| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2852387 | 88 | F | WA | 08/01/2025 |
COVID19 |
MODERNA |
|
Death, Myocarditis, Pain
Death, Myocarditis, Pain
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Died a violently painful death. Myocarditis
Died a violently painful death. Myocarditis
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| 2852388 | 11 | F | CA | 08/01/2025 |
MNQ |
SANOFI PASTEUR |
u8494aa |
Erythema, Urticaria
Erythema, Urticaria
|
At 2:38pm soon after vaccine menquadfi was administered the patient started to show the following s...
At 2:38pm soon after vaccine menquadfi was administered the patient started to show the following symptoms: hives and redness on her chest and upper back.
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| 2852404 | 67 | F | FL | 08/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Injection site erythema, Injection site pain, Neck pain, Pain
Injection site erythema, Injection site pain, Neck pain, Pain
|
INJECTION SITE REACTION RED CIRCLE ABOUT 4 INCHES IN DIAMETER - PAIN RADIATING UP NECK
INJECTION SITE REACTION RED CIRCLE ABOUT 4 INCHES IN DIAMETER - PAIN RADIATING UP NECK
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| 2852405 | 3 | F | OR | 08/01/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
A5573 |
Expired product administered
Expired product administered
|
The patient was administered the DTaP vaccine (Lot number: A5573), which expired on 07/13/2025. Desp...
The patient was administered the DTaP vaccine (Lot number: A5573), which expired on 07/13/2025. Despite being expired for nearly three weeks, the vaccine was stored in the refrigerator beyond its expiration date. I spoke with PA, the provider present at the clinic, who expressed no concerns regarding the potential harm of the vaccine to the patient. Subsequently, I communicated with MOC, apologized for the oversight, and they acknowledged the situation without issue.
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| 2852406 | 50 | F | NV | 08/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9l944 |
Rash
Rash
|
Sore right arm from 06/20/2025 from right deltoid to mid left arm after MA gave 2 vaccines 1. Shingr...
Sore right arm from 06/20/2025 from right deltoid to mid left arm after MA gave 2 vaccines 1. Shingrix and also a Tdap in same right arm. I called patient back and patient agreed to 2 vaccines in same arm. Patient came in today for 2nd Shingrix which was not given due to sore arm from June 20, 2025. MA verbally stated to me that she asked this patient if she wanted each vaccine in one arm and Patient stated yes. It was first shingrix and also a tdap which was needed in her right deltoid. Patient did report incident untill now and no redness or swelling or temperature change on arm noted at this time . I confronted my supervisor which she also observed patients arm. Just patients complaint of being sore. Instructed pt to make appointment with provider for follow up right arm soreness which she said she would but did not schedule appointment today and left this clinic
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| 2852407 | 57 | M | WA | 08/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Vaccine reconstituted with normal saline instead of adjuvant suspension component, no adverse reacti...
Vaccine reconstituted with normal saline instead of adjuvant suspension component, no adverse reaction noted, patient alerted.
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| 2852408 | 13 | F | CA | 08/01/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
H3N97 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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PATIENT GIVEN HEPATITIS A VACCINE BEFORE IT WAS DUE. VACCINE DUE 9/17/25. NO ADVERSE REACTIONS NOTED
PATIENT GIVEN HEPATITIS A VACCINE BEFORE IT WAS DUE. VACCINE DUE 9/17/25. NO ADVERSE REACTIONS NOTED
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| 2852409 | 62 | F | FL | 08/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8790AA |
Injection site erythema, Injection site pruritus, Injection site reaction
Injection site erythema, Injection site pruritus, Injection site reaction
|
PT REPORTED INJECTION SITE REACTION TO THE FLU VACCINE. THE SKIN WAS SLIGHTLY PINK, EXTENDING AROUND...
PT REPORTED INJECTION SITE REACTION TO THE FLU VACCINE. THE SKIN WAS SLIGHTLY PINK, EXTENDING AROUND 2 INCHES IN EACH DIRECTION ABOUT THE INJECTION SITE. SHE POINTED TO THE SITE WHERE THE TECHNICIAN GAVE HER THE INJECTION WHICH WAS IN THE LOWER RIGHT DELTOID. SHE STATED IT WAS A LITTLE ITCHY, BUT SHE WAS GOING TO TAKE SOME BENADRYL. PATIENT SEEMED WELL OTHERWISE, AND STAYED TO HAVE A CONVERSATION ABOUT SOME OF HER OTHER MEDS. SHE JUST WANTED TO BE SURE TO REPORT FOR OUR RECORDS. I TOLD HER I WOULD PLACE A PT NOTE IN HER PROFILE, AND REPORT TO VAERS.
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| 2852410 | 17 | F | CA | 08/01/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
9460063 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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There is no adverse reaction> This is the report for a wrong dose of Hepatitis B vaccine for 17 y...
There is no adverse reaction> This is the report for a wrong dose of Hepatitis B vaccine for 17 years old> Patient is 17 years old (she is 3 months away from the cut off age of vaccine recommended) . She was given the first dose of Heplisav B today 8/1/25. Confirmed per the her mother, no adverse reaction
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| 2852411 | 51 | F | CA | 08/01/2025 |
COVID19 |
MODERNA |
|
Tinnitus
Tinnitus
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tinnitus
tinnitus
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| 2852412 | 26 | F | AZ | 08/01/2025 |
COVID19 FLU3 MMR |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. |
ME6072 U8790AA Y008077 |
Dizziness, Gaze palsy, Posture abnormal, Seizure; Dizziness, Gaze palsy, Posture...
Dizziness, Gaze palsy, Posture abnormal, Seizure; Dizziness, Gaze palsy, Posture abnormal, Seizure; Dizziness, Gaze palsy, Posture abnormal, Seizure
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PATIENT WAS GIVEN MMR LEFT ARM AND COVID AND FLU RIGHT ARM PATIENT STATED DIZZY AFTER DONE AND I TOL...
PATIENT WAS GIVEN MMR LEFT ARM AND COVID AND FLU RIGHT ARM PATIENT STATED DIZZY AFTER DONE AND I TOLD HER TO STAY PUT SHE TOOK SOME DEEP BREATH LEAN TO SIDE EYES ROLLED UP AND STARTED HAVING CONVULSIONS. CALLED 911 SENT PARAMEDICS OUT WAS CHECKED DID NOT WANT TO GO TO EMERGENCY ROOM SAID WAS FINE AFTER BEING CHECKED STAYED HERE FOR HOUR I FOLLOWED UP WITH CALL . SHE STATED WAS FINE .
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| 2851916 | F | LA | 07/31/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Product use in unapproved indication, Toothache; Product use in unapproved indic...
Product use in unapproved indication, Toothache; Product use in unapproved indication, Toothache; Product use in unapproved indication, Toothache
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She began treatment with pneumococcal vaccination; This literature report has been received from th...
She began treatment with pneumococcal vaccination; This literature report has been received from the authors of the published article and refers to a 44-year-old female patient. The patient's medical history included childhood asthma, uncontrolled type 2 diabetes mellitus, osteomalacia with spontaneous rib fractures, Cushing's syndrome post-transsphenoidal pituitary resection, adrenocortical insufficiency, left lower lobe resection for mucinous adenocarcinoma in situ. The patient's concurrent conditions included asthma. The patient's concomitant medications included LAMA-LABA-ICS therapy and nasal irrigation. On unspecified date, the patient received treatment with pneumococcal vaccination (unknown vaccine) (dose, strength, route of administration, lot #, and expiration date were not provided) as an asthma treatment (product use in unapproved indication).
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| 2851917 | M | 07/31/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Echocardiogram, Ejection fraction normal, Heart transplant, Hepatitis B surface ...
Echocardiogram, Ejection fraction normal, Heart transplant, Hepatitis B surface antigen positive, Liver function test normal
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HBsAg Negative at POD 412 Post Heart Transplant; HBV PCR Negative at POD 412 Post Heart Transplant; ...
HBsAg Negative at POD 412 Post Heart Transplant; HBV PCR Negative at POD 412 Post Heart Transplant; HBsAb Titer was 277.2 mIU/mL pre-Transplant and 449.8 mlU/mL One Year Post-Transplant; Initial report received on 19-Jun-2025. This report was retrieved from the following publication: A 71-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and on postoperative day (POD) 412 after heart transplant, the patient's hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) polymerase chain reaction (PCR) remained negative. Medical history included advanced heart failure due to ischemic cardiomyopathy. The patient's pre-transplant hepatitis B surface antibody (HBsAB) titer was 277.2 mIU/mL. No concomitant medications were reported. Three years prior to transplant, the patient was vaccinated with the two-dose series of a hepatitis B vaccine HEPLISAV-B (lot numbers, expiration dates and NDC numbers not available). On an unknown date, three years after receiving HEPLISAV-B, the patient received a heart from a donor who was Hepatitis B Virus (HBV) Nucleic Acid Test Positive (NAT), and hepatitis B core antibody (HBcAb) positive. The patient received one dose of hepatitis B immunoglobulin (HBIG) 20,000 units intravenously (IV) intraoperatively followed by 5,000 units IV daily for 7 days in addition to starting tenofovir alafenamide 25 mg by mouth daily on postoperative day (POD) O for approximately 1 year. HBsAg, HBsAb and HBV PCR were monitored every 3 months. One-year post-transplant, and approximately 4 years after receiving HEPLISAV-B, the patient remained immune to HBV with an HBsAb titer of 449.8 mlU/mL. At POD 412 the patient's HBsAg and HBV PCR remained negative. Tenofovir alafenamide prophylaxis was discontinued on POD 448. Liver function tests (LFTs) were normal at baseline and stable post-transplant. His allograft function is stable with the most recently calculated ejection fraction of 68.5% measured by transthoracic echocardiography. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
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| 2851918 | F | 07/31/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Antibody test positive, Echocardiogram, Ejection fraction normal, Heart transpla...
Antibody test positive, Echocardiogram, Ejection fraction normal, Heart transplant, Hepatitis B surface antibody positive
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Vaccinated With One Dose of HEPLISAV-B and Then Received One Dose of ENGERIX-B; HBsAg Negative at PO...
Vaccinated With One Dose of HEPLISAV-B and Then Received One Dose of ENGERIX-B; HBsAg Negative at POD 177 Post Heart Transplant; HBsAb Titer was 276.7 mIU/mL at Transplant and 267.1 mlU/mL Two Months Post-Transplant; Initial report received on 19-Jun-2025. This report was retrieved from the following publication: A 53-year-old female received one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received one dose of recombinant hepatitis B vaccine ENGERIX-B approximately one year pre-heart transplant. She remained hepatitis b surface antigen (HBsAg) negative postoperative day (POD) 177. Medical history included advanced heart failure due to arrhythmogenic right ventricular cardiomyopathy. No concomitant medications were reported. One year prior to transplant, the patient was vaccinated with one dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available). One year prior to transplant, the patient was vaccinated with the second dose of a hepatitis B vaccine ENGERIX-B (lot number and expiration date not available). On an unknown date, one year after receiving HEPLISAV-B, the patient received a heart from a donor who was HBsAg negative, hepatitis B core antibody (HBcAB) negative, and hepatitis B virus (HBV) nucleic acid test (NAT) positive. The patient was immune to HBV with a hepatitis B surface antibody (HBsAB) titer of 276.7 mIU/mL at the time of transplant. Of note, the donor was also hepatitis C (HCV) NAT positive for which patient completed a course of sofosbuvir/velpatasvir 400/100 mg 1 tablet by mouth daily for 12 weeks per institutional protocol. She also received entecavir 0.5 mg by mouth daily beginning on POD 2 for an anticipated duration of 1 year and monitoring plans for HBsAg monthly. Two months post-transplant, the patient remained immune to HBV with an HBsAB titer of 267.1 mIU/mL. At POD 121 the patient remained HBsAg negative. At POD 177 she had normal liver function tests. On an unknown date, the patient had a stable allograft function. On transthoracic echocardiograph, the patient had a calculated ejection fraction of 57.6% No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
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| 2851919 | AZ | 07/31/2025 |
TDAP |
SANOFI PASTEUR |
U8503AA |
Product storage error
Product storage error
|
patient declined to take the vaccine, so the medical assistant returned it to the refrigerator; Init...
patient declined to take the vaccine, so the medical assistant returned it to the refrigerator; Initial information received on 28-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics and is reported patient declined to take the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], so the medical assistant returned it to the refrigerator. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-JUL-2025, patient declined to take the vaccine, so the medical assistant returned it to the refrigerator (product storage error) and The vaccine was then used by someone on 22-Jul-2025 at 04:34 pm, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U8503AA and expiry date: 30-Apr-2027 via unknown route in unknown administration site for immunization 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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| 2851931 | 0.08 | F | FL | 07/31/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
T432D |
Expired product administered
Expired product administered
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Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a ot...
Maladministration of Engerix-B After the Expiration Date; 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 6-year-old female patient who received HBV (Engerix B) (batch number T432D, expiry date 16-JUN-2019) for prophylaxis. On 19-JUN-2019, the patient received the 2nd dose of Engerix B. On 19-JUN-2019, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The medical assistant reported that the patient received Engerix-B expired second dose, which led to expired vaccine used. This shot was administered in a different location but same Health Company.
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| 2851932 | 77 | M | PA | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Asthma, Condition aggravated, Dyspnoea
Asthma, Condition aggravated, Dyspnoea
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breathing difficulty/ as the day progressed/ got worse; has asthma, that was exacerbated by a recent...
breathing difficulty/ as the day progressed/ got worse; has asthma, that was exacerbated by a recent flu shot; Initial information received on 22-Jul-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare profesisonal. This case was linked to other case US-SA-2025SA214057 (Dupixent case) This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma. Concomitant medications included calcium; vitamin D3; chondroitin sulfate sodium, glucosamine hydrochloride, manganese gluconate, sodium borate decahydrate (glucosamine & chondoritin); and fish oil. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation) Information on the batch number was requested corresponding to the one at time of event occurrence On 21-Jul-2025 the patient developed breathing difficulty/ as the day progressed/ got worse (dyspnoea) (unknown latency) following the administration of influenza vaccine. On an unknown date the patient developed has asthma, that was exacerbated by a recent flu shot (asthma) (unknown latency) following the administration of influenza vaccine. Reportedly, the patient was hospitalized, due to severe breathing difficulty yesterday morning. As the day progressed, he got worse and went to er at 10pm. He was admitted at around 2am, after he was given 3 breathing treatments. He has asthma, that was exacerbated by a recent flu shot. The patient was started on steroid and is breathing better now. Action taken was not applicable. Patient received 3 breathing treatments and steroid for the events. At the time of reporting, the outcome was Recovering / Resolving for both the events. Seriousness criteria: The patient was hospitalized for this event (Dyspnoea). from JUL-2025; Sender's Comments: Sanofi company comment dated 25-JUL-2025: This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine. Further information regarding allergic history and tolerance, laboratory investigations excluding alternative etiologies, hospitalization details for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. The patient has a history of asthma that might play confounding role in the occurrence of dyspnea. US-SA-2025SA214057:Dupixent case
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| 2851933 | 66 | M | OH | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Swelling
Swelling
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Reported Symptoms: 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING
Reported Symptoms: 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING
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| 2851934 | 84 | M | WI | 07/31/2025 |
COVID19 FLU4 |
MODERNA SANOFI PASTEUR |
U8156AA |
Rash, Vomiting; Rash, Vomiting
Rash, Vomiting; Rash, Vomiting
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Reported Symptoms: 10037844:RASH; 10047700: VOMITING; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10037844:RASH; 10047700: VOMITING; Narrative: Other Relevant HX: Other:
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| 2851935 | 67 | M | OH | 07/31/2025 |
FLU4 |
SANOFI PASTEUR |
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Wrong product administered
Wrong product administered
|
Reported Symptoms: 10063978: WRONG VACCINE ADMINISTERED; Narrative: Other Relevant HX: Patient got r...
Reported Symptoms: 10063978: WRONG VACCINE ADMINISTERED; Narrative: Other Relevant HX: Patient got regular rather than high dose vaccine. Other: incorrect vaccine
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| 2851936 | 55 | F | WA | 07/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Chest discomfort, Pain, Pruritus
Chest discomfort, Pain, Pruritus
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Reported Symptoms: 10008493:CHEST TIGHTNESS OF; 10033371:PAIN; 10037087:PRURITUS; 10037844:RASH; Nar...
Reported Symptoms: 10008493:CHEST TIGHTNESS OF; 10033371:PAIN; 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other: localized pain, chest tightness
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| 2851937 | M | OH | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Atrial fibrillation, Atrial flutter, Blister
Atrial fibrillation, Atrial flutter, Blister
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Reported Symptoms: 10003658:ATRIAL FIBRILLIATION; 10003662:ATRIAL FLUTTER; 10005216:BLISTERS; Narrat...
Reported Symptoms: 10003658:ATRIAL FIBRILLIATION; 10003662:ATRIAL FLUTTER; 10005216:BLISTERS; Narrative: Other Relevant HX: Other: BLISTER; ATRIAL FIBRILLATION; FLUTTER
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| 2851938 | 78 | M | OH | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Patient was inadvertent...
Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Patient was inadvertently given, in error, a second influenza vaccine instead of TDAP vaccine. PCP was informed. Patient was informed and advised of possible adverse reactions. [Reported from facility] Other: none
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| 2851939 | M | OH | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Malaise
Malaise
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Reported Symptoms: 10025482: MALAISE; Narrative: Other Relevant HX: Other: MALAISE
Reported Symptoms: 10025482: MALAISE; Narrative: Other Relevant HX: Other: MALAISE
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| 2851940 | 68 | M | WI | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Fatigue, Headache, Hyperhidrosis, Myalgia, Vomiting
Fatigue, Headache, Hyperhidrosis, Myalgia, Vomiting
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Reported Symptoms: 10016256: FATIGUE; 10019211: HEADACHE; 10028322: MUSCLE PAIN; 10042661: SWEATING;...
Reported Symptoms: 10016256: FATIGUE; 10019211: HEADACHE; 10028322: MUSCLE PAIN; 10042661: SWEATING; 10047700: VOMITING; Narrative: Other Relevant HX: Other VOMITING; MUSCLE PAIN; FATIGUE; SWEATING; HEADACHE
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| 2851941 | 33 | M | AK | 07/31/2025 |
FLUC3 |
NOVARTIS VACCINES AND DIAGNOSTICS |
160234 |
Anaphylactic reaction
Anaphylactic reaction
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Reported Symptoms: 10002218: ANAPHYLAXIS; Narrative: This is a historical ADR that was marked as obs...
Reported Symptoms: 10002218: ANAPHYLAXIS; Narrative: This is a historical ADR that was marked as observed. Occurred in (withheld) in 2014. No records or details known. Patient reports anaphylaxis Other Relevant HX: Other: ANAPHYLAXIS
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| 2851942 | 64 | F | OH | 07/31/2025 |
FLU4 |
SANOFI PASTEUR |
UT8055JA |
Urticaria
Urticaria
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Reported Symptoms: 10046735: URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
Reported Symptoms: 10046735: URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
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| 2851943 | 59 | M | OH | 07/31/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FK9893 FK9893 |
Cough, Dyspnoea, Imaging procedure abnormal, Lymphadenopathy, Myalgia; Pain in e...
Cough, Dyspnoea, Imaging procedure abnormal, Lymphadenopathy, Myalgia; Pain in extremity, Photophobia, Pyrexia
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Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10019211:HEADACHE; 10025197:LYMPHADENOPATHY; 1...
Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10019211:HEADACHE; 10025197:LYMPHADENOPATHY; 10028411:MYALGIA; 10034960:PHOTOPHOBIA; 10040604:SHORTNESS OF BREATH; Narrative: Patient's pain in arm was so severe he presented to emergency room. Imaging of the left arm axillary area revealed 3 lymph nodes. Patient was discharged with recommendation to use cold compresses, tylenol, and ibuprofen. Other Relevant HX: Other: left axillary lymphadenopathy;SHORTNESS OF BREATH; PHOTOPHOBIA
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| 2851944 | 83 | M | OH | 07/31/2025 |
FLU4 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Patient got high dose flu vaccine and it w...
Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Patient got high dose flu vaccine and it was later discovered that the patient had already had the flu vaccine at his doctor office 9.25.23. Other Relevant HX: Other: none
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| 2851945 | M | OH | 07/31/2025 |
COVID19 |
MODERNA |
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Rash
Rash
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Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
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| 2851946 | M | OH | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Face oedema, Swelling face
Face oedema, Swelling face
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Reported Symptoms: 10014222:EDEMA FACE; Narrative: Other Relevant HX: Other: FACIAL SWELLING
Reported Symptoms: 10014222:EDEMA FACE; Narrative: Other Relevant HX: Other: FACIAL SWELLING
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| 2851947 | F | WY | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Pruritus, Rash, Urticaria
Pruritus, Rash, Urticaria
|
Reported Symptoms: 10037087: PRURITUS; 10037844: RASH; 10046735: URTICARIA; Narrative: Other Relevan...
Reported Symptoms: 10037087: PRURITUS; 10037844: RASH; 10046735: URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
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| 2851948 | 60 | M | WI | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident
Cerebrovascular accident
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Reported Symptoms: 10042244:STROKE; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10042244:STROKE; Narrative: Other Relevant HX: Other:
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| 2851949 | 76 | M | OH | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Reported via (withheld)...
Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Reported via (withheld) copying here: Patient here given a flu vaccine instead of a Covid vaccine. Patient was also given a RSV vaccine. LPN notified pact provider as well as the nurse manager. LPN called patient, explained the situation, patient was very understanding, will wait till at least two weeks to get his covid vaccine. Other: none
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| 2851950 | M | OH | 07/31/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Influenza like illness
Influenza like illness
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Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: this is a historical d...
Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: this is a historical documentation with visit on 12-5-23. Other: INFLUENZA-LIKE ILLNESS
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| 2851951 | 45 | M | OH | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Myalgia, Pyrexia
Dizziness, Myalgia, Pyrexia
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Reported Symptoms: 10013573:DIZZINESS; 10016558:FEVER; 10028411:MYALGIA; Narrative: Other Relevant H...
Reported Symptoms: 10013573:DIZZINESS; 10016558:FEVER; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: FEVER
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| 2852022 | 4 | F | MI | 07/31/2025 |
DTAPIPV MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
LN4930 |
Vaccination error; Vaccination error; Vaccination error; Vaccination error
Vaccination error; Vaccination error; Vaccination error; Vaccination error
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Pt received Prevnar20 which was not needed. Pt was informed of what happened.
Pt received Prevnar20 which was not needed. Pt was informed of what happened.
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| 2852024 | 3 | M | TX | 07/31/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
TC3N5 |
Product preparation issue
Product preparation issue
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Nurse did not reconstitute vaccine and only gave the diluent of normal saline in an injection. No ...
Nurse did not reconstitute vaccine and only gave the diluent of normal saline in an injection. No adverse effects noted at time of vaccination or when notifying parent of error.
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| 2852025 | 69 | M | NC | 07/31/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Milk allergy; Milk allergy
Milk allergy; Milk allergy
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Acquired milk allergy
Acquired milk allergy
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| 2852026 | 4 | F | TX | 07/31/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
TC3N5 |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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Nurse did not reconstitute vaccine and only gave the diluent of normal saline in an injection. No ...
Nurse did not reconstitute vaccine and only gave the diluent of normal saline in an injection. No adverse effects noted at time of vaccination or when notifying parent of error.
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| 2852027 | 16 | F | NY | 07/31/2025 |
TDAP |
SANOFI PASTEUR |
U8115AA |
Syncope
Syncope
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Anxious prior to immunization, administered, patient waited approximately 1-2 minutes before departi...
Anxious prior to immunization, administered, patient waited approximately 1-2 minutes before departing. When she arrived to the waiting room to check out, patient experienced a vasovagal episode and was assisted to the floor by her mother. Unwitnessed by medical staff. Patient was offered some juice/crackers/granola bar/ice pack, after approximately 10 minutes was able to get to a chair and departed the facility approximately 5-10 minutes later.
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| 2852028 | 9 | F | AL | 07/31/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y012776 Y012776 |
Crying, Hyperhidrosis, Hyperventilation, Hypopnoea, Muscle twitching; Pallor, Ra...
Crying, Hyperhidrosis, Hyperventilation, Hypopnoea, Muscle twitching; Pallor, Rash, Syncope
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Patient experienced an adverse reaction approximately 3 minutes after receiving Immunizations while ...
Patient experienced an adverse reaction approximately 3 minutes after receiving Immunizations while mother inquiring of a rash of the upper extremities with assistance of Interpreter and Provider. After evaluating the rash, Patient was standing in front of chair interacting appropriately and suddenly became diaphoretic, dusky, shallow respirations collapsing towards floor with brief <5 sec. bilateral twitching of digits. She was assisted to the sitting chair position and then to a lying position with assistance of two additional chairs. Verbal & tactile stimulation provided, while being placed on the monitor and Oxygen therapy initiated via HFM open at 10 LPM via portable O2 tank. HR 102, SpO2 100%, RR 16 BMP, slowly regaining skin color, consciousness and respiratory efforts deep with intermittent crying spells and mild hyperventilation. Continued calm coaching of respiratory efforts with facial O2 in good position and airway patent. 911 dispatched EMS for ground transportation @ 09:47 AM. EMS arrived @ 10:00 AM. BG results 103, BP 137/84, HR 122, SpO2 100%, Awake, calm with intermittent crying spells when hearing her mother cry out to help her. 10:20 AM Sitting upright in chair, O2 removed, and ambulated from chair to stretcher with assistance for EMS ground transportation to ER for further evaluation.
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| 2852029 | 68 | F | MI | 07/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site pruritus, Injection site warmth
Injection site erythema, Injection site pruritus, Injection site warmth
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6cm x 8cm reddened area, hot to touch, itchy. This is not at the injection site but starts 5cm belo...
6cm x 8cm reddened area, hot to touch, itchy. This is not at the injection site but starts 5cm below site and medically, towards the body. No blisters
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| 2852030 | 45 | F | GA | 07/31/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UT8423KA UT8423KA |
Anaemia, Blood pressure increased, Erythema, Hypoaesthesia, Migraine; Polycystic...
Anaemia, Blood pressure increased, Erythema, Hypoaesthesia, Migraine; Polycystic ovarian syndrome, Rash, Skin discolouration, Tremor
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Sept 30 i got off work, I work night shift, we walked out and we had a choice of the Covid and Flu, ...
Sept 30 i got off work, I work night shift, we walked out and we had a choice of the Covid and Flu, and i turned down the Covid and did the Flu. I was fine the next day i felt ok. Oct 2 i was supposed to go to work and i had spot on my ankles knees and cheeks but it wasnt full body. I went to doctor but they didnt think it was anything to do with the vaccine. She gave me some cream and I went home. Oct 3 i woke up with rash and my fingers were white and numb, i was shaky, My blood pressure was up. I had a low grade temp of 99.8. I took some meds and when i went to the hospital it went down i was there for over 6 to 7 hours, and they doctors where in and out of the room, They ran allergy test, he didn't mention the Flu vaccine in his reactions and but he pulled my vaccine records. After a while i left the hospital my face was red. They told me i needed to see a specialist and they made me a referral to a Derm but i needed to talk to my PCP and get her to send her to a Cardiologist, Rheumatologist and Neurologist. I did see a Rheumatologist who said i was fine. I did see a Cardiologist who said that he is concerned. He thinks this is auto immune. They told me i have PCOS, Armenia, Migraines. I still have to go in for an MRI.
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| 2852031 | 26 | F | ME | 07/31/2025 |
HPV9 |
MERCK & CO. INC. |
Y019459 |
Dizziness, Feeling hot, Injection site haemorrhage, Injection site pain, Injecti...
Dizziness, Feeling hot, Injection site haemorrhage, Injection site pain, Injection site swelling
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Patient was given second HPV vaccine, upon receiving the vaccine patient had some bleeding, at first...
Patient was given second HPV vaccine, upon receiving the vaccine patient had some bleeding, at first this RN felt it could have been just initial from the injection itself however continued to bleed and swelled slightly at the site of the injection. Patient did not report any difficulty breathing, or throat tightness. Some tenderness on palpation of the site along with dizziness and feeling hot. Area was wrapped with coban to reduce swelling and cleaned. Patient was advised to lay down on the table and provided with an ice pack and told to remain in the room for 15 minutes to monitor for any additional reaction.
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| 2852032 | 89 | F | TN | 07/31/2025 |
UNK UNK UNK UNK VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache; Myalgia, Naus...
Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache; Myalgia, Nausea; Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache; Myalgia, Nausea; Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache; Myalgia, Nausea
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pt states she woke up next day after her vaccines and she had muscle pain, headache, chills, nausea,...
pt states she woke up next day after her vaccines and she had muscle pain, headache, chills, nausea, stomach ache, fatigue, and does not feel like herself.
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| 2852033 | 64 | F | CT | 07/31/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
946609 946609 946609 946609 946609 |
Abdominal pain, Acute myocardial infarction, Asthenia, Atrial fibrillation, Card...
Abdominal pain, Acute myocardial infarction, Asthenia, Atrial fibrillation, Cardiac failure congestive; Cardiomegaly, Chest X-ray abnormal, Chest pain, Constipation, Dyspnoea; Echocardiogram abnormal, Feeling abnormal, Heart failure with preserved ejection fraction, Hypokalaemia, Hypomagnesaemia; Myalgia, Oedema, Palpitations, Pulmonary oedema, Rhabdomyolysis; Right ventricular enlargement, Right ventricular systolic pressure increased, Vomiting
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10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admiss...
10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia. 11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started. 11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
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| 2852034 | 18 | M | UT | 07/31/2025 |
MENB MNP |
PFIZER\WYETH PFIZER\WYETH |
LL0642 LX5014 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Received Penbraya and Trumenba at same visit. Youth without symptoms.
Received Penbraya and Trumenba at same visit. Youth without symptoms.
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| 2852035 | 18 | M | UT | 07/31/2025 |
MENB MNP |
PFIZER\WYETH PFIZER\WYETH |
LL0642 LX5014 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Penbraya and Trumenba given at same visit
Penbraya and Trumenba given at same visit
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| 2852036 | 65 | F | NC | 07/31/2025 |
PNC20 UNK |
PFIZER\WYETH UNKNOWN MANUFACTURER |
LP4948 |
Erythema, Pruritus; Erythema, Pruritus
Erythema, Pruritus; Erythema, Pruritus
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here for an acute visit ON 7/23/2025 c/o redness, itching in right arm after Prevnar 20 vaccine. No ...
here for an acute visit ON 7/23/2025 c/o redness, itching in right arm after Prevnar 20 vaccine. No fever/chills/body aches, no wheezing or breathing problems, no swelling in mouth/lips. Redness has been spreading down her arm, used ice pack for the first 2 days, no longer using, staying active.
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