| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2821757 | 70 | M | AZ | 01/20/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FJ8762 FJ8762 |
Acute kidney injury, Asthenia, Breakthrough COVID-19, Dysstasia, Electrolyte imb...
Acute kidney injury, Asthenia, Breakthrough COVID-19, Dysstasia, Electrolyte imbalance; SARS-CoV-2 test positive, Upper respiratory tract infection, Ventilation/perfusion scan normal
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Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient presented to the ED due to generalized weakness. He travelled last week, fell sick with URI and then developed generalized weakness on Sat 6/29/24, when he had difficulty standing up. He tested positive for COVID-19 and was found to have AKI and multiple electrolyte abnormalities. Was started on remdesivir, dexamethasone, and IV fluids. Pt improved throughout 3 days and was discharged home. Other Relevant HX: 73-year-old gentleman with a history of HTN, HLD, CKD, CAD, BPH, and anemis who presented to the ER with generalized weakness. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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โ | |||||
| 2821758 | 28 | M | AZ | 01/20/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8735 ER8735 ER8735 ER8735 |
Breakthrough COVID-19, Chest X-ray normal, Chest pain, Computerised tomogram tho...
Breakthrough COVID-19, Chest X-ray normal, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal; Ejection fraction normal, Electrocardiogram ST-T change, Electrocardiogram T wave inversion, Hypophagia, Increased viscosity of bronchial secretion; Nausea, Pain, Presyncope, Productive cough, SARS-CoV-2 test positive; Scan with contrast normal, Sputum discoloured, Viral cardiomyopathy
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was recently diagnosed with COVID-19 about a week ago and being watched at home. She continues to have cough productive of whitish phlegm but sometimes has dark and thick mucus with it. Today, after a prolonged bout of coughing at home and nearly passing out from it, she decided to come to ED. Has not been eating well or drinking enough in past 3 days due to nausea. Cough provokes soreness of the body and chest pain but denies SOB, orthopnea or new leg swelling. ED evaluation was unremarkable including CXR, but the ECG showed new changes including diffuse ST/T changes involving Inferior leads and T-inversion in the anterior-lateral leads. ECG changes thought to be most likely secondary to COVID19 viral cardiomyopathy. Patient was started on dexamethasone x 7 days in the hospital and was discharged to home. Other Relevant HX: Transgender female with a significant past medical history of PTSD, recurrent major depressive disorder (MDD), asthma, and cannabis dependence, presented to the Emergency Department (ED) after nearly passing out from a prolonged bout of coughing. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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โ | |||||
| 2821759 | 79 | M | AZ | 01/20/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
|
Arthralgia, COVID-19, Cellulitis, Condition aggravated, Dyspnoea; Gout, Hypervol...
Arthralgia, COVID-19, Cellulitis, Condition aggravated, Dyspnoea; Gout, Hypervolaemia, Intensive care, Polyuria, Productive cough; SARS-CoV-2 test positive
More
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Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: Patient was admitted on A...
Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: Patient was admitted on AUG 13, 2024@23:24:54 and discharged Aug 30,2024 Patient is a 83 year old MALE w PMH significant for recent septic shock (Group A strep) due to RLE cellulitis/necrotic ulcer s/p debridement (on vanc and cipro), HFpEF (no records), Afib (on no AC), AAA 4.3cm, COPD, lymphedema, gout who presented to the facility as a transfer from another hospital for celluitus/placement upon discharge. Patient was volume overloaded on admission and aggressively diuresed until he became euvolemic. His R knee pain was treated for gout and eventually improved. Patient became dyspneic with increased cough/sputum and oxygen requirements. He tested positive for COVID and upgraded to ICU for HFNC. He was seen by palliative care who thought the patient did not meet hospice requirements. He was treated with abx and treated with remdesivir/dexamethasone for COVID-19. Pt was discharged back to the hospital facility when he was medically stable. Other Relevant HX: PMH of #acute hypoxic resp failure/ARDS - secondary to COVID pneumonia and HAP- improving #Multilobar Klebsiella Enterobacter PNA with elevated PCT and CRP #Severe pulmonary HTN #COVID + #Hospital acquired pneumonia #COPD #RLE weakness-injury vs deconditioning #RLE cellulitis and necrotic ulcer sp debridement and IV abx #Bilateral Lymphedema #Gout #R knee pain #Septic shock due to group A strep-resolved #HFpEF #Afib #bradycardia #sacral wound #Pancreatic mass #Constipation #HTN #BPH Other: Covid-19 infection during hospitalization
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โ | |||||
| 2821760 | 71 | M | AZ | 01/20/2025 |
COVID19-2 |
PFIZER\BIONTECH |
HF5017 |
Breakthrough COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
Breakthrough COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
|
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for worsening faitgue and cough, found to be COVID + and hospitalized for COVID treatment. Discharged home without complications. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
More
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โ | |||||
| 2821761 | 78 | F | AZ | 01/20/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
|
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Discharged home Other Relevant HX: Other: : Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
More
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| 2821762 | 1.42 | F | FL | 01/20/2025 |
HEPA |
MERCK & CO. INC. |
Y006121 |
Peripheral swelling
Peripheral swelling
|
7 hours following vaccination with hepatitis A vaccine patient started developing significant swelli...
7 hours following vaccination with hepatitis A vaccine patient started developing significant swelling in her hands and in her feet and lower legs.
More
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| 2821820 | 16 | M | MI | 01/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB044A |
No adverse event
No adverse event
|
none he had no reaction
none he had no reaction
|
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| 2821821 | 84 | F | OH | 01/20/2025 |
COVID19 |
MODERNA |
029L2012 |
Pain in extremity
Pain in extremity
|
arms 1 vaccine in each arm pain in location 3 years getting worse
arms 1 vaccine in each arm pain in location 3 years getting worse
|
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| 2821822 | 1.25 | M | ID | 01/20/2025 |
DTAPIPVHIB HEPA |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UK043AA Y011643 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
Patient was given a second Hep A vaccine that was not supposed to be given. He was to get a Prevnar,...
Patient was given a second Hep A vaccine that was not supposed to be given. He was to get a Prevnar, but a Hep A was accidentally pulled and administered instead.
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| 2821823 | 62 | F | VA | 01/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Paraesthesia, Vertigo
Paraesthesia, Vertigo
|
(Personal hx shingles 2009 affecting right side of head/face, tx zovirax within 1st hr of 1st lesion...
(Personal hx shingles 2009 affecting right side of head/face, tx zovirax within 1st hr of 1st lesion and limited to 3 lesions. ) Post vax day 2, unexpected vertigo late afternoon, seemingly left leaning resolved after full night's sleep. No fevers or chills. Post vax day 3 noted tingling scalp occipital area, along single line of where I had shingles 2009, but no actual lesions noted, just tingling.
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| 2821824 | 63 | F | FL | 01/20/2025 |
MMR |
MERCK & CO. INC. |
y009430 |
Extra dose administered
Extra dose administered
|
Additional dose administered
Additional dose administered
|
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| 2821825 | 41 | F | MA | 01/20/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
FP9TJ |
No adverse event, Underdose
No adverse event, Underdose
|
Adult patient was administered a pediatric dose in error . Patient was informed and the provider was...
Adult patient was administered a pediatric dose in error . Patient was informed and the provider was informed. No side effects or adverse effect noted. Patient will be booked for an appointment for the full dose
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| 2821826 | 26 | M | MN | 01/20/2025 |
FLU3 FLU3 TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Cough, Fatigue, Influenza virus test negative, Oropharyngeal pain, Pyrexia; SARS...
Cough, Fatigue, Influenza virus test negative, Oropharyngeal pain, Pyrexia; SARS-CoV-2 test negative; Cough, Fatigue, Influenza virus test negative, Oropharyngeal pain, Pyrexia; SARS-CoV-2 test negative
More
|
Fever, fatigue, cough, sore throat
Fever, fatigue, cough, sore throat
|
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| 2821827 | 75 | F | TX | 01/20/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
LP1780 LP1780 LP1780 LP1780 |
Blood pressure increased; Blood pressure increased, Dizziness; Blood pressure in...
Blood pressure increased; Blood pressure increased, Dizziness; Blood pressure increased; Blood pressure increased, Dizziness
More
|
12/23/24 elevated BP started 1/7/2025 172/106; BP still variable
12/23/24 elevated BP started 1/7/2025 172/106; BP still variable
|
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| 2821828 | 34 | F | CA | 01/20/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Feeling of body temperature change, Paraesthesia
Feeling of body temperature change, Paraesthesia
|
Left arm, face and leg paresthesia with preserved reflexes, altered temperature sensation within 10...
Left arm, face and leg paresthesia with preserved reflexes, altered temperature sensation within 10 minutes or administration.
More
|
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| 2821829 | 0.5 | M | CO | 01/20/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK044AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
Patient was in for 6 month wcc. And provider ordered a Pentacel, patient was then given the pentacel...
Patient was in for 6 month wcc. And provider ordered a Pentacel, patient was then given the pentacel but the vaccine vials were not mixed and was only given the Dtap and Polio portion. MOC was notified the same day about the vaccine error and informed to come back at earliest convience to recieve the HIB portion of the vaccine. MOC states that she will come back within the next 1-2 weeks to recieve vaccine. There were no additional side affects presented by parents after recieving vaccine.
More
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| 2821830 | 1 | M | AR | 01/20/2025 |
HEPA HEPA HIBV HIBV MMR MMR PNC20 PNC20 VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
BM4R5 BM4R5 UJ992AA UJ992AA X026329 X026329 HP7365 HP7365 X026319 X026319 |
Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Inject...
Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling; Malaise, Milk allergy, Rash vesicular, Vomiting; Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling; Malaise, Milk allergy, Rash vesicular, Vomiting; Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling; Malaise, Milk allergy, Rash vesicular, Vomiting; Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling; Malaise, Milk allergy, Rash vesicular, Vomiting; Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling; Malaise, Milk allergy, Rash vesicular, Vomiting
More
|
Patient was very sick for about two weeks after receiving this round of shots, left leg was swollen ...
Patient was very sick for about two weeks after receiving this round of shots, left leg was swollen and broke out in a terrible spotty rash, almost looked like chicken pox. I have photos that can be attached. He was very tired, lots of throwing up. I spoke with the mother of patient and she said she was told that this was normal. I do not believe that it is and he was very sick. He has been sick multiple times since receiving this round of shots.
More
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| 2821831 | 64 | M | NY | 01/20/2025 |
PNC20 RSV |
PFIZER\WYETH PFIZER\WYETH |
lg5579 ln5466 |
Palpitations; Palpitations
Palpitations; Palpitations
|
experienced palpitations for a few days after vaccination
experienced palpitations for a few days after vaccination
|
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| 2821833 | 1.25 | F | MI | 01/20/2025 |
DTAP HIBV PNC20 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH |
3CA11C1 UK019AA LJ5281 |
Unevaluable event; Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event; Unevaluable event
|
NONE NOTED
NONE NOTED
|
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| 2821834 | 58 | M | MO | 01/20/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0172 |
Pain in extremity, Peripheral swelling
Pain in extremity, Peripheral swelling
|
Swollen and sore arm
Swollen and sore arm
|
โ | |||||
| 2821835 | 14 | F | NJ | 01/20/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4LM54 |
Extra dose administered
Extra dose administered
|
Pt received a second dose of flu by mistake. First dose was on 11/2024
Pt received a second dose of flu by mistake. First dose was on 11/2024
|
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| 2821836 | 19 | F | OH | 01/20/2025 |
COVID19 |
MODERNA |
|
Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy test
Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy test
|
3 miscarriages after vaccines. 1st vaccine: 02/26/2021, miscarriage 07/2021, 2nd vaccine: 9/15/2021,...
3 miscarriages after vaccines. 1st vaccine: 02/26/2021, miscarriage 07/2021, 2nd vaccine: 9/15/2021, 3rd vaccine: 10/13/2021, 2nd miscarriage 01/2022, 3rd miscarriage: 05/2022
More
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| 2821837 | 89 | F | FL | 01/20/2025 |
FLU3 |
SEQIRUS, INC. |
946591 |
Death
Death
|
Resident had Flu and Prevnar 20 vaccine on 1/18/2025 at around 9am
Resident had Flu and Prevnar 20 vaccine on 1/18/2025 at around 9am
|
โ | |||||
| 2821838 | 0.17 | F | OH | 01/20/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK137AA |
Wrong product administered
Wrong product administered
|
Patient should have received Pediarix, I accidentally gave the Pentacel . My fault. Was thinking i...
Patient should have received Pediarix, I accidentally gave the Pentacel . My fault. Was thinking it contained the Hepatitis b instead of the Hib.
More
|
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| 2821839 | 74 | F | FL | 01/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Gave RSV shot not realizing that she had already received on 9/22/23. Talked to patient, and she did...
Gave RSV shot not realizing that she had already received on 9/22/23. Talked to patient, and she did not feal any different and is fine.
More
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| 2821840 | 84 | F | NC | 01/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
D5AP5 |
Injection site pain, Muscular weakness, X-ray
Injection site pain, Muscular weakness, X-ray
|
Patient called and spoke to pharmacist on 1/20/25 to report had noticed arm pain in Right arm in whe...
Patient called and spoke to pharmacist on 1/20/25 to report had noticed arm pain in Right arm in where she received 2nd shingrix vaccine on 9/12/24. System has reported as administration into Left arm but patient states remembers getting in right arm since she had a previous masectomy and avoids getting vaccines in left arm so it was in the right arm. She went to her medical MD and they did an Xray since pain was not resolving and patient then was referred to physical therapy. Did one session of physical therapy as of last week. Patient reports weakness and pain (like a toothache where it hurts all the time) in the right arm. She is using Salonpas and takes Advil for pain. She called to report this adverse event to pharmacy
More
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| 2821841 | 65 | F | FL | 01/20/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LJ5281 LJ5281 |
Cellulitis, Erythema, Heart rate increased, Influenza like illness, Pyrexia; Ski...
Cellulitis, Erythema, Heart rate increased, Influenza like illness, Pyrexia; Skin warm, Swelling
More
|
Patient developed swelling, redness and warm to touch reaction about 3 days after shot was given. L...
Patient developed swelling, redness and warm to touch reaction about 3 days after shot was given. Later developed fever and flu like symptoms. ER Doctor diagnosed her with Cellulitis after patient went in
More
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| 2821842 | 73 | F | FL | 01/20/2025 |
FLU3 PNC20 |
SEQIRUS, INC. PFIZER\WYETH |
388488 LC5482 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Duplicate Prevnar 20 vaccine. The system did not flag previous vaccination, and it does not show the...
Duplicate Prevnar 20 vaccine. The system did not flag previous vaccination, and it does not show the 1/28/2023 vaccine in state shots. First dose was 1/28/2023, second dose given 1/16/2025.
More
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| 2821843 | 4 | M | MS | 01/20/2025 |
DTAPIPV FLU3 MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
U7931AB UT8415LA Y006783 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
More
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4.25 CM X 3.50 CM INDURATED, ERYTHEMATOUS, WARM AREA TO RIGHT THIGH, TENDER TO TOUCH. PER DAD - NOTE...
4.25 CM X 3.50 CM INDURATED, ERYTHEMATOUS, WARM AREA TO RIGHT THIGH, TENDER TO TOUCH. PER DAD - NOTED TO HAVE SWOLLEN, RED, AND WARM AREA TO RIGHT THIGH WHEN HE WAS PICKED UP FROM SCHOOL AROUND 3PM ON 1/14/2025. AREA GOT BIGGER OVERNIGHT. NO FEVER. NO RESPIRATORY SYMPTOMS. NO NAUSEA, VOMITING, OR DIARRHEA. TREATMENT WITH CETIRIZINE QAM AND BENADRYL QPM, PRN HYDROCORTISONE CREAM FOR ITCHING.
More
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| 2821844 | 11 | F | 01/20/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0589 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Patient was given an adult Pfizer (12+) vaccine when pt should have been given the pediatric Pfizer ...
Patient was given an adult Pfizer (12+) vaccine when pt should have been given the pediatric Pfizer vaccine. No adverse effects were reported by patient's parent.
More
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| 2821845 | 74 | F | SC | 01/20/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
|
Hypertension; Hypertension
Hypertension; Hypertension
|
High blood pressure
High blood pressure
|
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| 2821846 | 44 | F | FL | 01/20/2025 |
HPV9 PNC20 TDAP |
MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site pain, Pain; Injection site erythema, Inj...
Injection site erythema, Injection site pain, Pain; Injection site erythema, Injection site pain, Pain; Injection site erythema, Injection site pain, Pain
More
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An area of redness and muscle pain on the left upper arm failed to resolve about an inch beneath the...
An area of redness and muscle pain on the left upper arm failed to resolve about an inch beneath the injection site. Pain in the mid left upper arm has continued for for days now. Pain increases when raising left arm above head. No issues with the vaccine administered in the right arm.
More
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| 2821847 | 68 | F | NJ | 01/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Herpes zoster, Rash, Rash pruritic
Herpes zoster, Rash, Rash pruritic
|
Recieved vaccine at 4:00 pm on 1/17/25. By 1:00 pm (less than 24 hours) on 1/18/25, observed a rash ...
Recieved vaccine at 4:00 pm on 1/17/25. By 1:00 pm (less than 24 hours) on 1/18/25, observed a rash on stomach. Itchy and painful. By 1/19/25 rash increased in size and pain intensified. Saw family doctor on 1/20/25 at 2:00 pm, who confirmed it was shingles and immediately prescribed Valacyclovir. Have never had shingles before. Physician: Dr.
More
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| 2821848 | 0.17 | F | PA | 01/20/2025 |
DTPPVHBHPB FLU3 PNC20 RV5 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
U7907AA AE2J7 LC5483 Y003996 |
Product administered to patient of inappropriate age, Wrong patient received pro...
Product administered to patient of inappropriate age, Wrong patient received product; Product administered to patient of inappropriate age, Wrong patient received product; Product administered to patient of inappropriate age, Wrong patient received product; Product administered to patient of inappropriate age, Wrong patient received product
More
|
Given flulavel that was on the tray to give the older sibling.
Given flulavel that was on the tray to give the older sibling.
|
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| 2821849 | 4 | M | TX | 01/20/2025 |
MMRV |
MERCK & CO. INC. |
X018814 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Expired Vaccine, No adverse reaction
Expired Vaccine, No adverse reaction
|
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| 2821850 | 78 | F | OH | 01/20/2025 |
RSV |
PFIZER\WYETH |
LN5463 |
Erythema, Pain in extremity, Peripheral swelling, Skin discolouration
Erythema, Pain in extremity, Peripheral swelling, Skin discolouration
|
PATIENT STATED THAT HER ARM WAS RED, PAINFUL, AND SWOLLEN AFTER RECEIVING HER VACCINATION. IT IS ST...
PATIENT STATED THAT HER ARM WAS RED, PAINFUL, AND SWOLLEN AFTER RECEIVING HER VACCINATION. IT IS STILL SORE 3 WEEKS AFTER RECEIVING THE VACCINATION. THERE IS AN AREA THAT IS DISCOLORED ON HER ARM, BUT IS LOWER THAN WHERE THE PATIENT STATES THAT THE VACCINE WAS GIVEN
More
|
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| 2821851 | 17 | M | GA | 01/20/2025 |
HPV9 HPV9 HPV9 HPV9 MENB MENB |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
Y000205 Y000205 Y000205 Y000205 3L339 3L339 |
Cold sweat, Presyncope; Syncope; Cold sweat, Presyncope; Syncope; Cold sweat, Pr...
Cold sweat, Presyncope; Syncope; Cold sweat, Presyncope; Syncope; Cold sweat, Presyncope; Syncope
More
|
Patient was given HPV vaccination by medical assistant and within five minutes of receiving the vacc...
Patient was given HPV vaccination by medical assistant and within five minutes of receiving the vaccination, he walked up to front desk, became clammy, and had vasovagal episode-- he did not injure himself during vasovagal event lasting less than a minute-- vitals were normal on recheck. He went to ER for further evaluation
More
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| 2821852 | 72 | M | TN | 01/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient presented to pharmacy to request vaccine and it was administered. It was by discovered by ou...
Patient presented to pharmacy to request vaccine and it was administered. It was by discovered by our clinical service team that patient had received same vaccine on 11/29/2023. It was no longer in local pharmacy records. Spoke with pt on 1/19/25 and pt did not recall receiving and did not report any adverse events.
More
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| 2821854 | 15 | M | CA | 01/20/2025 |
HEP HEP HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
X006977 X006977 X006977 X006977 |
Antibody test negative, Antinuclear antibody positive, Arthralgia, Blood calcium...
Antibody test negative, Antinuclear antibody positive, Arthralgia, Blood calcium normal, Blood creatine phosphokinase increased; Blood parathyroid hormone normal, Brain fog, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Epstein-Barr virus infection; Lymphadenopathy, Malaise, Muscular weakness, Pain, Pyrexia; Rheumatoid factor negative, Urticaria
More
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Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physi...
Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physical findings, mental fogginess, body aches, malaise
More
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| 2821855 | 66 | M | FL | 01/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received second dose of vaccine wasn't aware he received a first dose. Was advised by h...
Patient received second dose of vaccine wasn't aware he received a first dose. Was advised by his MD to get one. Patient states he is fine no adverse. effects. No hospital or doctor visit required.
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| 2821856 | 0.42 | F | IN | 01/20/2025 |
MMRV |
MERCK & CO. INC. |
Y009106 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None at this time
None at this time
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| 2821857 | 11 | F | MA | 01/20/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
EK7DG 3CA22C1 |
Erythema, Pruritus, Skin warm; Erythema, Pruritus, Skin warm
Erythema, Pruritus, Skin warm; Erythema, Pruritus, Skin warm
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Redness, itchy, warm to the touch
Redness, itchy, warm to the touch
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| 2821858 | 0.33 | F | UT | 01/20/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
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Eyelid ptosis, Lethargy, Visual impairment; Eyelid ptosis, Lethargy, Visual impa...
Eyelid ptosis, Lethargy, Visual impairment; Eyelid ptosis, Lethargy, Visual impairment; Eyelid ptosis, Lethargy, Visual impairment
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The evening of the vaccinations she began to have a droopy right eye. The symptoms lasted about 30 m...
The evening of the vaccinations she began to have a droopy right eye. The symptoms lasted about 30 minutes and resolved. 3 days later she had another event of droopy eye that lasted 2+ hours. Her vision seemed affected and had slight bouts of lethargy
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| 2821859 | 17 | F | IN | 01/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVA982A |
Expired product administered
Expired product administered
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Expired 1031/2024
Expired 1031/2024
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| 2821868 | 0.17 | U | CA | 01/20/2025 |
RV5 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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ROTATEQ vaccine at 8 weeks old and came back at 28 weeks old to the HCP's office without receiv...
ROTATEQ vaccine at 8 weeks old and came back at 28 weeks old to the HCP's office without receiving the second dose of the ROTATEQ vaccine; No additional AE; This spontaneous report was received from a pharmacist and refers to an infant patient of unknown age (reported as 28 weeks old at the time of healthcare professional's (HCP) office visit) and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (at 8 weeks old), the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date (at 28 weeks old), the patient returned to HCP's office without receiving the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (inappropriate schedule of product administration). No additional adverse event was reported. Lot # was requested and will be provided if available.
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| 2821869 | 11 | U | OR | 01/20/2025 |
MMRV |
MERCK & CO. INC. |
X018570 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse side effects were reported/ No additional AE; PROQUAD vaccine that expired 1/5/2025 and w...
No adverse side effects were reported/ No additional AE; PROQUAD vaccine that expired 1/5/2025 and was administered to a patient on 1/15/2025; This spontaneous report was received from Other Health Professional and refers to an 11-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 15-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), lot #X018570, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No adverse side effects were reported.
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| 2821870 | U | NE | 01/20/2025 |
HEPA |
MERCK & CO. INC. |
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No adverse event, Product dose omission issue
No adverse event, Product dose omission issue
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Pharmacist called stating a 60 year old patient received their 1st dose of VAQTA on 2/14/2023 but mi...
Pharmacist called stating a 60 year old patient received their 1st dose of VAQTA on 2/14/2023 but missed their 2nd dose.; No additional AE/no PQC reported.; This spontaneous report was received from a pharmacist and refers to a 60-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug rection or allergies were not reported. On 14-FEB-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 adult dose, administered for prophylaxis (dose, lot number, expiration date, and route of administration were not provided), but missed their second dose (product dose omission issue). Caller stated the patient has not had any symptoms. No additional adverse event (AE) reported.
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| 2821871 | 5 | F | GA | 01/20/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y005000 |
Discomfort, Product storage error, Swelling; Discomfort, Product storage error, ...
Discomfort, Product storage error, Swelling; Discomfort, Product storage error, Swelling
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Discomfort; Swelling; This spontaneous report was received from a licensed practical nurse and refer...
Discomfort; Swelling; This spontaneous report was received from a licensed practical nurse and refers to a 5-year-old female. The patient has no pre-existing allergies, birth defects of medical conditions nor illness at the time of vaccination. None adverse events following a prior vaccination. The patient's concomitant therapies were not reported. On 05-AUG-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot #Y005000, expiration date: 26-AUG-2025, administered subcutaneously in the left arm for prophylaxis; and with the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), lot #1145R, expiration date: 22-AUG-2025, administered intramuscularly in the right arm (formulation and indication were not provided). It was reported that during the day of the vaccine administration, there was a power loss for approximately 2 hours; however, the vaccines were moved to another refrigerator and freeze before they reached the excursion point. All safety guidelines were followed and the vaccines were safe and kept the temperature range. It was reported that the patient's response to the vaccines was normal; however, on an unspecified day in 2024, she experienced swelling and discomfort. No treatment was given for the events. At the time of reporting, the outcome of the events was not known. The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) was unknown. This is one of several reports from the same source.; Sender's Comments: US-009507513-2501USA004806:
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| 2821873 | 0.25 | F | 01/20/2025 |
DTAPHEPBIP DTAPHEPBIP HIBV HIBV PNC13 PNC13 RV1 RV1 UNK UNK |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen satur...
Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting; Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting; Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting; Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting; Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea, Hypoxia; Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting
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Bacterial Pneumonia; This 12-month-old female subject was enrolled in a study. The subject received ...
Bacterial Pneumonia; This 12-month-old female subject was enrolled in a study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 24-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 24-OCT-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 24-OCT-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 21-JUL-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. The subject's past medical history included upper respiratory tract infection, respiratory syncytial virus infection and viral upper respiratory tract infection (with cough). Concurrent medical conditions included upper respiratory tract infection. On 31-MAR-2023, 158 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 253 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 pneumonia bacterial (Verbatim: Bacterial Pneumonia). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol), amoxicillin, ceftriaxone sodium (Rocephin) and oxygen. Bexsero vs Placebo was continued with no change. The outcome of pneumonia bacterial was resolved on 13-APR-2023. Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray-In APR-2023 with viral appearance, no focal infiltrate. The investigator considered that there was no reasonable possibility that the pneumonia bacterial may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the pneumonia bacterial may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. GSK Receipt Date: 17-APR-2023. Subject was a 1 year old female with history of recurrent viral illnesses this past year including Respiratory Syncytial Virtus but no prior hospitalization. They presented with a 2 day history of cough and fever preceded by runny nose for a few days prior to onset of cough. Treated with tylenol for fevers. Subject was nursing frequently, but otherwise with decrease appetite, emesis couple times with coughing. Mom noted some increased work of breathing and checked sats with owlette at home with sats in the low 80's prompting visit to the Emergency room (ER) on 4/2/23. In the ER, was initially noted to be setting fine on room air, but upon falling asleep dropped to mid 80's. Albuterol nebulizer was administered but no significant response as no wheezing was noted. Subject was admitted to pediatrics for observation. Event clinical details noted above. Event diagnosis was hypoxia. Concurrent conditions viral upper respiratory infection and bacterial pneumonia. Concomitant medications included oxygen, rocephin, and amoxicillin. Subject was admitted to hospital on 4/2/23 and discharged on 4/3/23 Follow-up information received on 24-Apr-2023 and 01-May-2023. Summary of changes: Narrative updated. Follow-up information received on 10-MAY-2023 and 16-MAY-2023. Summary of changes: Treatment medications (Oxygen, Rocephin, Amoxicillin), narrative, hospitalization dates were updated. Follow-up information received on 17-MAY-2023. Summary of changes: Treatment medication (Albuterol) was updated. Follow-up information received on 20-JUN-2023. Summary of changes: Event term was updated from "hypoxia" to "Pneumonia", Emergency Room Visit ticked. Follow-up information received on 11-jul-2023. Summary of changes: past medical history added. Follow-up information received on 23-AUG-2023. Summary of changes: Treatment medication end date was updated (Rocephin). Follow up information received on 13Sep2023. Summary of changes: Indication updated for Amoxicillin hypoxia to pneumonia. Follow up information received on 30-Oct-2023. Summary of changes: Historical condition of viral upper respiratory tract infection (with cough) added. Follow up information received on 13-FEB-2024. Summary of changes: general narrative updated. Follow-up information received on 22-AUG-2024 Summary of changes: Dose, unit for treatment drug Amoxicillin was updated. Follow up information received on: 20-NOV-2024 Summary of changes: Dose and unit for treatment drug Albuterol was updated. Follow up information received on: 06-JAN-2025 Summary of changes: Dose for treatment drug Albuterol was updated from 0.0 to Unknown Upon internal review the case was updated on 08-JAN-2025, The action taken with Prevnar vaccine was changes from not applicable to no change. Follow up information received on: 14-JAN-2025 Summary of changes: General narrative comments updated, Event start date updated, Relevant medical condition Viral Upper Respiratory Infection with cough start date updated, Event term updated from Pneumonia to Bacterial pneumonia, TTO updated.; Sender's Comments: A case of Pneumonia bacterial, 158 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV ,the 3rd dose of Hiberix, and 253 days after receiving 2nd dose of Rotarix lyophilized formulation, in 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility and alternative risk factor (h/o upper respiratory tract infection, respiratory syncytial virus infection ).
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| 2821874 | F | 01/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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red at the injection site; swollen at the injection site; sore at the injection site; arm is also wa...
red at the injection site; swollen at the injection site; sore at the injection site; arm is also warm at the injection site; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no reaction on previous exposure to drug (received 1st dose of vaccine on an unknown date). Concomitant products included metformin hydrochloride (Metformin) and losartan potassium (Losartan). On 21-DEC-2024, the patient received the 2nd dose of Shingrix .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: arm is also warm at the injection site). On 22-DEC-2024, the patient experienced injection site pain (Verbatim: sore at the injection site). On 23-DEC-2024, the patient experienced injection site erythema (Verbatim: red at the injection site) and injection site swelling (Verbatim: swollen at the injection site). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved and the outcome of the injection site warmth was not reported. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. Additional Information: GSK Receipt Date: 24-DEC-2024 Patient reported for soreness (From: 22 Dec 2024 To: Ongoing) Dates for Redness: (From: 23 Dec 2024 To: Ongoing) Dates for Swelling arm: (From: 23 Dec 2024 To: Ongoing). Patient did not had a reaction to the first shingles shot. The second shot patient arm was sore, red and swollen at the injection site. Patient arm was also warm at the injection site. It had been a couple of days since the second Shingles shot. Patient had not been able to locate what need to do to reduce the swelling nor how long it will last. Soreness symptoms not treated. Redness symptoms not treated. Swelling arm not treated.
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