| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
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| 2856526 | 78 | F | OH | 09/02/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Dizziness, Malaise, Myalgia
Dizziness, Malaise, Myalgia
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Patient received vaccine and was exiting the store and did not feel well. Felt dizzy and complained ...
Patient received vaccine and was exiting the store and did not feel well. Felt dizzy and complained of muscle aches
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| 2856527 | 8 | M | WA | 09/02/2025 |
DTAP HEP MMRV VARCEL |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
3ca55c1 y003449 z008220 y015100 |
Extra dose administered, No adverse event, Product administered to patient of in...
Extra dose administered, No adverse event, Product administered to patient of inappropriate age; Extra dose administered, No adverse event, Product administered to patient of inappropriate age; Extra dose administered, No adverse event, Product administered to patient of inappropriate age; Extra dose administered, No adverse event, Product administered to patient of inappropriate age
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no adverse reaction reported
no adverse reaction reported
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| 2856528 | 36 | F | FL | 09/02/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
PD324 PD324 |
Back pain, Brain natriuretic peptide normal, Chest X-ray normal, Chest pain, Ful...
Back pain, Brain natriuretic peptide normal, Chest X-ray normal, Chest pain, Full blood count normal; Human chorionic gonadotropin normal, Metabolic function test normal, Pyrexia, Troponin normal
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SHOT GIVEN 8/28/25 EMPLOYEE STATES FEVER 8/29/25 WITH CHEST AND BACK PAIN. DO NOT KNOW ONSET TIME. ...
SHOT GIVEN 8/28/25 EMPLOYEE STATES FEVER 8/29/25 WITH CHEST AND BACK PAIN. DO NOT KNOW ONSET TIME. EMPLOYEE WENT TO ER 9/1/25
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| 2856529 | 73 | M | 09/02/2025 |
COVID19 |
MODERNA |
30L20A |
Blood pressure abnormal, Cerebral haemorrhage, Memory impairment, Visual field d...
Blood pressure abnormal, Cerebral haemorrhage, Memory impairment, Visual field defect
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on a blood pressure medication; affect his eyesight/ problem with his peripheral vision; having prob...
on a blood pressure medication; affect his eyesight/ problem with his peripheral vision; having problems remembering things; had a brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (had a brain bleed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30L20A and 022M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Open heart surgery (mitral valve reconstruction) on 17-Mar-2020. Concurrent medical conditions included Diabetic. Concomitant products included Insulin porcine (Insulin) for Diabetes. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (had a brain bleed) (seriousness criterion medically significant). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (on a blood pressure medication), VISUAL FIELD DEFECT (affect his eyesight/ problem with his peripheral vision) and MEMORY IMPAIRMENT (having problems remembering things). The patient was treated with Surgery for Cerebral haemorrhage. At the time of the report, CEREBRAL HAEMORRHAGE (had a brain bleed) was resolving, BLOOD PRESSURE ABNORMAL (on a blood pressure medication) outcome was unknown and VISUAL FIELD DEFECT (affect his eyesight/ problem with his peripheral vision) and MEMORY IMPAIRMENT (having problems remembering things) had not resolved. Concomitant medication also included blood pressure medication. Patient did not receive any other vaccines. On 02-Oct-2023, the patient had brain bleeding and had to do emergency surgery. The patient was saved but it did affect his eyesight. He could not drive for 6 months. His neurosurgeon said there was no reason why this should have happened. The patient did not have any high blood pressure, and he did not think the diabetes caused this either. The brain bleed had really changed his life- he was very active, played golf and all that. Ever since he went into emergency surgery on 02-Oct-2023, he was doing better. The current symptoms he had were the problem with his peripheral vision and that he was having problems remembering things. The patient can drive again as well. He was currently on blood pressure medication. The blood pressure medication was a very low dose as they did not want this to happen to him again. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788915 (E2B Linked Report).; Reporter's Comments: Causality for Cerebral haemorrhage, Visual field defect and Memory impairment was assessed as not related, due to long latency. Underlying diabetes could be a confounding factor for the events. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788915:Wife's case
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| 2856530 | 35 | F | MO | 09/02/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946065 |
Pain, Rash, Rash pruritic, Skin warm, Swelling
Pain, Rash, Rash pruritic, Skin warm, Swelling
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Woke up the next day with itchy rash on the neck, swollen, stinging. Hot to the touch lips and cheek...
Woke up the next day with itchy rash on the neck, swollen, stinging. Hot to the touch lips and cheeks.
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| 2856531 | 41 | F | TN | 09/02/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37F34 |
Extra dose administered
Extra dose administered
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Pt was not due for another TDap. Vaccine record showed patient was due for TDap vaccine today but sh...
Pt was not due for another TDap. Vaccine record showed patient was due for TDap vaccine today but she was not. Administered TDap prior to realizing she had one in July 2025.
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| 2856532 | 0.83 | M | ID | 09/02/2025 |
HIBV |
MERCK & CO. INC. |
Y015929 |
Wrong product administered
Wrong product administered
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The patient was given the incorrect vaccine. Hib was given when the patient was supposed to get Prev...
The patient was given the incorrect vaccine. Hib was given when the patient was supposed to get Prevnar20. No treatment/adverse outcomes after the event.
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| 2856533 | 80 | M | 09/02/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Malaise, Pain, Pain in extremity, Pyrexia; Malaise, Pain, Pain in extremity, Pyr...
Malaise, Pain, Pain in extremity, Pyrexia; Malaise, Pain, Pain in extremity, Pyrexia
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he experienced a little soreness in the arm; soreness; malaise; fever; This spontaneous case was rep...
he experienced a little soreness in the arm; soreness; malaise; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever) in an 80-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Immunosuppression NOS. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever). The patient was treated with Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient had less side effects with Moderna (COVID19) vaccine. He said he had both Moderna and Pfizer. With Pfizer, he had the second dose and everything else had been with Moderna. He also mentioned that he had heard on the news that Moderna was more effective than Pfizer in the older population and that he had less side effects with the Moderna vaccination. It was reported that with Moderna COVID19 vaccine, he experienced a little soreness in the arm for 2 days. In terms of the Pfizer vaccine, he stated it had been a while either 2022 or 2023 when he received the vaccine, but he experienced a mild fever, soreness, malaise which aspirin cured after the 2nd day. He was at that age where his immunity was marginal at best and that he continued with wearing a mask in public places. It was unknown if the patient experienced any additional symptoms or events.
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| 2856534 | 09/02/2025 |
COVID19 |
MODERNA |
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Neoplasm malignant
Neoplasm malignant
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cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MA...
cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a patient of an unknown age and gender 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 NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (cancer) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the reporter expressed concerns about the COVID vaccine and referred to personal experiences with cancer and expressed strong negative sentiments towards the company. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: Very limited information was provided at this time. The benefit-risk relationship of product is not affected by this report.
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| 2856535 | 45 | M | CA | 09/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FE3590 FE3590 |
Angina pectoris, Body height, Brain fog, Bundle branch block right, Chest pain; ...
Angina pectoris, Body height, Brain fog, Bundle branch block right, Chest pain; Condition aggravated, Electrocardiogram, Electrocardiogram abnormal, Inappropriate schedule of product administration, Weight
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Pains -heart-chest; Pain-chest; I had/have a heart right bundle branch block. My EKG claimed from 42...
Pains -heart-chest; Pain-chest; I had/have a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death; I had/have a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death; destroyed my heart more, left me in more pains; Brain fogs; DOSE 2 22Oct2021; This is a spontaneous report and received from Consumer or other non HCPs. A 49-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 2, single (Lot number: FE3590) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Previous Mild RBBB heart" (ongoing); "High Blood Pressure" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "eczema" (unspecified if ongoing); "Schizoaffective disorder" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Dry skin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: influenza virus vaccine, administration date: 22Oct2020, when the patient was 44-year-old, for immunization; tetanus/diphth/pertuss (tdap) adult/adol, administration date: 13Jul2018, when the patient was 42-year-old, for Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 04Mar2021, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Cardiac pain", "Chest pain", "Electrocardiogram abnormal", "Bundle branch block right", "Brain fog", "Heart disorder", "General body pain". The following information was reported: ANGINA PECTORIS (caused and prolonged hospitalization, disability, medically significant, life threatening), outcome "not recovered", described as "Pains -heart-chest"; CHEST PAIN (caused and prolonged hospitalization, disability, life threatening), outcome "not recovered", described as "Pain-chest"; ELECTROCARDIOGRAM ABNORMAL (caused and prolonged hospitalization, disability, life threatening), BUNDLE BRANCH BLOCK RIGHT (caused and prolonged hospitalization, disability, life threatening), outcome "not recovered" and all described as "I had/have a heart right bundle branch block. My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death"; CONDITION AGGRAVATED (caused and prolonged hospitalization, disability, life threatening), outcome "not recovered", described as "destroyed my heart more, left me in more pains"; BRAIN FOG (non-serious), outcome "not recovered", described as "Brain fogs"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "DOSE 2 22Oct2021". The events "pains -heart-chest" and "i had/have a heart right bundle branch block. my ekg claimed from 420 to almost 500 and anything over 500 i can die of sudden death" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5'8; Electrocardiogram: (unspecified date) 420-470, notes: up & down; (2021) 420 to almost 500 and anything over 500, notes: My EKG claimed from 420 to almost 500 and anything over 500 I can die of sudden death; Weight: (unspecified date) 196. Therapeutic measures were taken as a result of angina pectoris, chest pain, electrocardiogram abnormal, bundle branch block right. It was unknown if therapeutic measures were taken as a result of brain fog. Clinical course: The patient had a heart right bundle branch block. His EKG climbed from 420 to almost 500 and anything over 500, he can die of sudden death (Bundle branch block right). Prolongation of existing hospitalization (treatment received during existing hospitalization) due to consistent pains in heart/chest. The treatment received for the adverse event/incident were EKGs, Ibuprofen, breathing treatments and cardiology visit at different (name withheld) prisons over the years since that shot Pfizer covid-19 vaccine EN6204. He was made to suffer in pain. He has been in heart-chest-body pains since the first EN6204 shot. The covid-19-mrna vaccine without nothing. This was his second complaint, the first one was in 2022 for 365 million total. The patient was taking any other medication within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200062233 same patient, different vaccine dose/event;
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| 2856537 | F | 09/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Disease recurrence, Drug ineffective, Suspected COVID-19; Disease recurrence, Dr...
Disease recurrence, Drug ineffective, Suspected COVID-19; Disease recurrence, Drug ineffective, Suspected COVID-19
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approximately October, suffered with Covid, with symptoms; suffered the loss of her taste buds. Seve...
approximately October, suffered with Covid, with symptoms; suffered the loss of her taste buds. Several medical professionals have suggested that she may have had Covid without symptoms; suffered the loss of her taste buds. Several medical professionals have suggested that she may have had Covid without symptoms; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "suffered the loss of her taste buds. Several medical professionals have suggested that she may have had Covid without symptoms"; DISEASE RECURRENCE (medically significant) with onset Oct2023, outcome "not recovered", described as "approximately October, suffered with Covid, with symptoms". Clinical course: During the Covid pandemic, the husband and wife received Pfizer's Covid vaccines and boosters. Since July of approximately 2023, she has suffered the loss of her taste buds. Several medical professionals have suggested that she may have had Covid without symptoms. Later in 2023, approximately October, both suffered with Covid, with symptoms. The loss of her taste buds proceeded her experience with Covid. The husband asking if Pfizer can offer any possible cure for the situation the wife is currently experiencing? The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
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| 2856538 | 09/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blister, Pruritus
Blister, Pruritus
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so many blisters/big blister; itching every day, night.; This is a spontaneous report received from ...
so many blisters/big blister; itching every day, night.; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old 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: BLISTER (non-serious), outcome "unknown", described as "so many blisters/big blister"; PRURITUS (non-serious), outcome "unknown", described as "itching every day, night.". The events "so many blisters/big blister" and "itching every day, night." required physician office visit. Therapeutic measures were taken as a result of blister, pruritus. Additional information: After COVID injection (Pfizer COVID-19 vaccine), the patient had so many blisters and all that, itching (face) every day, night. Doctor gave medicine cream (unspecified) but nothing is working. The patient's son told to take second injection too, COVID injection. The COVID injection has damaged the patient all the way. Patient cannot go anywhere, cannot dress up, wear the dress, go to market and all. Not in emergency. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2856540 | M | WV | 09/02/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Giant cell arteritis, Headache; Giant cell arteritis, Headache
Giant cell arteritis, Headache; Giant cell arteritis, Headache
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headache; giant cell arteritis; This is a spontaneous report received from a Consumer or other non H...
headache; giant cell arteritis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02857811 (Merck). A male patient in his 80's received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (death), outcome "fatal"; GIANT CELL ARTERITIS (death), outcome "fatal". The patient date of death was unknown. Reported cause of death: "headache", "giant cell arteritis". It was not reported if an autopsy was performed. Clinical course: The consumer was transferred from CRT with questions about Capvaxive (which neither she nor her husband were administered) and mentioned during the call that her husband had experienced a headache and giant cell arteritis after being administered one of Pfizer's vaccines. Consumer was not sure at this time if it was the Pfizer flu vaccine or the Covid vaccine that caused the side effects because her husband had received both. The dates of administration and when the side effects occurred were unknown. He has since passed away. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: headache; giant cell arteritis
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| 2856541 | AZ | 09/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Heart rate
COVID-19, Heart rate
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Your vaccine I stayed covid free since 2020! I had an increased resting heart rate for months after ...
Your vaccine I stayed covid free since 2020! I had an increased resting heart rate for months after Covid, had no energy.; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), in 2024 as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "Your vaccine I stayed covid free since 2020! I had an increased resting heart rate for months after Covid, had no energy.". The patient underwent the following laboratory tests and procedures: Heart rate: increased, notes: an increased resting heart rate for months after Covid, had no energy. Clinical course: The patient is hoping for fighting the (name) regime and how they prohibited people from getting the Covid vaccine. The patient is extremely upset that he/she is no longer able to get it. The patient did the "Noravax" last year and got Covid. The patient has stayed covid free from Pfizer vaccine since 2020. The patient had an increased resting heart rate for months after Covid, had no energy. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2856542 | 09/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Hydrocephalus, Post-acute COVID-19 syndrome, SARS-Co...
COVID-19, Drug ineffective, Hydrocephalus, Post-acute COVID-19 syndrome, SARS-CoV-2 test
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long COVID; fluid on the brain; COVID; COVID; This is a spontaneous report received from a Consumer ...
long COVID; fluid on the brain; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing); "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2025, outcome "unknown" and all described as "COVID"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown", described as "long COVID"; HYDROCEPHALUS (medically significant), outcome "unknown", described as "fluid on the brain". Clinical course: The patient took the Pfizer shot, but got COVID anyways, and now got long COVID, which gave fluid on the brain. The patient was totally incapacitated and crippled in a wheelchair. The patient had gone through the mill since 27Aug2025, when finally got to the doctor to get tested. The patient took all vaccines and this was a side effect from the vaccine and the disease and was glad to be alive. The patient will visit the neurologist in 2 weeks. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2025) COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2856543 | 18 | F | 09/02/2025 |
MEN |
UNKNOWN MANUFACTURER |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient received dose 3 of Menquadfi with no adverse event; Initial information received on 26-Aug-2...
patient received dose 3 of Menquadfi with no adverse event; Initial information received on 26-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 18 years old female patient who received dose 3 of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2018, the patient received an unknown dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization On an unknown date in 2023 she also received an unknown dose 2 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization. On 26-Aug-2025 she also received an unknown dose 3 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization (extra dose administered) (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2856544 | 3 | F | MD | 09/02/2025 |
DTAP DTAP HIBV HIBV |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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administration of extra doses of DAPTACEL, with no reported adverse event; Initial information recei...
administration of extra doses of DAPTACEL, with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA261152 This case involves a 3 years old female patient who was administration an extra doses of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) for Immunisation. On 17-Jul-2023, the patient received dose 3 of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site. for immunisation On 27-Aug-2025, the patient received 0.5 ml of dose 4 of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength- standard, expiry date- 31-Aug-2026 and lot 3CA55C1) once via intramuscular route in the left thigh for Immunization with no reported adverse event (extra dose administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA261152:DAPTACEL
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| 2856546 | 1.33 | F | 09/02/2025 |
DTAP DTAPIPVHIB |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
UK305AB |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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inappropriate use due to administration of PENTACEL instead of DTaP with no ae; Initial information ...
inappropriate use due to administration of PENTACEL instead of DTaP with no ae; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 months old female patient who had inappropriate administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine (DTAP) with no ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine and HIB vaccine for Immunisation. On 28-Aug-2025 at 11:03 AM, the patient received a 0.5 ml dose (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (Frequency: Once, lot number: UK305AB, expiry date: 30-Sep-2026, strength: standard) via intramuscular route in the right vastus lateralis as immunization instead of dtap with no ae (wrong product administered) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2856547 | F | PA | 09/02/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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Pregnant patient received vaccine , with no reported adverse event; Initial information received on ...
Pregnant patient received vaccine , with no reported adverse event; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult female patient who was exposed to vaccine influenza USP trival A-B SUBVIRION NO preservative vaccine [Fluzone] in context of pregnant patient received vaccine , with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Pregnant patient received vaccine , with no reported adverse event occurred at 20 Weeks of pregnancy. The date of last menstrual period was reported as 11-Apr-2025. The estimated due date is 11-Jan-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On an unknown date, the pregnant patient received dose 1 of suspect influenza USP trival A-B SUBVIRION NO preservative vaccine Suspension for injection (Unknown strength) lot UT8792LA and expiry date Jun-2026 via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) (exposure during pregnancy) (Latency same day) There were no information related to relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2856548 | 34 | F | PA | 09/02/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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vaccine flu trivalent administered during pregnancy with no reported adverse event; Initial informat...
vaccine flu trivalent administered during pregnancy with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female patient who was exposed to vaccine influenza USP trival A-B subvirion NO preservative vaccine [fluzone] in context of vaccine flu trivalent administered during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine flu trivalent administered during pregnancy with no reported adverse event occurred at 33 Weeks of pregnancy and the patient was exposed to influenza USP trival A-B subvirion NO preservative vaccine at 33 weeks of pregnancy, during third pregnancy trimester for influenza USP TRIVAL A-B subvirion NO preservative vaccine. The date of last menstrual period was reported as 11-Jan-2025. The estimated due date is 18-Oct-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 27-Aug-2025, the patient received Dose 1 of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength) with UT8792LA and expiry date Jun-2026 via intramuscular route in unknown administration site for Prophylactic vaccination (Immuisation) during pregnancy with no reported adverse event (Exposure during pregnancy) (Latency same day) There were no information related to relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2856549 | 75 | F | GA | 09/02/2025 |
FLU3 RSV |
SEQIRUS, INC. PFIZER\WYETH |
388468 HM9866 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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The patient had previously received the Arexvy RSV shot on 11/18/2023. The Abrysvo shot was given on...
The patient had previously received the Arexvy RSV shot on 11/18/2023. The Abrysvo shot was given on 09/04/2024. The patient should not have received the dose of Abrysvo due to already receiving the Arexvy shot on the previous year. This was an error. Patient has not reported any adverse effects thus far.
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| 2856550 | 65 | M | FL | 09/02/2025 |
PNC21 |
MERCK & CO. INC. |
y011819 |
Asthenia, Fatigue, Feeling hot, Tremor
Asthenia, Fatigue, Feeling hot, Tremor
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Patient called on 9/2/25 stating that since he received his vaccine on 8/29 he had symptoms of feeli...
Patient called on 9/2/25 stating that since he received his vaccine on 8/29 he had symptoms of feeling extremely tired, weak, hot but no fever, shaky in the legs. He felt his worst on 8/31 but has been improving each day since but still not 100%
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| 2856551 | 50 | F | MI | 09/02/2025 |
PNC21 |
MERCK & CO. INC. |
z002626 |
Vaccination site erythema, Vaccination site pain, Vaccination site urticaria
Vaccination site erythema, Vaccination site pain, Vaccination site urticaria
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Pt. had a vaccination site reaction causing redness, itchiness, and some pain. Spread to most of upp...
Pt. had a vaccination site reaction causing redness, itchiness, and some pain. Spread to most of upper arm. This was reported to the pharmacy 5 days after the event initiated and was still present but healing. Pt. was advised to seek care if the area did not continue to heal or reversed course and pt. had presented to have a VAERS done.
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| 2856566 | 64 | M | FL | 09/02/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LC1279 LP4947 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient received Prevnar 20 on 9/10/24 as well as 8/28/25. Patient has had no abnormal side effects.
Patient received Prevnar 20 on 9/10/24 as well as 8/28/25. Patient has had no abnormal side effects.
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| 2856567 | 46 | F | 09/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
7Pk53 |
Underdose
Underdose
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Patient was given adolescent dose, not adult dose of Hepatitis A vaccine.
Patient was given adolescent dose, not adult dose of Hepatitis A vaccine.
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| 2856569 | 62 | F | TX | 09/02/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3M9DS 3M9DS |
Arthralgia, Bone pain, Gait inability, Intensive care, Nausea; Vomiting
Arthralgia, Bone pain, Gait inability, Intensive care, Nausea; Vomiting
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PATIENT REPORTED SEVERE NAUSEA, VOMITING, BONE AND JOINT PAIN, INABILITY TO WALK. WAS TAKEN TO URGEN...
PATIENT REPORTED SEVERE NAUSEA, VOMITING, BONE AND JOINT PAIN, INABILITY TO WALK. WAS TAKEN TO URGENT CARE WHERE SHE WAS TRANSPORTED VIA AMBULANCE TO HOSPITAL. PATIENT STATED SHE WAS IN ICU FOR APPROXIMATELY 5 DAYS.
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| 2856570 | 2 | M | CA | 09/02/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7767BA |
Injection site rash
Injection site rash
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Mom reports L thigh rash at injection site which lasted about 3 days, has photo. In image rash, appe...
Mom reports L thigh rash at injection site which lasted about 3 days, has photo. In image rash, appears as large single blotch, not raised, with irregular border.
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| 2856571 | 90 | M | PA | 09/02/2025 |
COVID19 |
MODERNA |
3044069 |
Expired product administered
Expired product administered
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RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
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| 2856572 | 58 | F | MA | 09/02/2025 |
FLU3 RSV |
SANOFI PASTEUR PFIZER\WYETH |
TFAA2531 LN5490 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient stated they needed flu and RSV. My access to internet was unavailable at the time. I adminis...
Patient stated they needed flu and RSV. My access to internet was unavailable at the time. I administered both and when entering in database realized she had already received both on 8/19/25.
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| 2856574 | 27 | F | NY | 09/02/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
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Chest X-ray normal, Mobility decreased, Pain in extremity, Peripheral swelling, ...
Chest X-ray normal, Mobility decreased, Pain in extremity, Peripheral swelling, X-ray limb; Chest X-ray normal, Mobility decreased, Pain in extremity, Peripheral swelling, X-ray limb
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About 6 hours later, I woke up with a very swollen left hand. The swelling progressed the next day ...
About 6 hours later, I woke up with a very swollen left hand. The swelling progressed the next day and was very painful, difficult to move the hand. I had a normal chest xray and was treated with medrol dosepak and the swelling improved in about 1-2 days
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| 2856575 | 74 | M | PA | 09/02/2025 |
COVID19 |
MODERNA |
3044069 |
Expired product administered
Expired product administered
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RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
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| 2856576 | 77 | M | PA | 09/02/2025 |
COVID19 |
MODERNA |
3044069 |
Expired product administered
Expired product administered
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RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
RESIDENT RECIEVED EXPIRED VACCINE (6/14/25)
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| 2856577 | 15 | M | MA | 09/02/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9G523 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Wrong vaccine administered to patient. Patient has previously completed Hepatitis B series
Wrong vaccine administered to patient. Patient has previously completed Hepatitis B series
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| 2786615 | AZ | 09/01/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
UNK 7992N |
Rash; Pruritus, Rash
Rash; Pruritus, Rash
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rash which then turned into a full-blown body rash; This non-serious case was reported by a consume...
rash which then turned into a full-blown body rash; This non-serious case was reported by a consumer and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 30-JUN-2024, the patient received the 2nd dose of Shingles vaccine. In JUL-2024, 3 days after receiving Shingles vaccine, the patient experienced generalized rash (Verbatim: rash which then turned into a full-blown body rash). In OCT-2024, the outcome of the generalized rash was resolved (duration 3 months). It was unknown if the reporter considered the generalized rash to be related to Shingles vaccine. It was unknown if the company considered the generalized rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 The patient had second dose of the shingles shot and within three days started out with a rash which then turned into a full-blown body rash for three months. The patient enquired while reading about the side effects of shingles vaccine, that the Moderna Covid shots and the flu shots could have adverse effects from getting the shingles shot because the patient had a three-month full-blown body rash, and was very hesitant to take any Covid shots or flu shots and need someone to call and explain about it.
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| 2856212 | F | 09/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Erythema, Feeling hot, Pyrexia, Swelling, Tenderness
Erythema, Feeling hot, Pyrexia, Swelling, Tenderness
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erythema of left deltoid; Fever; Swelling; tenderness; Warmth; This non-serious case was reported by...
erythema of left deltoid; Fever; Swelling; tenderness; Warmth; This non-serious case was reported by the other health professional and described the occurrence of erythema in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 01-AUG-2025, the patient received Boostrix. In AUG-2025, less than a week after receiving Boostrix, the patient experienced erythema (Verbatim: erythema of left deltoid), fever (Verbatim: Fever), swelling (Verbatim: Swelling), pain (Verbatim: tenderness) and feeling of warmth (Verbatim: Warmth). The outcome of the erythema, fever, swelling, pain and feeling of warmth were not resolved. It was unknown if the reporter considered the erythema, fever, swelling, pain and feeling of warmth to be related to Boostrix. It was unknown if the company considered the erythema, fever, swelling, pain and feeling of warmth to be related to Boostrix. Additional Information: GSK Receipt Date: 03-AUG-2025 The patient experienced fever, swelling, tenderness, warmth, and erythema of left deltoid which were ongoing.
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| 2856213 | 51 | F | VA | 09/01/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Head titubation, Influenza like illness, Injection site pain, Insomnia, Muscle c...
Head titubation, Influenza like illness, Injection site pain, Insomnia, Muscle contractions involuntary; Tic
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Injection site pain; Flu-like symptoms; Facial tic; Difficulty sleeping; facial involuntary movement...
Injection site pain; Flu-like symptoms; Facial tic; Difficulty sleeping; facial involuntary movements (muscle contractions); nodding (little fast nodding); This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles as a teenager). Concurrent medical conditions included arthritis, frozen shoulder, epilepsy, facial flushing (face flushes with exertion, since having shingles) and allergy to antibiotic (allergic to penicillin, erythromycin, sulfa). On 20-AUG-2025, the patient received Shingrix (intramuscular, left deltoid). In AUG-2025, an unknown time after receiving Shingrix, the patient experienced muscle contractions involuntary (Verbatim: facial involuntary movements (muscle contractions)) and nodding of head (Verbatim: nodding (little fast nodding)). On 20-AUG-2025, the patient experienced injection site pain (Verbatim: Injection site pain), influenza-like symptoms (Verbatim: Flu-like symptoms), facial tic (Verbatim: Facial tic) and difficulty sleeping (Verbatim: Difficulty sleeping). The outcome of the injection site pain was resolving and the outcome of the influenza-like symptoms was resolved and the outcome of the facial tic and difficulty sleeping were not resolved and the outcome of the muscle contractions involuntary and nodding of head were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, difficulty sleeping, muscle contractions involuntary and nodding of head to be related to Shingrix. The reporter considered the facial tic to be related to Shingrix. It was unknown if the company considered the injection site pain, influenza-like symptoms, difficulty sleeping, muscle contractions involuntary and nodding of head to be related to Shingrix. The company considered the facial tic to be related to Shingrix. Additional Information: GSK Receipt Date: 26-AUG-2025 This report was submitted via the online direct entry reporting system. Facial tic was reported as worsened. he doctor's office did not give the patient/reporter the lot and expiration date. The reporter was the patient. On 20 Aug 2025, she received her first Shingrix dose, in her left arm, at her rheumatologist's office. That day she developed flu-like symptoms and had pain at the injection site. That evening she developed involuntary facial tics on the left side of her face. The tics were now on both sides of her face and occur every night. She had difficulty sleeping due to the facial tics. Two days after vaccination, she spoke with her rheumatologist. The doctor thought the tics were an expression of arthritic/injection pain. The patient believed the tics were related to Shingrix vaccination. According to her it started with facial involuntary movements (muscle contractions) and nodding (little fast nodding), mostly present in the left side which was the same side of the vaccine administration (left shoulder). She mentioned she had already called to the Safety area of GSK, and that a pharmacist told her to call the Medical Information line for getting more information, she confirmed that the side effect was reported to the CDC. Nothing else was reported.
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| 2856214 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Varicella
Varicella
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Chickenpox; This non-serious case was reported by a consumer via interactive digital media and descr...
Chickenpox; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: Chickenpox). The outcome of the chickenpox was not reported. It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine. It was unknown if the company considered the chickenpox to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-AUG-2025 This case was reported by a consumer via interactive digital media. The patient got shingles vaccine. The patient ended up having chickenpox as an adult. The patient ended up with chickenpox as 2 weeks aft his/her daughter had shingles. The reporter stated that it was not fun.
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| 2856215 | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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I never got the 2nd one; This non-serious case was reported by a consumer via interactive digital me...
I never got the 2nd one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (The patient got the first Shingrix shot about 3 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I never got the 2nd one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:24-AUG-2025 The patient got the first Shingrix shot about 3 years ago and never got the 2nd one. The reporter asked if he/she still get the 2nd shot. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2856216 | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional...
Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in May-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient received one dose of Shingrix, and asking at the time of reporting would they need to start series over. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2856217 | F | NY | 09/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Anaphylactic reaction
Anaphylactic reaction
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Potential anaphylactic reaction in a planned Boostrix administration; This serious case was reported...
Potential anaphylactic reaction in a planned Boostrix administration; This serious case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced anaphylactic reaction (Verbatim: Potential anaphylactic reaction in a planned Boostrix administration) (serious criteria GSK medically significant). The outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the anaphylactic reaction to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. 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-AUG-2025 The registered nurse wanted to know if there was presence of polyethylene glycol in Boostrix given that one of her patients was believed to have an allergy to it after presenting an anaphylactic reaction when receiving the depo injection postpartum. The Health Care Provider mentioned that the patient was late on her Boostrix dose, although then confirmed it was going to be the first dose.; Sender's Comments: A case of Anaphylactic reaction, unknown time after receiving Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2856218 | 4 | F | CA | 09/01/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5C79N |
Incorrect route of product administration
Incorrect route of product administration
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wrong route; This non-serious case was reported by a nurse via call center representative and descri...
wrong route; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5C79N, expiry date 19-OCT-2026) for prophylaxis. On an unknown date, the patient received Kinrix (subcutaneous). On an unknown date, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: wrong route). The outcome of the intramuscular formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-AUG-2025 Nurse reported a 4-year-old patient received Kinrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
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| 2856219 | 77 | IL | 09/01/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age, Product ...
No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
More
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geriatric patient was prescribed by a physician to receive a HIB (ACT-HIB) vaccine beforethey would ...
geriatric patient was prescribed by a physician to receive a HIB (ACT-HIB) vaccine beforethey would have their surgery with no reported adverse event; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old and unknown gender geriatric patient who was prescribed by a physician to receive a Hib (Prp/T) Vaccine [Act-Hib] before they would have their surgery with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the geriatric patient was prescribed by a physician to receive an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported for immunization before they would have their surgery with no reported adverse event (product prescribing issue) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, the patient that was older than 5 years old being prescribed to receive ACT-HIB vaccine. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2856221 | NE | 09/01/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y019176 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE; TE. PROQUAD was administered to one patient; This spontaneous report was received ...
No additional AE; TE. PROQUAD was administered to one patient; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-Aug-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y019176, expiration date: 18-May-2026) 0.5 mL administered by Unknown route. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), administered by Unknown route (lot # and expiration date were not reported). as Prophylaxis. Previously to the administration, the vaccine had a temperature excursion of 2.2C for 2 hours 48 minutes 0 seconds. The vaccine also had a previous temperature excursion. No additional adverse event (AE).
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| 2856222 | F | 09/01/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Decreased appetite, Dysgeusia, Fatigue, Insomnia, Memory impairment; Weight decr...
Decreased appetite, Dysgeusia, Fatigue, Insomnia, Memory impairment; Weight decreased
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Icant sleep almost 1year already; have salty taste in my mouth ang bitter taste; felt tired everyday...
Icant sleep almost 1year already; have salty taste in my mouth ang bitter taste; felt tired everyday; have no appetite until now; I loose at lot of weight; Sometimes I forgot things; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient had 11st dose on unknown date). 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 sleeplessness (Verbatim: Icant sleep almost 1year already), taste bitter-salty (Verbatim: have salty taste in my mouth ang bitter taste), tiredness (Verbatim: felt tired everyday), appetite absent (Verbatim: have no appetite until now), weight loss (Verbatim: I loose at lot of weight) and forgetfulness (Verbatim: Sometimes I forgot things). The outcome of the sleeplessness and appetite absent were not resolved and the outcome of the taste bitter-salty, tiredness, weight loss and forgetfulness were not reported. It was unknown if the reporter considered the sleeplessness, taste bitter-salty, tiredness, appetite absent, weight loss and forgetfulness to be related to Shingrix. It was unknown if the company considered the sleeplessness, taste bitter-salty, tiredness, appetite absent, weight loss and forgetfulness to be related to Shingrix. Additional Information: GSK receipt date: 16-AUG-2025 Patient stated that after receiving second dose of the shingles vaccine, they can't sleep almost 1 year already. Patient had salty taste in mouth ang bitter taste. Patient felt tired every day. Also had no appetite until time of reporting they lose a lot of weight. Sometimes they forgot things. A friend described to patient the excruciating pain he felt when he was diagnosed with shingles. The rash lasted for weeks and the pain kept him from work and spending time with friends and family. Once they heard his experience, patient knew they didn't want to take a chance. So they talked to doctor about protecting from shingles.
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| 2856223 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-AUG-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the vaccine and dealing with shingles now. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856224 | 71 | F | 09/01/2025 |
COVID19 |
MODERNA |
30L20A |
Chest pain, Laboratory test, Pain
Chest pain, Laboratory test, Pain
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Patient had pains in her chest that went around to her back; Patient had pains in her chest that wen...
Patient had pains in her chest that went around to her back; Patient had pains in her chest that went around to her back; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Patient had pains in her chest that went around to her back) and PAIN (Patient had pains in her chest that went around to her back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30L20A and 022M20A) for COVID-19 prophylaxis. Concurrent medical conditions included High cholesterol. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Patient had pains in her chest that went around to her back) and PAIN (Patient had pains in her chest that went around to her back). At the time of the report, CHEST PAIN (Patient had pains in her chest that went around to her back) and PAIN (Patient had pains in her chest that went around to her back) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: heart was okay. No concomitant medication was reported. The patient did not have any vaccines 4 weeks prior to her last dose. After she had the vaccine, she had pains in her chest that went around to her back. She would have to get up and walk around and drink water. It would go away but it kept happening. She went to her cardiologist and did a bunch of tests and was told that her heart was okay. Cardiologist ran a series of stress tests and nuclear tests to make sure that her heart was not damaged. Sometimes she still had that pain in her chest - not often but she still gets it. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788916 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788916:Husband's case
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| 2856246 | GA | 09/01/2025 |
PNC PNC21 |
PFIZER\WYETH MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No additional AE; Inbound transfer from a Specialist. A pharmacist is reporting administering CAPVAX...
No additional AE; Inbound transfer from a Specialist. A pharmacist is reporting administering CAPVAXIVE today after the patient has already received PREVNAR 20 IN March 2025. See request case 02855367. Patient is 60 years old with unknown chronic medical conditions/im; This spontaneous report was received from a pharmacist and refers to a 60-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included unknown chronic medical conditions/immunocompromised. Concomitant therapies were not reported. In March 2025, the patient received Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)) (lot # and expiration date were not reported). On 12-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # and expiration date were not reported) (inappropriate schedule of product administration). The reporter inquired if this is "ok" or are there any concern to be aware of. No additional AE (no adverse event).
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| 2856248 | 12 | F | MI | 09/01/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
2014634 |
Circumstance or information capable of leading to medication error, Injection si...
Circumstance or information capable of leading to medication error, Injection site haemorrhage, Underdose; Circumstance or information capable of leading to medication error, Injection site haemorrhage, Underdose
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during the administration, the patient moved their arm and did not received the full dose; the patie...
during the administration, the patient moved their arm and did not received the full dose; the patient bleeding a little at the injection site; This spontaneous report was received from a Pharmacist and refers to a(n) 12-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 14-Aug-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, lot #; expiration date, route of administration, anatomical location not provided) with no medical concerns after administration; and on 15-Aug-2025 (also reported as last Friday), she received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #2014634, expiration date: 20-Sep-2025) administered Intramuscularly in the arm (unspecified side) as human papillomavirus (HPV) Vaccination, following the 2 doses schedule. When receiving the second dose, the patient moved her arm and did not receive the full dose (accidental underdose). She also had a little bleeding in the injection site. The patient was accompanied by her mother and waited full 15 minutes waiting the period for observation or reactions, but did not have medical concerns and was sent home. At the reporting time, the outcome of the injection site bleeding was unknown. The causal relationship between the event of vaccination site bleeding and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported.
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| 2856249 | F | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Guillain-Barre syndrome
Guillain-Barre syndrome
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Shingrix vaccine gave me GBS, which has disabled me for approximately one year; This serious case wa...
Shingrix vaccine gave me GBS, which has disabled me for approximately one year; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Shingrix vaccine gave me GBS, which has disabled me for approximately one year) (serious criteria disability and GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reporter considered the guillain barre syndrome to be possibly related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK receipt date: 24-AUG-2025 This case was reported by a patient via interactive digital media. The patient reported that Shingrix vaccine gave her GBS (Guillain Barre syndrome), which had disabled her for approximately one year. She had a questioned how could had advertised product and not been part of the vaccine GBS (Guillain Barre syndrome) fund.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2856250 | F | FL | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pruritus, Rash
Pruritus, Rash
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Rash; Itching; This non-serious case was reported by a consumer via call center representative and d...
Rash; Itching; 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. On 04-AUG-2025, the patient received the 1st dose of Shingrix. In AUG-2025, less than a week after receiving Shingrix, the patient experienced rash (Verbatim: Rash) and pruritus (Verbatim: Itching). The outcome of the rash and pruritus were unknown. It was unknown if the reporter considered the rash and pruritus to be related to Shingrix. It was unknown if the company considered the rash and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 08-AUG-2025 Customer reported she received the first dose of Shingrix on 04 Aug 2025. Stated that she developed a rash and itching after receiving the vaccine.
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