| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2825956 | 10 | F | WI | 02/12/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
HR4RB |
Incorrect dose administered
Incorrect dose administered
|
Vaccinator administered an Adult dose Hepatitis A vaccine (Havarix)1.0ml to a 10 year old child.
Vaccinator administered an Adult dose Hepatitis A vaccine (Havarix)1.0ml to a 10 year old child.
|
||||||
| 2825957 | 31 | M | IA | 02/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0173 EW0173 |
Arterial injury, Cardiac arrest, Cardiac stress test abnormal, Catheterisation c...
Arterial injury, Cardiac arrest, Cardiac stress test abnormal, Catheterisation cardiac abnormal, Coronary arterial stent insertion; Death, Muscular weakness, Myocarditis, Paraesthesia, Pericarditis
More
|
Diagnosed with myocarditis following ER visit in January 2024 with no history of heart problems. Pri...
Diagnosed with myocarditis following ER visit in January 2024 with no history of heart problems. Primary complaint for months leading up to that point was frequent tingling and weakness in both legs. Did not resolve after ER visit, failed stress test. Cardiac catheterization was performed 2/2024 with stent placement due to damaged diagonal vein in heart. At some point in medical records diagnosis was changed to pericarditis. Never diagnosed with hypertension or high blood pressure. Died 12/09/2024 of cardiac arrest. He had received his 2nd Pfizer injection on 05/26/2021 at facility, product number EW0187.
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|
β | β | β | β | ||
| 2825958 | 71 | M | TN | 02/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
m7g39 |
Herpes zoster, Post herpetic neuralgia, Rash
Herpes zoster, Post herpetic neuralgia, Rash
|
He got shingles. He came in because he thought the rash was bedbugs but he had shingles in 2 contigu...
He got shingles. He came in because he thought the rash was bedbugs but he had shingles in 2 contiguous dermatomes - T9ish on the right. He then came back to see me again today, 2/12/2025, because he now has postherpetic neuralgia. I understand that you can't get shingles from the vaccine because there's no live virus in the vaccine,,but he has a history of chickenpox. Could the vaccine or the resulting immune response have caused his VZV to reactivate and cause the disease?
More
|
β | |||||
| 2825959 | 54 | F | NJ | 02/12/2025 |
COVID19 |
MODERNA |
|
Myalgia, Palpitations, Sleep disorder
Myalgia, Palpitations, Sleep disorder
|
Palpitations lasting 4 hours and HR up to 152. Sat decreased to 89% on room air. now at 94 with HR 1...
Palpitations lasting 4 hours and HR up to 152. Sat decreased to 89% on room air. now at 94 with HR 102.Unable to sleep for next 4 ours. Myalgia severe ongoing after Spikevax12+ given yesterday afternoon.
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|
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| 2825960 | 77 | F | IA | 02/12/2025 |
COVID19 |
MODERNA |
8080803 |
Diplopia, Magnetic resonance imaging head normal, Scan with contrast normal, VIt...
Diplopia, Magnetic resonance imaging head normal, Scan with contrast normal, VIth nerve paralysis
More
|
Patient developed acute, painless vertical diplopia less than 24 hours after receiving her COVID sho...
Patient developed acute, painless vertical diplopia less than 24 hours after receiving her COVID shot. MRI brain with and without contrast was unremarkable. Subsequent ophthalmologic evaluation showed an acute, isolated left-sided cranial nerve 6 palsy.
More
|
β | |||||
| 2825961 | 14 | F | CO | 02/12/2025 |
MMR YF |
MERCK & CO. INC. SANOFI PASTEUR |
X028014 Y011017 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Patient in office for catch up vaccination. She received all catch up needed including MMR and Vari...
Patient in office for catch up vaccination. She received all catch up needed including MMR and Varicella. Patient didn't need an extra dose of MMR and Varicella as she has already completed vaccine series.
More
|
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| 2825962 | 17 | M | NC | 02/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4S5YG |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient was given a 3rd dose of MCV4O instead of 2nd dose of meningococcal B (MenB). No adverse reac...
Patient was given a 3rd dose of MCV4O instead of 2nd dose of meningococcal B (MenB). No adverse reaction, no treatment needed. Called patient to have appointment scheduled for 2nd MenB administered.
More
|
||||||
| 2825963 | 49 | F | WI | 02/12/2025 |
COVID19 |
MODERNA |
3043823 |
Chills, Feeling abnormal, Pain, Vomiting
Chills, Feeling abnormal, Pain, Vomiting
|
she is feeling horrible today, she is complaining of body aches, vomiting and chills
she is feeling horrible today, she is complaining of body aches, vomiting and chills
|
||||||
| 2825964 | 52 | F | SC | 02/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Biopsy bone marrow, Blood test, CALR gene mutation, Essential thrombocythaemia, ...
Biopsy bone marrow, Blood test, CALR gene mutation, Essential thrombocythaemia, Gene mutation identification test positive; Platelet count increased
More
|
I received the Pfizer COVID vaccine in April and May of 2021. Prior to that vaccine series, my plate...
I received the Pfizer COVID vaccine in April and May of 2021. Prior to that vaccine series, my platelet counts were always in normal lab range. After the vaccine series, my platelet count rose continually and were outside the normal lab ranges. I went to a hematologist in March 2023 and after blood work, genetic testing and a bone marrow biopsy, I was diagnosed with essential thrombocytosis (ET) with a CALR mutation on exon 9 in September 2023. My correlation is the COVID vaccine series disrupted my genetics and caused the ET. I had no history of high platelets prior to the COVID vaccine series.
More
|
β | |||||
| 2825965 | 76 | F | MO | 02/12/2025 |
PNC21 |
MERCK & CO. INC. |
y011819 |
Balance disorder, Malaise, Mobility decreased, Pain, Tremor
Balance disorder, Malaise, Mobility decreased, Pain, Tremor
|
Patient said she woke up in the middle of the night after getting the vaccine and "something wa...
Patient said she woke up in the middle of the night after getting the vaccine and "something was wrong". She states she didn't feel right and couldn't keep her balance. She also reported uncontrollable shaking (like she was feverish, without a fever) and total body aches. She states she is now "unable to get around."
More
|
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| 2825966 | 15 | F | OH | 02/12/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
LN0591 946596 |
Syncope; Syncope
Syncope; Syncope
|
Patient fainted in pharmacy waiting room after receiving covid and flu vaccines on 2/11/25 around 7p...
Patient fainted in pharmacy waiting room after receiving covid and flu vaccines on 2/11/25 around 7pm. Her father was also present. Her face appeared pale but was otherwise ok and responsive to questions. She was instructed to sit down and given water and granola snack bar. She began to recover quickly and was monitored for any additional side effects or symptoms. Patient indicated she had not eaten since school and had not eaten dinner. She left pharmacy with father and was feeling well. Patient and father were instructed to call us if symptoms returned or worsened.
More
|
||||||
| 2825967 | 34 | F | FL | 02/12/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Abdominal pain, Alpha-1 anti-trypsin, Amnesia, Antibody test, Anxiety; Balance d...
Abdominal pain, Alpha-1 anti-trypsin, Amnesia, Antibody test, Anxiety; Balance disorder, Blood glucose normal, Blood iron, Blood thyroid stimulating hormone, Electrophoresis protein normal; Fatigue, Glycosylated haemoglobin, HIV test negative, Hernia, Hypoaesthesia; Light chain analysis, Neurological symptom, Paraesthesia, Serum ferritin decreased, Sexually transmitted disease test; Urinary tract pain, Urine analysis, Vision blurred, Vitamin D decreased, Vitamin test
More
|
Between 09/1/23 - 11/15/23 - Abdominal & Urinary pain, feeling of a UTI or Hernia, No confirmati...
Between 09/1/23 - 11/15/23 - Abdominal & Urinary pain, feeling of a UTI or Hernia, No confirmation of UTI, slight Confirmation of Hernia. Stroke like symptoms, blurred vison, memory loss, tingling & numbness on right ride of the body, extreme fatigue , anxiety, loss of balance,
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|
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| 2825968 | 60 | M | VA | 02/12/2025 |
VARCEL |
MERCK & CO. INC. |
Y010373 |
Adverse reaction, Wrong product administered
Adverse reaction, Wrong product administered
|
Patient received varivax vaccine instead of varicella-zoster lab work. Provider made aware and discu...
Patient received varivax vaccine instead of varicella-zoster lab work. Provider made aware and discussed with the patient of the error. Patient voiced is fine. No adverse reactions noted.
More
|
||||||
| 2825969 | 76 | F | PA | 02/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Blood test normal, Computerised tomogram head normal, Confusional state, Erythem...
Blood test normal, Computerised tomogram head normal, Confusional state, Erythema, Gait inability; Injection site swelling, Laboratory test normal, Pyrexia, SARS-CoV-2 test negative, Walking aid user
More
|
husband said he helped pt out of the bed but she got her foot caught under a rug so he had to help h...
husband said he helped pt out of the bed but she got her foot caught under a rug so he had to help her into a rolling chair to move her around. She had confusion, her right was swollen around the injection site and she was running fever. He assisted her to the kitchen table and then to the living room chair in the rolling chair because she was unable to walk on her own. He contacted a nurse friend of theirs and she was concerned that she may have had a stroke and recommended she be taken to the ER. He contacted an ambulance to take her to ER Hospital. They did multiple test that were all normal. She was running fever and her right arm was red so she was admitted for observation for 48 hours. She was discharged after PT and OT approved her to go home and told to contact PCP for follow up. She is scheduled to be seen on 2/17/25.
More
|
β | |||||
| 2825970 | 15 | M | NY | 02/12/2025 |
HPV9 |
MERCK & CO. INC. |
Yoo7322 |
Arthralgia, Mobility decreased
Arthralgia, Mobility decreased
|
Left shoulder pain with decreased range of motion.
Left shoulder pain with decreased range of motion.
|
||||||
| 2825971 | 55 | F | GA | 02/12/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LM2215 n77j2 |
Injection site pruritus, Injection site swelling, Injection site warmth; Injecti...
Injection site pruritus, Injection site swelling, Injection site warmth; Injection site pruritus, Injection site swelling, Injection site warmth
More
|
Received vaccine at about 9:30 A.M. on February 8. Patient says by that evening, her arm began swell...
Received vaccine at about 9:30 A.M. on February 8. Patient says by that evening, her arm began swelling, became hot to the touch and itchy. Swelling has spread away from vaccine site down to her elbow and around to the inside of her upper arm over the last 4 days. Benadryl helped to relieve some of the itching, but the swelling and redness remains.
More
|
||||||
| 2825972 | 1 | M | PA | 02/12/2025 |
DTAPIPVHIB HEPA MMR PNC20 |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
UK043AA Y012054 Y004115 LC5483 |
Diarrhoea, Irritability, Pyrexia; Diarrhoea, Irritability, Pyrexia; Diarrhoea, I...
Diarrhoea, Irritability, Pyrexia; Diarrhoea, Irritability, Pyrexia; Diarrhoea, Irritability, Pyrexia; Diarrhoea, Irritability, Pyrexia
More
|
Extreme irritability, loose stool, fever
Extreme irritability, loose stool, fever
|
||||||
| 2825973 | 16 | F | OH | 02/12/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR |
Y007322 FN5548 U8193AA |
Fall, Head injury; Fall, Head injury; Fall, Head injury
Fall, Head injury; Fall, Head injury; Fall, Head injury
|
Patient fell after standing up to get her sweatshirt. Pt fell to the ground she did hit her head, no...
Patient fell after standing up to get her sweatshirt. Pt fell to the ground she did hit her head, not sure if that was impacted on the chair or on the floor. Patient was taken to ER for treatment
More
|
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| 2825974 | 4 | F | SC | 02/12/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
MZ379 Y005808 X024648 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered
More
|
Vaccine listed as Kinrix was past expiration date Vaccine expired on 1/25/25 and was given on 2/5/25...
Vaccine listed as Kinrix was past expiration date Vaccine expired on 1/25/25 and was given on 2/5/25.
More
|
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| 2825975 | 12 | F | TX | 02/12/2025 |
COVID19 |
MODERNA |
3043000 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Age-inappropriate vaccination. The patient received Moderna vaccine scheduled for patient 6 months t...
Age-inappropriate vaccination. The patient received Moderna vaccine scheduled for patient 6 months to 11 years
More
|
||||||
| 2825976 | 16 | M | IN | 02/12/2025 |
MENB |
PFIZER\WYETH |
HJ1517 |
Fatigue, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Fatigue, Headache, Pain in extremity, Peripheral swelling, Pyrexia
|
Fatigue, Arm Swelling/Soreness, Headache, Fever
Fatigue, Arm Swelling/Soreness, Headache, Fever
|
||||||
| 2825977 | 9 | F | MA | 02/12/2025 |
HEPA |
MERCK & CO. INC. |
|
Extra dose administered
Extra dose administered
|
The patient had a physical on 2/5/25 at the clinic. During the physical, the patient had another dos...
The patient had a physical on 2/5/25 at the clinic. During the physical, the patient had another dose of Hepatitis A vaccine. She was accompanied by her father who was given the VIS for the Hepatitis A vaccine and agreed to go forward with the vaccine. On 2/11/25, staff from the DPH called the clinic to inform us that the patient had previously received a dose of Hepatitis A at the DPH on 1/28/25.
More
|
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| 2825978 | 71 | M | SC | 02/12/2025 |
FLU3 PNC21 VARZOS |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
UT8437CA Y013009 93KK4 |
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L...
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness
More
|
Almost immediately after receiving 3 vaccinations patient stated he wanted to remain seated for a fe...
Almost immediately after receiving 3 vaccinations patient stated he wanted to remain seated for a few minutes. He appeared to be light headed and dizzy and stated that this sometimes occurs after receiving vaccines. Pharmacist stayed with patient and fanned him to help him stay cool. Patient was taking deep breaths. Pharmacist sent work associate to get patient a bottle of cold water to try to cool patient down. Patient took a sip of water and immediately passed out. This was approximately 5-8 minutes after vaccinations completed. Pharmacist was standing in front of patient and his head fell into pharmacist. Patient was unconscious for approximately 30 seconds. Pharmacist called for associate assistance and off duty EMT shopping in store came to assist. Local emergency assistance was called and arrived at pharmacy in about 10 minutes. Patient's blood pressure was monitored and EKG was taken. EMT staff stated at first patient blood pressure appeared low but within about 5 minutes returned to normal. Exact pressure was not provided to pharmacist. EMT stated ekg appeared to be abnormal possibly indicating atrial fibrillation. Patient refused to go to hospital and left on own approximately 40 minutes after receiving vaccines. Pharmacy staff checked on patient later same day and following day and patient reports feeling fine.
More
|
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| 2825979 | 28 | F | CO | 02/12/2025 |
COVID19 |
MODERNA |
|
Mechanical urticaria
Mechanical urticaria
|
Significant Dermatographia. I thought it was an allergic reaction at first.
Significant Dermatographia. I thought it was an allergic reaction at first.
|
||||||
| 2825980 | 92 | M | AR | 02/12/2025 |
PNC20 |
PFIZER\WYETH |
lj5284 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
|
large, red, hot to touch area and swelling around injection site. patient was advised to see dr. p...
large, red, hot to touch area and swelling around injection site. patient was advised to see dr. patient given cephalexin 500mg capsules for 1 week , no further problems reported
More
|
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| 2825981 | 39 | M | NV | 02/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
fz3102 fz5889 |
Tinnitus; Tinnitus
Tinnitus; Tinnitus
|
first sign of tinnitus after 14-30 days
first sign of tinnitus after 14-30 days
|
β | |||||
| 2825982 | 71 | M | NY | 02/12/2025 |
MNQ |
SANOFI PASTEUR |
U8369BA |
Product preparation issue
Product preparation issue
|
Medication was already constituted but was accidently reconstituted by adding 0.7 ml of sterile dilu...
Medication was already constituted but was accidently reconstituted by adding 0.7 ml of sterile diluent before administration in which 1.3 ml was given to the patient. The full amount of the 0.5ml of Menquadfi was delivered in addition to the 0.7 ml of sterile diluent.
More
|
||||||
| 2825983 | 11 | M | CA | 02/12/2025 |
TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
X449Y Y011017 |
Extra dose administered, Pyrexia; Extra dose administered, Pyrexia
Extra dose administered, Pyrexia; Extra dose administered, Pyrexia
|
Patient was administered an additional dose of tdap and varicella. The first doses of tdap and varic...
Patient was administered an additional dose of tdap and varicella. The first doses of tdap and varicella were initially administered 1/29/25. Due to an error of verification from a medical assistant, the patient received another dose of tdap and varicella on 2/4/25. Patients mother reported patient to have fever as a side effect which occurred 2/4/25. Patients mother reported fever to last only 3 days. Patients mother gave tylenol to help with fever. Patients mother reported patient to have overcome fever.
More
|
||||||
| 2825999 | 68 | F | 02/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered
Extra dose administered
|
Patient received an accidental second dose of this vaccination. Patient received the first dose on 1...
Patient received an accidental second dose of this vaccination. Patient received the first dose on 10/10/2023, and the accidental second dose was given 2/10/2025. Per staff working that day, the first dose was not visible in our state immunization registry, making it appear as though she was due for this dose.
More
|
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| 2826001 | 58 | M | IN | 02/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Cancer surgery, Chemotherapy, Haematuria, Ureteric cancer
Cancer surgery, Chemotherapy, Haematuria, Ureteric cancer
|
Pt had bloody urine. Went to ER. Diagnosed with ureter high grade cancer needing chemo and surgery....
Pt had bloody urine. Went to ER. Diagnosed with ureter high grade cancer needing chemo and surgery. I work at a cancer hospital and I've seen a large rise in cancer after people are taking the covid shots
More
|
β | β | ||||
| 2826002 | 4 | F | CA | 02/12/2025 |
FLU3 HEP HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5ZG92 95BJ9 DN273 Y012594 |
Extra dose administered, Pyrexia; Extra dose administered, Pyrexia; Extra dose a...
Extra dose administered, Pyrexia; Extra dose administered, Pyrexia; Extra dose administered, Pyrexia; Extra dose administered, Pyrexia
More
|
Patient was administered an additional dose of MMRV and hep B. The first doses of MMR and varicella ...
Patient was administered an additional dose of MMRV and hep B. The first doses of MMR and varicella were initially administered 1/29/25. Due to an error of verification from a medical assistant, the patient received another dose of MMRV and hep B on 2/4/25. Patients mother reported patient to have fever as a side effect which occurred 2/4/25. Patients mother reported fever to last only 3 days. Patients mother gave Tylenol to help with fever. Patients mother reported patient to have overcome fever.
More
|
||||||
| 2826003 | 84 | M | TX | 02/12/2025 |
COVID19 COVID19 COVID19 UNK UNK UNK |
MODERNA MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Biopsy prostate abnormal, Bone cancer, Bone scan abnormal, Cachexia, Death; Ment...
Biopsy prostate abnormal, Bone cancer, Bone scan abnormal, Cachexia, Death; Mental impairment, Muscle atrophy, Pain, Personality change, Positron emission tomogram prostate; Prostate cancer, Prostatic specific antigen increased, Weight decreased; Biopsy prostate abnormal, Bone cancer, Bone scan abnormal, Cachexia, Death; Mental impairment, Muscle atrophy, Pain, Personality change, Positron emission tomogram prostate; Prostate cancer, Prostatic specific antigen increased, Weight decreased
More
|
"turbo" prostate & bone cancer - hormone therapy from 2022-2023 (about 10 months) - se...
"turbo" prostate & bone cancer - hormone therapy from 2022-2023 (about 10 months) - severe pain, wasting away (lost over 100 pounds), muscle loss, rapid mental decline, personality changes
More
|
β | β | β | |||
| 2826004 | 38 | F | WA | 02/12/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site inflammation, Injection site pruritus, I...
Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
More
|
Within 24 hours, my right arm at the vaccination site was inflamed, red, hot to the touch and very i...
Within 24 hours, my right arm at the vaccination site was inflamed, red, hot to the touch and very itchy.
More
|
||||||
| 2826005 | 2 | F | AK | 02/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
5YB5G |
Incorrect dose administered, Product administered to patient of inappropriate ag...
Incorrect dose administered, Product administered to patient of inappropriate age
More
|
*Inadvertently given Tdap vaccine rather than Dtap appropriate for her age. Parents notified. This ...
*Inadvertently given Tdap vaccine rather than Dtap appropriate for her age. Parents notified. This is the child's 4th dose. CDC says this would be considered invalid and the child would need to be immunized with Dtap. Immunize site states "Tdap given to a child younger than age 7 years as either dose 4 or 5 can be counted as valid for Dtap dose 4 or 5."
More
|
||||||
| 2826006 | 11 | F | WV | 02/12/2025 |
HPV9 HPV9 HPV9 HPV9 MNQ MNQ MNQ MNQ TDAP TDAP TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
|
Angiogram normal, Discomfort, Electromyogram abnormal, Injected limb mobility de...
Angiogram normal, Discomfort, Electromyogram abnormal, Injected limb mobility decreased, Magnetic resonance imaging normal; Magnetic resonance neurography, Muscle atrophy, Muscle disorder, Muscle spasms, Muscular weakness; Musculoskeletal discomfort, Musculoskeletal stiffness, Neuralgic amyotrophy, Pain, Pain in extremity; Posture abnormal, Tendon transfer, Winged scapula; Angiogram normal, Discomfort, Electromyogram abnormal, Injected limb mobility decreased, Magnetic resonance imaging normal; Magnetic resonance neurography, Muscle atrophy, Muscle disorder, Muscle spasms, Muscular weakness; Musculoskeletal discomfort, Musculoskeletal stiffness, Neuralgic amyotrophy, Pain, Pain in extremity; Posture abnormal, Tendon transfer, Winged scapula; Angiogram normal, Discomfort, Electromyogram abnormal, Injected limb mobility decreased, Magnetic resonance imaging normal; Magnetic resonance neurography, Muscle atrophy, Muscle disorder, Muscle spasms, Muscular weakness; Musculoskeletal discomfort, Musculoskeletal stiffness, Neuralgic amyotrophy, Pain, Pain in extremity; Posture abnormal, Tendon transfer, Winged scapula
More
|
Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. T...
Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. This lasted for approximately 4-6 weeks. I thought it was just vaccine soreness and as we were getting ready to follow up to check on this, the pain and mobility issues began to subside so we did not schedule. She did continue to complain of a muscle spasm in her neck with discomfort. We mentioned this at her 2023 well child visit, but the doctor said it was probably just from her looking down at her phone or something. Late fall (2023), we noticed drooping in her shoulder. Unaware of what it was from or what was wrong, we started off with a chiropractor (2 visits). This was of zero benefit so we started OMT in January 2024. After a few sessions, the doctor determined it was in fact her trap muscle vs an alignment issue. We were referred to a local orthopedic doctor (Dr) who then referred us for the first of 2 EMGs. This concluded her spinal accessory nerve was not functioning. We attempted physical therapy with nerve stimulation, but nothing was helping. At this point, we were starting into summer of 2024. An MRI was ordered to confirm no tumors or masses compressing the nerve, there was not. We were then referred to an orthopedic doctor specializing in brachial plexus (Dr). We had a second EMG completed. He sent us to hospital for a neurography to check for hour glass constrictions in her nerve. The radiologist concluded it had most likely been to long to see the constrictions. Dr felt confident her diagnosis was Parsonage Turner Syndrome due to her HPV vaccine (autoimmune response), but we needed to do our due diligence and rule everything out. She had a group of vessels noted on the neurography so we were referred to a neurosurgeon and had an angiogram completed to see if that was an issue. This was determined to be nothing and not contributory at all. At this point, it was November of 2024. Dr determined she would not recover at all due to the extensive and severe muscle deterioration in her trapezius and sternocleidomastoid muscles. It was causing pronounced muscle weakness and scapular winging which in turn caused forward shoulder rotation. She was experiencing a lot of stiffness, pain, and discomfort. Since her scapula had very little support due to trap muscle deterioration, she had to have a triple muscle transfer on 1/13/25. We were informed she would never recover and this was strictly a surgery to help deal with the damage. She will have lifelong damage and complications.
More
|
β | β | ||||
| 2826007 | 1.58 | M | CA | 02/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
52992 |
Extra dose administered
Extra dose administered
|
An additional dose was given. PCP was informed what happened.
An additional dose was given. PCP was informed what happened.
|
||||||
| 2826008 | 70 | F | TX | 02/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Balance disorder, Head discomfort, Headache, Hyperacusis, Photophobia; Tremor
Balance disorder, Head discomfort, Headache, Hyperacusis, Photophobia; Tremor
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The day after the second vaccination, I woke up with extreme sensitivity to light in my left eye and...
The day after the second vaccination, I woke up with extreme sensitivity to light in my left eye and to sound in my left ear. It was extremely painful. The pain was about the size of a CD on the left side of my head. It felt as though my skull was swelling and might explode. I was also off balance and had a tremor in my left hand. This lasted for weeks and then gradually became less. The light and sound sensitivity flares up from time to time - maybe once a month or so. The balance problems and tremor remain.
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| 2826009 | 96 | F | CA | 02/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Death, Dementia, General physical health deterioration...
Cerebrovascular accident, Death, Dementia, General physical health deterioration, Wheelchair user
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Several months after her one and only Pfizer Covid shot & its booster 2 weeks later, my Mom'...
Several months after her one and only Pfizer Covid shot & its booster 2 weeks later, my Mom's issues from old age accelerated rapidly. She became wheelchairbound instead of using a walker, with fast-onset dementia, culminating in a series of small strokes beginning 8/12/22, leading to her death on 8/29/22. I have video of the οΏ½balcony visits' allowed during Covid before the vaccine rollout, and you can see, although elderly, she was cognizant and present in mind. Several months after the shot/booster, she was declining in an unnatural and alarming way.
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β | β | ||||
| 2826014 | M | TX | 02/12/2025 |
MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Amblyopia, Autism spectrum disorder, Behaviour disorder, Blood bilirubin increas...
Amblyopia, Autism spectrum disorder, Behaviour disorder, Blood bilirubin increased, Delayed dark adaptation; Dyspnoea, Eye disorder, Eye operation, Intensive care, Learning disorder; Sleep disorder
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I don't remember which shots. But the nurse took patient from me - after he had latched on perf...
I don't remember which shots. But the nurse took patient from me - after he had latched on perfectly and fed, and the nurse said how cute he was - to οΏ½give him his shots'. They were the newborn shots required on 11/04/04. About 20 - 30 minutes later she ran into my room breathless, said he had trouble breathing, had bilirubin and had been moved to the ICU, and was there until 11/09/2004. He had eye issues & surgeries ages 18 months & 5 years, sleeping issues, darkness issues, behavioral issues, learning issues, and was finally diagnosed at age 5 1/2 with moderate/severe autism by Dr Health Clinic.
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| 2826015 | 39 | F | HI | 02/12/2025 |
FLU3 |
SANOFI PASTEUR |
U8524DA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse event at the time of administered
No adverse event at the time of administered
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| 2826017 | M | FL | 02/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call c...
hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 16-SEP-2022, batch no XM22G with expiry date 31-AUG-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 The pharmacist called to informed that till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. This case had been linked to the case US2025017230, reported by the same reporter.; Sender's Comments: US-GSK-US2025017230:same reporter
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| 2826039 | 12 | M | TX | 02/12/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y010656 U8369AA 3CA30C1 |
Injection site pain, Injection site swelling; Injection site pain, Injection sit...
Injection site pain, Injection site swelling; Injection site pain, Injection site swelling; Injection site pain, Injection site swelling
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Patient complaing of pain and swollen at injection site (R) arm. MCV- L ARM- TDAP- L ARM HPV R ARM
Patient complaing of pain and swollen at injection site (R) arm. MCV- L ARM- TDAP- L ARM HPV R ARM
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| 2826040 | 55 | F | TX | 02/12/2025 |
COVID19 |
MODERNA |
3042648 |
Tinnitus
Tinnitus
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patient has ongoing tinnitis (ringing in the ear) since vaccination. Provider has ruled out other ca...
patient has ongoing tinnitis (ringing in the ear) since vaccination. Provider has ruled out other causes. Believes it may be attributed to Covid vaccination.
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| 2825670 | M | 02/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Guillain-Barre syndrome, Paralysis
Guillain-Barre syndrome, Paralysis
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My husband got Gillian Barre syndrome from the vaccine; This serious case was reported by a consumer...
My husband got Gillian Barre syndrome from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: My husband got Gillian Barre syndrome from the vaccine) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient got Guillain Barre syndrome from the vaccine and he was paralyzed The reporter asked not to get the vaccine.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2825671 | U | 02/11/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected Vaccination Failure; have now had shingles twice in the past 3 months; This serious case w...
Suspected Vaccination Failure; have now had shingles twice in the past 3 months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: have now had shingles twice in the past 3 months). 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 Shingrix and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 The patient got the 2 Shingrix shots in 2022 and now had shingles twice in the past 3 months. The reporter asked if it was recommended that he/she got a booster of some sort and it would help or harm his/her. This case was considered as suspected vaccination failure as details regarding 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2825672 | F | NC | 02/11/2025 |
UNK |
UNKNOWN MANUFACTURER |
946624 |
Influenza, Influenza A virus test positive
Influenza, Influenza A virus test positive
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Diagnosed with the flu A; This spontaneous case initially received on 30-Jan-2025, was reported by a...
Diagnosed with the flu A; This spontaneous case initially received on 30-Jan-2025, was reported by a non health professional and concerns a child female patient. Medical history or concomitant medications were reported as unknown. No allergy information provided. There was no product complaint associated with this case. Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Flu immunization, Dose regimen: 0.5 ml, Route of administration: not reported, anatomical location: right deltoid Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 28-Jan-2025, the patient experienced Diagnosed with the flu A (Medically Significant, outcome: Unknown). The reporter informed that her child was diagnosed with the flu during a trip to her pediatrician then. Vaccination was given at Health Services Clinic. Flu was verified by nasal swab. Flu virus was Flu A. Onset date was 28-Jan-2025 and Recovery date was 20-Jan-2025 (as reported). Source of infection was unknown (likely a peer at her school). Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown Reporter assessment The reporter provide the seriousness of the event as unknown and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(relevant medical history, concomitant medications, diagnostic report)
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| 2825686 | 73 | F | PA | 02/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
Z7NG7 |
Arthralgia, Chills, Gait inability, Gaze palsy
Arthralgia, Chills, Gait inability, Gaze palsy
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Extreme joint pain through body. Unable to walk. Headache.. chills..
Extreme joint pain through body. Unable to walk. Headache.. chills..
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| 2825687 | 65 | M | TX | 02/11/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Ascites, Balance disorder, Blood loss anaemia, Coma, Death; Haematemesis, Haemat...
Ascites, Balance disorder, Blood loss anaemia, Coma, Death; Haematemesis, Haematochezia, Intensive care, Liver injury, Oesophageal variceal ligation; Oesophageal varices haemorrhage, Paracentesis, Transfusion, Weight decreased
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Liver damage, diagnosed after throwing up blood and having blood in stool. Esophageal varices bleedi...
Liver damage, diagnosed after throwing up blood and having blood in stool. Esophageal varices bleeding, ended up in ICU in a coma for 4 days. 5 varices closed. Still had problems with leaking blood, was anemic as a result. Had balance issues, lost 100 pound of weight between the time of the shot and his final hospitalization January 23rd 2025. Had a second banding done, another 5 clips. Anemia treatments (blood and plasma and IV iron), Removal of ascites started a month apart and by the end was having it every other week, then daily. Patient died in hospital January 30, 2025, 9: 30 pm.
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β | β | β | β | ||
| 2825693 | F | 02/11/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; my wife had the double shot so she wouldn't and still got Shingl...
Suspected vaccination failure; my wife had the double shot so she wouldn't and still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: my wife had the double shot so she wouldn't and still got 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 05-FEB-2025 This case was reported by a patient's husband via interactive digital media. The patient had the double shot so she would not and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2825695 | 70 | F | OK | 02/11/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
B9279 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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late second dose until January 15th 2025; This non-serious case was reported by a pharmacist via cal...
late second dose until January 15th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 12-JUL-2024 with batch number 797F9 and lot expiry 30-DEC-2025). On 15-JAN-2025, the patient received the 2nd dose of Twinrix. On 15-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose until January 15th 2025). The outcome of the drug dose administration interval too long was unknown. 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: The pharmacist reported that a patient got their first dose of Twinrix and late second dose The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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