| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2825249 | U | 02/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; still got them/Shingles; This serious case was reported by a consumer...
Suspected vaccination failure; still got them/Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got my shingle shots and still got them). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got shingle shots and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2825250 | U | 02/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got the shots and had shingles right now. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2825251 | M | 02/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
suspected vaccination failure; he got the shingles; This serious case was reported by a consumer via...
suspected vaccination failure; he got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. Reporter's husband got the Shingles shot and a few years later he got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2825252 | U | 02/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise, Pyrexia
Malaise, Pyrexia
|
Ive never been so sick in my life; 104 temp for days; This non-serious case was reported by a consum...
Ive never been so sick in my life; 104 temp for days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Ive never been so sick in my life) and fever (Verbatim: 104 temp for days). The outcome of the sickness was not reported and the outcome of the fever was resolved. It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine. It was unknown if the company considered the sickness and fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-FEB-2025 The case was received from the patient via interactive digital media. The reporter had never been so sick in his/her life. The reporter reported that the second vaccine nearly killed him/her. The reporter had 104 temperature for days. The reporter thought the first dose was bad, but the second shot was horrible. The reporter reported that beware and plan round being sick.
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| 2825253 | U | 02/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Fatigue
Fatigue
|
tiredness; This non-serious case was reported by a consumer via interactive digital media and descri...
tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness). The outcome of the tiredness was not reported. It was unknown if the reporter considered the tiredness to be related to Arexvy. It was unknown if the company considered the tiredness to be related to Arexvy. Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had received a dose Arexvy vaccine and experienced tiredness. The reporter had a question how long was tiredness.
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| 2825255 | 75 | M | ME | 02/07/2025 |
COVID19 |
MODERNA |
3044202 |
Chest tube insertion, Computerised tomogram thorax abnormal, Dyspnoea, Pneumotho...
Chest tube insertion, Computerised tomogram thorax abnormal, Dyspnoea, Pneumothorax spontaneous, Pulmonary embolism
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presented with progressive shortness of breath, found to have spontaneous pneumothorax and pulmonary...
presented with progressive shortness of breath, found to have spontaneous pneumothorax and pulmonary emboli superimposed on his chronic interstitial lung disease
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โ | โ | ||||
| 2825256 | 17 | F | MA | 02/07/2025 |
FLU3 |
SEQIRUS, INC. |
388532 |
Product substitution error
Product substitution error
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Private vaccine supplied influenza vaccine given instead of state supplied influenza vaccine. Corre...
Private vaccine supplied influenza vaccine given instead of state supplied influenza vaccine. Correct vaccine, correct dose, just incorrect stock.
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| 2825257 | 50 | F | NC | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Injection site rash, Pain, Pain in extremity, Peripheral swelling
Injection site rash, Pain, Pain in extremity, Peripheral swelling
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Patient reported a sore arm that was painful to move and swelling. A large red rash around 4-4.5 in...
Patient reported a sore arm that was painful to move and swelling. A large red rash around 4-4.5 inches in diameter was reported around the vaccination site. Patient did not report a fever, but was concerned about cellulitis
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| 2825258 | 73 | F | MI | 02/07/2025 |
COVID19 |
PFIZER\BIONTECH |
GH9703 |
COVID-19 pneumonia, Dyspnoea, Hypoxia, Respiratory failure
COVID-19 pneumonia, Dyspnoea, Hypoxia, Respiratory failure
|
Name: Medical Record #: Age: 75 y.o. DOB: Admit date: 1/28/2025 Discharge date: 1/31/2025...
Name: Medical Record #: Age: 75 y.o. DOB: Admit date: 1/28/2025 Discharge date: 1/31/2025 Attending Physician at the Time of Discharge: DO Primary Care Physician: DO Reason for Admission: hypoxia Brief Summary of Hospital Stay: 75 y.o. female with ESRD on hemodialysis presented to ED with difficulty breathing. Admitted with covid infection causing acute hypoxic respiratory insufficiency. She was started on dexamethasone with gradual improvement. She underwent usual hemodialysis while admitted. Problem list: Acute respiratory insufficiency with hypoxia due to covid pneumonia -dexamethasone through 2/4 -guaifenesin, incentive spirometry, mobilize ESRD on hemodialysis -T/Th/Sat Coronary artery disease -aspirin, atorvastatin -metoprolol, Imdur Hypertension -amlodipine Diabetes mellitus type 2 -increase tresiba to 15U while on decadron, back to 8U after -home humalog Hypothyroid -levothyroxine Although leaving today, this patient will require ongoing assessment and treatment, with adjustments to the plan as appropriate. Medicine is complicated and unforseen changes in status may occur. Discharged to Home.
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| 2825259 | 59 | F | MI | 02/07/2025 |
FLU3 |
SEQIRUS, INC. |
388487 |
Incorrect dose administered
Incorrect dose administered
|
Patient was incorrectly given a High dose influenza vaccine instead of a regular dose influenza vacc...
Patient was incorrectly given a High dose influenza vaccine instead of a regular dose influenza vaccination for the season.
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| 2825260 | 55 | F | MI | 02/07/2025 |
COVID19 |
MODERNA |
004M20A |
COVID-19, Chest X-ray normal, Haemodialysis, Nausea, Vomiting
COVID-19, Chest X-ray normal, Haemodialysis, Nausea, Vomiting
|
Name: Medical Record #: Age: 59 y.o. DOB: Admit date: 2/1/2025 Discharge date: 02/03/2025 ...
Name: Medical Record #: Age: 59 y.o. DOB: Admit date: 2/1/2025 Discharge date: 02/03/2025 Admitting Physician: MD Attending Physician at the Time of Discharge: MD Primary Care Physician: PAC Reason for Admission: Nausea/vomiting Hospital Course: This is a 59-year-old female with significant history of ESRD on HD TTS, type 2 diabetes, and hypertension who presented due to intractable nausea/vomiting. Workup was significant for COVID-19 infection. Nausea and vomiting improved with antiemetic therapy. Patient was not hypoxemic during hospitalization. Chest x-ray did not demonstrate any infiltrates. Patient was started on remdesivir while inpatient. Prior to discharge, patient was able to ambulate and did not desaturate. Hemodialysis schedule was kept while inpatient. Disposition upon discharge is stable and improving. Patient was discharged with Tessalon Perles and Atrovent for supportive care for COVID-19 infection. Patient was provided with a work note per her request. Discharged to Home.
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โ | |||||
| 2825261 | 75 | M | MI | 02/07/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FE3590 FE3590 FE3590 FE3590 |
Atrial flutter, Bundle branch block left, Bundle branch block right, COVID-19, C...
Atrial flutter, Bundle branch block left, Bundle branch block right, COVID-19, Cardioversion; Chest X-ray normal, Cough, Dyspnoea, Electrocardiogram QRS complex prolonged, Electrocardiogram T wave abnormal; Hypokalaemia, Influenza, Influenza A virus test positive, SARS-CoV-2 test positive, Supraventricular tachycardia; Troponin increased
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Name: Age: 78 y.o. Admit date: 1/30/2025 Discharge date: Feb 3, 2025 Attending Physician at t...
Name: Age: 78 y.o. Admit date: 1/30/2025 Discharge date: Feb 3, 2025 Attending Physician at the Time of Discharge: MD Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER. ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable. Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission. Brief Summary of Hospital Stay: Principal Problem: Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis. CXR neg. F/u Cardiologist Dr. Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter. COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia. Hypokalemia - replaced. Active Problems: Chronic renal insufficiency -CKD 3a - stable. Benign paroxysmal positional vertigo Dyslipidemia associated with type 2 diabetes mellitus - on statin. Essential hypertension - monitor BP. Hypothyroid - TSH ok. On synthroid. Malignant neoplasm of prostate - stable. On flomax. Diabetes mellitus - BS stable. Resume home meds. The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home.
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| 2825262 | 75 | M | AR | 02/07/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
COVID-19, Death, Dyspnoea, Intensive care, Pulse absent; Respiratory arrest
COVID-19, Death, Dyspnoea, Intensive care, Pulse absent; Respiratory arrest
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Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patien...
Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patient stopoped breathing and no pulse. Transfer to ICU. Expired 2/7 2:25
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โ | โ | ||||
| 2825263 | 59 | F | NY | 02/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
025J20A 025J20A 025J20A |
Atrial fibrillation, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, D...
Atrial fibrillation, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, Dizziness; Echocardiogram, Electrocardiogram, Heart rate irregular, Left ventricular hypertrophy, Loss of consciousness; Magnetic resonance imaging heart
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after taking my second dose i started feeling light headed off and on but didnot think it was covid ...
after taking my second dose i started feeling light headed off and on but didnot think it was covid vaccine. I was always healthy. I had to get booster and it was even worse. I ended up passing out . I went to drs in january 2023 and she recomended me see a cardiologist. After getting EKg, heart ultrasound and MRI i found out i had Cadiomyopathy hypertrophic. irregular heart beat and thickening in left valve. Never had issues before
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| 2825264 | 11 | F | IN | 02/07/2025 |
MNQ |
SANOFI PASTEUR |
U8194AA |
Dizziness, Loss of consciousness
Dizziness, Loss of consciousness
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PT WAS TERRIFIED OF NEEDLES. SAID SHE WOULD THROW UP, GAGGED BUT DIDN'T THROW UP. SAID SHE WOUL...
PT WAS TERRIFIED OF NEEDLES. SAID SHE WOULD THROW UP, GAGGED BUT DIDN'T THROW UP. SAID SHE WOULD PASS OUT. AFTER 20 MINUTES OF TRYING TO CALM HER, THE VACCINE WAS ADMINISTERED. ABOUT A MINUTE LATER SHE PASSED OUT IN MOM'S ARMS. I LAID HER ON THE FLOOR AND ELEVATED HER FEET. CHECK HER BREATHING WHICH WAS FINE. WAS GETTING THE SMELLING SALTS WHEN SHE WOKE UP AND ASKED WHY SHE WAS ON THE FLOOR. SHE ASKED FOR A DRINK, GAVE HER A BOTTLE OF WATER. AFTER A COUPLE MINUTES I ALLLOWED TO SIT UP ON THE FLOOR. SHE WAS A LITTLE DIZZY SO SHE STAYED THERE FOR SEVERAL MINUTES THEN MOVED TO A CHAIR. I GAVE HER SOME CHOCOLATE CANDY. AFTER ABOUT 15 MINUTES SHE WAS FEELING WELL ENOUGH TO WALK AND LEAVE.
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| 2825265 | 0.5 | M | NE | 02/07/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
TC47K |
Dysstasia, Injection site nodule
Dysstasia, Injection site nodule
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leg has a knot at the injection site, infant will not stand on the left leg
leg has a knot at the injection site, infant will not stand on the left leg
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| 2825266 | 67 | M | CT | 02/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
30155BA 30155BA |
Balance disorder, Computerised tomogram head abnormal, Headache, Ischaemic strok...
Balance disorder, Computerised tomogram head abnormal, Headache, Ischaemic stroke, Malaise; Nausea
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11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent t...
11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent to ED . In ED on 11/19 was diagnosed with stoke
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โ | โ | ||||
| 2825267 | 32 | F | TX | 02/07/2025 |
FLU3 |
SEQIRUS, INC. |
AW1664A |
Arthralgia, Limb injury, Product administered at inappropriate site, X-ray limb
Arthralgia, Limb injury, Product administered at inappropriate site, X-ray limb
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1. Injury of right shoulder Received influenza vaccine on November 16, 2024 at clinic. Since then, ...
1. Injury of right shoulder Received influenza vaccine on November 16, 2024 at clinic. Since then, pt developed chronic right shoulder pain. Denied any skin changes. Otherwise, denies any previous shoulder injury/procedures. Exam today otherwise, unremarkable. No TTP around injection site. No skin changes. Pt does recall an unusual higher injection site. - will obtain right shoulder plain film to r/o any bony abnormality - referral sent to physical therapy for evaluation - clinical presentation suggestive of SIRVA (shoulder injury related to vaccine administration), which is not a contraindication for receiving flu vaccine, rather the medical staff may have given the vaccine at the subdeltoid bursa - f/u with me in February 2025 for re-assessment - return precautions provided Ordered: Referral Request 2.0 -
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| 2825268 | 8 | M | CO | 02/07/2025 |
HEPA VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
T5727 Y011017 |
Circumstance or information capable of leading to medication error; Circumstance...
Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error
More
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Pt received un-needed vaccines due to getting confused with another pt. Mother was notified of event...
Pt received un-needed vaccines due to getting confused with another pt. Mother was notified of event, and spoke with provider after receiving vaccines.
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| 2825269 | 1 | F | PA | 02/07/2025 |
VARCEL |
MERCK & CO. INC. |
Y004555 |
Culture wound negative, Herpes simplex test negative, Rash, Rash vesicular, Vari...
Culture wound negative, Herpes simplex test negative, Rash, Rash vesicular, Varicella virus test positive
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On 2/4 started with vesicular rash on left arm which spread down the left arm to left hand
On 2/4 started with vesicular rash on left arm which spread down the left arm to left hand
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| 2825270 | 64 | F | MT | 02/07/2025 |
PNC20 |
PFIZER\WYETH |
0005-2000-02 |
Rash, Rash pruritic
Rash, Rash pruritic
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The only reaction I have had as of today is a small and some what itchy rash on parts of my right an...
The only reaction I have had as of today is a small and some what itchy rash on parts of my right and left leg, under my left breast, as well as my left side of my abdomen. Also small amount on my lower back. I felt fine after I received Prevnar 20 vaccine and I feel fine now. The rash is bothersome but not painful.
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| 2825271 | 11 | M | NC | 02/07/2025 |
HEPA HPV9 MNQ TDAP |
MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y011731 Y008119 7GF79 3RE73 |
Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection s...
Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous
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rt upper arm noted with red rash above injection site and warm to touch. cheeks also red with raised...
rt upper arm noted with red rash above injection site and warm to touch. cheeks also red with raised rash. ice pack applied to arm. 15 minute recheck by provider revealed arm rash almost gone and no longer warm to touch but cheeks still red. No difficulty breathing. mom states after rash started that she thinks she remembers that child had the same reaction to Hep A vaccine when he received the 1st dose. Provider instructed mom to give a zyrtec before bed.
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| 2825272 | 0.42 | M | NE | 02/07/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
TC47K |
Injection site erythema, Pyrexia
Injection site erythema, Pyrexia
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mother states pt has little red spots at injection sites- has fever of 105 (over)
mother states pt has little red spots at injection sites- has fever of 105 (over)
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| 2825273 | 29 | F | VT | 02/07/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y000205 CX4HL |
Erythema, Injection site induration, Pruritus, Skin disorder, Swelling; Erythema...
Erythema, Injection site induration, Pruritus, Skin disorder, Swelling; Erythema, Injection site induration, Pruritus, Skin disorder, Swelling
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Patient reports "red bulls' eye (similar to Lyme disease), bubbling up under the skin, swe...
Patient reports "red bulls' eye (similar to Lyme disease), bubbling up under the skin, swelling, itchiness, that lasted about a week hen went away. Now, there is a hard feeling under the skin that is the size of a pea that can be felt, on the left side of the arm at the injection site." Patient believes this is from the HPV vaccine, however, the TDAP vaccine was recorded as being given on this site. Patient declines any fevers, chills. Used Hydrocortisone cream on the area. Declined ED/EC visit.
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| 2825274 | 37 | M | 02/07/2025 |
FLU3 FLU3 HEPA HEPA IPV IPV TDAP TDAP VARCEL VARCEL |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
p224h p224h 2345b 2345b x1c891m x1c891m u8232aa u8232aa y007637 y007637 |
Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; S...
Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope
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Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only...
Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only one day on 1/24/2025, and some swelling on his left arm from 1/24/2025 to 1/27/2025. Pt stated he had one episode of fainting on 1/26/2025 in the morning. Pt stated at the ER, he had lab drawn, chest xray, and was told by the doctor all the results were normal. Pt stated he was told by the ER doctor that he had reaction due to receiving multiple vaccinations and he was not told of any allergic reaction.
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| 2825275 | 0.83 | M | DE | 02/07/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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third dose of Covid-19 vaccine administered one month too early. This dose, therefore, dose not coun...
third dose of Covid-19 vaccine administered one month too early. This dose, therefore, dose not count towards the primary series. Discussed and informed parents of administration error on 2/7/2025.
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| 2825276 | 57 | F | ID | 02/07/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Pain in extremity, Restlessness; Chills, Pain in extremity, Restlessness
Chills, Pain in extremity, Restlessness; Chills, Pain in extremity, Restlessness
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Pain in arm, shivering all night, super restless, I took Tylenol last night and this morning more ma...
Pain in arm, shivering all night, super restless, I took Tylenol last night and this morning more manageable but still there
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| 2825277 | 18 | F | CO | 02/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
42B22 |
Wrong product administered
Wrong product administered
|
Patient given the incorrect vaccine
Patient given the incorrect vaccine
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| 2825278 | 16 | M | CO | 02/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
42B22 |
Wrong product administered
Wrong product administered
|
Incorrect vaccine given
Incorrect vaccine given
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| 2825279 | 11 | M | FL | 02/07/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
X4T99 9YB4G |
Injection site discharge, Injection site induration, Injection site pain, Inject...
Injection site discharge, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site discharge, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
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Patient noticed a small bump on left deltoid, mom popped it and it drained clear water. Since then a...
Patient noticed a small bump on left deltoid, mom popped it and it drained clear water. Since then area has been tender, hard to palpated with distinct localized area. Area warm and hard to touch, induration. Per patient, was painful until this morning. Denies pain when provider touch. Start mupirocin 2 % topical ointment 1 application 2 times a day for 15 days Start clindamycin HCL 300 mg capsule 150 mg 3 times a day as directed for 5 days
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| 2825280 | F | IN | 02/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site pain
Injection site pain
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Pain in injection area; This non-serious case was reported by a consumer via call center representat...
Pain in injection area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in injection area). The outcome of the injection site pain was resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Patient was the reporter. Patient received her 1st Shingrix vaccine in October 2023 in the right arm and has had intense pain since receiving the vaccine. Patient stated she received the 2nd vaccine in January 2024 in the left arm and had not had any pain. Patient had reached out to her health professional and the pain was ongoing.
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| 2825281 | 78 | M | IA | 02/07/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Abdominal distension, Arthralgia, Injection site bruising, Injection site discol...
Abdominal distension, Arthralgia, Injection site bruising, Injection site discolouration, Malaise
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Client reports pain and swelling at injection site along with some malaise starting after vaccinatio...
Client reports pain and swelling at injection site along with some malaise starting after vaccination on 12/18/24. Developed bruising to injection area. Client used analgesics and ice to area. Client stopped in to office today to show left arm to staff. Left upper arm has old bruising- yellow/purple in color. No warmth or redness known. Area of swelling closer to inner area just above elbow is noted by this author but he states that is not a new issue since vaccination. Reports no further discomfort but was concerned as bruising, although appears to be dissipating, remains after >45 days. Advised to continue to monitor and utilize heat/ice if necessary. See healthcare provider if concerns persist or symptoms worsen. Will discuss further COVID vaccinations with his healthcare provider and this agency. Patient verbalizes understanding, agrees with plan of care and intends to comply.
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| 2825282 | 75 | F | OH | 02/07/2025 |
COVID19 COVID19 FLU3 FLU3 RSV RSV COVID19 COVID19 FLU3 FLU3 RSV RSV |
NOVAVAX NOVAVAX SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH |
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Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursit...
Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling
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Don?t know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol w...
Don?t know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol was prescribed.
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| 2825283 | 4 | F | AK | 02/07/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
5H95B X011431 Y013350 |
Product storage error; Product storage error; Product storage error
Product storage error; Product storage error; Product storage error
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Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use. This did not include MMR and Variceela
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| 2825284 | 77 | F | FL | 02/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
JB272A |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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It was discovered after the fact that this patient had already received a dose if the Arexvy vaccine...
It was discovered after the fact that this patient had already received a dose if the Arexvy vaccine on 10/05/2023. Patient has not had any adverse reactions and is aware that she received two doses and does not ever need another dose.
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| 2825285 | 42 | F | AK | 02/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
CX4HL |
Product storage error
Product storage error
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Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2825286 | 30 | M | 02/07/2025 |
COVID19 |
NOVAVAX |
6024MF020 |
Expired product administered
Expired product administered
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Expired vaccine administered. Vaccine was expired by 3 days.
Expired vaccine administered. Vaccine was expired by 3 days.
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| 2825287 | 0.33 | M | SC | 02/07/2025 |
HIBV HIBV IPV IPV RV5 RV5 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
UK016AC UK016AC W1C741M W1C741M Y011483 Y011483 |
C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram he...
C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased; C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased; C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased
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Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted t...
Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted to ICU.
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| 2825288 | 85 | F | MI | 02/07/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
BH57H |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None, nurse was supposed to give a Tdap and instead gave a Dtap
None, nurse was supposed to give a Tdap and instead gave a Dtap
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| 2825289 | 91 | F | FL | 02/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
No adverse event
No adverse event
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n/a nothing reported from patient or her daughter when called
n/a nothing reported from patient or her daughter when called
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| 2825290 | 0.33 | M | CT | 02/07/2025 |
DTAPIPV HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
42Y93 UK0422A HH590 2032353 |
Agitation, Infant irritability, Product administered to patient of inappropriate...
Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age
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Patient received 1 dose of DTAP-IVP Kinrix which is designated for ages 4-6 and he is 4 months old. ...
Patient received 1 dose of DTAP-IVP Kinrix which is designated for ages 4-6 and he is 4 months old. The error was not known until 01/24/25 when I spoke with the physician when it did not appear on patient's medical record, (technical issues on the facilitie's part). I contacted GSK, obtained the following information: Inadvertent use of Kinrix in children younger then 4 years, immunogenicity & safety. I then phoned mother of child, informed her of the error and common side effects, agitation and irritabiity. She reported the patient had experienced these. I notified her that the doses were valid and would not need to be repeated and to call for further concerns. Today, she reports the patient is fine, doing well and had no further adverse side effects.
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| 2825291 | 1.33 | F | CA | 02/07/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9KB9G |
Erythema, Injection site erythema, Peripheral swelling, Rash
Erythema, Injection site erythema, Peripheral swelling, Rash
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localized erythema on Left thigh, followed by erythema and swelling extending to Left foot and then ...
localized erythema on Left thigh, followed by erythema and swelling extending to Left foot and then to Right foot and then diffuse rash to trunk/ body
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| 2825292 | 0.58 | M | MI | 02/07/2025 |
DTAPIPVHIB PNC21 RV5 |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
UJ202AA Y011819 2032352 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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PCV 21 given instead of PCV 15
PCV 21 given instead of PCV 15
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| 2825293 | 11 | M | ID | 02/07/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
7GF79 3CA17C1 |
Dizziness, Pallor; Dizziness, Pallor
Dizziness, Pallor; Dizziness, Pallor
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Patient had a Meningococcal vaccine and a T-dap vaccine today. After those vaccines, patient became...
Patient had a Meningococcal vaccine and a T-dap vaccine today. After those vaccines, patient became light headed and pale. He did not LOC at all. He laid down for about 15 min and then started feeling better. His mother stated that he works him self up before vaccines and this is probably the issue. Dr. evaluated the patient and felt like he was doing much better after the 15 min and assessment was done by MD. Tried to call the patient's mother to check up on him. No answer, but I left a message to call us back for an update .RN
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| 2825294 | 82 | F | AL | 02/07/2025 |
FLU3 PNC20 |
SEQIRUS, INC. PFIZER\WYETH |
388478 LG5573 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient received Prevnar 20 and had already received this shot 12/28/2022 and 8/1/2023 but shots did...
Patient received Prevnar 20 and had already received this shot 12/28/2022 and 8/1/2023 but shots did not show on immprint.
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| 2825295 | 1 | M | AR | 02/07/2025 |
VARCEL |
MERCK & CO. INC. |
Y013347 |
Erythema, Induration, Skin lesion, Skin warm
Erythema, Induration, Skin lesion, Skin warm
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Patient is a 13 m.o. male brought by mother presenting with a red, hard area to the leg. He got sho...
Patient is a 13 m.o. male brought by mother presenting with a red, hard area to the leg. He got shots (12 mos) about 11 days ago and mom not sure if it was in the exact same area but he had a smaller lesion up until 4 days ago, then it worsened and got red, warm.
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| 2825296 | 86 | F | PA | 02/07/2025 |
COVID19 |
MODERNA |
3043835 |
Injection site pain, Injection site reaction, Limb discomfort, Pain, Tenderness
Injection site pain, Injection site reaction, Limb discomfort, Pain, Tenderness
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Heaviness and pain in deltoid at site of vaccination. Raising arm hurts, touching arm hurts, and ev...
Heaviness and pain in deltoid at site of vaccination. Raising arm hurts, touching arm hurts, and even just sitting still it aches. Hot water bottle did not help. She's had it against all night, It didn't help. She also took 2 Tylenol last night cause it was so painful but it didn't help.
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| 2825297 | 82 | F | ID | 02/07/2025 |
FLU3 |
SANOFI PASTEUR |
49281-124-65 |
Injection site pain, Shoulder injury related to vaccine administration, X-ray li...
Injection site pain, Shoulder injury related to vaccine administration, X-ray limb
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shoulder injury related to vaccine administration (SIRVA) S49.80xA, pain in the left deltoid startin...
shoulder injury related to vaccine administration (SIRVA) S49.80xA, pain in the left deltoid starting about 48 hours after vaccination and persisting, no other apparent cause.
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| 2825298 | U | AZ | 02/07/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
4777F |
Product preparation issue
Product preparation issue
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only been administered with the saline solution; only been administered with the saline solution; Th...
only been administered with the saline solution; only been administered with the saline solution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only been administered with the saline solution) and inappropriate dose of vaccine administered (Verbatim: only been administered with the saline solution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Reporter stated that six different patients received a Hiberix vaccine and two of them had only been administered with the saline solution. Reporter did not know which were the two patients that received the full dose. Vaccination date was asked, nevertheless the reporter mentioned it occurred between September and December of last year (twenty-twenty four). They asked about any concerning information regarding safety, or if they have to readminister those two doses. No patient demographics were provided and no further information was provided. The patients received only saline solution of Hiberix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2825299 | 2 | M | WI | 02/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 2XK44 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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No adverse events known to date
No adverse events known to date
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