| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2830529 | 1 | M | PA | 03/10/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UJ983AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administered a dose of PENTACEL yesterday, but did not realize that it had expired on 12Feb2025 with...
administered a dose of PENTACEL yesterday, but did not realize that it had expired on 12Feb2025 with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 1 years old male patient who administered a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)].yesterday, but did not realize that it had expired on 12feb2025 with no reported ae [adverse event]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine and Pneumococcal vaccine conj 15v (CRM197) for Immunisation. On 04-Mar-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine,Suspension for injection, lot UJ983AA, expiry date: 12-feb-2025, via intramuscular route in the left thigh for Immunization with no adverse event expired product administered) (latency: same day). Action taken was not applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Sender's Comments:Reporter can be contacted by Sanofi.
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| 2830530 | CA | 03/10/2025 |
YF |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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reconstituted product with a sterile diluent live virus instead of what comes with product with no r...
reconstituted product with a sterile diluent live virus instead of what comes with product with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case (live processed together on 05-Mar-2025) received from a Pharmacist. This case involves, the patient received the Yellow Fever Vaccine- [YF-VAX] as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Feb-2025, the patient received Yellow Fever Vaccine- Solution for injection (unknown strength, expiry date, batch number) for Immunization as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event (product preparation error) (latency-same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly, Temperature excursion: negative disposition, no human error and product not used. Caller previously reported that a dose of YF-VAX was administered to a patient after it had been reconstituted with an alternate diluent (not the intended YF-VAX diluent). The alternate diluent used for reconstitution was sterile diluent live virus vaccines. Caller noted that the invalid dose was administered on 28-Feb-2025. The patient is traveling on 15-Mar-2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2830531 | 1.25 | M | AZ | 03/10/2025 |
HIBV |
SANOFI PASTEUR |
UJ995AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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1-year-old patient received an expired act-hib vaccine with no reported adverse event; Initial infor...
1-year-old patient received an expired act-hib vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Immunisation. On 05-Mar-2025, the patient received a dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UJ995AA with unknown strength and expiry date) via intramuscular route in the right vastus lateralis for Immunization. On 05-Mar-2025 the patient received an expired act-hib vaccine with no reported adverse event (expired product administered). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2830532 | M | 03/10/2025 |
COVID19 UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
COVID-19; COVID-19
COVID-19; COVID-19
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COVID-19; This spontaneous case, initially received on 21-Feb-2025, was reported by a non health pro...
COVID-19; This spontaneous case, initially received on 21-Feb-2025, was reported by a non health professional and concerns an elderly male patient. At the time of the event the patient had Osteoarthritis. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Influenza vaccination, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Not reported, Lot number: Not reported and would be requested upon follow up. Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunization. Adverse reactions/events and outcomes: On 02-Jan-2025, the patient experienced COVID-19 (outcome: Not recovered / Not resolved). experienced COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted. Lab test: SARS-COV-2 TEST on an unknown date. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide a seriousness or causality assessment; Reporter's Comments: The causality of events was related to the administration of Flucelvax (TIV)
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| 2830533 | 82 | F | 03/10/2025 |
FLUA4 VARZOS |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
No batch number No batch number |
Ear pain, Headache, Neck pain; Ear pain, Headache, Neck pain
Ear pain, Headache, Neck pain; Ear pain, Headache, Neck pain
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Ear pain; Neck pain; Head pain; This spontaneous case, initially received on 24-Feb-2025, was report...
Ear pain; Neck pain; Head pain; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an elderly female patient. Administration of company suspect drug: On 20-Sep-2023, the patient received Fluad Quadrivalent for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine, Dose regimen: .5 ml, route of administration and anatomical location: not reported. Lot number: No batch number available and will be requested upon followup. Non-company suspect drugs: Shingrix (Varicella zoster vaccine rgE (CHO), Indication not reported, Dose, route of administration and anatomical location were not reported. Lot number: No batch number available and will be requested upon follow-up. Adverse reactions/events and outcomes: On Sep-2023, the patient experienced Ear pain (outcome: Recovered / Resolved, stop date: 2023), Neck pain (outcome: Recovered / Resolved, stop date: 2023), Head pain (outcome: Recovered / Resolved, stop date: 2023). Because patient had a severe reaction from both the flu shot and a Shingrix shot, she was interested in obtaining a list of ingredients in the flu shot. She received the Fluad Quadrivalent (Influenza Vaccine, Adjuvanted) on 20-Sep-2023. She was interested in the components of Fluad 2023. She did not have the batch number. Her reaction was the same for the flu shot and the Shingles vaccine- ear, head, neck pain that lasted 2 weeks after the shingles shot but only a few days after the flu shot. She was trying to determine what ingredient was in both medications. She did not take medication for the symptoms and until the second shot, she didn't realize the cause of the problem. She was not hospitalized. She had never previously had reactions to any shots. She was happy to discuss the event if someone wants to reach out to her. The patient had event a few days after the flu shot. Fluad Quadrivalent action taken: Not Applicable Reporter's assessment: The reporter considered the events as non-serious and causality was not reported.; Reporter's Comments: All events were considered related.
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| 2830534 | 4 | M | NY | 03/10/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Induration, Peripheral swelling, Swelling
Induration, Peripheral swelling, Swelling
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Child had an extensive local reaction with induration swelling entire upper arm and upper chest acro...
Child had an extensive local reaction with induration swelling entire upper arm and upper chest across the clavicle which persisted over 24 hours, seen in office with still significant swelling 3/10/25
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| 2830535 | 45 | F | PR | 03/10/2025 |
HPV9 |
MERCK & CO. INC. |
Y018389 |
Dizziness
Dizziness
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After vaccine administration patient felt excessive dizziness and expressed she was about to faint, ...
After vaccine administration patient felt excessive dizziness and expressed she was about to faint, but she did not. She was remained in sitting position with elevated legs. She was provided with cold compresses around the neck area. She was provided water and salt crackers as per her request. She started to feel better and was fully recuperated. She was advised to remain in the Pharmacy area for around 15 minutes.
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| 2830541 | 0.17 | M | OK | 03/10/2025 |
DTAPHEPBIP HIBV HPV9 RV1 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
TC47K Y003146 Y011500 Y003754 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Patient was given Gardasil 9 instead of Prevnar 15. Patient was closely monitored in the clinic for...
Patient was given Gardasil 9 instead of Prevnar 15. Patient was closely monitored in the clinic for 20 minutes after injection given. NO sie reaction and NO physical reaction. Patient parents where notified and given instructions as to what they should watch for and advised to take to ER if any concerns. Provider and clinic manager wehre notified.
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| 2830542 | 21 | F | WV | 03/10/2025 |
RSV |
PFIZER\WYETH |
ln5464 |
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
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The morning after the shot, the patient had pain, swelling, redness, and the appearance of lots of t...
The morning after the shot, the patient had pain, swelling, redness, and the appearance of lots of tiny itchy bumps within a 2-3 inch diameter around the injection site. No systemic side effects. I am a pharmacist, and i told her to use hydrocortisone 1% cream OTC on the affected area 4 times daily for about a week. She as an OB appointment on 3/11/25, and i told her to ask the dr if it could be an allergic reaction (itchy red bumps) and ask if it would be safe or not to get the vaccine again in the future.
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| 2830543 | 63 | F | NJ | 03/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Abdominal distension, Blood test, Computerised tomogram, Gastritis, Inflammation
Abdominal distension, Blood test, Computerised tomogram, Gastritis, Inflammation
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The vaccine caused inflammation in my body which aggravated my gastritis. That led to significant ab...
The vaccine caused inflammation in my body which aggravated my gastritis. That led to significant abdominal bloating which has lasted for months. All other causes of the bloating have been ruled out through lab work and imaging.
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| 2830545 | 54 | F | VA | 03/10/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
N77J2 N77J2 |
Influenza like illness, Injection site erythema, Oropharyngeal pain, Pain, Strep...
Influenza like illness, Injection site erythema, Oropharyngeal pain, Pain, Streptococcus test positive; Tachycardia
More
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Flu-like symptoms with injection site redness beginning late 03/06/25. Had tachycardia, sore throat,...
Flu-like symptoms with injection site redness beginning late 03/06/25. Had tachycardia, sore throat, and persistent body aches from 3/6-3/10 with some improvement. Injection site redness evolved with spread distally in an annular pattern. No swelling or tenderness.
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| 2830546 | 59 | F | GA | 03/10/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site pain, Pain
Injection site pain, Pain
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Pain at the injection site that radiates down arm and to back and neck. Has improved after a 10 day ...
Pain at the injection site that radiates down arm and to back and neck. Has improved after a 10 day taper course of prednisone, but pain still comes and goes.
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| 2830547 | 68 | F | TX | 03/10/2025 |
HEPAB PNC21 RSV TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity; Pain...
Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity
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Patient complains of having sore arms on 3/9/25 due to vaccines administered on 3/8/25. She states ...
Patient complains of having sore arms on 3/9/25 due to vaccines administered on 3/8/25. She states use of cold compress and also an over the counter NSAID. She states she is feeling better today (3/10/25).
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| 2830548 | 38 | F | SD | 03/10/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
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Pt had red circle on arm where vaccine was given, shown to pharmacy on 3/10/25. Pt stated it was war...
Pt had red circle on arm where vaccine was given, shown to pharmacy on 3/10/25. Pt stated it was warm, firm, itchy and sore.
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| 2830549 | 62 | F | CT | 03/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Feeling abnormal, Nausea, Pain, Swelling
Fatigue, Feeling abnormal, Nausea, Pain, Swelling
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Pain, swelling, nauseous, fatigue, still feeling terribly ill 6 days after the shot.
Pain, swelling, nauseous, fatigue, still feeling terribly ill 6 days after the shot.
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| 2830550 | 1 | F | WA | 03/10/2025 |
MMR |
MERCK & CO. INC. |
Y000225 |
Rash
Rash
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Whole body rash starting 15 days after vaccination and worsening in severity over the next 3 days ho...
Whole body rash starting 15 days after vaccination and worsening in severity over the next 3 days hours.
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| 2830569 | 73 | F | SC | 03/10/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
030B71A 030B71A 030B71A 030B71A 017C21A 017C21A 017C21A 017C21A |
Altered visual depth perception, Biopsy artery abnormal, Blindness unilateral, G...
Altered visual depth perception, Biopsy artery abnormal, Blindness unilateral, Giant cell arteritis, Headache; Impaired driving ability, Loss of personal independence in daily activities, Lumbar spinal stenosis, Lumbar vertebral fracture, Neck pain; Optic atrophy, Pain in jaw, Quality of life decreased, Red blood cell sedimentation rate increased, Retinal artery occlusion; Sciatica, Spinal compression fracture, Spinal disorder, Vertebroplasty, Visual impairment; Altered visual depth perception, Biopsy artery abnormal, Blindness unilateral, Giant cell arteritis, Headache; Impaired driving ability, Loss of personal independence in daily activities, Lumbar spinal stenosis, Lumbar vertebral fracture, Neck pain; Optic atrophy, Pain in jaw, Quality of life decreased, Red blood cell sedimentation rate increased, Retinal artery occlusion; Sciatica, Spinal compression fracture, Spinal disorder, Vertebroplasty, Visual impairment
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I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & ...
I have GCA from Covid-19 vac. no health issues before the jab. I am legally blind in left eye & partial in right eye. Makes driving an daily chores challenging. I am no longer driving to many near misses due to poor depth perseption for one eye. I got 1st shot at pharmacy on Tues 4/7/21. Two (days) later on Thursday I started a (horrible) neck, head pain. Got worse where I couldn't lay me head on side of pillow. Doctor at time dismissed it as nerves & stress. Told to relax and wait. It kept getting worse, now my jaws were painful. Few weeks later I started losing my vision in upper left of left eye. Next day upper right portion, then lower left and lower right portion. Called eye doc. said to see optomologist ASAP. That was Thursday of same week. Did test and blood work. Sedrate over 100 ASAP get 80mg. prednesone started. On Monday did biopsy of left temple, yes I have GCA. Stayed on 80mg of pred so right eye wont go. for many, many months. That worked, eye doc said I had stoke in eye and dead opticle nerves, sight will never come back. Went on Acterma Acti pen 1xwk, now on tyene inject. Was on methotraxte & folic now 4yr. later no longer on that. To keep treating me doc said to get 2nd shot. No!! but I did. Said no more 'live' vaccines After many months of being on high dose of pred. 80mg. so right eye won't go, it caused my spine to become pithy. Within that 2nd year I had total of 11 comp. fractures which were Kpoplastied, cemented. Last yr. 24 I developed spinal stenosis with facet fractures L4 & L5. Have had 3 epidurals and now '25 waiting for another process to releive pain & sciatic nerves. I hope the worst is over, I have great doctors here locally, as I did in another city. I looked into compensation but because I am retired & insurance takes care of my bills so far, I am denied. I also get state aid. I don't agree because my life is severely reduced, And no independence. But I am thankful, I could have been blind if not for my opthmologist. There are a few other people with same devestation after Covid-19 vac. I hope my problem will help research and study. I guess at early onset of Covid-19 vacc. not much was known abt. side effects. I happened to be one of a few who didn't recover.
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| 2830284 | 58 | F | CA | 03/09/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Lymphadenopathy
Lymphadenopathy
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TDAP Boostrix I received TDAP on 02/27/2025 at pharmacy Brand GlaxoSmithKline Biologicals (TDap Bo...
TDAP Boostrix I received TDAP on 02/27/2025 at pharmacy Brand GlaxoSmithKline Biologicals (TDap Boostrix) I received Boostrix TDAP on my upper left arm on February 27, 2025 within less than a week I noticed my lymph node swallowed on my lower left armpit around March 5,2025. I reported to pharmacy on 03/06/2025 and spoke to pharmacist, he suggested to wait for two days observation then to call doctor.
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| 2830285 | 50 | M | MD | 03/09/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Feeling hot, Hyperhidrosis, Lethargy, Musculoskeletal stiffness, Ocular discomfo...
Feeling hot, Hyperhidrosis, Lethargy, Musculoskeletal stiffness, Ocular discomfort; Pain in extremity, Vision blurred
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Blurred Vision, pressure in the eyes, painful left arm, chills, hot sweats, stiff muscles, extreme l...
Blurred Vision, pressure in the eyes, painful left arm, chills, hot sweats, stiff muscles, extreme lethargy lasting into it's 4th day (still experiencing as of 3/9/25)
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| 2830286 | 51 | F | TN | 03/09/2025 |
DTAP |
SANOFI PASTEUR |
CVS Pharmacy, g |
Arrhythmia, Electrocardiogram ambulatory abnormal, Palpitations
Arrhythmia, Electrocardiogram ambulatory abnormal, Palpitations
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Heart palpitations began the day after I received the vaccine. I tested with a Holter monitor and wa...
Heart palpitations began the day after I received the vaccine. I tested with a Holter monitor and was prescribed Propranolol.
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| 2830287 | 50 | F | IN | 03/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Diarrhoea
Diarrhoea
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Severe diarrhea
Severe diarrhea
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| 2830288 | 17 | M | OR | 03/09/2025 |
COVID19 COVID19 FLU3 FLU3 HPV9 HPV9 MNQ MNQ |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
8081260 8081260 P224H P224H Y013712 Y013712 3E99M 3E99M |
C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogr...
C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Inflammatory marker increased; Myocarditis, Pericarditis, Troponin increased, White blood cell count increased; C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Inflammatory marker increased; Myocarditis, Pericarditis, Troponin increased, White blood cell count increased; C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Inflammatory marker increased; Myocarditis, Pericarditis, Troponin increased, White blood cell count increased; C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Inflammatory marker increased; Myocarditis, Pericarditis, Troponin increased, White blood cell count increased
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Chest pain started the day after vaccines, presented to care with one day of chest pain, found to ha...
Chest pain started the day after vaccines, presented to care with one day of chest pain, found to have diffuse ST elevation on EKG, elevated troponin, low-normal ventricular function on echo, elevated inflammatory markers - diagnosed with pericarditis with myocarditis component. Treatment with NSAIDs ongoing and patient is improving.
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| 2830289 | 68 | F | GA | 03/09/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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Vaccination error- pt did not need the vaccine (already got in 2022)
Vaccination error- pt did not need the vaccine (already got in 2022)
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| 2830290 | 60 | F | MS | 03/09/2025 |
COVID19 |
PFIZER\BIONTECH |
FA7485 |
Balance disorder, Dizziness, Magnetic resonance imaging, Vertigo, Visual impairm...
Balance disorder, Dizziness, Magnetic resonance imaging, Vertigo, Visual impairment
More
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Imbalance; Vision changes; Vertigo; Dizziness
Imbalance; Vision changes; Vertigo; Dizziness
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| 2830291 | 49 | M | GA | 03/09/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
lk6650 7zm55 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Patient received his second shingrix immunization one month after the first immunization, rather tha...
Patient received his second shingrix immunization one month after the first immunization, rather than 2 months after the first. Patient had no adverse reactions to the second vaccination.
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| 2830292 | 4 | M | TX | 03/09/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Contusion, Decreased appetite, Fatigue, Vomiting
Contusion, Decreased appetite, Fatigue, Vomiting
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Bruise on leg still visible 6 days fter vaccine. Child has had fatigue and not ate but a few bites ...
Bruise on leg still visible 6 days fter vaccine. Child has had fatigue and not ate but a few bites in several days. Vomiting 3 days in a row. Especially at night. Yesterday at 4 am vomiting green bile.
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| 2830293 | 6 | F | OH | 03/09/2025 |
DTAPIPV DTAPIPV |
SANOFI PASTEUR SANOFI PASTEUR |
U8009AB U8009AB |
Cellulitis, Injection site erythema, Injection site pain, Injection site swellin...
Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles; Injection site warmth
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Swelling, erythema, tenderness, warmth and blistering at injection site, worsening over 2-3 days. ...
Swelling, erythema, tenderness, warmth and blistering at injection site, worsening over 2-3 days. Treated with OTC Children's Tylenol, Benadryl as well as RX Cephalexin for cellulitis.
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| 2830294 | 39 | F | MO | 03/09/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y013009 H97H2 |
Chills, Headache, Injection site erythema, Pain, Pyrexia; Chills, Headache, Inje...
Chills, Headache, Injection site erythema, Pain, Pyrexia; Chills, Headache, Injection site erythema, Pain, Pyrexia
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Patient had headache, fever, body aches/chills and a red lump at the injection site. Despite ibuprof...
Patient had headache, fever, body aches/chills and a red lump at the injection site. Despite ibuprofen and ice, lump/redness continues to get larger. Patient had her spouse draw a line around the redness and it has spread beyond the drawn area.
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| 2830296 | 58 | F | SC | 03/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Injection site erythema, Injection site nodule, Injection site swelling
Injection site erythema, Injection site nodule, Injection site swelling
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Patient reports a large nodule at the injection site that is painful, red, and swollen. She has not ...
Patient reports a large nodule at the injection site that is painful, red, and swollen. She has not tried any medications yet at this time. Informed patient to monitor and call us back or go to emergency room if needed.
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| 2830297 | 68 | F | WA | 03/09/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
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Injection site bruising, Injection site rash; Injection site bruising, Injection...
Injection site bruising, Injection site rash; Injection site bruising, Injection site rash
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administered flublok and prevnar into right arm - developed rash about 3 inches BELOW vaccination si...
administered flublok and prevnar into right arm - developed rash about 3 inches BELOW vaccination site and to elbow. not around injection sites. minor bruise to injection site appears to be unrelated but still submitting report
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| 2830298 | 0.33 | F | CA | 03/09/2025 |
RV1 RV1 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
32PF3 32PF3 32PF3 |
Abdominal distension, Abdominal pain, Cleft lip repair, Clostridium difficile in...
Abdominal distension, Abdominal pain, Cleft lip repair, Clostridium difficile infection, Clostridium test positive; Faeces discoloured, Gastrointestinal tube insertion, Laboratory test, Lethargy, Nucleic acid test; Occult blood positive, Pyrexia, Rotavirus test positive, Urinary system X-ray, X-ray gastrointestinal tract
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Unclear if related. Patient got Rotarix #2 without issue on 2/18. Got a mouth surgery on 2/25. 2/26 ...
Unclear if related. Patient got Rotarix #2 without issue on 2/18. Got a mouth surgery on 2/25. 2/26 had fever, abd pain, lethargy, abdominal bloating, and rust-colored heme-positive stool. Needed an orogastric tube, NPO. Needed broad-spectrum antibiotics. Oral vancomycin for presumed C difficile. Unclear whether rotavirus is at all related. VAERs filed due to it being detectable in a stool PCR panel (but rotavirus Antigen was negative in stool workup).
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| 2830299 | 19 | F | AZ | 03/09/2025 |
UNK |
UNKNOWN MANUFACTURER |
4T8496MA |
Fatigue, Nausea, Oropharyngeal pain, Urticaria
Fatigue, Nausea, Oropharyngeal pain, Urticaria
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Hives on both arms, fatigue, sore throat, nausea
Hives on both arms, fatigue, sore throat, nausea
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| 2830338 | 64 | F | TX | 03/09/2025 |
PNC21 |
MERCK & CO. INC. |
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Depressed level of consciousness, Seizure like phenomena
Depressed level of consciousness, Seizure like phenomena
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seizure-like adverse reaction, partial loss of consciousness
seizure-like adverse reaction, partial loss of consciousness
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| 2830339 | 13 | M | CA | 03/09/2025 |
IPV IPV |
SANOFI PASTEUR SANOFI PASTEUR |
w1c741m w1c741m |
Asthenia, Influenza virus test negative, Pyrexia, Respiratory syncytial virus te...
Asthenia, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Sinus congestion, Sinusitis
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sinusitis (chronic congestion) came back, weakness and intermittent fever. Treated with a course of...
sinusitis (chronic congestion) came back, weakness and intermittent fever. Treated with a course of antibiotics but congestion hasn't resolved 2+ months after vaccination
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| 2830340 | 39 | F | OR | 03/09/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0158 |
Injection site pain, Injection site rash, Pain
Injection site pain, Injection site rash, Pain
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Extreme pain at injection site approximately 12 hours after injection. It was MUCH more sore than th...
Extreme pain at injection site approximately 12 hours after injection. It was MUCH more sore than that of any other vaccine I have had. It hurt to move the arm and it was even more painful if someone or something applied pressure to the arm. This lasted for about 24 hours. About one week later, a rash occurred on the affected arm. It went from just below the shoulder to just above the elbow and lasted for about 48 hours.
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| 2830341 | 39 | F | OR | 03/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0173 EW0173 |
Arthralgia, Chills, Fatigue, Headache, Influenza like illness; Pyrexia
Arthralgia, Chills, Fatigue, Headache, Influenza like illness; Pyrexia
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6-7 hours after injection flu like symptoms began and continued for the next 24 hours. Symptoms incl...
6-7 hours after injection flu like symptoms began and continued for the next 24 hours. Symptoms included fever, chills, joint pain, fatigue, and headache. It felt just as if I had the flu.
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| 2830342 | 40 | F | OR | 03/09/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0198 EW0198 EW0198 |
Arthralgia, Breast tenderness, Chills, Dysmenorrhoea, Fatigue; Headache, Influen...
Arthralgia, Breast tenderness, Chills, Dysmenorrhoea, Fatigue; Headache, Influenza like illness, Menstrual disorder, Menstrual headache, Oligomenorrhoea; Pyrexia
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This was my booster. I started experiencing flu like symptoms 6-7 hours after the injection. Symptom...
This was my booster. I started experiencing flu like symptoms 6-7 hours after the injection. Symptoms included, fever, chills, joint pain, fatigue and headache. This lasted for approximately 24 hours after onset of symptoms. My next menstrual period after this booster was effected as well. I experienced EXTREME breast tenderness, increase in menstrual flow, increased intensity of menstrual headaches, increased intensity of menstrual cramps, and increased duration of menstruation. This was all very odd because I normally have mild to no menstrual symptoms due to having Mirena IUD. Periods returned to normal after this event.
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| 2830343 | 55 | F | CA | 03/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Muscle swelling, Pain, Rash, Skin warm
Muscle swelling, Pain, Rash, Skin warm
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Swollen deltoid, rash, warm to touch, and pain.
Swollen deltoid, rash, warm to touch, and pain.
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| 2830248 | IL | 03/08/2025 |
HEP |
MERCK & CO. INC. |
X01182 |
No adverse event, Underdose
No adverse event, Underdose
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No adverse side effects were reported.; HCP calling to inquire about a pediatric RECOMBIVAX HB vacci...
No adverse side effects were reported.; HCP calling to inquire about a pediatric RECOMBIVAX HB vaccine that was administered to an adult, and if they can revaccinate with another pediatric dose, see request case 02752180. HCP refused to provide patient information at the time of the call.; This spontaneous report was received from a nurse practitioner concerning an adult patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 11-FEB-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Injection, batch# reported as X01182 which is an invalid batch/lot number for Hepatitis B Vaccine (Recombinant), expiration date reported as 01-OCT-2025) 1 dosage form (pediatric dose) (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (underdose.) The reporter inquired if they could revaccinate with another pediatric dose. No adverse side effects were reported (no adverse event). No additional information available.
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| 2830249 | 5 | 03/08/2025 |
MMRV |
MERCK & CO. INC. |
Y003880 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient is asymptomatic. No additional AE; a 5 year old patient was inadvertently administered a do...
Patient is asymptomatic. No additional AE; a 5 year old patient was inadvertently administered a dose of PROQUAD instead of MMRII on 02/20/2025.; This spontaneous report was received from an office manager and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Feb-2025, the patient was inadvertently administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y003880, expiration date: 05-Aug-2025) (dose, route of administration and anatomical location were not provided) which was diluted with sterile diluent, (expiration date, and lot # were not reported) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (wrong product administered). The patient was asymptomatic, no additional adverse event and no additional details were reported.
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| 2830250 | 7 | F | ND | 03/08/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y013579 |
No adverse event, Product storage error
No adverse event, Product storage error
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Improper storage of produc in use; No additional AE; This spontaneous report was received from a reg...
Improper storage of produc in use; No additional AE; This spontaneous report was received from a registered nurse referring to a 7-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis a vaccine inact (HAVRIX), Elasomeran (MODERNA COVID-19 VACCINE), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Iodinated glycerol (IPOL) and Diphtheria vaccine toxoid;Pertussis vaccine acellular 3- On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. On 08-JAN-2025, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot#: Y013579, expiration date: 03-FEB-2026, that was verified to be valid vial, administered subcutaneously with sterile diluent in the left thigh for prophylaxis (strength and dose were not reported) (product storage error). The administered dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was received and stored in the refrigerator that experienced a temperature excursion (on 13-NOV-2024) for a Total time of 1344 in the range 15๏ฟฝFto 46๏ฟฝF. No additional adverse event (AE) (No adverse event). This case was one of several reports received from the same reporter with the case US-009507513-2254349.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 04/16/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2830251 | WI | 03/08/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y012075 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE; inadvertent administration of PROQUAD during a temperature excursion.; This sponta...
No additional AE; inadvertent administration of PROQUAD during a temperature excursion.; This spontaneous report was received from a Registered Nurse and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 24-Feb-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (involved lot # Y012075, expiration date: 05-Jan-2026) reconstituted with sterile diluent, and administered as prophylaxis (strength, route, and site of administration were not provided) (Product storage error). The administered dose of the vaccine experienced a temperature excursion of 42.83 Fahrenheit degrees for 720 hours 0 minutes 0 seconds. No previous temperature excursion was reported. There was no adverse event reported. No product quality complaint was involved.
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| 2830252 | F | IN | 03/08/2025 |
MMR MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
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Antibody test negative; Antibody test negative
Antibody test negative; Antibody test negative
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The HCP reports that one of her staff members recently had a titer test and showed no immunity to Ru...
The HCP reports that one of her staff members recently had a titer test and showed no immunity to Rubella; This spontaneous Prospective pregnancy report was received from a medical assistant regarding a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date, the patient may have been vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection, 0.5 mL/series, reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported) or may have been vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL (0.5 ml/series) (vaccination scheme frequency, lot number, expiration date, route of administration and anatomical site of injection were not reported for any of the vaccines), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported); both vaccines indicated as prophylaxis. On an unknown date, the patient became pregnant. Her last menstrual period was estimated as 23-DEC-2024 and her pregnancy due date was estimated as 29-SEP-2025. The pregnancy and fetal outcome were not provided. She was 10 weeks pregnant at the time of the report. The reporter stated that on an unknown date (reported as recently), the patient had a titer test that showed no immunity to Rubella (Rubella antibody negative). It was reported that the patient๏ฟฝs vaccination history is unknown, but the physician mentioned Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) because they contain rubella. The reporter also stated that it could not be confirmed if the patient received any vaccines/medications during her pregnancy. At the reporting time, the outcome of the event Rubella antibody negative was unknown. The causal relationship between the suspect vaccines and sterile diluents, regarding the event was not provided.
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| 2830259 | 18 | M | 03/08/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Generalised tonic-clonic seizure
Generalised tonic-clonic seizure
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tonic-clonic seizure lasting a few minutes
tonic-clonic seizure lasting a few minutes
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| 2830260 | 39 | M | MO | 03/08/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
1808978 1808978 |
Autoimmune disorder, Colonoscopy, Computerised tomogram, Crohn's disease, M...
Autoimmune disorder, Colonoscopy, Computerised tomogram, Crohn's disease, Malaise; Sigmoidoscopy, Stool analysis
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I became ill about 18 months later and was diagnosed with Crohn's Disease
I became ill about 18 months later and was diagnosed with Crohn's Disease
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| 2830261 | 74 | F | AL | 03/08/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a second dose of Prevnar 20. It was not noticed that the patient had already recei...
Patient was given a second dose of Prevnar 20. It was not noticed that the patient had already received this vaccine on 5/22/23. Patient did not report any adverse events
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| 2830262 | 11 | F | TX | 03/08/2025 |
MMRV |
MERCK & CO. INC. |
Y008282 |
Injection site discolouration, Injection site erythema, Injection site pain, Inj...
Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
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Per mom and patient, patient received HPV & MMRV on Wed 3/5/25. On Thur 3/6 patient noticed loca...
Per mom and patient, patient received HPV & MMRV on Wed 3/5/25. On Thur 3/6 patient noticed localized redness and swelling, increased pain at injection site (back of L arm) but did not tell anyone. Friday 3/7 it became worse & per patient she noticed a small white dot at injection site so she alerted her mother and older sister. Patient denies any known insect stings or bites. Sister applied hydrocortisone 1% cream that night after patient applied warm water. Today, mother and patient report swelling & redness is reduced. Minimal redness & swelling noted at injection site. No discharge present. Patient reports 8/10 pain when touched at injection site. Oral temp 98.5 F.
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| 2830263 | 75 | M | GA | 03/08/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Discovered this was a vaccine duplications pt also received Prevnar 20 on 9/1/22. Patient has not ex...
Discovered this was a vaccine duplications pt also received Prevnar 20 on 9/1/22. Patient has not experiences any symptoms or side effects from dose administered.
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| 2830264 | 1 | M | PA | 03/08/2025 |
HEPA MMR PNC20 |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
Y012054 Y004114 LC5483 |
Ear infection, Seizure; Ear infection, Seizure; Ear infection, Seizure
Ear infection, Seizure; Ear infection, Seizure; Ear infection, Seizure
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Unprovoked seizure (afebrile) and reported to ER on 3/1/2025. On 3/1/2025 child reported to also hav...
Unprovoked seizure (afebrile) and reported to ER on 3/1/2025. On 3/1/2025 child reported to also have ear infection at hospital and treated with amoxicillin for 7 days. Then had another myoclonic seizure (unprovoked/afebrile) on 3/6/2025 and reported to the hospital in good state of health no symptoms other than the seizure at this time. Given a loading dose of keppra and started on maintenance keppra and given Diastat for rescue until able to be seen by Neurology. There is no family history of seizure.
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| 2830265 | 0.5 | M | PA | 03/08/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7836AA HN5978 X013617 |
Febrile convulsion, Seizure; Febrile convulsion, Seizure; Febrile convulsion, Se...
Febrile convulsion, Seizure; Febrile convulsion, Seizure; Febrile convulsion, Seizure
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Reported to the ER on 8/18/2025 with seizure activity. Diagnosed with a feeble seizure
Reported to the ER on 8/18/2025 with seizure activity. Diagnosed with a feeble seizure
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