| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2181976 | 56 | F | NY | 03/16/2022 |
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 |
EW0172 EW0172 EW0172 EW-0172 EW-0172 EW-0172 EW0172 EW0172 EW0172 |
Abdominal discomfort, Eructation, Laboratory test; Discomfort, Duodenogastric re...
Abdominal discomfort, Eructation, Laboratory test; Discomfort, Duodenogastric reflux, Dyspepsia, Eating disorder, Endoscopy abnormal; Eructation, Hernia, Inflammation, Pain; Abdominal discomfort, Eructation, Laboratory test; Discomfort, Duodenogastric reflux, Dyspepsia, Eating disorder, Endoscopy abnormal; Eructation, Hernia, Inflammation, Pain; Appendicectomy, Appendix disorder, Computerised tomogram normal, Dyspepsia, Endoscopy normal; Gastric emptying study, Gastrooesophageal reflux disease, Magnetic resonance imaging, Metaplasia, Oesophagogastric fundoplasty; Oesophagram, Pain, Ultrasound scan normal, X-ray
More
|
Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporte...
Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoking", start date: 2021 (ongoing), notes: stopped smoking and then, Chantix was recalled and she started smoking again in 2021. The patient's concomitant medications were not reported. Past drug history included: Chantix, start date: 2021, stop date: 2021, for Smoking cessation, notes: Expiry Date: May2023, Dosage permanently discontinued. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: ER8733, Anatomical Location: left arm), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning in digestive tract"; ERUCTATION (non-serious) with onset 2021, outcome "not recovered", described as "Belching". The events "burning in digestive tract" and "belching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was not on any other vaccine 4 weeks prior to Pfizer vaccination. The patient had no AE(s) prior to Pfizer vaccination. The patient reported that she started smoking again after Chantix recall, she cannot remember the exact date, but started smoking again in 2021. She stated she was down to 2 cigarettes a day and alternating with 1 cigarette. She was up to 5 cigarettes a day now, depending on the day. She has had many tests for her digestive symptoms, unspecified and the doctors cannot make a diagnosis. This week she was having a digestive motility test. These events did not resulted in emergency room visit. She clarified these events occurred after stopping Chantix, and after she had the second Pfizer Covid vaccine, adult. Events Burning in digestive tract and Belching occurred at the end of May2022 or beginning of Jun2022. Belching still persisted. No follow-up attempts are needed. No further information is expected.
More
|
||||||
| 2127892 | 32 | F | 02/19/2022 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ew0191 ew0191 ew0167 ew0167 |
COVID-19, Drug ineffective, SARS-CoV-2 test; Arthralgia, Brain fog, Exercise tol...
COVID-19, Drug ineffective, SARS-CoV-2 test; Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Fibromyalgia; Inflammatory marker test, Laboratory test, Loss of personal independence in daily activities, Pain in extremity; Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Fibromyalgia; Inflammatory marker test, Laboratory test, Loss of personal independence in daily activities, Pain in extremity
More
|
covid test result=Positive / covid test date=Jan2022; covid test result=Positive / covid test date=J...
covid test result=Positive / covid test date=Jan2022; covid test result=Positive / covid test date=Jan2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Jun2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and intramuscular, administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hepatitis b, for Immunization; Flu, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Additional information: The patient was not received any other vaccine in four weeks. The patient was not had Covid prior to vaccination. The patient had no known allergies. The patient tested for Covid post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events DRUG INEFFECTVE, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
More
|
|||||||
| 2825371 | 82 | M | FL | 02/08/2025 |
PNC20 |
PFIZER\WYETH |
lc5482 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
The day after vaccine administration, it was brought to our attention that patient already came in a...
The day after vaccine administration, it was brought to our attention that patient already came in and received Prevnar 20 on 3/12/24. Patient was informed. States no adverse effects so far.
More
|
||||||
| 2825372 | 3 | F | CA | 02/08/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
58160-0884-52 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient was signed up to get the COVID shot, but was given the flu shot instead. Parents noticed aft...
Patient was signed up to get the COVID shot, but was given the flu shot instead. Parents noticed after the vaccine was given.
More
|
||||||
| 2825373 | 72 | F | NH | 02/08/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Aldolase normal, Anaemia macrocytic, Biopsy bone marrow abnormal, Biopsy muscle ...
Aldolase normal, Anaemia macrocytic, Biopsy bone marrow abnormal, Biopsy muscle abnormal, Blood creatine phosphokinase normal; Bone marrow failure, Dysphonia, Dysstasia, Fasciitis, Gait disturbance; Immune thrombocytopenia, Immunoglobulin therapy, Laboratory test normal, Lymphocytic infiltration, Magnetic resonance imaging abnormal; Mastication disorder, Mobility decreased, Muscle spasms, Muscular weakness, Posture abnormal; Pruritus, Speech disorder, Tongue movement disturbance, Trismus, Walking aid user
More
|
In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up a...
In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair. She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse. In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth. In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed. Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up. On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted. prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
More
|
✓ | |||||
| 2825374 | 76 | F | WV | 02/08/2025 |
COVID19 |
MODERNA |
|
Burning sensation, Injection site reaction, Pruritus, Sleep disorder, Urticaria
Burning sensation, Injection site reaction, Pruritus, Sleep disorder, Urticaria
|
broke out in itchy burning welts at injection site,over next few days spread down right arm, back , ...
broke out in itchy burning welts at injection site,over next few days spread down right arm, back , left arm,torso and legs. It has been 2 months and not completly healed, tried antihistamines and prednisone. nothing eased the extreme burning and itching, sleep was difficult.
More
|
||||||
| 2825375 | 19 | M | WA | 02/08/2025 |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B AW1606B |
Acute disseminated encephalomyelitis, Alpha 1 foetoprotein normal, Amino acid le...
Acute disseminated encephalomyelitis, Alpha 1 foetoprotein normal, Amino acid level, Ammonia normal, Anti-aquaporin-4 antibody negative; Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative, Bacterial test negative; Beta 2 microglobulin normal, Biopsy brain abnormal, Biopsy muscle normal, Blast cell count decreased, Blood aluminium normal; Blood chromium, Blood copper decreased, Blood folate, Blood glucose normal, Blood lactate dehydrogenase increased; Blood lead normal, Blood zinc increased, Brain oedema, C-reactive protein increased, CD19 lymphocytes decreased; CD34 cell count decreased, CD4 lymphocytes decreased, CSF cell count increased, CSF culture negative, CSF glucose normal; CSF immunoglobulin decreased, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF virus no organisms observed; CSF white blood cell count increased, Complement analysis, Computerised tomogram, Computerised tomogram abdomen normal, Computerised tomogram head normal; Cough, Cranioplasty, Creatinine urine increased, Cytogenetic analysis normal, Decompressive craniectomy; Encephalomalacia, Endotracheal intubation, Faecal calprotectin increased, Flow cytometry, Fungal test negative; Gram stain negative, HIV test negative, Head injury, Heavy metal normal, Hemiparesis; Human chorionic gonadotropin negative, Immunoglobulin therapy, Intensive care, Laboratory test normal, Lactate pyruvate ratio; Lactic acidosis, Leptospira test, Leukocytosis, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal; Mycobacterium tuberculosis complex test negative, Mycoplasma test negative, Neutrophil count decreased, Noninfective encephalitis, Plasmapheresis; Posturing, Progressive multifocal leukoencephalopathy, Pupil fixed, Pyrexia, Red blood cell sedimentation rate increased; Retching, Scan with contrast abnormal, Tachycardia, Toxoplasma serology negative, Treponema test negative; Ultrasound Doppler normal, Ultrasound testes normal, Ventricular drainage, Ventriculo-peritoneal shunt, Vitamin A; Vitamin B1, Vitamin B12 normal, Vitamin B6, Vitamin C, White matter lesion; Acute disseminated encephalomyelitis, Alpha 1 foetoprotein normal, Alpha tumour necrosis factor increased, Amino acid level, Ammonia normal; Amoeba test negative, Anti-aquaporin-4 antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative; Apallic syndrome, Arteriogram carotid, Autoantibody negative, Beta 2 microglobulin normal, Biopsy brain abnormal; Biopsy muscle abnormal, Blood aluminium normal, Blood chromium normal, Blood copper normal, Blood culture negative; Blood folate normal, Blood glucose normal, Blood homocysteine normal, Blood lactate dehydrogenase increased, Blood lactic acid decreased; Blood lead normal, Blood pyruvic acid normal, Blood zinc normal, Brain herniation, Brain oedema; C-reactive protein increased, CD3 lymphocytes decreased, CD4 lymphocytes decreased, CSF culture negative, CSF glucose increased; CSF neutrophil count increased, CSF oligoclonal band absent, CSF protein decreased, CSF protein increased, CSF red blood cell count positive; CSF virus no organisms observed, Central nervous system lesion, Cerebral haemorrhage, Cerebral ventricle dilatation, Cerebrospinal fluid leakage; Coma, Complement analysis, Complement factor normal, Computerised tomogram abdomen, Computerised tomogram head abnormal; Computerised tomogram normal, Creatinine urine increased, Cryptococcus test, Depressed level of consciousness, Double stranded DNA antibody; Encephalomalacia, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Faecal calprotectin increased, Flow cytometry; Free fatty acids, Fungal test negative, Genetic testing, Gram stain negative, HIV test negative; HLA-B gene status assay, Heavy metal normal, Human chorionic gonadotropin negative, Interleukin level, Interleukin level increased; Leptospira test, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Metagenomic analysis; Mycobacterium test negative, Mycoplasma test negative, Red blood cell sedimentation rate increased, Scan with contrast abnormal, Syphilis test negative; Toxoplasma serology negative, Tuberculin test negative, Ultrasound testes normal, Vitamin A normal, Vitamin B1; Vitamin B12 normal, Vitamin B6 normal, Vitamin C normal, Whole-genome sequencing; Acute disseminated encephalomyelitis, Alpha 1 foetoprotein normal, Amino acid level, Ammonia normal, Anti-aquaporin-4 antibody negative; Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative, Bacterial test negative; Beta 2 microglobulin normal, Biopsy brain abnormal, Biopsy muscle normal, Blast cell count decreased, Blood aluminium normal; Blood chromium, Blood copper decreased, Blood folate, Blood glucose normal, Blood lactate dehydrogenase increased; Blood lead normal, Blood zinc increased, Brain oedema, C-reactive protein increased, CD19 lymphocytes decreased; CD34 cell count decreased, CD4 lymphocytes decreased, CSF cell count increased, CSF culture negative, CSF glucose normal; CSF immunoglobulin decreased, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF virus no organisms observed; CSF white blood cell count increased, Complement analysis, Computerised tomogram, Computerised tomogram abdomen normal, Computerised tomogram head normal; Cough, Cranioplasty, Creatinine urine increased, Cytogenetic analysis normal, Decompressive craniectomy; Encephalomalacia, Endotracheal intubation, Faecal calprotectin increased, Flow cytometry, Fungal test negative; Gram stain negative, HIV test negative, Head injury, Heavy metal normal, Hemiparesis; Human chorionic gonadotropin negative, Immunoglobulin therapy, Intensive care, Laboratory test normal, Lactate pyruvate ratio; Lactic acidosis, Leptospira test, Leukocytosis, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal; Mycobacterium tuberculosis complex test negative, Mycoplasma test negative, Neutrophil count decreased, Noninfective encephalitis, Plasmapheresis; Posturing, Progressive multifocal leukoencephalopathy, Pupil fixed, Pyrexia, Red blood cell sedimentation rate increased; Retching, Scan with contrast abnormal, Tachycardia, Toxoplasma serology negative, Treponema test negative; Ultrasound Doppler normal, Ultrasound testes normal, Ventricular drainage, Ventriculo-peritoneal shunt, Vitamin A; Vitamin B1, Vitamin B12 normal, Vitamin B6, Vitamin C, White matter lesion; Acute disseminated encephalomyelitis, Alpha 1 foetoprotein normal, Alpha tumour necrosis factor increased, Amino acid level, Ammonia normal; Amoeba test negative, Anti-aquaporin-4 antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative; Apallic syndrome, Arteriogram carotid, Autoantibody negative, Beta 2 microglobulin normal, Biopsy brain abnormal; Biopsy muscle abnormal, Blood aluminium normal, Blood chromium normal, Blood copper normal, Blood culture negative; Blood folate normal, Blood glucose normal, Blood homocysteine normal, Blood lactate dehydrogenase increased, Blood lactic acid decreased; Blood lead normal, Blood pyruvic acid normal, Blood zinc normal, Brain herniation, Brain oedema; C-reactive protein increased, CD3 lymphocytes decreased, CD4 lymphocytes decreased, CSF culture negative, CSF glucose increased; CSF neutrophil count increased, CSF oligoclonal band absent, CSF protein decreased, CSF protein increased, CSF red blood cell count positive; CSF virus no organisms observed, Central nervous system lesion, Cerebral haemorrhage, Cerebral ventricle dilatation, Cerebrospinal fluid leakage; Coma, Complement analysis, Complement factor normal, Computerised tomogram abdomen, Computerised tomogram head abnormal; Computerised tomogram normal, Creatinine urine increased, Cryptococcus test, Depressed level of consciousness, Double stranded DNA antibody; Encephalomalacia, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Faecal calprotectin increased, Flow cytometry; Free fatty acids, Fungal test negative, Genetic testing, Gram stain negative, HIV test negative; HLA-B gene status assay, Heavy metal normal, Human chorionic gonadotropin negative, Interleukin level, Interleukin level increased; Leptospira test, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Metagenomic analysis; Mycobacterium test negative, Mycoplasma test negative, Red blood cell sedimentation rate increased, Scan with contrast abnormal, Syphilis test negative; Toxoplasma serology negative, Tuberculin test negative, Ultrasound testes normal, Vitamin A normal, Vitamin B1; Vitamin B12 normal, Vitamin B6 normal, Vitamin C normal, Whole-genome sequencing
More
|
#Acute demyelinating encephalomyelitis is the adverse event. He received an influenza vaccination 10...
#Acute demyelinating encephalomyelitis is the adverse event. He received an influenza vaccination 10/28 in the setting of a recent URI which had resolved per his report/filing out of the flu shot screen record. 11/3 /24 he presented to his hospital with R hemiparesis and cerebral edema. He was transferred to hospital and then to another Hospital, where he spent 3 months. He transferred to Medical Center 2/4/25 for ongoing care. 19 y/o man without significant past medical history who developed an acute disseminated encephalomyelitis in Nov 2024 with prolonged hospitalization at Hospital now transferred to for continuity of care. Following prodrome of respiratory infection and flu vaccination, patient developed progressive encephalopathy. He was discovered to have a acute, multifocal, tumefactive demyelinating lesions complicated by cerebral edema requiring decompressive craniectomy and CSF diversion. Extensive work-up at tertiary medical center with multiple sub-specialties to include neuroimmunology, rheumatology and infectious disease was unrevealing after investigating several infectious, autoimmune, inflammatory, neoplastic, genetic, toxic causes. Patient received several bouts of immunosuppressive treatment to include IVMP, IVIG, PLEX, rituximab, tocilizumab and cyclophosphamide which were, per review of imaging and records, able to control the progressive inflammation as evidenced by resolution of the areas of enhancement. Subsequent imaging revealed evolving cystic encephalomalacia involving the bilateral cerebellum, right pons, bilateral thalami, and extensive L>R subcortical white matter.Treatments received at hospital: - PLEX #1 (11/9), PLEX #2 (11/10), PLEX #3 (11/12), PLEX #4 (11/14), PLEX #5 (11/16), PLEX #6 (11/18), PLEX #7 (11/20) - IV Methyiprednisolone 1 gm x 7 days - Meropenum x 7 days - 11/20 prednisone course discontinued and started IV dexamethasone - 11/20 s/p IV tocilizumab (1st dose) - 11/21 s/p IT rituximab (1st dose) + IT decadron (1st dose) - 11/28 s/p IT rituximab (2nd dose) + IT decadron (2nd dose) and initiated on IV cyclophosphamide 2 mg/kg IV daily (1st dose) - 11/29 2nd dose of Tocilizumab - 12/2 cyclophosphamide dose held as ANC <750 - 12/2 per Genetics, genome sequencing report resulted negative, will plan for reanalysis in 2 years - 12/2 repeat bMRI W WO contrast obtained to assess for response to recent treatments (last done on 11/17) with significant encephalomalacia in bilateral basal ganglia and R pons with concern for poor prognosis - 12/3 MRI results discussed extensively with family - 12/4 Rheumatology recommend IV tocilizumab monthly (next dose 12/29) -12/5 Allergy/immunology recommend Bactrim for PJP ppx given CD4 ct < 200 - 12/8 Patient transferred from NNICU to step down unit. Overnight bromocriptine started for fevers/tachycardia - 12/12 minor head trauma after hitting right side of head on bed rail during coughing fit. Staple came lose from scalp. CT head stable. Exam stable. Low concern for significant injury. NSGY replaced staple. -- 12/13 ongoing neuro-storming with fevers/tachycardia. Currently on SCH APAP, ibuprofen, bomocriptine, gabapentin. PRN morphine for breakthrough fevers. BLE doppler without evidence - 12/17 rheumatology sign-off -12/23 LP. CSF w N4>9, P65, G55, RBC 537>0. Had planned for cytokine testing but lab was - 12/26 Brain MRI WWO with VWI - new right parietal lobe enhancement, persistent left parietal and left BG enhancement; no evidence of vasculitis - 12/30 Neurosurgery decided against repeat biopsy. 3rd dose Tocilizumab given. Started on IVMP 250mg daily x5 days. Plan for shunt/cranioplasty approximately 1/9.
More
|
✓ | ✓ | ||||
| 2825376 | 83 | F | 02/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash
Rash
|
full body rash - arnica, symptoms resolving; recommended oatmeal and diphenhydramine
full body rash - arnica, symptoms resolving; recommended oatmeal and diphenhydramine
|
|||||||
| 2825377 | 41 | F | TX | 02/08/2025 |
FLU3 HEP MMR TDAP |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
391637 CT3Z7 XO28353 NZ552 |
Anal incontinence, Dyspnoea, Loss of consciousness; Anal incontinence, Dyspnoea,...
Anal incontinence, Dyspnoea, Loss of consciousness; Anal incontinence, Dyspnoea, Loss of consciousness; Anal incontinence, Dyspnoea, Loss of consciousness; Anal incontinence, Dyspnoea, Loss of consciousness
More
|
Doctor have patient receiving 4 vaccines at the pharmacy (flu, Hep B, Tdap, and MMR). Patient passed...
Doctor have patient receiving 4 vaccines at the pharmacy (flu, Hep B, Tdap, and MMR). Patient passed out and soil on herself and stating that she could not breath with her hands on the heck after 5 mins receiving the vaccine. Epi pen 0.3 mg was used and called 911. Paramedic arrived and check on patient's vital. Patient felt better after receiving the Epi pen and refused to go to the hospital. Pharmacist have patient stayed at the pharmacy for a little over 1 hour to make sure she felt ok
More
|
||||||
| 2825378 | 25 | F | CT | 02/08/2025 |
COVID19 |
NOVAVAX |
6024MF021 |
Injection site atrophy, Injection site discolouration
Injection site atrophy, Injection site discolouration
|
Not entirely sure when this started, but the last week of January I noticed fat atrophy to left delt...
Not entirely sure when this started, but the last week of January I noticed fat atrophy to left deltoid in area of recent novavax vaccination 12/24/24. Two small spots of skin hyperpigmentation in center of ~1-1.5 inch area of atrophy. The indentation is very noticeable visually and with palpation. No pain or associated symptoms.
More
|
||||||
| 2825379 | 54 | F | FL | 02/08/2025 |
COVID19 |
MODERNA |
|
Arthralgia, Back pain, Breast enlargement, Burning sensation
Arthralgia, Back pain, Breast enlargement, Burning sensation
|
First my hands were on fire and 2 months after the second vaccination My breasts started to increas...
First my hands were on fire and 2 months after the second vaccination My breasts started to increase in size from a "B" cup to now a "DD" cup size and still growing. My breast have never changed even when I was 9 months pregnant for 3 pregnancys. Now, ever since having the Covid 19 vax my boobs keep growing. My weight has not changed. But because of this my back hurts my shoulders hurt as a result from the weight of my breasts and bra digging into my shoulders. I have had a hysterctomy so it is not from hormal change. This all happened after the VAX.
More
|
✓ | |||||
| 2825380 | 77 | F | FL | 02/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Dyspnoea, Extra dose administered, Oxygen saturation abnormal
Dyspnoea, Extra dose administered, Oxygen saturation abnormal
|
Patient and husband received first dose of Shingrix series on this date and caregiver also requeste...
Patient and husband received first dose of Shingrix series on this date and caregiver also requested Arexvy for both of them. Pharmacy did not catch that both patients had already received Arexvy in October 2023 (single dose series) so they received 2 doses. When it was discovered, caregiver was notified and asked if they had experienced any side effects. Caregiver first stated no. Then he mentioned that that next morning his wife woke up and had difficulty breathing. He called 911, he did say he mentioned to them that they had vaccines that previous afternoon but is unaware if he notified Dr at the hospital. Patient was admitted to hospital for 3 days as they could not get her oxygen levels to normalize.
More
|
✓ | |||||
| 2825381 | 69 | F | AL | 02/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
LN4P2 |
Erythema, Feeling hot, Mobility decreased, Pain, Swelling
Erythema, Feeling hot, Mobility decreased, Pain, Swelling
|
Swelling, heat, pain/soreness causing difficulty raising arm, and red spots that have remained on l...
Swelling, heat, pain/soreness causing difficulty raising arm, and red spots that have remained on left arm . Patient noticed yesterday, reaction was more severe when she woke up this morning. Advised patient to continue to monitor localized reaction, apply cold compress to arm are, taking tylenol for the pain and benadryl for possible allergy.
More
|
||||||
| 2825383 | 55 | F | FL | 02/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Erythema, Injection site erythema, Injection site pruritus, Pruritus
Erythema, Injection site erythema, Injection site pruritus, Pruritus
|
Pt caretaker reported a red arm at the injection site and expanding down the arm. Slightly itchy.
Pt caretaker reported a red arm at the injection site and expanding down the arm. Slightly itchy.
|
||||||
| 2825384 | 67 | M | FL | 02/08/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Extra dose administered
Extra dose administered
|
patient was given a duplicate vaccine outside of guidelines; previous dose was administered 07/29/24
patient was given a duplicate vaccine outside of guidelines; previous dose was administered 07/29/24
|
||||||
| 2825385 | 29 | M | CO | 02/08/2025 |
COVID19 |
MODERNA |
|
Headache, Malaise, Palpitations, Seizure
Headache, Malaise, Palpitations, Seizure
|
Husband became ill started with headaches,then persisted into heart palpitations and ending in seizu...
Husband became ill started with headaches,then persisted into heart palpitations and ending in seizures
More
|
✓ | |||||
| 2825386 | 45 | F | WA | 02/08/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
207A21A 207A21A |
Chills, Dizziness, Fatigue, Injection site pain, Pain in extremity; Pyrexia, Tre...
Chills, Dizziness, Fatigue, Injection site pain, Pain in extremity; Pyrexia, Tremor
More
|
Felt light headed within minutes of injection. Subsided after about 20 minutes. Within 2 hours had p...
Felt light headed within minutes of injection. Subsided after about 20 minutes. Within 2 hours had pain in injection area and arm, fever of 101, shaking, shivering, tired. Lasted 3 days.
More
|
||||||
| 2825131 | F | TX | 02/07/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945658 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
First Dose Received Heplisav-B, Second Dose Received Engerix-B; Initial report received on 24-Jan-20...
First Dose Received Heplisav-B, Second Dose Received Engerix-B; Initial report received on 24-Jan-2025. A pharmacist reported that a 19-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 13-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #945658, expiration date 31-Jan-2027, NDC #43528-003-05) was administered intramuscularly in the right deltoid. On 12-Jan-2025, 30 days after having been vaccinated with HEPLISAV-B, the patient was given ENGERIX-B (lot #95BJ9, expiration date 25-Jul-2026, NDC #58160082052) in the left deltoid as the second dose of hepatitis B vaccine. The vaccine was administered at another Pharmacy. No adverse events were reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
More
|
|||||||
| 2825132 | F | KY | 02/07/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Incomplete course of vaccination
Incomplete course of vaccination
|
It's Been Over A month , Do I Need to Restart The Series; Initial report received on 29-Jan-20...
It's Been Over A month , Do I Need to Restart The Series; Initial report received on 29-Jan-2025. A pharmacist reported that a female (age, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose after more than one month. No medical history or concomitant medications were reported. On 01-Sep-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot #, expiration date, NDC # 43528-002-05, route, and site not available). At the time of reporting, more than one month after receiving the first dose, the patient had not received the next dose. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
More
|
|||||||
| 2825133 | U | 02/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu...
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure
More
|
Suspected vaccination failure; I had both shingle vaccines and still got shingles; This serious case...
Suspected vaccination failure; I had both shingle vaccines and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had both shingle vaccines and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-JAN-2025 The patient had both shingle vaccines and still got shingles. Very painful feels like rubbing crushed glass on your skin. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose )and Shingles vaccine(2nd dose).
More
|
||||||||
| 2825134 | 64 | F | PA | 02/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
Underdose
Underdose
|
adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the...
adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose; adult patient was administered a pediatric dose of the Engerix-B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 14-JAN-2025, the patient received Engerix B pediatric. On 14-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose) and adult use of a child product (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine). The outcome of the accidental underdose and adult use of a child product were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-JAN-2025 The reporter called to report an adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose, which led to an adult use of a child product and accidental underdose. Reporter asked about to advise whether to give another pediatric dose (and when) or when to administer an adult Engerix-B dose. The vaccine administration facility was the same as primary reporter.
More
|
||||||
| 2825135 | 18 | U | TN | 02/07/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVA993A |
Expired product administered
Expired product administered
|
Menveo to a pair of twins, and the dosage was 0.5. But it had expired 31-Dec-2024; This non-serious ...
Menveo to a pair of twins, and the dosage was 0.5. But it had expired 31-Dec-2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis. On 31-JAN-2025, the patient received Menveo .5 ml. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo to a pair of twins, and the dosage was 0.5. But it had expired 31-Dec-2024). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 The registered nurse reported they had a medical assistant that administered Menveo to a pair of twins (patients), but it had expired, which led to an expired vaccine used. The reporter wanted to know what to do about this situation. The vaccine administration facility was the same as primary reporter. This case was linked with US2025013442, reported by the same reporter for different patient (second twin).; Sender's Comments: US-GSK-US2025013442:twin patients with same initials
More
|
||||||
| 2825136 | 5 | M | MO | 02/07/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
T343J |
Expired product administered
Expired product administered
|
administered today an expired Kinrix vaccine; This non-serious case was reported by a other health p...
administered today an expired Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis. On 31-JAN-2025, the patient received Kinrix (left arm). On 31-JAN-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered today an expired Kinrix vaccine). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter reported that a patient received today (on the day of reporting) an expired Kinrix vaccine which led to an expired vaccine used. The injection was administered in the left arm. No additional event was reported.
More
|
||||||
| 2825147 | 51 | F | WY | 02/07/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
m7639 m7639 m7639 m7639 m7639 99y4j 99y4j 99y4j 99y4j 99y4j |
Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood crea...
Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood creatinine, Eosinophil count; Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Immature granulocyte count, Lymphocyte count; Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Myalgia; Neutrophil count, Platelet count, Polymyalgia rheumatica, Red blood cell count, Red blood cell nucleated morphology; Red cell distribution width, Walking aid user, White blood cell count; Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood creatinine, Eosinophil count; Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Immature granulocyte count, Lymphocyte count; Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Myalgia; Neutrophil count, Platelet count, Polymyalgia rheumatica, Red blood cell count, Red blood cell nucleated morphology; Red cell distribution width, Walking aid user, White blood cell count
More
|
developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome...
developed extreme pain in muscles, from feet up to shoulders and jaw. bloodwork, prednisone, outcome was polymyalgia rheumatica. it got super extreme after the second shot to point of me going to the urgent care. was on a cane for 3 weeks before going to urgent care. will be fighting PMR for years til remission.
More
|
||||||
| 2825151 | F | 02/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
A half of the adult dosage of Hepatitis A was administered to 16 year old; This non-serious case was...
A half of the adult dosage of Hepatitis A was administered to 16 year old; This non-serious case was reported by a consumer via patient support programs and described the occurrence of adult product administered to child in a 16-year-old female patient who received HAV (Havrix adult) for prophylaxis. On an unknown date, the patient received Havrix adult .5 ml. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: A half of the adult dosage of Hepatitis A was administered to 16 year old). The outcome of the adult product administered to child was unknown. Additional Information: GSK Receipt Date: 08-JAN-2025 A half of the adult dosage of Hepatitis A was administered to 16 year old, which led to adult product administered to child.
More
|
||||||||
| 2825152 | U | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills
Chills
|
shivers; This non-serious case was reported by a consumer via interactive digital media and describe...
shivers; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Patient had Shingles several years ago). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shivers (Verbatim: shivers). The outcome of the shivers was not reported. It was unknown if the reporter considered the shivers to be related to Shingrix. It was unknown if the company considered the shivers to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient had shingles several years ago and then got the shot to prevent them. Patient had the first shot to prevent shingles and had the shivers and asked if they should still get the Second shot.
More
|
||||||||
| 2825153 | M | TN | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Extra dose administered
Extra dose administered
|
not received the 2nd dose; This non-serious case was reported by a pharmacist via call center repres...
not received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccination in October 2022). 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: not received the 2nd dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 08-JAN-2025 Patient he got his 1st dose of Shingrix in October 2022 but has not received the 2nd dose. The patient inquired if he can get the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||
| 2825154 | F | IN | 02/07/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration, Incomplete course of vaccinati...
Inappropriate schedule of product administration, Incomplete course of vaccination; Inappropriate schedule of product administration, Incomplete course of vaccination
More
|
she never came back for the 3rd dose; 2nd on 19July2023; This non-serious case was reported by a pha...
she never came back for the 3rd dose; 2nd on 19July2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix (received 1st dose of Engerix on 12th July 2022). On an unknown date, the patient did not receive the 3rd dose of Engerix B. On 19-JUL-2023, the patient received the 2nd dose of Engerix B. On 19-JUL-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd on 19July2023). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: she never came back for the 3rd dose). The outcome of the incomplete course of vaccination and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter reported that a patient received the 1st and 2nd dose of Engerix-B in year 2023. She never came back for the 3rd dose. And now, she was on dialysis and Engerix-B dose in adult formulation was 1 ml given in 0, 1 and 6 months but adult dialysis patient got 2 ml and doing 4 times. She did received 1 ml twice in year 2023, she never completed the 3rd dose. The 1st dose was received on 12th July 2022 and 2nd dose was received on 19th July 2023, which led to Drug dose administration interval too long. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination.
More
|
|||||||
| 2825155 | 65 | F | AZ | 02/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
KR3XD |
Underdose
Underdose
|
65 year-old female patient received Engerix-B pediatric dose; 65 year-old female patient received En...
65 year-old female patient received Engerix-B pediatric dose; 65 year-old female patient received Engerix-B pediatric dose by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis. On 13-JAN-2025, the patient received the 1st dose of Engerix B pediatric. On 13-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 65 year-old female patient received Engerix-B pediatric dose) and accidental underdose (Verbatim: 65 year-old female patient received Engerix-B pediatric dose by mistake). The outcome of the adult use of a child product and accidental underdose were unknown. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient received Engerix-B pediatric dose by mistake as a possible first dose in the series, which led to adult use of a child product and accidental underdose.
More
|
||||||
| 2825157 | F | 02/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
|
Suspected vaccination failure; has had shingles; This serious case was reported by a consumer via in...
Suspected vaccination failure; has had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had 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: 29-JAN-2025 This case was reported by the patient via interactive digital media. The patient said that she was vaccinated and has had shingles. Reporter believed the vaccine lessened the pain though. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This was 1 of 3 linked cases reported by the same reporter for different patients.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR013185:same reporter different patient US-GSK-US2025AMR013183:same reporter different patient
More
|
||||||||
| 2825159 | 24 | M | IL | 02/07/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Anaphylactic reaction, Pruritus, Rash, Throat tightness
Anaphylactic reaction, Pruritus, Rash, Throat tightness
|
Reported Symptoms: 10002218:ANAPHYLAXIS; 10037087:PRURITUS; 10037844:RASH; 10043517:THROAT CONSTRICT...
Reported Symptoms: 10002218:ANAPHYLAXIS; 10037087:PRURITUS; 10037844:RASH; 10043517:THROAT CONSTRICTION; Narrative: Pt is a 29 yo male. Per available records, there is documentation going back as far as 12/13/2019 that pt has a documented allergy to the flu shot. This appears to have been first documented by the clinic. The reported ADR is throat swelling and urticaria upon administration of the influenza vaccine. Unfortunately, all other information is unknown and/or not available to this writer. Other Relevant HX: Other: RASH; AIRWAY CONSTRICTION
More
|
||||||
| 2825160 | 77 | M | IL | 02/07/2025 |
COVID19 |
MODERNA |
|
Feeling abnormal, Seizure, Tremor, Unresponsive to stimuli
Feeling abnormal, Seizure, Tremor, Unresponsive to stimuli
|
Reported Symptoms: 10039906:SEIZURE; Narrative: Pt is a 77-year-old male who received the COVID and ...
Reported Symptoms: 10039906:SEIZURE; Narrative: Pt is a 77-year-old male who received the COVID and shingles vaccine on the same day (5/3/22) at the Health Dept on 5/3/22 at 10am. Per notes, pt started to feel bad 1-2 hours after. Pt then presented to the ED and was subsequently hospitalized that same day on 5/3/22 following a witnessed seizure. Per notes, he had shaking in the head and upper body and was not responsive during that event. He was in a hospital. He was seen by neurosurgery and neurology there. He was started on Keppra and dexamethasone. He does not recall anything about the seizure but his daughter witnessed it. Of note, pt had received COVID vaccines prior to event including: Moderna (1/23/21), Moderna (2/10/21), Pfizer (10/23/21). Of note, in July 2024, pt had another seizure and was sent to the ER. In the note records, it is stated that pt "has known seizure disorder secondary to his meningioma and falls with his neurosurgeon for this. Nursing staff discussed with his long-term care facility staff and he has not had any of his seizure medication approximately 2 weeks. Likely cause for his possible seizure today." Other Relevant HX: Other: SEIZURE
More
|
✓ | |||||
| 2825161 | 80 | M | CA | 02/07/2025 |
COVID19 FLU4 |
PFIZER\BIONTECH SANOFI PASTEUR |
HF9300 UT8057BA |
Rash; Rash
Rash; Rash
|
Reported Symptoms: 10037844:RASH; Narrative: Patient recievd Covid-19 vaccine (Pfizer) and high dose...
Reported Symptoms: 10037844:RASH; Narrative: Patient recievd Covid-19 vaccine (Pfizer) and high dose flu (Sanofi) on 10/24/2023. Reports rash following injections. Unclear of which vaccine may have caused rash. No documentation if treatment was received. Other Relevant HX: Other: RASH
More
|
||||||
| 2825162 | 72 | M | CA | 02/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT8437AA |
Cough, Fatigue, Nasal congestion
Cough, Fatigue, Nasal congestion
|
Reported Symptoms: 10011232:COUGHING; 10016256:FATIGUE; 10028735:NASAL CONGESTION; Narrative: Patien...
Reported Symptoms: 10011232:COUGHING; 10016256:FATIGUE; 10028735:NASAL CONGESTION; Narrative: Patient received influenza vaccine on 9/26/24. Per allergies/adverse reactions tab in system, patient reported cough, nasal congestion, and fatigue with the influenza vaccine. Other Relevant HX: Patient previously received the influenza vaccine: 09/29/2022, 10/15/21, 10/18/2023, 9/24/2020, 10/04/2019, 09/28/2018, 10/26/2017, 10/21/2016, 10/05/2015, 11/05/2014, 10/08/2023, 10/03/2012, 09/20/2011, 10/26/2010, 11/12/2009 and 12/2008 Other: COUGH; NASAL CONGESTION; FATIGUE
More
|
||||||
| 2825163 | 64 | M | TN | 02/07/2025 |
COVID19 |
MODERNA |
3032233 |
Rash
Rash
|
Reported Systems: 10037844:RASH; Narrative: Other Relevant HX: RASH
Reported Systems: 10037844:RASH; Narrative: Other Relevant HX: RASH
|
||||||
| 2825164 | 59 | M | KY | 02/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT81484LA |
Face oedema
Face oedema
|
Reported Symptoms: 10016025:FACE EDEMA; Narrative: Pt reported had history of facial swelling from i...
Reported Symptoms: 10016025:FACE EDEMA; Narrative: Pt reported had history of facial swelling from influenza vaccine in 2023 so had to decline 2024 vaccine. patient has allergy to eggs and blamed the reaction on eggs although eggs no longer a risk for allergic reaction from flu shots. Provider flagged pt's chart with allergy to flu shot with comment "due to egg allergy". Other Relevant HX: EDEMA OF FACE
More
|
||||||
| 2825165 | 75 | M | IL | 02/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8489BA |
Balance disorder, Diarrhoea, Dizziness
Balance disorder, Diarrhoea, Dizziness
|
Reported Symptoms: 10004070:BALANCE DIFFICULTY; 10012727:DIARRHEA; 10013573:DIZZINESS; Narrative: Pt...
Reported Symptoms: 10004070:BALANCE DIFFICULTY; 10012727:DIARRHEA; 10013573:DIZZINESS; Narrative: Pt has a long documented history of receiving an annual flu shot (at least since 2003). Pt has received high dose flu shots since 2017. Pt received his annual flu shot on 10/4/24. At an appointment that happened to come a few days later, pt shared that he had experienced diarrhea and feeling off balance for the day after receiving the shot. Pt said he used walker during this time. No other complaints or actions regarding this event were documented. Other Relevant HX: Other: DIARRHEA; OFF BALANCE
More
|
||||||
| 2825166 | 80 | M | PA | 02/07/2025 |
COVID19 |
MODERNA |
3042648 |
Throat tightness
Throat tightness
|
Reported Symptoms: 10043517:THROAT CONSTRICTION; Narrative: Other Relevant HX: Other: AIRWAY CONSTRI...
Reported Symptoms: 10043517:THROAT CONSTRICTION; Narrative: Other Relevant HX: Other: AIRWAY CONSTRICTION
More
|
||||||
| 2825167 | 38 | M | CT | 02/07/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Peripheral swelling
Peripheral swelling
|
Reported Symptoms: 10023698:LARGE ARM SWELLING; Narrative: Other Relevant HX: Other: SWELLING OF ARM
Reported Symptoms: 10023698:LARGE ARM SWELLING; Narrative: Other Relevant HX: Other: SWELLING OF ARM
|
||||||
| 2825168 | 77 | M | IL | 02/07/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8489BA U8489BA U8489BA |
Anaphylactic reaction, Angioedema, Erythema, Erythema multiforme, Joint swelling...
Anaphylactic reaction, Angioedema, Erythema, Erythema multiforme, Joint swelling; Peripheral swelling, Pharyngeal swelling, Pruritus, Rash, Swelling face; Throat tightness, Urticaria
More
|
Reported Symptoms: 10002218:ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10037087...
Reported Symptoms: 10002218:ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; 10038198:REDNESS; 10042691:SWELLING OF FACE; 10043528:THROAT TIGHTNESS; Narrative: Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergency room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt had been taking lisinopril from 2016 - 2024 without prior complaints. Pt presented to the ED again, the following week on 10/23/24. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling
More
|
||||||
| 2825169 | 49 | M | NV | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GX29L/3R3AM |
Pruritus, Pyrexia, Urticaria
Pruritus, Pyrexia, Urticaria
|
Reported Symptoms: 10016558:FEVER; 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Per provider no...
Reported Symptoms: 10016558:FEVER; 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Per provider note: "Patient states that he developed hives and fever from the first dose of the shingles vaccine and does not want a second dose." Other Relevant HX: Other: URTICARIA; FEVER
More
|
||||||
| 2825170 | 47 | M | NV | 02/07/2025 |
COVID19 |
JANSSEN |
213D21A |
Pruritus, Urticaria
Pruritus, Urticaria
|
Reported Systems: 10037087:PRURITUS; 10046735:URICARIA; Narrative: Patient notes that after booster ...
Reported Systems: 10037087:PRURITUS; 10046735:URICARIA; Narrative: Patient notes that after booster dose of Johnson and Johnson Covid-19 Vaccine she developed localized hives like reaction to the arm with in 12 hours of injection. Other Relevant HX: Other: URTICARIA
More
|
||||||
| 2825171 | 50 | M | VA | 02/07/2025 |
COVID19 |
PFIZER\BIONTECH |
HM7006 |
Angioedema
Angioedema
|
Reported Symptoms: 10002424:ANGIOEDEMA; Narrative: Other Relevant HX: Other: ANGIOEDEMA
Reported Symptoms: 10002424:ANGIOEDEMA; Narrative: Other Relevant HX: Other: ANGIOEDEMA
|
||||||
| 2825172 | 81 | M | ID | 02/07/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3042648 UT8463CA |
Guillain-Barre syndrome; Guillain-Barre syndrome
Guillain-Barre syndrome; Guillain-Barre syndrome
|
Reported Symptoms: 10018767:GULLIAN-BARRE SYNDROME; Narrative: 81 yo male patient in NAD who follow...
Reported Symptoms: 10018767:GULLIAN-BARRE SYNDROME; Narrative: 81 yo male patient in NAD who follows with the Blue team for his PCP comes in today for follow up post hospitalization. Developed Guillian-Barre after flu and COVID shot. Patient was treated at Medical Center and then was at rehab 10/19-11/12. Other Relevant HX: Other: GUILLAIN BARRE
More
|
✓ | ✓ | ||||
| 2825173 | M | OH | 02/07/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Guillain-Barre syndrome
Guillain-Barre syndrome
|
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN ...
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN BARRE
More
|
|||||||
| 2825174 | 49 | M | NV | 02/07/2025 |
FLUX |
UNKNOWN MANUFACTURER |
XF35009 |
Hypersensitivity, Pruritus, Urticaria
Hypersensitivity, Pruritus, Urticaria
|
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient states t...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient states that he had an allergic reaction the same day as flu shot 1/3/2018. Small hives to arms and legs. And has not resolved with Benadryl or lotions. Other Relevant HX: Other: URTICARIA
More
|
||||||
| 2825175 | 91 | M | NV | 02/07/2025 |
COVID19 |
MODERNA |
013M20A |
Diarrhoea
Diarrhoea
|
Reported Symptoms: 10012727:DIARRHEA; Narrative: Other Relevant HX: Other: DIARRHEA (2/26/21@16:00)
Reported Symptoms: 10012727:DIARRHEA; Narrative: Other Relevant HX: Other: DIARRHEA (2/26/21@16:00)
|
||||||
| 2825176 | 47 | M | NV | 02/07/2025 |
COVID19 |
JANSSEN |
1808609 |
Abdominal pain
Abdominal pain
|
Reported Symptoms: 10000081:ABDOMINAL PAIN; Narrative: Per nurse call: She did report flank pain th...
Reported Symptoms: 10000081:ABDOMINAL PAIN; Narrative: Per nurse call: She did report flank pain the day after her vaccine that lasted until yesterday. She states that the pain was relentless.it is gone today but she was asked to call her pcp to discuss. She does not have any of the other symptoms as above. Other Relevant HX: Other: ABDOMINAL PAIN
More
|
||||||
| 2825247 | M | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Blood pressure inadequately controlled, Condition aggravated, Tremor
Blood pressure inadequately controlled, Condition aggravated, Tremor
|
Severely shaking hands after second; Uncontrollable blood pressure; This non-serious case was report...
Severely shaking hands after second; Uncontrollable blood pressure; This non-serious case was reported by a consumer via patient support programs and described the occurrence of blood pressure inadequately controlled in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure (controlled). Concomitant products included carvedilol. On 01-NOV-2022, the patient received the 2nd dose of Shingrix. On 03-NOV-2022, 2 days after receiving Shingrix, the patient experienced blood pressure inadequately controlled (Verbatim: Uncontrollable blood pressure). On 15-DEC-2022, the patient experienced tremor of hands (Verbatim: Severely shaking hands after second). The outcome of the blood pressure inadequately controlled was not resolved and the outcome of the tremor of hands was resolving. It was unknown if the reporter considered the blood pressure inadequately controlled and tremor of hands to be related to Shingrix. It was unknown if the company considered the blood pressure inadequately controlled and tremor of hands to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 The patient had controlled blood pressure for more than 25 years with one medication. The patient's doctors have since changed the medication 7 times and finally put the patient on a Beta Blocker with bad side effects. The patient had been to the ER twice for extremely high Blood Pressure in the last two years. The patient never had an issue until receiving the two shots of Shingrix. The patient have more to share in future conversations. The patient had severely shaking hands after second dose. The symptoms were not treated. Consented to follow up.
More
|
||||||||
| 2825248 | 0.33 | M | TX | 02/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient was given influenza vaccine at 4 months of age; This non-serious case was reported by a othe...
Patient was given influenza vaccine at 4 months of age; This non-serious case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Concurrent medical conditions included bronchiolitis. Concomitant products included salbutamol sulfate (Albuterol Sulfate). On 05-FEB-2025, the patient received FluLaval 2024-2025 season .5 ml. On 05-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient was given influenza vaccine at 4 months of age). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 05-FEB-2025 The reporter reported that the 4 months old patient received Flulaval vaccine which led to, inappropriate age at vaccine administration. The expiry date of Flulaval vaccine was unknown. The patient received Albuterol sulfate for bronchiolitis.
More
|