| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2833786 | 1.5 | M | OH | 03/30/2025 |
MMR |
MERCK & CO. INC. |
|
Heart rate increased, Pyrexia
Heart rate increased, Pyrexia
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Fever and high heart rate (190 bpm)
Fever and high heart rate (190 bpm)
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| 2833787 | 41 | M | TX | 03/30/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0167 EW0167 EW0167 |
Bronchoscopy abnormal, Chills, Dizziness, Dyspnoea, Eosinophilic granulomatosis ...
Bronchoscopy abnormal, Chills, Dizziness, Dyspnoea, Eosinophilic granulomatosis with polyangiitis; Fatigue, Haemoptysis, Injection site erythema, Injection site pain, Injection site swelling; Lymphadenopathy, Myalgia, Nausea, Pyrexia
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September 2,2021- had redness, pain and swelling at injection site. Later that night had chills, fa...
September 2,2021- had redness, pain and swelling at injection site. Later that night had chills, fatigue, dizzy, muscle aches and feel nauseated with shortness of breath. This continued and progressed with a fever and swollen lymph nodes. I called the dr office to notify them of my reactions and was told not to go into the office due to COVID at the time and to try to wait but if symptoms worsened to go to the ER. My symptoms progressively got worse in less than 2 weeks I was coughing up blood and my wife took me to the emergency room. I have continued to cough up blood since 2021 and have since that date been diagnosed with a rare autoimmune disease EGPA Vasculitis, Churg Strauss Disease
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โ | โ | โ | |||
| 2833788 | 45 | F | TX | 03/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0191 EW0191 EW0191 EW0191 EW0191 FA7485 FA7485 FA7485 FA7485 FA7485 |
Angiogram normal, Ataxia, Cognitive disorder, Cognitive test, Computerised tomog...
Angiogram normal, Ataxia, Cognitive disorder, Cognitive test, Computerised tomogram normal; Depression, Dizziness, Dystonia, Electromyogram abnormal, Electronystagmogram; Electronystagmogram abnormal, Fatigue, Gait inability, Impaired work ability, Intracranial venous sinus stenosis; Magnetic resonance imaging, Neuropathy peripheral, Post-acute COVID-19 syndrome, Scan with contrast, Tinnitus; Vascular imaging, Vertigo, Vision blurred, Vitreous floaters, Walking aid user; Angiogram normal, Ataxia, Cognitive disorder, Cognitive test, Computerised tomogram normal; Depression, Dizziness, Dystonia, Electromyogram abnormal, Electronystagmogram; Electronystagmogram abnormal, Fatigue, Gait inability, Impaired work ability, Intracranial venous sinus stenosis; Magnetic resonance imaging, Neuropathy peripheral, Post-acute COVID-19 syndrome, Scan with contrast, Tinnitus; Vascular imaging, Vertigo, Vision blurred, Vitreous floaters, Walking aid user
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On 4/27/24 I had a vertigo attack in the movie theatre and couldn't walk, admitted into the hos...
On 4/27/24 I had a vertigo attack in the movie theatre and couldn't walk, admitted into the hospital. The hospital doctors initially thought it was BPV vertigo, after 20 visits of PT, nothing corrected the vertigo. I was unable to walk without a walker/cane, ataxia, dystonia, dizziness/vertigo, chronic fatigue, blurred vision, eye floaters, tinnitus, peripheral neuropathy in my feet. After extensive testing and diagnostics the Neurologist diagnosed me with Post Covid Syndrome. I had to take a leave of absence from work for 6 months. Went back to to work in October 2024, but still need accommodations.
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โ | โ | ||||
| 2833789 | 0.58 | M | CT | 03/30/2025 |
DTAP DTAP |
SANOFI PASTEUR SANOFI PASTEUR |
|
Allergy test, Crying, Fatigue, Injection site erythema, Screaming; Vomiting
Allergy test, Crying, Fatigue, Injection site erythema, Screaming; Vomiting
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My son got the DTap vaccine on Wednesday 3/26 in the morning. When we got him home, he was out of i...
My son got the DTap vaccine on Wednesday 3/26 in the morning. When we got him home, he was out of it. He started screaming crying and was inconsolable for about an hour and finally fell asleep. That night he developed a red mark on his leg that was about 2-3 inches in size a couple of inches away from the injection site. When he went to bed, he woke up out of his sleep and was screaming (this is unusual for him). On Friday morning, I gave him his usual morning bottle and he vomited the entire bottle all over me right after finishing. He then threw up five more times over the course of the next 5 hours. He was exhausted and slept on me for over an hour. I brought him to the doctor, and they ordered allergy testing to determine if this was caused by the vaccine- results TBD. Looking back, he inconsolably cried and passed out on me for hours after his previous doses of DTap.
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| 2833731 | 1 | M | OH | 03/29/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
W008711 W008711 |
Biopsy skin, Blister, Body temperature increased, Rash, Skin lesion; Varicella p...
Biopsy skin, Blister, Body temperature increased, Rash, Skin lesion; Varicella post vaccine
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Varicella zoster virus infection; This spontaneous report was received from a physician and refers t...
Varicella zoster virus infection; This spontaneous report was received from a physician and refers to a 3-year-old male patient. The patient's medical history and concomitant therapies were not provided. Current conditions included peanut allergy. On 23-JAN-2023 (reported as at age 1), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number W008711, with no expiration date provided that was verified to be valid with expiration date was established as 14-MAR2024, with sterile diluent administered on right thigh for prophylaxis (strength, specific dosage, dose number, route of administration and date were not provided). On 11-MAR-2025, the patient experienced maximum temperature of 38.0 C and herpes zoster rash involving right ear, scalp and face. Patient had multiple number of lesions distributed on dermatomal in cranial nerve V distribution. On 17-MAR-2025, vesicle/lesion skin sample was collected. On an unknown date in March 2025, he was hospitalized due to the rash with initial concern of Herpes Simplex Virus (HSV) that was found to be Varicella zoster virus (VZV) and on 19-MAR-2025, at hospital discharge was improving from the event (recovering) The causal relationship between the event and suspect vaccine was not provided. Lot # is being requested and will be submitted if received.
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โ | |||||
| 2833733 | 03/29/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Cerebrovascular accident, Eye haemorrhage, Heart failure with reduced ejection f...
Cerebrovascular accident, Eye haemorrhage, Heart failure with reduced ejection fraction, Hypertension
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stroke; heart failure ef factor lowered; had bad eye bleed; struggle continually with HBP; This is a...
stroke; heart failure ef factor lowered; had bad eye bleed; struggle continually with HBP; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; HEART FAILURE WITH REDUCED EJECTION FRACTION (medically significant), outcome "unknown", described as "heart failure ef factor lowered"; EYE HAEMORRHAGE (non-serious), outcome "unknown", described as "had bad eye bleed"; HYPERTENSION (non-serious), outcome "not recovered", described as "struggle continually with HBP". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2833741 | 0.83 | M | 03/29/2025 |
HEP HEP PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
|
Abnormal faeces, Diarrhoea, Dyspnoea, Lethargy, Pyrexia; Vomiting; Abnormal faec...
Abnormal faeces, Diarrhoea, Dyspnoea, Lethargy, Pyrexia; Vomiting; Abnormal faeces, Diarrhoea, Dyspnoea, Lethargy, Pyrexia; Vomiting
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Extreme vomiting that started 3 hours after vaccination, almost requiring ER visit due to child stru...
Extreme vomiting that started 3 hours after vaccination, almost requiring ER visit due to child struggling to breathe with constant vomiting. Extreme vomiting lasted 6 hours. Low grade fever and lethargic. Very strong smelling loose stools for 1 day after. Then loose stools for a few days after vaccination.
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| 2833744 | 65 | F | CT | 03/29/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Arthralgia, Contusion, Hypoaesthesia, Pain in extremity, Peripheral swelling
Arthralgia, Contusion, Hypoaesthesia, Pain in extremity, Peripheral swelling
|
Swollen and pain in right arm. Pain in shoulder joint, elbow, and wrists. Arm is numb and there is...
Swollen and pain in right arm. Pain in shoulder joint, elbow, and wrists. Arm is numb and there is a bruise. One week has gone by, swelling is down, but arm still in pain and still numb.
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| 2833745 | 11 | M | FL | 03/29/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Brain operation, Central venous catheterisation, Cerebrospinal fluid leakage, Co...
Brain operation, Central venous catheterisation, Cerebrospinal fluid leakage, Computerised tomogram, Craniopharyngioma; Drain placement, Epiphysiolysis, Headache, Hip surgery, Hypopituitarism; Lumbar spinal drainage complication, Magnetic resonance imaging head abnormal, Migraine, Nasal operation, Neck pain; Visual impairment
More
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Headaches and migraines after HPV Vaccination. Then more severe migraines, partial blindness in one...
Headaches and migraines after HPV Vaccination. Then more severe migraines, partial blindness in one eye. Leading up to discovering a craniopharyngioma on July 27, 2023. Surgery to remove craniopharyngioma on Aug. 3, 2023. CSF leak on Aug. 10, 2023. Lumbar drain put back in on Aug. 14, 2023. Aug. 16, 2023 - Starts Vasopressin/DDAVP every 12 hours. On Aug. 18, 2023 the nurse removed too much CSF 20-40 ml which caused severe head and neck pain, he also started on hydrocortisone every 8 hours. Started taking Levothyroxine every morning before breakfast. Due to surgical removal of craniopharyngioma - he now has panhypopituitarism. Aug. 23, 2023 PICC line and lumbar drain are removed. Aug. 25, 2023 patient is released from the hospital. On March 7, 2024 patient starts on Norditropin. On 12 March 2024, patient has nose surgery to clean up scar tissue from brain surgery. 11 July 2024 patient has hip surgery for SCFE
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โ | โ | ||||
| 2833746 | 0.42 | F | LA | 03/29/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
|
Autopsy, Death; Autopsy, Death; Autopsy, Death; Autopsy, Death
Autopsy, Death; Autopsy, Death; Autopsy, Death; Autopsy, Death
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Death. Infant found deceased face down in crib the morning after vaccines administered.
Death. Infant found deceased face down in crib the morning after vaccines administered.
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โ | |||||
| 2833747 | 79 | F | 03/29/2025 |
COVID19 |
NOVAVAX |
6024mf001 |
Arthralgia, Chills, Malaise, Pyrexia
Arthralgia, Chills, Malaise, Pyrexia
|
Patient reported that after receiving the Novavax Covid-19 vaccine, she reported the "worst sym...
Patient reported that after receiving the Novavax Covid-19 vaccine, she reported the "worst symptoms and every side effect possible from a vaccine". Confirmed that this was chills, fever, general malaise, shoulder soreness etc. Patient is still experiencing these side. Patient did not report taking any treatments to help alleviate these symptoms. As of time of entering, patient states that they are feeling much better today (3/29/2025) compared to yesterday (3/28/2025).
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| 2833748 | 69 | M | KS | 03/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
Unknown |
Rash, Rash vesicular
Rash, Rash vesicular
|
Blistering, severely painful rash along left buttock radiating down to the left leg. No local inject...
Blistering, severely painful rash along left buttock radiating down to the left leg. No local injection site reaction. No hives. No angioedema or anaphylaxis.
More
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| 2833749 | 16 | M | IN | 03/29/2025 |
HPV9 MNP |
MERCK & CO. INC. PFIZER\WYETH |
y011500 lj0075 |
Malaise, Syncope, Vomiting; Malaise, Syncope, Vomiting
Malaise, Syncope, Vomiting; Malaise, Syncope, Vomiting
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Syncope and vomiting a few minutes after the second vaccination. Mother states that he has had a si...
Syncope and vomiting a few minutes after the second vaccination. Mother states that he has had a similar reaction in the past to vaccines so we were prepared. He came to after about 5 minutes. I had him to drink water and take a mint to suck on. He laid down on the floor for a few minutes until he was feeling well enough to stand. I helped him up to stand and he sat in the waiting area chair for a few more minutes until he was feeling well enough to walk out with him mother to go home.
More
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| 2833750 | 79 | M | GA | 03/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
PATIENT INADVERTANTLY RECIEVED TWO DOSES ONE MONTH APART
PATIENT INADVERTANTLY RECIEVED TWO DOSES ONE MONTH APART
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| 2833751 | 53 | F | GA | 03/29/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6655 7ZM55 |
Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling,...
Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia; Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
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Pt came to the pharmacy today reporting of redness, swelling, and pain in both injection sites as we...
Pt came to the pharmacy today reporting of redness, swelling, and pain in both injection sites as well as a fever starting the night of the injection that has calmed down after a few days. She also reported shortness of breath lasting a couple days. Patient took Tylenol and Motrin to help with the symptoms.
More
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| 2833752 | 22 | F | IN | 03/29/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Aphasia, Confusional state, Depressed level of consciousness, Fear, Hyperhidrosi...
Aphasia, Confusional state, Depressed level of consciousness, Fear, Hyperhidrosis; Hypotonia
More
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Pt was sitting in chair, administered tdap vaccine and within seconds pt became floppy and non verba...
Pt was sitting in chair, administered tdap vaccine and within seconds pt became floppy and non verbal. Pt was difficult to arouse for at least 20 seconds, when she came to she was diaphoretic, confused and scared.
More
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| 2833753 | 63 | M | NC | 03/29/2025 |
COVID19 |
MODERNA |
|
Eye pain, Headache, Migraine, Sleep study
Eye pain, Headache, Migraine, Sleep study
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Pain in eyes leading to temples to migrine head ache now into the 33th month
Pain in eyes leading to temples to migrine head ache now into the 33th month
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| 2833754 | 65 | F | OR | 03/29/2025 |
PNC20 |
PFIZER\WYETH |
LX2497 |
Injection site erythema, Injection site pain, Injection site swelling, Periphera...
Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
More
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Patient stated to me on 3-28-25 that when the vaccinator gave her the shot it was painful. Her arm g...
Patient stated to me on 3-28-25 that when the vaccinator gave her the shot it was painful. Her arm got swollen and red and marks were radiating outward from vaccination site. the redness went down to elbow area and there was a bump above elbow. she went to the dermatologist because her primary doctor was unavailable. she was given a prednisone taper.
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| 2833755 | 32 | F | 03/29/2025 |
VARCEL |
MERCK & CO. INC. |
|
Joint stiffness, Joint swelling, Pain, Polyarthritis
Joint stiffness, Joint swelling, Pain, Polyarthritis
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Generalized body ache, migratory poly arthritis, joint stiffness, swelling of both ankles
Generalized body ache, migratory poly arthritis, joint stiffness, swelling of both ankles
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| 2833756 | 78 | F | TN | 03/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
JB27A |
Pain in extremity
Pain in extremity
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Patient received vaccine in Aug 2023, came into pharmacy and asked for the RSV vaccine and it was ad...
Patient received vaccine in Aug 2023, came into pharmacy and asked for the RSV vaccine and it was administered again. Spoke with patient the day after vaccination and she reported no adverse events or excess symptoms besides sore arm (also received Shingrix vaccine in opposite arm)
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| 2833757 | 72 | F | NM | 03/29/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0588 |
Injection site erythema, Injection site induration, Injection site pruritus, Inj...
Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
More
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Red, hot, hard, itchy injection Site
Red, hot, hard, itchy injection Site
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| 2833758 | 18 | F | TN | 03/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Injection site pain, Injection site swelling, Injection site warmth
Injection site pain, Injection site swelling, Injection site warmth
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By later on same day, patient reports soreness of site. By next day, swelling/fullness in area of va...
By later on same day, patient reports soreness of site. By next day, swelling/fullness in area of vaccine with pain, warmth, tenderness to touch. These same symptoms continued and worsened by around day 3 after vaccination. Patient sought care on 3/28/2025 due to ongoing symptoms BUT symptoms had already began to improve day by day.
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| 2757208 | 1.17 | CT | 03/28/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN |
1820096 1820096 1820096 |
Angiopathy, Anhidrosis, Disability, Dyspnoea, Gastrointestinal disorder; Hyperse...
Angiopathy, Anhidrosis, Disability, Dyspnoea, Gastrointestinal disorder; Hypersensitivity, Injection related reaction, Nail discolouration, Neuropathy peripheral, Pain; Rash, Seizure, Tachycardia, Thrombosis with thrombocytopenia syndrome; Autoscopy, Back pain, Blood test normal, Chest pain, Dizziness; Dyspnoea, Dysstasia, Echocardiogram normal, Electrocardiogram normal, Electromyogram normal; Exercise tolerance decreased, Fatigue, Feeling abnormal, Feeling cold, Full blood count normal; Gait disturbance, Head discomfort, Heart rate irregular, Hypoaesthesia, Hypohidrosis; Illness, Liver function test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Metabolic function test normal; Mobility decreased, Muscle tightness, Nail discolouration, Neck pain, Nervous system disorder; Pain in extremity, Panic reaction, Peripheral vascular disorder, Sensory disturbance, Thyroid function test normal
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VITT; seizure at work; full body neuropathy; essentially disabled; blood vessels don't work any...
VITT; seizure at work; full body neuropathy; essentially disabled; blood vessels don't work anymore; eruption left side of body; tachycardia; pain that persists; lost ability to sweat; fingernails are purple; dietary issues; severe mast cell allergy; shortness of breath; injection related symptom; 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, route of admin not reported, batch number: 1820096) dose and frequency not reported, administered on 03-Jun-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced vitt, seizure at work, full body neuropathy, blood vessels don't work anymore, essentially disabled, eruption left side of body, tachycardia, pain that persists, lost ability to sweat, fingernails are purple, dietary issues, severe mast cell allergy, shortness of breath, and injection related symptom. (dose series 1). Caller reports that 90 seconds after the injection into his left shoulder, he had an eruption on the left side of body, throughout his left leg. Caller reports he is in pain on a daily basis, and that pain persists. Caller reports this pain and other issues have gradually gotten worse overtime. Caller reports he lost the ability the sweat, and to obtain a muscle pump because his blood vessels don't work anymore. Caller reports Tachycardia. Caller reports his fingernails are purple. Caller reports he has dietary issues. Caller reports severe mast cell allergy. Caller reports shortness of breath, nerve damage, visible clots under ultrasound. Caller reports he has Anti-pf4 disorder. Caller reports he has VITT which is the reason they pulled the vaccine from the market. Caller reports his platelets are crashing. Caller reports he had a seizure at work. Caller reports he has full body neuropathy. Caller stated that purpose of the call is to find out how to communicate with Johnson and Johnson for his request regarding medical and financial compensation following his Janssen Covid19 vaccination. Caller stated there is no ability to sue JnJ because they are given blanket immunity by the government, from government or state or vaccine company there is really no recourse for people who have injured, nobody wants wants to touch this. Caller reports he received the Janssen Covid19vaccine on 03-JUN-2021 in his left shoulder, he said he gave the previous agent the lot number and that he does not have the expiration date. He said 4 years ago he was a body builder and he went from squats and dead lifting to now disabled, essentially disabled. He reports experiencing blood clotting, nerve damage and he has spent about 80 thousand dollars on doctors, medications, supplements, and that does not cover the amount lost from not being able to work. He said he is trying to figure out how to fix this. The action taken with janssen covid-19 vaccine was not applicable. The outcome of vitt, seizure at work, full body neuropathy, blood vessels don't work anymore, essentially disabled, eruption left side of body, tachycardia, lost ability to sweat, fingernails are purple, dietary issues, severe mast cell allergy, shortness of breath and injection related symptom was not reported. The patient had not recovered from pain that persists. This report was associated with a product quality complaint: Product Complaint 90000358241. This report was serious (other medically important condition).; Sender's Comments: V0: Thrombosis with thrombocytopenia syndrome, Seizure, Neuropathy peripheral, Disability. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
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| 2833537 | NJ | 03/28/2025 |
HEPA |
MERCK & CO. INC. |
Y012227 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; PRODUCT was administered after a temperature excursion; This spontaneous ...
No additional AE reported; PRODUCT was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. On 17-Mar-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (frequency once; lot # Y012227, expiration date: 12-Nov-2025; strength, dose and route were not reported) for prophylaxis by a health professional, which was administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event). This is one of four reports received from the same reporter.
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| 2833538 | M | MN | 03/28/2025 |
HEP |
MERCK & CO. INC. |
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Hepatitis B surface antigen negative, Vaccination failure
Hepatitis B surface antigen negative, Vaccination failure
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Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This liter...
Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This literature marketed report has been received from the authors of the published article and refers to a 43-year-old male adult patient. The patient's medical history included heart transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included alemtuzumab (induction). On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis. On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown. The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
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| 2833539 | F | MN | 03/28/2025 |
HEP |
MERCK & CO. INC. |
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Hepatitis B surface antigen negative, Vaccination failure
Hepatitis B surface antigen negative, Vaccination failure
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Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This liter...
Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This literature marketed report has been received from the authors of the published article and refers to a 71-year-old female adult patient. The patient's medical history included lung transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included anti-thymocyte globulin (ATG) (induction). On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis. On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown. The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
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| 2833540 | F | MN | 03/28/2025 |
HEP |
MERCK & CO. INC. |
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Hepatitis B surface antigen negative, Vaccination failure
Hepatitis B surface antigen negative, Vaccination failure
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Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This liter...
Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71); This literature marketed report has been received from the authors of the published article and refers to a 53-year-old female adult patient. The patient's medical history included lung transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included alemtuzumab (induction). On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis. On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown. The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
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| 2833541 | F | CA | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist v...
Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). In JAN-2025, the patient received the 2nd dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date:25-MAR-2025 The reporter was a Pharmacist that was calling in regards to her mother who had taken the first Shingrix vaccine in 2018 and then, received her 2nd vaccine 2 months ago. Daughter did not give me any further information in regards to her mother. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments: US-GSK-US2025036051:same reporter
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| 2833542 | 12 | M | CA | 03/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
EP274 |
Expired product administered
Expired product administered
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Expired Engerix-B administration; This non-serious case was reported by a nurse via call center repr...
Expired Engerix-B administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HBV (Engerix B) (batch number EP274, expiry date 14-MAR-2025) for prophylaxis. On 19-MAR-2025, the patient received Engerix B. On 19-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix-B administration). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-MAR-2025 A registered nurse wanted to know the efficacy on Engerix-B immunization after given an expired dose to patient after the expiration date (less than 30 days), which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025033657:Same reporter/Different patient
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| 2833543 | GA | 03/28/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
3D72S |
Product storage error
Product storage error
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Dose administered after temperature excursion; This non-serious case was reported by a other health ...
Dose administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Dose administered after temperature excursion). The outcome of the incorrect storage of drug 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: 20-MAR-2025 Healthcare Provider stated they stored Priorix in the freezer instead of the fridge and lowest temperature reached would be probably -17 degrees Fahrenheit and the vaccine was administered to about 4 patients after the temperature excursion, which led to incorrect storage of vaccine. Caller did not have any patient demographics or dates of administration. The reporter consented to follow up.
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| 2833544 | M | MO | 03/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
E42X5 |
Expired product administered
Expired product administered
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The vaccine was administer on 24-Mar-2025, and the vaccine was expire since 15-Mar-2025; This non-se...
The vaccine was administer on 24-Mar-2025, and the vaccine was expire since 15-Mar-2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HBV (Engerix B) (batch number E42X5, expiry date 15-MAR-2025) for prophylaxis. On 24-MAR-2025, the patient received Engerix B. On 24-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: The vaccine was administer on 24-Mar-2025, and the vaccine was expire since 15-Mar-2025). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-MAR-2025 The reporter was informed by a nurse that a vaccine (Engerix-B) was expired and was given to a patient, which led to expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
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| 2833545 | F | 03/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Respiratory disorder
COVID-19, Drug ineffective, Respiratory disorder
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Covid-19; Covid-19; almost not breathing; This is a spontaneous report received from a Consumer or o...
Covid-19; Covid-19; almost not breathing; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient in her 50's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "almost not breathing". The event "almost not breathing" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient mentioned that she had a reaction with the Pfizer Covid-19 shot, and that was years ago when she was under 60 years old (she is now over 60 years old). She explained that when she received the Pfizer COVID vaccine years ago, she had to go to the hospital because she was almost not breathing. She said it was scary for her and they recommended not to get the second shot. So her doctor told her not to take the covid shot. She now has COVID and was prescribed Paxlovid. So now that she has Covid-19 and will be taking Paxlovid, she was wondering if she will have a reaction to the medication as well because she had a reaction last time with Pfizer covid-19 shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2833559 | NJ | 03/28/2025 |
RV5 |
MERCK & CO. INC. |
X027423 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; ROTATEQ was administered after a temperature excursion; This spontaneous ...
No additional AE reported; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. On 17-Mar-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (frequency once, lot # X027423, expiration date: 05-Oct-2025; strength and dose were not reported) administered by oral route for prophylaxis by a health professional, which was administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event). This is one of four reports received from the same reporter.
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| 2833560 | 03/28/2025 |
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 and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAR-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had the shingles vaccine and got it anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2833611 | F | GA | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product storage error
No adverse event, Product storage error
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Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si...
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
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| 2833612 | 29 | F | GA | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
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No adverse event, Product storage error
No adverse event, Product storage error
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Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si...
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
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| 2833613 | 23 | GA | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
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No adverse event, Product storage error
No adverse event, Product storage error
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Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si...
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction
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| 2833614 | 38 | GA | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product storage error
No adverse event, Product storage error
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Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si...
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
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| 2833615 | 30 | GA | 03/28/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth; Product storage error
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Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si...
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction. Client complained of heat, itching, swelling, reddness, and pain at injection site. No papules or tohter complaint voiced. Self medicated with tylenol and benadryl. Hydrocortizone cream applied to injection site.
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| 2833616 | 58 | F | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TY7MZ |
Extra dose administered
Extra dose administered
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Patient received a 3rd dose of Shingrix vaccine.
Patient received a 3rd dose of Shingrix vaccine.
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| 2833617 | 4 | M | MI | 03/28/2025 |
DTAPIPV |
SANOFI PASTEUR |
u8209cb |
Cellulitis
Cellulitis
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parent reports they went to ER yesterday 3/27/2025 for eval and was told he has cellulitis. Unable ...
parent reports they went to ER yesterday 3/27/2025 for eval and was told he has cellulitis. Unable to locate any ER report. Family cancelled appt with provider in this office yesterday. We have not seen injection to verify local reaction or cellulitis.
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| 2833618 | 60 | F | CT | 03/28/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6651 D4G9L |
Fatigue, Injection site discharge, Injection site erythema, Injection site warmt...
Fatigue, Injection site discharge, Injection site erythema, Injection site warmth; Fatigue, Injection site discharge, Injection site erythema, Injection site warmth
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Had pneumococcal and tetanus vaccines both injected IM to left arrm Received Tuesday Warm red area b...
Had pneumococcal and tetanus vaccines both injected IM to left arrm Received Tuesday Warm red area began late Tuesday night Pt now says area has discoimfort in region Is applying ice and taking Tylenol Feels maybe a little tired but no definitive nor acute consistent symptoms. Was prescribed Keflex on 3/21/25. Went to ED on 3/24/25 for worsening spread. Was prescribed doxycycline additionally.
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| 2833619 | 27 | F | TX | 03/28/2025 |
HPV9 |
MERCK & CO. INC. |
5887745-01293 |
Diarrhoea, Dizziness, Nausea, Vomiting
Diarrhoea, Dizziness, Nausea, Vomiting
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Dizzy. Nauseous. Vomiting. Bile. Diarrhea
Dizzy. Nauseous. Vomiting. Bile. Diarrhea
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| 2833620 | 69 | F | NY | 03/28/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Chills, Injection site erythema, Injection site pain, Injection site swelling, U...
Chills, Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan
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Patient returned to PCP office on 03/26/2025, c/o redness, swelling and pain at site of PCV20 inject...
Patient returned to PCP office on 03/26/2025, c/o redness, swelling and pain at site of PCV20 injection on left upper arm last week. Denies fever, SOB but felt chilly. Also worried about abdomen , worry about shingles. Referral of abd. US given.
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| 2833621 | 65 | M | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
94se2 |
Nausea, Pain in extremity, Vertigo, Vomiting
Nausea, Pain in extremity, Vertigo, Vomiting
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patient states that he had a very sore arm, vertigo, nausea / vomiting that required a visit to urge...
patient states that he had a very sore arm, vertigo, nausea / vomiting that required a visit to urgent care a couple of days after receiving vaccine; patient has now recovered
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| 2833622 | 0.58 | M | ME | 03/28/2025 |
DTPPVHBHPB MMR PNC20 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
U7907AA Y007613 LC5484 2095065 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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MMR given incorrectly due to age. MMR vaccine given at same time as other vaccines, no reaction per ...
MMR given incorrectly due to age. MMR vaccine given at same time as other vaccines, no reaction per mother.
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| 2833623 | 51 | F | MA | 03/28/2025 |
PNC15 |
MERCK & CO. INC. |
Y013009 |
Cold sweat, Erythema, Injection site erythema, Myalgia
Cold sweat, Erythema, Injection site erythema, Myalgia
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redness , had myalgias, cold sweats and developed erythema over her left arm at the site of the inje...
redness , had myalgias, cold sweats and developed erythema over her left arm at the site of the injection
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| 2833624 | 83 | F | SD | 03/28/2025 |
COVID19 |
MODERNA |
3043823 |
Injection site erythema, Injection site rash, Injection site swelling, Injection...
Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
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Red, hot, raised rash at injection site. 5.5 cm x 10 cm
Red, hot, raised rash at injection site. 5.5 cm x 10 cm
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| 2833625 | 86 | F | SD | 03/28/2025 |
COVID19 |
MODERNA |
3043823 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Red, hot, raised rash at injection site. 5.5 cm x 6 cm
Red, hot, raised rash at injection site. 5.5 cm x 6 cm
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| 2833626 | 100 | F | SD | 03/28/2025 |
COVID19 |
MODERNA |
3043823 |
Injection site erythema, Injection site rash, Injection site warmth
Injection site erythema, Injection site rash, Injection site warmth
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Red, hot, raised rash at injection site. 5 cm x 6 cm
Red, hot, raised rash at injection site. 5 cm x 6 cm
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