✓
2826955	79	M	GA	02/18/2025	RSV UNK	GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER	929PN	Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Patient received two doses of Arexvy RSV vaccine when only one dose is indicated. The first dose was... Patient received two doses of Arexvy RSV vaccine when only one dose is indicated. The first dose was on 12/06/2023 and the second dose was on 09/12/2024 (listed as date of adverse reaction on item 5). More
2826956	19	F	CA	02/18/2025	MENB MENB	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS		Blood test normal, Chest pain, Feeling abnormal, Injection site pain, Pain; Pain... Blood test normal, Chest pain, Feeling abnormal, Injection site pain, Pain; Pain in extremity, X-ray normal More	Pain began radiating deep into my left shoulder from injection site. I work in health care, have had... Pain began radiating deep into my left shoulder from injection site. I work in health care, have had many vaccines, and never thought twice. Figured it was just a painful vaccine. the pain continued to spread over the course of the next few hours into my chest, other arm, fingers. I went to bed after telling my spouse I felt off but just wanted to sleep. I woke in the night screaming in pain. Upon arrival to the hospital my entire body ached and pulsated. I was in excruciating pain. I sat in the ER lobby for 2 hours. By the time I was actually seen by a physician another hour later, the pain had some what subsided. More

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