| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2839010 | 90 | M | IA | 04/30/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
|
Passed away
Passed away
|
โ | |||||
| 2839011 | 73 | M | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
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| 2839012 | 76 | F | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
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| 2839013 | 69 | M | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
||||||
| 2839014 | 81 | M | ME | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Expired product administered
Expired product administered
|
Vaccine was expired upon administration. Exp date 04/19/2025
Vaccine was expired upon administration. Exp date 04/19/2025
|
||||||
| 2839015 | 71 | M | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
||||||
| 2839016 | 42 | F | SD | 04/30/2025 |
HPV9 |
MERCK & CO. INC. |
Y015179 |
Mobility decreased
Mobility decreased
|
Patient is unable to raise their arm over 90 degrees
Patient is unable to raise their arm over 90 degrees
|
||||||
| 2839017 | 70 | F | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
||||||
| 2839018 | 73 | F | GA | 04/30/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient...
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
More
|
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| 2839019 | 22 | F | MI | 04/30/2025 |
HPV9 |
MERCK & CO. INC. |
Y012776 |
Loss of consciousness
Loss of consciousness
|
patient passed out for less than 30 seconds
patient passed out for less than 30 seconds
|
||||||
| 2839020 | 76 | M | MN | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
EK4176 |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
|
Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
|
โ | |||||
| 2839021 | OH | 04/30/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
Underdose
Underdose
|
Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious...
Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050558:same reporter/different patient
More
|
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| 2839022 | 51 | F | ME | 04/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Back pain, Dyspnoea, Headache, Neck pain, Pain in extremity
Back pain, Dyspnoea, Headache, Neck pain, Pain in extremity
|
Patient provided information: Difficulty breathing, back pain, arm pain, head ache, neck pain. As of...
Patient provided information: Difficulty breathing, back pain, arm pain, head ache, neck pain. As of writing this the patient is at the ED.
More
|
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| 2839023 | 19 | F | VA | 04/30/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Dose was given 1 month too soon. Due 5/25/25
Dose was given 1 month too soon. Due 5/25/25
|
||||||
| 2839024 | 56 | F | MN | 04/30/2025 |
COVID19 |
MODERNA |
039C21A |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
|
Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
|
โ | |||||
| 2839025 | 49 | M | MI | 04/30/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Cardiac arrest, Cardiac assistance device user, Cardioversion, Implantable defib...
Cardiac arrest, Cardiac assistance device user, Cardioversion, Implantable defibrillator insertion, Laboratory test normal; Loss of consciousness
More
|
I am writing to report a serious cardiac event that occurred in August 2024. At that time, my heart ...
I am writing to report a serious cardiac event that occurred in August 2024. At that time, my heart stopped, and I required defibrillation via an automated external defibrillator (AED). I regained consciousness en route to the hospital. Subsequent extensive testing has not identified a cause for this event, and I have since had an internal defibrillator implanted. I received the Moderna COVID-19 vaccine prior to this event and am concerned about a potential correlation between the vaccination and my cardiac arrest, particularly given discussions regarding potential cardiac issues in men my age following mRNA vaccines. I urge the FDA to investigate potential links between COVID-19 vaccines and unexplained cardiac events. I am available to provide further details about my experience if needed. Thank you for your time and attention to this important matter.
More
|
โ | โ | ||||
| 2839026 | 64 | F | CA | 04/30/2025 |
PNC21 |
MERCK & CO. INC. |
y019158 |
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
|
swollen, redness, painful injection site and fever a day after the administration. patient reporte...
swollen, redness, painful injection site and fever a day after the administration. patient reported possible cellulitis and treatment at urgent care with an injection of steroid or antibiotic. Patient is not sure if patient recieved antibiotic or steroid injection at urgent care but it help reduce injection site reaction.
More
|
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| 2839027 | 74 | F | MT | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Given 3 days beyond expiration date. No adverse reactions reports.
Given 3 days beyond expiration date. No adverse reactions reports.
|
||||||
| 2839028 | 81 | F | OH | 04/30/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Palpitations, Peripheral swelling, Rash, Vision blurred
Palpitations, Peripheral swelling, Rash, Vision blurred
|
5 days after vaccine, pt had heart palpitations and blurred vision. The next day she had swelling an...
5 days after vaccine, pt had heart palpitations and blurred vision. The next day she had swelling and rash in the arm. @ days after that it was gone.
More
|
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| 2839029 | 19 | M | CA | 04/30/2025 |
ANTH JEV1 TYP |
EMERGENT BIOSOLUTIONS INTERCELL AG SANOFI PASTEUR |
300216A JEV23K06E X1A271M |
Face injury, Fall, Laboratory test normal, Loss of consciousness; Face injury, F...
Face injury, Fall, Laboratory test normal, Loss of consciousness; Face injury, Fall, Laboratory test normal, Loss of consciousness; Face injury, Fall, Laboratory test normal, Loss of consciousness
More
|
As the patient was receiving his oversea shots at 8:57 am he passed out and fell face flat into the ...
As the patient was receiving his oversea shots at 8:57 am he passed out and fell face flat into the ground in front of him from the sitting position. We proceeded to sternum rub him and pick him up to lay him down on the gurney. where he woke up after being out for 3 seconds at 8:58 am, He was seen by a provider and cleared of any TBI.
More
|
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| 2839030 | 0.75 | F | KY | 04/30/2025 |
MMR |
MERCK & CO. INC. |
Y014391 |
Urticaria
Urticaria
|
Hives on face, arm, leg and buttocks within 5 minutes of receiving vaccine. Benadryl 3/4 tsp, decadr...
Hives on face, arm, leg and buttocks within 5 minutes of receiving vaccine. Benadryl 3/4 tsp, decadron 4mg administered orally in office and topical steroid applied. Patient observed for 40 minutes in the office and cleared to leave by Dr.
More
|
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| 2839031 | 35 | F | IL | 04/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Condition aggravated, Fatigue, Genital herpes, Headache, Herpes simplex; Migrain...
Condition aggravated, Fatigue, Genital herpes, Headache, Herpes simplex; Migraine, Myalgia, Oral herpes, SARS-CoV-2 antibody test positive
More
|
Chronic low grade to moderate fatigue. A increase in headaches and now having migraines. Muscle sore...
Chronic low grade to moderate fatigue. A increase in headaches and now having migraines. Muscle soreness. An increase in herpes outbreaks (3+ times a year now) as well as the herpes sores presenting in a different location both on my lip and genital region. A possibility that I have heavier bleeding during my menstrual cycle since the immunization, however I am not positive that is resulting from the shot.
More
|
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| 2839032 | 59 | M | MN | 04/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
A5T73 |
Injection site erythema, Injection site induration, Injection site swelling
Injection site erythema, Injection site induration, Injection site swelling
|
Patient's wife called on 4/30/25 to report patient's reaction to his Shingrix shot given o...
Patient's wife called on 4/30/25 to report patient's reaction to his Shingrix shot given on 4/28/25. He has ~2 inch diameter red, raised, hard area where the vaccine was injected (right deltoid). No difficulties breathing, no rash/hives.
More
|
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| 2839033 | 78 | F | MI | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Blindness unilateral, Vision blurred
Blindness unilateral, Vision blurred
|
The patient has experienced loss of vision in their right eye. She describes it as white, fuzzy, or...
The patient has experienced loss of vision in their right eye. She describes it as white, fuzzy, or lines through it. She's seen an eye doctor who says it isn't retinal, but they are going to explore more concerns. With post market reporting for the vaccine showing optical adverse events, I thought there's a chance this could be related to the Comirnaty injection.
More
|
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| 2839034 | 60 | F | CA | 04/30/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Asthenia, Chills, Fatigue, Headache, Injection site pain; Myalgia, Nausea
Asthenia, Chills, Fatigue, Headache, Injection site pain; Myalgia, Nausea
|
chills headache muscular pain and fatigue. no energy and pain at the injection site, some nausea
chills headache muscular pain and fatigue. no energy and pain at the injection site, some nausea
|
||||||
| 2839035 | 11 | F | PA | 04/30/2025 |
IPV TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
X1C891M LK59T |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
|
Vaccine given 14 days too soon. No adverse reaction.
Vaccine given 14 days too soon. No adverse reaction.
|
||||||
| 2839036 | 5 | F | NM | 04/30/2025 |
DTAPIPV HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42Y93 C24B9 Y017511 |
Asthma, Condition aggravated; Asthma, Condition aggravated; Asthma, Condition ag...
Asthma, Condition aggravated; Asthma, Condition aggravated; Asthma, Condition aggravated
More
|
Child developed an asthma exacerbation the day after the vaccine administration and was seen in the ...
Child developed an asthma exacerbation the day after the vaccine administration and was seen in the ER, prescribed albuterol. Parent reports a history of asthma flare ups after vaccine administration when she was an infant as well.
More
|
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| 2839037 | OH | 04/30/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
Underdose
Underdose
|
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult p...
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050558:same reporter/different patient
More
|
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| 2839038 | 1.08 | F | MO | 04/30/2025 |
MMR MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y007623 Y012077 Y010045 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
None
None
|
||||||
| 2839039 | 6 | F | PA | 04/30/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9PT2F |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Given too soon
Given too soon
|
||||||
| 2839040 | 61 | F | NC | 04/30/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z002626 Z002626 |
Chills, Diarrhoea, Injection site inflammation, Injection site rash, Pyrexia; Ra...
Chills, Diarrhoea, Injection site inflammation, Injection site rash, Pyrexia; Rash erythematous
More
|
Patient developed a rash after the injection below site. Rash was described as very red and inflamed...
Patient developed a rash after the injection below site. Rash was described as very red and inflamed. Patient also experienced chills, fever, and diarrhea.
More
|
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| 2839041 | 40 | F | NJ | 04/30/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
072L20A 072L20A 072L20A |
Arthralgia, Brain fog, Chronic obstructive pulmonary disease, Computerised tomog...
Arthralgia, Brain fog, Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Computerised tomogram head; Dyspnoea, Fatigue, Generalised oedema, Paranasal sinus polypectomy, Sinuplasty; Sinus polyp, Sinusitis, Skin disorder, Type 1 diabetes mellitus, Wheezing
More
|
Skin issue, difficulty breathing, joint pain, generalized edema, fatigue brain fog, sinusitis, wheez...
Skin issue, difficulty breathing, joint pain, generalized edema, fatigue brain fog, sinusitis, wheezing, COPD, Insulin dependent diabetes
More
|
โ | |||||
| 2839042 | 0.58 | M | MI | 04/30/2025 |
RV1 RV1 RV1 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
EX434 EX434 ex434 ex434 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
More
|
patient was given a third dose of rotovirus in error
patient was given a third dose of rotovirus in error
|
||||||
| 2839043 | 78 | F | MI | 04/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
lm7786 lm7786 |
Body temperature increased, COVID-19, Cellulitis, SARS-CoV-2 test positive, Vomi...
Body temperature increased, COVID-19, Cellulitis, SARS-CoV-2 test positive, Vomiting; White blood cell count increased
More
|
Patient developed vomiting and increased temp, was transferred to hospital r/t acute change in condi...
Patient developed vomiting and increased temp, was transferred to hospital r/t acute change in condition and tested positive for covid at the hospital
More
|
โ | |||||
| 2839044 | 78 | M | NM | 04/30/2025 |
COVID19 |
PFIZER\BIONTECH |
FR8734 |
Asthenia, Dizziness, Fatigue
Asthenia, Dizziness, Fatigue
|
Chronic Fatigue; Lack of energy; Dizziness. No treatments given or recommended.
Chronic Fatigue; Lack of energy; Dizziness. No treatments given or recommended.
|
||||||
| 2839045 | 81 | M | MA | 04/30/2025 |
FLU3 |
SANOFI PASTEUR |
|
Acoustic stimulation tests, Computerised tomogram, Deafness unilateral
Acoustic stimulation tests, Computerised tomogram, Deafness unilateral
|
Loss of hearing left ear
Loss of hearing left ear
|
โ | |||||
| 2839046 | 66 | F | NC | 04/30/2025 |
COVID19 PNC21 |
PFIZER\BIONTECH MERCK & CO. INC. |
LP1780 Y011819 |
Injected limb mobility decreased, Injection site nerve damage, Muscular weakness...
Injected limb mobility decreased, Injection site nerve damage, Muscular weakness; Injected limb mobility decreased, Injection site nerve damage, Muscular weakness
More
|
Patient states that when vaccine was administered the needle "hit a nerve" and consequentl...
Patient states that when vaccine was administered the needle "hit a nerve" and consequently she has had issues with mobility and strength in her left arm.
More
|
||||||
| 2839047 | 65 | F | MN | 04/30/2025 |
MNQ |
SANOFI PASTEUR |
U8375AA |
Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus
|
Evening of vaccination, her left arm became red and swollen from the shoulder through the wrist. The...
Evening of vaccination, her left arm became red and swollen from the shoulder through the wrist. The next day it was itchy as well. Came into clinic 4/30/2025 to show RN/MD. It has been improving since then, but there remains areas of raised, red, pruritic rash. Areas include the left deltoid area, posterior to shoulder, anterior upper arm, and an area in the back right lateral to the spine and medial to the shoulder. Reports no fevers and no other symptoms. Feeling fine otherwise.
More
|
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| 2839048 | 52 | F | WA | 04/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
H97H2 |
Injection site erythema, Injection site pain, Pyrexia
Injection site erythema, Injection site pain, Pyrexia
|
Patient was having fever the night after having the vaccines and it was gone by the time patient rep...
Patient was having fever the night after having the vaccines and it was gone by the time patient reports the adverse events. It was a localized red patch around the injection and then it get bigger and bigger but not just remained localized around the injection site. Patient also reports some pain. Recommended Bendery, hydrocortisone cream and if not getting better or the redness radiate to the rest of body or the other arm, recommend to ER to urgent care for some prednisone but not SOB reported.
More
|
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| 2839049 | 58 | F | CO | 04/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
016B21A 016B21A 016B21A 021C21A 021C21A 021C21A |
Atelectasis, Back pain, Chest X-ray normal, Chest discomfort, Computerised tomog...
Atelectasis, Back pain, Chest X-ray normal, Chest discomfort, Computerised tomogram thorax abnormal; Condition aggravated, Cough, Dyspnoea, Malaise, Pulmonary embolism; Scan with contrast abnormal, Sleep disorder, Tachycardia; Atelectasis, Back pain, Chest X-ray normal, Chest discomfort, Computerised tomogram thorax abnormal; Condition aggravated, Cough, Dyspnoea, Malaise, Pulmonary embolism; Scan with contrast abnormal, Sleep disorder, Tachycardia
More
|
After my second injection my shortness of breath really increased, had to be put on home oxygen, I a...
After my second injection my shortness of breath really increased, had to be put on home oxygen, I also developed tachycardia. I had made 3 trips to the ER Because I was so short of breath. At approximately 6/25/21 I had developed a 100 degree fever with pain in my lower back rt side. I also felt bubbling and rubbing in my lower lungs. It was so painful that I could only sleep on my side. I felt that something was really wrong. I messaged my Dr twice. All she did was order a plain Xray of my chest in her office, it was normal. She didn't do any more, I was disappointed and worried. By 11 pm 7/1/21 I was so sick, coughing alot too, I drove myself to the ER.
More
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โ | |||||
| 2839050 | 0.17 | F | WA | 04/30/2025 |
DTAP HEP HIBV IPV PNC20 RV1 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
|
Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain; ...
Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain; Crying, Discomfort, Encephalitis, Pain
More
|
At roughly 3 hours after the shot, our child began showing signs of discomfort. The child began to i...
At roughly 3 hours after the shot, our child began showing signs of discomfort. The child began to intensely cry uncontrollable for 3+ hours. We were unable to calm her down due to encephalitis. We called our primary care provider, and they recommend Tylenol. This medicine knocked her out for about 6 hours until she woke up crying again. We had to administer additional tylenol to control the pain for the child.
More
|
โ | |||||
| 2839051 | 0.17 | F | NE | 04/30/2025 |
DTAPIPVHIB HEP PNC20 RV5 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
UK199AA 4D333 LK6651 2117042 |
Cyanosis, Staring, Vomiting projectile; Cyanosis, Staring, Vomiting projectile; ...
Cyanosis, Staring, Vomiting projectile; Cyanosis, Staring, Vomiting projectile; Cyanosis, Staring, Vomiting projectile; Cyanosis, Staring, Vomiting projectile
More
|
Per patient's mother at 1955 patient was taking her famotidine and projectile vomited. Followin...
Per patient's mother at 1955 patient was taking her famotidine and projectile vomited. Following that patient's lips and around mouth were a bluish/purple color. Patient then began to have bubbles come out of her mouth and had a "blank stare." Per mother reported that patient then was not tracking or responding for approximately 2 minutes following episode.
More
|
||||||
| 2839052 | 57 | F | OH | 04/30/2025 |
COVID19 UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Arthralgia, Injected limb mobility decreased, Myalgia, Pain in extremity; Arthra...
Arthralgia, Injected limb mobility decreased, Myalgia, Pain in extremity; Arthralgia, Injected limb mobility decreased, Myalgia, Pain in extremity; Arthralgia, Injected limb mobility decreased, Myalgia, Pain in extremity
More
|
I pain in arms a little after 24 muscle joint area pain, and began to spread towards my elbow today ...
I pain in arms a little after 24 muscle joint area pain, and began to spread towards my elbow today and i went to open a door and i noticed it was painful which was my left which i got the Covid and flu shot in. Yesterday i couldn't use the other arm so it changed sides. Today as well i am having issues with neck
More
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||||||
| 2839053 | 83 | F | NH | 04/30/2025 |
COVID19 |
MODERNA |
8081260 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
no adverse event. Vaccine administered was 3 days beyond the beyond use date.
no adverse event. Vaccine administered was 3 days beyond the beyond use date.
|
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| 2839054 | 64 | F | 04/30/2025 |
TDAP VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8115AA MG5S9 |
Injection site erythema, Injection site swelling, Injection site warmth, Pain in...
Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia; Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
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Patient complains of severe pain in both arms, her right arm shows signs of injection site reaction ...
Patient complains of severe pain in both arms, her right arm shows signs of injection site reaction with mild redness that was reportedly much more swollen, red, and hot a couple of days previous to today. She says that she is still experiencing fever at night. She was referred to her pcp for follow up.
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| 2839055 | PA | 04/30/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation error
Product preparation error
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seems that they may use the Shingrix diluent for the Priorix lyoph powder; vaccines where given with...
seems that they may use the Shingrix diluent for the Priorix lyoph powder; vaccines where given without the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in specified number of patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: seems that they may use the Shingrix diluent for the Priorix lyoph powder) and inappropriate dose of vaccine administered (Verbatim: vaccines where given without the diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 24-APR-2025 Other HCP reported that they had 2 situation which the diluent was not use to diluent the injection. Reporter stated that they had in the inventory 2 Priorix diluents left alone, so that's why they assume the Priorix vaccines were given without the diluent. Also, indicated that they also had the Shingrix vaccine, so due to this, it seems that they may use the Shingrix diluent for the Priorix lyoph. powder, HCP did not confirmed this. Priorix reconstituted with diluent of Shingrix instead of the supplied liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
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| 2839056 | F | FL | 04/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
T5P73 |
Underdose
Underdose
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Maladministration of Adult Dose on an Pediatric Patient; Adult Dose on an Pediatric Patient; This no...
Maladministration of Adult Dose on an Pediatric Patient; Adult Dose on an Pediatric Patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old female patient who received HBV (Engerix B) (batch number T5P73, expiry date 10-APR-2027) for prophylaxis. On 20-MAR-2025, the patient received Engerix B. On 20-MAR-2025, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Maladministration of Adult Dose on an Pediatric Patient) and overdose (Verbatim: Adult Dose on an Pediatric Patient). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist called to ask about guidance/safety concerns because a pediatric patient seventeen year old was administered with an adult dose, which led to adult product administered to child and overdose. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2839057 | TX | 04/30/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Product preparation issue
Product preparation issue
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Menveo - Only diluent administered; Menveo - Only diluent administered; This non-serious case was re...
Menveo - Only diluent administered; Menveo - Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo - Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Menveo - Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist stated that they had found a vial of the A component of Menveo (2 vials) in their fridge. As a result, they assumed that one of the five patients had only received the diluent portion of the vaccine, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The pharmacist mentioned that a physician had been considering re-vaccinating all five patients, but the pharmacist had been uncertain about this decision. The pharmacist had inquired about how soon the dose could be repeated.
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| 2839058 | 65 | F | PA | 04/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349L |
Extra dose administered
Extra dose administered
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3rd dose administered.; This non-serious case was reported by a other health professional via call c...
3rd dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in December 2021) and Shingrix (received second dose of Shingrix in February 2022). On 28-APR-2025, the patient received the 3rd dose of Shingrix. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered.). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 28-APR-2025 The nurse reported that he/she just gave a patient a Shingrix vaccine, however it was her third one which led ot extra dose administered, the other one was given in December of 2021, the second (dose) was on February of 2022..
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| 2839059 | 37 | F | MA | 04/30/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Aspiration bone marrow, Biopsy bone marrow, Blood folate, COVID-19, Electrophore...
Aspiration bone marrow, Biopsy bone marrow, Blood folate, COVID-19, Electrophoresis; Flow cytometry, Gene mutation, Gene sequencing, Haemoglobin, Hypogammaglobulinaemia; Immunophenotyping, Mean cell volume, Natural killer cell count, Sideroblastic anaemia, T-lymphocyte count; Vitamin B12
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hypogammaglobulinemia; LIG1 deficiency that presented with macrocytic sideroblastic anemia; LIG1 def...
hypogammaglobulinemia; LIG1 deficiency that presented with macrocytic sideroblastic anemia; LIG1 deficiency that presented with macrocytic sideroblastic anemia; Patient developed SARS-CoV-2 infection 1 year after completing the primary series; This literature-non-study case was reported in a literature article and describes the occurrence of HYPOGAMMAGLOBULINAEMIA (hypogammaglobulinemia) in a 37-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Lung infection (recurrent sinopulmonary infections as a child), Sinus infection (recurrent sinopulmonary infections as a child), Community acquired pneumonia (several hospitalizations), Seizure (several hospitalizations), Asthma (several hospitalizations for moderate-persistent asthma), Obstructive sleep apnea (several hospitalizations for mild obstructive sleep apnea) and Attention deficit hyperactivity disorder (several hospitalizations). Family history included Myelitis transverse (mother died at age 64 from complications related to transverse myelitis). Concurrent medical conditions included Macrocytic anemia (long-standing history of a mild underproduction macrocytic anemia). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HYPOGAMMAGLOBULINAEMIA (hypogammaglobulinemia) (seriousness criterion medically significant), SIDEROBLASTIC ANAEMIA (LIG1 deficiency that presented with macrocytic sideroblastic anemia), GENE MUTATION (LIG1 deficiency that presented with macrocytic sideroblastic anemia) and COVID-19 (Patient developed SARS-CoV-2 infection 1 year after completing the primary series). The patient was treated with Immunoglobulin human normal (Immunoglobulin) at an unspecified dose and frequency. At the time of the report, HYPOGAMMAGLOBULINAEMIA (hypogammaglobulinemia), SIDEROBLASTIC ANAEMIA (LIG1 deficiency that presented with macrocytic sideroblastic anemia) and GENE MUTATION (LIG1 deficiency that presented with macrocytic sideroblastic anemia) outcome was unknown and COVID-19 (Patient developed SARS-CoV-2 infection 1 year after completing the primary series) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aspiration bone marrow: normocellular marrow for age with a relative erythroid hyperplasia (myeloid to erythroid ratio of 0.6:1) associated with dyserythropoiesis in a subset of erythroids, including nuclear irregularities, binucleation, and budding, as well as megaloblastic maturation. Iron stain revealed >?15% ring sideroblasts.. On an unknown date, Biopsy bone marrow: normocellular marrow for age with a relative erythroid hyperplasia (myeloid to erythroid ratio of 0.6:1) associated with dyserythropoiesis in a subset of erythroids, including nuclear irregularities, binucleation, and budding, as well as megaloblastic maturation. Iron stain revealed >?15% ring sideroblasts.. On an unknown date, Blood folate: normal. On an unknown date, Electrophoresis: To confirm that the c.776+5G>T allele impacts splicing, reverse transcriptase polymerase chain reaction (RT-PCR) primers (LIG1_F: CAGGAGGAGGAAGAGCAGAC; LIG1_R: CAGGCATCTTCCACGGGAT) spanning the splice junction between exon 9 and 10 was performed. Agarose gel electrophoresis of RT-PCR amplicons showed a larger splicing product. Next-generation sequencing of this amplicon identified a 16-base pair insertion in transcripts derived from the c.776+5G>T allele (c.776ins16) predicted to result in a frameshift and termination present in 36% of the reads. It was unclear if this decreased transcript abundance was secondary to reduced efficiency of splicing at the normal splice donor site or nonsense-mediated decay of the aberrantly spliced mRNA. Whatever the mechanism, this finding supports\ed the notion that the c.776+5G>T allele was a genetic hypomorph.. On an unknown date, Flow cytometry: Flow cytometry on the marrow identified no abnormal myeloid, B, or T cell populations, and routine karyotype was 46, XX.. On an unknown date, Gene sequencing: (Negative) Clinical ALAS2 sequencing and In whole exome sequencing patient was found to have compound heterozygous LIG1 mutations (c.1922G>T, p.R641L and c.776+5G>T, NM_000234.3) that were confirmed to be in trans by PacBio long-range genomic sequencing.. On an unknown date, Haemoglobin: 11.6 gram per litre. On an unknown date, Immunophenotyping: Immunophenotyping showed mildly reduced CD19+ B cells, normal numbers of CD27+ memory B cells, and reduced immunoglobulin (Ig) class-switching with low IgM/IgD memory cells and virtual absence of IgA+ and IgG+ class switched memory B cells.. On an unknown date, Mean cell volume: 125 fL. On an unknown date, Natural killer cell count: Normal. On an unknown date, T-lymphocyte count: T cell was Normal. On an unknown date, Vitamin B12: Normal. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The patient's full brother and 2 maternal half-sisters are healthy. Vaccination titers were protective for only 3 of 23 pneumococcal serotypes. T and NK cell numbers were normal, and response to mitogen stimulation with phytohemagglutinin and CD3 was normal. The patient was started on replacement immunoglobulin. She developed SARS-CoV-2 infection 1?year after completing the primary series of the mRNA-1273 vaccine and was successfully managed with antiviral therapy as an outpatient. This was first reported case of LIG1 deficiency diagnosed in an adult patient. Patient had mild clinical phenotypes. Patient harbored one missense variant that results in reduced LIG1 activity and a splice site variant, which may allow for some residual wild-type enzyme activity, accounting for the relatively mild clinical presentations. This report broadens the clinical spectrum of LIG1 deficiency and highlights the increasing awareness that inborn errors of immunity may manifest with a wide range of immunological features and varying degrees of disease severity. As the immune deficiency can be subtle, LIG1 deficiency should be considered in the differential diagnosis of patients presenting to hematologists with macrocytic sideroblastic anemia. Patient did not show evidence of excessive somatic heteroplasmic mitochondrial DNA variants, which argues against a major impact of LIG1 deficiency on mitochondrial DNA replication and repair.; Reporter's Comments: Long-standing history of macrocytic anemia remains as a confounder for sideroblastic anaemia. The benefit-risk relationship of product is not affected by this report.
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