| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829624 | 03/05/2025 |
RSV |
PFIZER\WYETH |
HM9865 |
Product container issue
Product container issue
|
Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the dilu...
Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off; This is a spontaneous report received from an Other HCP from product quality group,. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HM9865, Expiration Date: 30Apr2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), outcome "unknown", described as "Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off". Additional information: Reporter had a box from previous, the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off. They had 2 in a box where this happened. Reporter clarified that it just broke off - on top, it had a metal part inside, so the top of the metal part, like where the actual vial was put to put the diluent in the little syringe part. It was on top of the vial, it was metal, and on top, there was a plasticky glass where the syringe went in and pulled back out. It was the plasticky part that went on. The syringe was okay; it was the syringe that it went into the end that sticks out. It came with a syringe and vial. Causality for "abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible.
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| 2829640 | 73 | M | FL | 03/05/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
3D72S |
Incorrect route of product administration
Incorrect route of product administration
|
injection may have been intramuscular instead of subcutaneous; This non-serious case was reported by...
injection may have been intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 73-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On 25-FEB-2025, the patient received Priorix (intramuscular). On 25-FEB-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: injection may have been intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was 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: 26-FEB-2025 Registered Pharmacist reported that she used 1in needle versus 5 by 8 in needle when administering Priorix on 25 FEB 2025 in a patient. Registered Pharmacist was concerned that injection may have been intramuscular instead of subcutaneous which led to Subcutaneous injection formulation administered by other route.
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| 2829641 | 47 | M | VA | 03/05/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Neck mass
Neck mass
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large lump under neck in lymph node area lasted for 6 weeks after tdap/dtap/td vaccination.
large lump under neck in lymph node area lasted for 6 weeks after tdap/dtap/td vaccination.
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| 2829644 | 03/05/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; still got it; This serious case was reported by a consumer via intera...
Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 27-FEB-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had vaccine and still got it. The patient got it in November and it was still lingering with him/her. The patient was taking that gabapentin to ease that burning pain. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2829658 | 16 | F | DE | 03/05/2025 |
FLU3 FLU3 HPV9 HPV9 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
UT8468MA UT8468MA y003462 y003462 |
Aphasia, Arthralgia, Dizziness, Fall, Feeling abnormal; Hyperhidrosis, Skin warm...
Aphasia, Arthralgia, Dizziness, Fall, Feeling abnormal; Hyperhidrosis, Skin warm; Aphasia, Arthralgia, Dizziness, Fall, Feeling abnormal; Hyperhidrosis, Skin warm
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Vaccines were given and patient sat on the exam table for 10 minutes. She was being sent back to her...
Vaccines were given and patient sat on the exam table for 10 minutes. She was being sent back to her classroom and asked to use the restroom first. She went into the restroom. When she came out of the rest room she fell to the floor. This was not witnessed and when she stated "I don't feel right" she was lying on her right side. She said she felt dizzy in the bathroom and wasn't sure if she passed out or not in there. She stated she was dizzy in there and felt funny and couldn't get words out. When she was on the floor, she was not sure if she lost consciousness but felt dizzy in her head and was warm to touch and diaphoretic. She states she hurt her left knee but does not know what she hit her knee on. Ice was applied to the left knee. A cold cloth was applied to her head and back of neck for comfort. She was ambulatory and able to walk back to her classroom assisted by the provider.
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| 2829659 | 4 | M | NY | 03/05/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8209CB Y003882 |
Urticaria; Urticaria
Urticaria; Urticaria
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Hives, seen in ER and given steroid and antihistamine and resolved, no other systemic symptoms
Hives, seen in ER and given steroid and antihistamine and resolved, no other systemic symptoms
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| 2829660 | 56 | F | NY | 03/05/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LX2497 LX2497 |
Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Injection site swellin...
Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Injection site swelling; Injection site warmth, Wheezing
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The day after receiving vaccine patient experienced wheezing, chest tightness, and shortness of brea...
The day after receiving vaccine patient experienced wheezing, chest tightness, and shortness of breath. The area became raised, hot itchy, spread to entire upper arm. Patient did not seek medical attention because she assumed it was a flare up of her asthma. Patient used inhaler during reaction which helped symptoms of wheezing. Patient stated symptoms resolved by the end of the week. Patient did apply topical Benadryl cream to affected area which did not help.
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| 2829661 | 0.33 | M | ME | 03/05/2025 |
DTAPIPVHIB DTAPIPVHIB PNC20 PNC20 RV1 RV1 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UK109AA UK109AA LG5574 LG5574 7E9Y2 7E9Y2 |
Blood glucose normal, Body temperature decreased, Cold sweat, Fatigue, Infant ir...
Blood glucose normal, Body temperature decreased, Cold sweat, Fatigue, Infant irritability; Pallor; Blood glucose normal, Body temperature decreased, Cold sweat, Fatigue, Infant irritability; Pallor; Blood glucose normal, Body temperature decreased, Cold sweat, Fatigue, Infant irritability; Pallor
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Parents called after-hours triage nurse and reported vaccines given around 1430, parents woke patien...
Parents called after-hours triage nurse and reported vaccines given around 1430, parents woke patient up from nap at approx 2130 and found him pale, clammy and rectal temp of 95.8 F, and some fussiness. Advised to go to ED, ED triage RN note at 3/3/25 2249 states arrived "pink and at baseline". ED physician note at 3/4/25 at 0025 states "Patient had vaccines at around 2 PM. Patient was acting normally throughout the rest the day feeding and making wet diapers appropriately. And slept until around 930 when parents had woken him up. His parents state that he was cyanotic around the lips face and bottoms of his feet. At that time he was also "limp ". Father describes him and pale and clammy. They tried to get him to feed and he fed for approximately 10 minutes but not as vigorous as normal. They had taken a rectal temperature which was 95 at the time. They had called their sister who is a pediatrician and spoke to their on-call pediatrician who advised him to come to the emergency department. By the time they got packed up to come here patient had looked back to normal with cyanosis resolved. Parents state that now patient is back to baseline but appears slightly sleepier than normal.." On 3/5/25 mom reported to PCP office RN that since discharge from ED at approx 0300 3/4/25 patient is "doing really good", he is very tired, a litte fussy, eating well between naps, "seems to be getting back to his normal self.', with temp 98.9F on 3/4/25.
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| 2829662 | 0.17 | F | TN | 03/05/2025 |
HEPA PNC20 RV5 |
MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
Y008483 LK6651 2117043 |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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Patient was given Hep A rather than Vaxelis. Patient is ok per mom. No symptoms of a reaction per ...
Patient was given Hep A rather than Vaxelis. Patient is ok per mom. No symptoms of a reaction per mom.
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| 2829664 | 17 | F | MI | 03/05/2025 |
FLU3 |
SANOFI PASTEUR |
U8515EA |
Incorrect dose administered
Incorrect dose administered
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high dose flu inadvertently given.
high dose flu inadvertently given.
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| 2829665 | 39 | M | FL | 03/05/2025 |
COVID19 |
PFIZER\BIONTECH |
Unknown |
Vitiligo
Vitiligo
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Vitiligo presented within 2 months
Vitiligo presented within 2 months
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โ | |||||
| 2829666 | 19 | F | MI | 03/05/2025 |
HPV9 |
MERCK & CO. INC. |
x022737 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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The patient was given a 3rd dose of HPV at age 19, she did not need it due to receiving both her fir...
The patient was given a 3rd dose of HPV at age 19, she did not need it due to receiving both her first doses prior to age 14. She did not have any adverse reactions to the immunization. I contacted my dental director and the health department to ask about next steps. I will contact the patient and I have added the event into VAERS.
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| 2829667 | 74 | F | KS | 03/05/2025 |
PNC20 RSV |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6655 PC57B |
Erythema, Pain, Swelling; Erythema, Pain, Swelling
Erythema, Pain, Swelling; Erythema, Pain, Swelling
|
Localized redness, swelling, pain. Treated with OTC analgesic. Informed patient to try cold therapy ...
Localized redness, swelling, pain. Treated with OTC analgesic. Informed patient to try cold therapy applications to the site, and OTC antihistamine.
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| 2829668 | 0.17 | M | CO | 03/05/2025 |
FLU3 |
SANOFI PASTEUR |
UT8514JA |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
DTaP was ordered to be given and the Influenza vaccine was given by mistake.
DTaP was ordered to be given and the Influenza vaccine was given by mistake.
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| 2829669 | 34 | F | AL | 03/05/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
3CA17C1 3CA17C1 |
Erythema, Pruritus, Swelling; Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling; Erythema, Pruritus, Swelling
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2/26/2025 employee noticed redness and some swelling. The next several days it worsen and was itchin...
2/26/2025 employee noticed redness and some swelling. The next several days it worsen and was itching. On 3/2/2025-3/3/2025 she noticed symptoms improving. Today (3/5/2025) she again states area is improving. Some redness and swelling still present but she denies any issues with moving of arm or shoulder. I informed her to let Employee Health know if symptoms worsen or stop improving.
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| 2829670 | 72 | F | FL | 03/05/2025 |
PNC20 |
PFIZER\WYETH |
Ik6650 |
Extra dose administered
Extra dose administered
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The patient received Prevanr 20 and the pharmacy on 2/24/25 and 10/22/2022
The patient received Prevanr 20 and the pharmacy on 2/24/25 and 10/22/2022
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| 2829671 | 14 | F | 03/05/2025 |
COVID19 |
MODERNA |
B0003 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrig...
Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrigerator so the 60 day expiration was 12/7/2024 & patient received vaccine on 12/10/2024. No side effects or adverse events noted.
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| 2829672 | 15 | M | 03/05/2025 |
COVID19 |
MODERNA |
B0003 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrig...
Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrigerator so the 60 day expiration was 12/7/2024 & patient received vaccine on 12/12/2024. No side effects or adverse reactions noted.
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| 2829673 | 50 | F | NJ | 03/05/2025 |
TDAP |
SANOFI PASTEUR |
3CA30C1 |
Injection site erythema, Injection site mass, Injection site pruritus
Injection site erythema, Injection site mass, Injection site pruritus
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redness, itching, and lump to LT deltoid region
redness, itching, and lump to LT deltoid region
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| 2829674 | 16 | M | MD | 03/05/2025 |
COVID19 MNQ |
MODERNA SANOFI PASTEUR |
3044143 U8493AA |
Underdose; Underdose
Underdose; Underdose
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Pt was administered the Moderna COVID vaccine for 6months-11year instead of 12+. Provider informed b...
Pt was administered the Moderna COVID vaccine for 6months-11year instead of 12+. Provider informed by staff. Parent informed.
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| 2829675 | 31 | F | ND | 03/05/2025 |
HEPA YF |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
z27pb uk125aa |
Dizziness, Headache, Malaise, Nausea; Dizziness, Headache, Malaise, Nausea
Dizziness, Headache, Malaise, Nausea; Dizziness, Headache, Malaise, Nausea
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Client calling today to report that Friday (5 days ago) she received Hep A and Yellow Fever. She wo...
Client calling today to report that Friday (5 days ago) she received Hep A and Yellow Fever. She woke up Saturday morning with dizziness. No other symptoms. As week has progressed, symptoms of dizziness are worsening, she has a headache and is nauseated. She denies fever, no local reaction at site of admin. She is up and about and working but does not feel well. She has been taking ibuprofen and has been hydrating with fluids. Advised her to be seen by her provider since symptoms are worsening. Today is Wednesday.
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| 2829676 | 34 | M | OH | 03/05/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 036B21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 009C21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A 070H21A |
Activated partial thromboplastin time shortened, Acute myocardial infarction, As...
Activated partial thromboplastin time shortened, Acute myocardial infarction, Asthenia, Asthma, Band neutrophil count; Band neutrophil percentage, Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Blood calcium normal; Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Blood urine absent, Brain natriuretic peptide normal; Capillary nail refill test, Carbon dioxide decreased, Chest X-ray normal, Chest pain, Chromaturia; Coagulation test normal, Condition aggravated, Differential white blood cell count, Dizziness, Dyspepsia; Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Eosinophil count decreased, Eosinophil percentage decreased; Fatigue, Full blood count, Glomerular filtration rate normal, Glucose urine absent, Haematocrit normal; Haemoglobin normal, Hyperhidrosis, Hypothyroidism, Immature granulocyte count, International normalised ratio normal; Iron deficiency anaemia, Leukocytosis, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal; Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume increased, Metabolic function test normal, Monocyte count normal; Monocyte percentage, Myocardial infarction, Nausea, Neck surgery, Neutrophil count increased; Neutrophil percentage increased, Nitrite urine absent, Osteoarthritis, Pain, Palpitations; Percutaneous coronary intervention, Platelet count normal, Protein urine absent, Prothrombin time normal, Red blood cell count normal; Red blood cell nucleated morphology, Red cell distribution width normal, Specific gravity urine normal, Thrombectomy, Thrombosis; Troponin I increased, Troponin increased, Urine ketone body absent, Urobilinogen urine decreased, White blood cell count increased; White blood cells urine negative, pH urine normal; Activated partial thromboplastin time shortened, Acute myocardial infarction, Asthenia, Asthma, Band neutrophil count; Band neutrophil percentage, Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Blood calcium normal; Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Blood urine absent, Brain natriuretic peptide normal; Capillary nail refill test, Carbon dioxide decreased, Chest X-ray normal, Chest pain, Chromaturia; Coagulation test normal, Condition aggravated, Differential white blood cell count, Dizziness, Dyspepsia; Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Eosinophil count decreased, Eosinophil percentage decreased; Fatigue, Full blood count, Glomerular filtration rate normal, Glucose urine absent, Haematocrit normal; Haemoglobin normal, Hyperhidrosis, Hypothyroidism, Immature granulocyte count, International normalised ratio normal; Iron deficiency anaemia, Leukocytosis, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal; Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume increased, Metabolic function test normal, Monocyte count normal; Monocyte percentage, Myocardial infarction, Nausea, Neck surgery, Neutrophil count increased; Neutrophil percentage increased, Nitrite urine absent, Osteoarthritis, Pain, Palpitations; Percutaneous coronary intervention, Platelet count normal, Protein urine absent, Prothrombin time normal, Red blood cell count normal; Red blood cell nucleated morphology, Red cell distribution width normal, Specific gravity urine normal, Thrombectomy, Thrombosis; Troponin I increased, Troponin increased, Urine ketone body absent, Urobilinogen urine decreased, White blood cell count increased; White blood cells urine negative, pH urine normal; Activated partial thromboplastin time shortened, Acute myocardial infarction, Asthenia, Asthma, Band neutrophil count; Band neutrophil percentage, Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Blood calcium normal; Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal; Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Blood urine absent, Brain natriuretic peptide normal; Capillary nail refill test, Carbon dioxide decreased, Chest X-ray normal, Chest pain, Chromaturia; Coagulation test normal, Condition aggravated, Differential white blood cell count, Dizziness, Dyspepsia; Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Eosinophil count decreased, Eosinophil percentage decreased; Fatigue, Full blood count, Glomerular filtration rate normal, Glucose urine absent, Haematocrit normal; Haemoglobin normal, Hyperhidrosis, Hypothyroidism, Immature granulocyte count, International normalised ratio normal; Iron deficiency anaemia, Leukocytosis, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal; Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume increased, Metabolic function test normal, Monocyte count normal; Monocyte percentage, Myocardial infarction, Nausea, Neck surgery, Neutrophil count increased; Neutrophil percentage increased, Nitrite urine absent, Osteoarthritis, Pain, Palpitations; Percutaneous coronary intervention, Platelet count normal, Protein urine absent, Prothrombin time normal, Red blood cell count normal; Red blood cell nucleated morphology, Red cell distribution width normal, Specific gravity urine normal, Thrombectomy, Thrombosis; Troponin I increased, Troponin increased, Urine ketone body absent, Urobilinogen urine decreased, White blood cell count increased; White blood cells urine negative, pH urine normal
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On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful th...
On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
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| 2829677 | 0.5 | M | NV | 03/05/2025 |
DTAPIPV HEP PNC20 |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH |
U7908AB Y004552 HR3650 |
Pyrexia; Pyrexia; Pyrexia
Pyrexia; Pyrexia; Pyrexia
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Patients mother called the office on 3/4/2025 stating the child had a very high fever of 107 on her ...
Patients mother called the office on 3/4/2025 stating the child had a very high fever of 107 on her at home thermometer and a possible seizure and took the child to the ER.
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| 2829678 | 79 | F | FL | 03/05/2025 |
COVID19 |
PFIZER\BIONTECH |
it5638 |
Hypoaesthesia, Mobility decreased, Pain
Hypoaesthesia, Mobility decreased, Pain
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Day after vaccination, patient called stating that they were feeling numbness, pain, and inability t...
Day after vaccination, patient called stating that they were feeling numbness, pain, and inability to move the left arm.
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| 2829679 | 80 | F | FL | 03/05/2025 |
FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
388489 388489 388489 388489 |
Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administere...
Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administered at inappropriate site; Hypoaesthesia, Pain in extremity; Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administered at inappropriate site; Hypoaesthesia, Pain in extremity
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Shot was given well above the muscle near shoulder. Instant pain. Pharmacist said arm will probably...
Shot was given well above the muscle near shoulder. Instant pain. Pharmacist said arm will probably be sore fo a couple of days. Just take over the counter meds. Shooting pain, fire like feeling from shoulder to tips of fingers and numbness. Took excedrin and used liacane patches still took well over an hour before it subsided. This same thing has happened several times. Mostly when I?m in bed.
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| 2829681 | 80 | F | ND | 03/05/2025 |
HEP RSV |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
945660 7L3ST |
Rash; Rash
Rash; Rash
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Patient reports one week after injection that she had a rash over all of her body.
Patient reports one week after injection that she had a rash over all of her body.
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| 2829682 | 50 | F | MO | 03/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Burning sensation, Injected limb mobility decreased, Pain, Peripheral swelling
Burning sensation, Injected limb mobility decreased, Pain, Peripheral swelling
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LEft arm was puffy after 2 days post vaccination. There is severe pain extending all the way up to h...
LEft arm was puffy after 2 days post vaccination. There is severe pain extending all the way up to her collarbone and shoulder/scalp area, and down to her ifngers. it is a burning kind of pain to the point of throwin up. she cannot move her wrist and it is very tender. pt has been using ice and sports cream to help reduce heat. the dr has sent in prednisone to help with inflammation in the meantime. . patient will see dr tomorrow for examination.
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| 2829683 | 72 | F | IL | 03/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash, Rash pruritic
Rash, Rash pruritic
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I noticed a rash underneath my breast about 9AM on the 28th, didnt go around to my back but it was u...
I noticed a rash underneath my breast about 9AM on the 28th, didnt go around to my back but it was up my neck and it was more on the left side of my body it did not itch it was not painful only had it 24-36 hours then it started itching and that lasted for about a day.
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| 2829685 | 0.33 | F | KY | 03/05/2025 |
PNC15 RV5 |
MERCK & CO. INC. MERCK & CO. INC. |
X020953 2003139 |
Rash; Rash
Rash; Rash
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Patient was given Rota Oral and Pneumo 15 second dose on 2/24. Mother states on 2/25 she noticed an ...
Patient was given Rota Oral and Pneumo 15 second dose on 2/24. Mother states on 2/25 she noticed an all body rash but no fever or warmth at injection site. Rash lasted 3 days.
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| 2829686 | 34 | M | OR | 03/05/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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C-reactive protein increased, Chest discomfort, Dyspnoea, Echocardiogram abnorma...
C-reactive protein increased, Chest discomfort, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal; Pericarditis
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Chest discomfort , shortness of breath. Ultimately diagnosed as Pericarditis. Three years of recurri...
Chest discomfort , shortness of breath. Ultimately diagnosed as Pericarditis. Three years of recurring pericarditis after vaccine.
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| 2829687 | 79 | M | NY | 03/05/2025 |
COVID19 |
MODERNA |
3043924 |
Injection site hypoaesthesia
Injection site hypoaesthesia
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Numbness an inch or two below injection site about the size of a half dollar.
Numbness an inch or two below injection site about the size of a half dollar.
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| 2829688 | 47 | M | WA | 03/05/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
8080797 8080797 8080797 |
Aortic aneurysm, Aortic valve incompetence, Chills, Computerised tomogram thorax...
Aortic aneurysm, Aortic valve incompetence, Chills, Computerised tomogram thorax abnormal, Echocardiogram abnormal; Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Exercise tolerance decreased, Fatigue, Full blood count normal; Laboratory test abnormal, Metabolic function test normal, Ventricular extrasystoles
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Frequent PVCs, fatigue, exercise intolerance, all started on the morning of November 17th. Vaccinat...
Frequent PVCs, fatigue, exercise intolerance, all started on the morning of November 17th. Vaccination was forgotten about and we didn't originally connect it to symptoms. Seen by PCP on Dec 9. referred for routine tests and to see electrophysiologist. Labs were unremarkable. Had Holter monitor and Echocardiogram in mid January. Holter showed 5% PVC load. Holter showed new aortic regurgitation as compared to echo from march 2023. Saw electrophysiologist Jan 29th who offered no insight. Was seen in ER in early February due to chills and echo changes causing concern for endocarditis. ER workup was negative. Saw cardiothoracic surgeon in mid February who recommended cardiopulmonary exercise testing. 1 week later was reminded about vaccine and looked up the date of vaccination and made connection. Symptoms slowly improving starting mid February but pvcs continue.
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| 2829689 | 2 | F | VA | 03/05/2025 |
HIBV |
SANOFI PASTEUR |
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Vaccination error
Vaccination error
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Unnecessary vaccine given
Unnecessary vaccine given
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| 2829690 | 16 | M | LA | 03/05/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
52N45 |
Angioedema, Urticaria
Angioedema, Urticaria
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pt developed hives and angioedema > 48 hours after his dose
pt developed hives and angioedema > 48 hours after his dose
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| 2829691 | 80 | M | MI | 03/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334y |
Amnesia, Feeling abnormal, Headache, Lethargy, Pyrexia
Amnesia, Feeling abnormal, Headache, Lethargy, Pyrexia
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woke up the morning after the vaccination and as he described "did not feel right!". wife...
woke up the morning after the vaccination and as he described "did not feel right!". wife stated he was very lethargic, had a severe headache, had a fever. Patient felt bad enough that wife called an ambulance and was taken to local emergency room. Patient has no recollection of going to the hospital via ambulance and didn't realize he had been admitted until he woke up in the hospital. Hospital treated symptoms and was released the following day. Hospital physician told patient to reach out to pharmacy and have them file a report.
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| 2829692 | 10 | F | NY | 03/05/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U7949AC U8000AA |
Pyrexia, Rash; Pyrexia, Rash
Pyrexia, Rash; Pyrexia, Rash
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She had a 102 fever the night of the vaccine and a 7-8cm erythematous rash on her right deltoid 24 h...
She had a 102 fever the night of the vaccine and a 7-8cm erythematous rash on her right deltoid 24 hours after the injection. Then around 4/29/24 she developed a fixed painful annular rash on her hands which was determined by a pediatric dermatologist to be erythema multiforme minor. The lesions took approximately one week to resolve.
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| 2829693 | 32 | F | WA | 03/05/2025 |
MMR |
MERCK & CO. INC. |
Y004117 |
Pregnancy test positive
Pregnancy test positive
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Patient took a pregnancy test on February 1st, and it came back positive. Since I received all my va...
Patient took a pregnancy test on February 1st, and it came back positive. Since I received all my vaccines on January 3rd and January 17th
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| 2829694 | 42 | F | GA | 03/05/2025 |
TD |
SANOFI PASTEUR |
U8492AA |
Feeling jittery, Injection site erythema, Injection site nodule, Injection site ...
Feeling jittery, Injection site erythema, Injection site nodule, Injection site swelling, Nausea
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Donor states she had a reaction to the last immunization she received at the center on 02/21/25. Don...
Donor states she had a reaction to the last immunization she received at the center on 02/21/25. Donor returned to the center on 03/05/25 to attempt donation where she stated to the medical staff about her reactions. She stated her reactions included redness and swelling at the injection site, a knot where the needle was inserted about the size of a needle tip, jitteriness, nausea the next day. Donor stated she hydrated and took hot tub baths. She stated she did not seek outside medical care. It is also noted that she left the center before her 15-minute waiting period expired.
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| 2829695 | 63 | F | CA | 03/05/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
33FD3 33FD3 33FD3 33FD3 |
Amnesia, Arteriogram carotid, C-reactive protein, Computerised tomogram head, El...
Amnesia, Arteriogram carotid, C-reactive protein, Computerised tomogram head, Electrocardiogram; Influenza A virus test, Influenza B virus test, Injection site pain, Magnetic resonance imaging head, Metabolic function test; Myalgia, Red blood cell sedimentation rate, Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast; Transient global amnesia, Troponin
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6 hours after injection, developed pain at injection site, followed by myalgias that lasted 36 hour...
6 hours after injection, developed pain at injection site, followed by myalgias that lasted 36 hours. 48 hours after injection developed acute memory loss. Diagnosed with transient global amnesia.
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| 2829696 | 12 | F | MI | 03/05/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4T99 |
Dizziness
Dizziness
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Dizziness 24 hours post vaccine
Dizziness 24 hours post vaccine
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| 2829697 | 54 | F | FL | 03/05/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
032H21A 032H21A 036B21A 036B21A 048A21A 048A21A |
Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, ...
Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, Electromyogram normal, Gait disturbance; Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Nerve conduction studies normal, Paraesthesia; Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, Electromyogram normal, Gait disturbance; Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Nerve conduction studies normal, Paraesthesia; Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, Electromyogram normal, Gait disturbance; Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Nerve conduction studies normal, Paraesthesia
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Woke up with paresthesia of right lower leg and foot. Waited over the weekend to see if it would go ...
Woke up with paresthesia of right lower leg and foot. Waited over the weekend to see if it would go away, but it didn't. Went to the ER on 7/24/23 where they did blood work, CT scan, EKG and stroke screening. No findings and referred me to see a neurologist and get an MRI. MRI/brain done 8/21/23. Mixed opinion on results. Radiologist concluded chronic lacunar infarct left corona radiata pons. Since I couldn't get into a neurologist for months, I set up a second opinion with a neurologist at He looked at the radiology and said he did NOT think I had evidence of lacunar infarct. Though he had no answer for my symptoms. I finally was able to get an appointment with a neurologist at who conducted NCS/EMG testing on 2/28/24. Results were negative. Advised to start low dose aspirin, regular carotid checks and visits with pcp. Was told I would probably never get sensation back. As of now, nothing has improved. My foot becomes very difficult to walk on after being on it for over an hour. Especially in shoes. Chronic numbness.
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| 2829698 | 37 | F | CA | 03/05/2025 |
FLU3 |
SEQIRUS, INC. |
AW1619A |
Arthralgia
Arthralgia
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Shoulder pain since injection date
Shoulder pain since injection date
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| 2829699 | 15 | M | CA | 03/05/2025 |
FLU3 |
SANOFI PASTEUR |
ut84681a |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Patient received flu vaccine early today on 03/05/2025 when actually needed on 8/1/25, no adverse ev...
Patient received flu vaccine early today on 03/05/2025 when actually needed on 8/1/25, no adverse events at this time.
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| 2829700 | 17 | F | NC | 03/05/2025 |
HPV9 |
MERCK & CO. INC. |
Y005835 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Child had n adverse event following the vaccine being given, normal vaccine protocol was given with ...
Child had n adverse event following the vaccine being given, normal vaccine protocol was given with an outcome of being vaccine monitored for 2 week after error occurred and retrained on precautions that should be taken to assure vaccine errors do not occur
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| 2829701 | 65 | F | ME | 03/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
A5T73 |
Anaphylactic shock, Cough, Wheezing
Anaphylactic shock, Cough, Wheezing
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PATIENT WENT INTO ANAPHYLACTIC SHOCK WITHIN 5 MINUTES AFTER SHINGLES VACCINATION. PATIENT BEGAN COUG...
PATIENT WENT INTO ANAPHYLACTIC SHOCK WITHIN 5 MINUTES AFTER SHINGLES VACCINATION. PATIENT BEGAN COUGHING AND WHEEZING, SHE SELF ADMINISTERED BENADRYL SHE BROUGHT HERSELF AS SHE HAS HAD MULTIPLE ALLERGIC REACTIONS TO VARIOUS DRUGS AND ALLERGENS AND "CAME PREPARED." PATIENT THEN BEGAN HAVING A DIFFICULT TIME BREATHING AND SELF-ADMINISTERED HER OWN EPI-PEN SHE BROUGHT WITH HER TO THE VACCINATION. ONE DOSE OF EPINEPHRINE WAS SELF-ADMINISTERED BY THE PATIENT IN THE THIGH AND SYMPTOMS RESOLVED QUICKLY. PATIENT WAITED ANOTHER 5 MINTUES RECOVERING AND PATIENT DECLINED EMS/FURTHER MEDICAL ATTENTION WHEN OFFERED TO THE PATIENT AS SHE HAS DEALT WITH ANAPHYLAXIS MULTIPLE TIMES.
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| 2829702 | 4 | M | MS | 03/05/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U7908AA U7908AA Y014304 Y014304 |
Injection site erythema, Injection site induration, Injection site nodule, Injec...
Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling; Injection site warmth; Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling; Injection site warmth
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11 CM TALL X 9 CM WIDE INDURATED, ERYTHEMATOUS, WARM AREA TO LEFT UPPER ARM CONSISTENT WITH INJECTIO...
11 CM TALL X 9 CM WIDE INDURATED, ERYTHEMATOUS, WARM AREA TO LEFT UPPER ARM CONSISTENT WITH INJECTION SITE REACTION - GIVEN DTAP/IPV TO THAT ARM. PAIN TO LEFT UPPER ARM. GOOD ROM. MOM WAS NOTIFIED OF A HARD KNOT, REDNESS, SWELLING, AND WARMTH TO LEFT UPPER ARM FROM DAYCARE IN THE AFTERNOON OF 2/27/2025. RED, WARM AREA GREW OVERNIGHT TO CURRENT SIZE 2/28/2025. NO FEVER, SOB, SORE THROAT, DIFFICULTY SWALLOWING, RUNNY NOSE, N/V/D. SITE IS PAINFUL TO TOUCH. TREATED WITH CETERIZINE QAM AND BENDADRYL QPM UNTIL SYMPTOMS IMPROVE. ALSO ADVISED TO USE HYDROCORTISONE CREAM FOR ANY ITCHING AND MOTRIN OR TYLENOL FOR ANY DISCOMFORT. SIZE OF SITE WAS MARKED AND MONITORED BY MOM, NOW IMPROVED.
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| 2829703 | 10 | M | NC | 03/05/2025 |
COVID19 |
PFIZER\BIONTECH |
LT5636 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was given Comirnaty vaccine that is for 12 years and older on 02/25/25. We were notified in offic...
Pt was given Comirnaty vaccine that is for 12 years and older on 02/25/25. We were notified in office by billing on 03/05/25. CMA called and spoke with parent and no adverse reaction.
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| 2829704 | 36 | F | MN | 03/05/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Adenomyosis, Laboratory test, Menopause, Menstruation irregular, Ultrasound pelv...
Adenomyosis, Laboratory test, Menopause, Menstruation irregular, Ultrasound pelvis; Adenomyosis, Laboratory test, Menopause, Menstruation irregular, Ultrasound pelvis
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After getting the mRNA Covid 19 Vaccine, I started to experience irregular periods. This has persist...
After getting the mRNA Covid 19 Vaccine, I started to experience irregular periods. This has persisted to present day (03/05/2025). I since have also been diagnosed with Adenomyosis and have experience perimenopause symptoms for the last 2 years.
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| 2829705 | 8 | F | TX | 03/05/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
AE2J7 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received Flu vaccine due to no records found that show Flu#2 was received. Flu vaccine was n...
Patient received Flu vaccine due to no records found that show Flu#2 was received. Flu vaccine was not listed on system and no outside media/records available. Electronic outside sources from "database" where delayed and updated post clinic visit. Patient did not have an adverse reaction and was discharged from the clinic asymptomatic. Parent of patient was contacted for follow up and ensure patient remained asymptomatic.
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| 2829706 | 0.67 | F | MI | 03/05/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7296AA |
Expired product administered
Expired product administered
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The vaccine was outdated. The expiration date was 02/26/2025 and was administered on 03/04/2025
The vaccine was outdated. The expiration date was 02/26/2025 and was administered on 03/04/2025
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