| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2833910 | 69 | M | CA | 04/01/2025 |
MNQ VARZOS |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
AMVA751A G3T43 |
Chest discomfort, Dyspnoea, Hyperhidrosis, Pyrexia, Tachycardia; Chest discomfor...
Chest discomfort, Dyspnoea, Hyperhidrosis, Pyrexia, Tachycardia; Chest discomfort, Dyspnoea, Hyperhidrosis, Pyrexia, Tachycardia
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|
Reported Symptoms: 10008493: CHEST TIGHTNESS OF; 10012703:DIAPHORESIS; 10013963:DYSPNEA; 10016558:FE...
Reported Symptoms: 10008493: CHEST TIGHTNESS OF; 10012703:DIAPHORESIS; 10013963:DYSPNEA; 10016558:FEVER; 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Evaluated in outside ED and felt not consistent with infectious or cardiac etiology. Resolved after a few days. Other: diaphoresis, dyspnea, chest tightness
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| 2833911 | 76 | M | TN | 04/01/2025 |
RSV |
PFIZER\WYETH |
HM9854 |
Fatigue, Headache, Insomnia, Myalgia
Fatigue, Headache, Insomnia, Myalgia
|
Reported Symptoms: 10016256:FATIGUE; 10019211:HEADACHE; 10022437:INSOMNIA; 10028411:MYALGIA; Narrati...
Reported Symptoms: 10016256:FATIGUE; 10019211:HEADACHE; 10022437:INSOMNIA; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: Insomnia: Fatigue
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|
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| 2833912 | M | DC | 04/01/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Asthma
Asthma
|
Reported Symptoms: 10003553:ASTHMA; Narrative: A 72yo male whose PMH included Renal cancer, Goiter, ...
Reported Symptoms: 10003553:ASTHMA; Narrative: A 72yo male whose PMH included Renal cancer, Goiter, Iron Deficiency Anemia, Dysphagia, OSA, Chronic Myeloid Leukemia, Malignant Tumor of Prostate, Adjustment Disorder with Depressed Mood, Chronic Pain post R. Hip Arthroplasty, CKD, OA of Knees,, ED, HTN, L. Renal Cyst, Hearing loss, Exposure to potentially Hazardous Substance, Acute PE, Long term current use of anticoagulant and back pain. On January 23, 2025, RN from CLINIC who did a post discharge f/u reported the patient had a historical ADR of influenza vaccine induced Asthma attack in 2018 and 2019, where he had to use nebulization treatment (which neb treatment patient received was not specified in the report). Other Relevant HX: Other: ASTHMA.
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| 2833914 | 73 | M | MS | 04/01/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UT8437CA UT8437CA UT8437CA |
Asthenia, Blood lactic acid normal, Fatigue, Lethargy, Pain; Pyrexia, Somnolence...
Asthenia, Blood lactic acid normal, Fatigue, Lethargy, Pain; Pyrexia, Somnolence, Tachycardia, Urinary incontinence, Urine analysis normal; White blood cell count increased
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|
Reported Symptoms: 10000424:ACHE; 10016256:FATIGUE; 10016558:FEVER; 10043071:TACHYCARDIA; 10047862:W...
Reported Symptoms: 10000424:ACHE; 10016256:FATIGUE; 10016558:FEVER; 10043071:TACHYCARDIA; 10047862:WEAKNESS; Narrative: Pt presented to the ER 2-3 hours after receiving COVID and flu vaccines. He presented with fever of 103.4, tachycardia, lethargy, body aches, and urinary incontinence. Pt was able to respond to RN's questions, but was falling asleep between questions and required loud verbal stimuli to emit response. He was found to have temp of 103.4 F, heart rate of 129 bpm, and WBC 11.9 on admission. Lactic acid normal, urinalysis unremarkable. He was given acetaminophen 1gm po for fever, IV fluids, and a dose of ceftriaxone IV 1gm in the ER. Temp came down to 100.3 ~1.5hr after acetaminophen. Pt was admitted overnight for observation. Pt was continued on IV fluids, acetaminophen PO prn, and ibuprofen x 1. No acute events overnight. Pt improved and plan is for pt to discharge home today. Other Relevant HX: Other: generalized weakness, fatigue, body aches
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β | |||||
| 2833915 | 43 | M | MS | 04/01/2025 |
FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Allergy to vaccine, Anaphylactic reaction, Eye oedema, Eye pruritus, Eye swellin...
Allergy to vaccine, Anaphylactic reaction, Eye oedema, Eye pruritus, Eye swelling; Lip swelling, Nasal oedema, Pruritus, Rash macular, Visual impairment
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|
Reported Symptoms: 10002218:ANAPHYLAXIS; 10014218:EDEMA CONJUCTIVAL; 10024570:LIP SWELLING; Narrativ...
Reported Symptoms: 10002218:ANAPHYLAXIS; 10014218:EDEMA CONJUCTIVAL; 10024570:LIP SWELLING; Narrative: Historical ADE reported. Patient presented to ER on 12/10/2010 with edema of eyes, nose and red itching blotches over her body as well as itchy eyes for the last 4 days. Patient stated was seen and treated with bactrim while being seen at (redacted name) hospital (redacted state). She reported only taking 2 doses since. Swelling worsened under her eyes and change in vision. No SOB or swallowing problems reported at the time. She also reports she received a flu shot last Wednesday and had not had one for over 20 years. Influenza vaccine was added to allergy list. Patient was given Solumedrol 80 mg IM once and Benadryl 25 mg IM once while inpatient. Swelling improved and resolved while inpatient. Other Relevant HX: Other: SWELLING AROUND EYES; LIP SWELLING
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| 2833916 | 57 | M | TN | 04/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
|
Pruritus
Pruritus
|
Reported Symptoms: 10037087:PRURITUS; Narrative: Other Relevant HX: Other: PRURITUS
Reported Symptoms: 10037087:PRURITUS; Narrative: Other Relevant HX: Other: PRURITUS
|
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| 2833917 | M | TN | 04/01/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Paraesthesia
Paraesthesia
|
Reported Symptoms: 10033987:PARESTHESIA; Narrative: Per review, "History of remote, severe epis...
Reported Symptoms: 10033987:PARESTHESIA; Narrative: Per review, "History of remote, severe episode of Guillain-Barre' related to a flu vaccine in the 1990's. States he was paralyzed from the shoulders down. Subsequently developed a DVT in the RLE due to prolonged immobility." Other Relevant HX: Other: PARESTHESIA.
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| 2833918 | M | TN | 04/01/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Chills
Chills
|
Reported Symptoms: 100008531:CHILS; Narrative: Other Relevant HX: Other: CHILLS
Reported Symptoms: 100008531:CHILS; Narrative: Other Relevant HX: Other: CHILLS
|
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| 2833919 | 37 | F | MS | 04/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
NG5FM |
Diarrhoea, Eructation, Nausea, Vomiting
Diarrhoea, Eructation, Nausea, Vomiting
|
Reported Symptoms: 10012727:DIARRHEA; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Per secure mess...
Reported Symptoms: 10012727:DIARRHEA; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Per secure message from pt: Good Afternoon, I'm writing in regard to my flu shot that I received at the clinic on 10/16/24 during lunch. Within 3-4 hours after receiving it, I continuously belched what seemed to have an egg taste, as well as felt extremely nauseous. I took a Zofran, and that settled my stomach until I went to sleep that night. During the night last night (10/17/24), I had extreme nausea, vomiting and diarrhea that are still present, and have not resolved with appropriate medications. Can you please speak with Dr. and have it annotated in my records that I've had these reactions to the Influenza vaccine, please? In my work place and my home, there are no persons that are sick, nor have any symptoms that are the same as those mentioned. Thank you. Other Relevant HX: Other: NAUSEA AND VOMITING; DIARRHEA
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| 2833920 | 76 | M | GA | 04/01/2025 |
COVID19 |
MODERNA |
8081564 |
Pruritus, Rash
Pruritus, Rash
|
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Patient went to ER for treatment, re...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Patient went to ER for treatment, received steroid shot. Was not admitted. Other Relevant HX: Other RASH
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| 2833921 | 58 | M | MS | 04/01/2025 |
COVID19 |
MODERNA |
026a21a |
Pulmonary haemorrhage
Pulmonary haemorrhage
|
Reported Symptoms: 10005103:BLEEEDING; Narrative: Patient reported he received covid vaccine on 3/5/...
Reported Symptoms: 10005103:BLEEEDING; Narrative: Patient reported he received covid vaccine on 3/5/21 and on 3/6/21 was hospitalized for bleeding in lungs at non facility hospital. Patient was discharged from hospital on 3/8/21 Other Relevant HX: Other: BLEEDING
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β | |||||
| 2833922 | 11 | M | MI | 04/01/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB043A |
Product preparation error
Product preparation error
|
Vaccine was diluted with the office stock diluet, Merck Sharp and Dohme LLC vaccines diluent, insted...
Vaccine was diluted with the office stock diluet, Merck Sharp and Dohme LLC vaccines diluent, insted of the vial that came in the box in error. Manager was notified, lead CMA, vaccine coordinator, health department, ordering provider, MCIR, and an ERS report was submitted. Per the health department, Menveo was not fully administered. Since the fourth stereotype was not administered the vaccine must be readmisnistered without a waiting period with no harm to the patient. I called and infromed patients mother of this. I informed her that I would be required to do continued education as well as peer review prior to vaccine administrations. She verbalized understanding with no questions.
More
|
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| 2833923 | 47 | M | OH | 04/01/2025 |
COVID19 COVID19 COVID19 COVID19 |
NOVAVAX NOVAVAX NOVAVAX NOVAVAX |
6024MF025 6024MF025 6024MF025 6024MF025 |
Abdominal pain upper, Basophil count increased, Blood alkaline phosphatase norma...
Abdominal pain upper, Basophil count increased, Blood alkaline phosphatase normal, Blood cholesterol normal, Blood creatinine decreased; Blood lactic acid, Blood triglycerides normal, Eosinophil count increased, Full blood count abnormal, High density lipoprotein decreased; Lipase increased, Low density lipoprotein normal, Nausea, Pancreatitis acute, Polychromasia; Vomiting, White blood cell count increased
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|
acute pancreatitis, 3-4 hours after booster had onset of severe epigastric abdominal pain with assoc...
acute pancreatitis, 3-4 hours after booster had onset of severe epigastric abdominal pain with associated nausea without vomiting. Only PO intake was a soda pop and some candy. abnormal CBC noted in ED
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| 2833924 | 62 | M | PA | 04/01/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LM3XG/n35N9 LM3XG/n35N9 |
Abdominal distension, Abdominal pain upper, Blood test abnormal, Colitis ulcerat...
Abdominal distension, Abdominal pain upper, Blood test abnormal, Colitis ulcerative, Condition aggravated; Diarrhoea, Haematochezia, Headache, Inflammation, Stool analysis abnormal
More
|
Starting the following day and was out of remission from ulcerative colitis. He had 2 blood samples...
Starting the following day and was out of remission from ulcerative colitis. He had 2 blood samples, and 2 stool samples checked through Dr. which confirmed out of remission. He was experiencing bloating, stomachache, headache, diarrhea, and blood in stool. They treated him with Stelara infusion. That didn't put him in remission. They are putting him on Budesonide capsules to help with inflammation.
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|
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| 2833925 | 60 | F | MA | 04/01/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Injection site bruising, Injection site swelling
Injection site bruising, Injection site swelling
|
The patient received the vaccine on 3/20/25 and woke up on Tuesday the 25th with a swollen area at t...
The patient received the vaccine on 3/20/25 and woke up on Tuesday the 25th with a swollen area at the injection site. She also had a bruise in the area. She iced the area and saw her primary care who also prescribed antibiotics for a precaution.
More
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| 2833926 | 16 | F | MO | 04/01/2025 |
MNQ |
SANOFI PASTEUR |
U8361AA |
Glossodynia, Headache, Nausea, Swollen tongue, Urticaria
Glossodynia, Headache, Nausea, Swollen tongue, Urticaria
|
Approximately 1 hour after vaccination received, hives began on left arm and spread to chest, face, ...
Approximately 1 hour after vaccination received, hives began on left arm and spread to chest, face, and entire body. Tongue began to swell and became painful, she developed a severe headache and nausea. Was given antihistamine/allergy relief medication by her Mother when symptoms began. Symptoms improved, but hives lasted for approximately 24 hours.
More
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| 2833927 | 50 | F | OH | 04/01/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LX4482 LX4482 |
Dizziness, Flushing, Headache, Injection site erythema, Injection site induratio...
Dizziness, Flushing, Headache, Injection site erythema, Injection site induration; Malaise, Myalgia, Pyrexia
More
|
- PEVNAR 20 vaccine administered on 3/26/25. - Onset of symptoms began on 3/27/25 with mild malaise,...
- PEVNAR 20 vaccine administered on 3/26/25. - Onset of symptoms began on 3/27/25 with mild malaise, followed by a low-grade fever, myalgias, and flushing. - Took Tylenol for symptom relief. - Persistent fatigue and malaise over the next few days, with significant weakness on 3/30/25. - Erythema and induration at the injection site noted on 3/31/25. - Denies pruritus, oral swelling, or dyspnea. - Current symptoms include dizziness and headache.
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| 2833928 | 0.58 | M | MO | 04/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3043000 B0002 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
There were 3 patients total who receive Covid-19 vaccines past the 60-day window of being in the ref...
There were 3 patients total who receive Covid-19 vaccines past the 60-day window of being in the refrigerator. PT: (redacted) DOB: 8/XX/24 received it on 3/19/25 and it expired on 3/16/25 with lot #3043000. Package date doesn't expire until 5/19/25. With lot # B0002 two patients received it with the expiration date of 12/1/24. PT: (redacted) DOB: 10/XX/06 given on 1/22/25, and PT: (redacted) DOB 7/XX/11 given on 12/17/24. No adverse reactions but just given past allowed expiration date.
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| 2833929 | 4 | M | TN | 04/01/2025 |
DTAPHEPBIP DTAPIPVHIB PNC20 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH |
PE24L UK107AA HH1326 |
Circumstance or information capable of leading to medication error, Wrong produc...
Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered
More
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Child was given an incorrect vaccine on 3/31/25. Nurse thought she was giving Pediarix, ActHIB &...
Child was given an incorrect vaccine on 3/31/25. Nurse thought she was giving Pediarix, ActHIB & Prevnar 20. Nurse was rushed by the parent due to needing to make a phone call & had another appt. scheduled at 4pm. Nurse administered the vaccines at 2:25pm. Nurse failed to scan the vaccines into the computer system prior to administration due to the circumstance of being rushed by the parent & child along with sibling were very uncooperative & unruly during the entire visit making the nurse nurse & frazzled. Nurse informed nursing supervisor of the event to begin the Incident Report process.
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| 2833930 | 11 | M | MI | 04/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
A274J |
Wrong product administered
Wrong product administered
|
was given a Men B Bexsero instead of the MCV4
was given a Men B Bexsero instead of the MCV4
|
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| 2833931 | 11 | M | FL | 04/01/2025 |
VARCEL |
MERCK & CO. INC. |
|
Rash, Rash erythematous
Rash, Rash erythematous
|
pts mother states he started getting bumps in the middle of both hands that are a little red. They s...
pts mother states he started getting bumps in the middle of both hands that are a little red. They started spreading over his fingers and are now painful. She contacted the dept of health where he was vaccinated and was told if he had a high fever to take him to doctor and to report his symptoms with us.
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| 2833932 | 29 | M | MI | 04/01/2025 |
HPV9 |
MERCK & CO. INC. |
Y012921 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient received prior HPV vaccines 02/2016 and 10/10/2013, he came to clinic 03/26/25 and a new 3 s...
Patient received prior HPV vaccines 02/2016 and 10/10/2013, he came to clinic 03/26/25 and a new 3 shot series was ordered, he received a dose on 03/26/2025. He then presented to clinic again on 03/29/2025 and received another dose. (He received 2 doses within 3 days of each other)
More
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| 2833933 | 0.5 | F | PA | 04/01/2025 |
COVID19 |
MODERNA |
3044211 |
Product preparation error
Product preparation error
|
Vaccine adminsitered prior to adequate thaw time (10 minutes at room temperature)
Vaccine adminsitered prior to adequate thaw time (10 minutes at room temperature)
|
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| 2833934 | 46 | F | WI | 04/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FM7553 FM7553 |
Arthralgia, Gait disturbance, Illness, Impaired work ability, Loss of personal i...
Arthralgia, Gait disturbance, Illness, Impaired work ability, Loss of personal independence in daily activities; Mobility decreased, Musculoskeletal stiffness, Pain, Rheumatoid arthritis, Rheumatoid factor positive
More
|
Severe illness preventing return to work, resolving within a day or two, but then joint pain and sti...
Severe illness preventing return to work, resolving within a day or two, but then joint pain and stiffness became more and more noticeable, and am now diagnosed with chronic Rheumatoid Arthritis. I can barely walk in the mornings, and can certainly not participate in triathlons and marathons any longer.
More
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β | |||||
| 2833935 | 2 | F | AL | 04/01/2025 |
HIBV |
SANOFI PASTEUR |
UK025AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient received ActHIB today, 04/01/2025 that expired 03/31/2025. No adverse reaction.
Patient received ActHIB today, 04/01/2025 that expired 03/31/2025. No adverse reaction.
|
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| 2833936 | 4 | M | MA | 04/01/2025 |
MMRV |
MERCK & CO. INC. |
X019300 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
MA approached nursing staff to ask about vaccination for pediatric patient, relayed that patient was...
MA approached nursing staff to ask about vaccination for pediatric patient, relayed that patient was due for MMR booster. Due to patient's age, MA was standing with PCP/MD and other RN, when MA asked provider to confirm if pt should get MMR or MMRV. MA asked where vaccines kept, MA retrieved vaccine and then administered to patient. After the visit, the MA approached this writer to inform that the vaccine administered was expired. This RN alerted the PM and MD of the situation, and this writer contacted vaccine management unit and DPH to report the event and receive instructions from DPH RN on next steps. This writer spoke with DPH RN this morning, who relayed that there shouldn't be any negative side effects, other than expected SE/AE of vaccine and that patient should seek booster dose within next 4 weeks. This writer called the patient's mother and relayed situation, and mother was understanding. Patient's father called back in requesting a write up of what happened, why it happened, and a statement showing that pt will have no adverse effects from this. This writer tried to explain that due to multiple parties being part of vaccine management at practice, expired vaccines were left in fridge, and staff are going to be reassigned duties to handle vaccine management. Patients parents confirmed no observation of adverse effects.
More
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| 2833937 | 55 | F | NC | 04/01/2025 |
PNC20 |
PFIZER\WYETH |
2416310 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient given duplicate vaccination from 4/2023. Patient has not reported any symptoms and was couns...
Patient given duplicate vaccination from 4/2023. Patient has not reported any symptoms and was counselled on potential issues
More
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| 2833938 | 78 | F | PA | 04/01/2025 |
RSV |
PFIZER\WYETH |
HM9863 |
Discomfort, Mobility decreased
Discomfort, Mobility decreased
|
Patient states that they started having symptoms day of. Having issues with bending arm down to use ...
Patient states that they started having symptoms day of. Having issues with bending arm down to use wheelchair and getting comfortable to sleep. She has tried Tylenol and ibuprofen without relief but does get some relief with her tramadol. There is no redness at the sight or any type of symptom of an infection. Pharmacy called patient's PCP to discuss their recommendations for patient beyond OTC medications.
More
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| 2833939 | 0.33 | M | NJ | 04/01/2025 |
DTAPIPVHIB DTAPIPVHIB PNC20 PNC20 DTAPIPVHIB DTAPIPVHIB |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH SANOFI PASTEUR SANOFI PASTEUR |
UK007AA UK007AA UK007AA UK007AA |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event
More
|
No adverse reaction, but medication error. Expired Pentacel vaccine was accidentally given to the pa...
No adverse reaction, but medication error. Expired Pentacel vaccine was accidentally given to the patient. Provider was made aware.
More
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| 2833940 | 37 | M | NJ | 04/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
4M24Z |
Underdose
Underdose
|
They are 5ml vials and the provider estimates that only 4.5ml was given in one arm due to the CMA ad...
They are 5ml vials and the provider estimates that only 4.5ml was given in one arm due to the CMA advising them that about a drop was left in the vial.
More
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| 2833942 | 2 | M | TN | 04/01/2025 |
DTAPHEPBIP DTAPIPVHIB PNC20 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH |
PE24L UK107AA HH1326 |
Circumstance or information capable of leading to medication error, Wrong produc...
Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered
More
|
Child presented to the health department for vaccines to be UTD per CDC catch-up schedule. Biologica...
Child presented to the health department for vaccines to be UTD per CDC catch-up schedule. Biological Father present with child & sibling. Children were extremely uncooperative & unruly during the entire visit. Father was in a rush to have visit completed by 2:30pm to make a phone call & to leave for another appt. at 4pm. Nurse felt rushed, nervous & frazzled in trying to get the children's vaccines prepared & administered. Both children were receiving the same vaccines during the visit. Nurse placed order of vaccines into the system & proceed to prepare the vaccines checking the vials of name of vaccines & expiration dates. As stated above, the nurse felt rushed by the father & failed to take the time to scan the vaccines prior to administration. Vaccines were administered & visit concluded. After the family had left the nurse began to scan the vaccines & document the required information & noticed that the wrong vaccine had been given. Child received Pentacel instead of the ActHIB vaccine. Nurse only focused on finding ActHIB on the vaccine vial & never noticed it being Pentacel. The child received 2 doses of DTap & IPV at day of visit. Nurse immediately notified her nursing supervisor & the Incident Report process began.
More
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| 2833943 | 65 | M | MA | 04/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n35n9 |
Discomfort, Dysaesthesia, Ear pain, Headache
Discomfort, Dysaesthesia, Ear pain, Headache
|
Left ear canal pain, discomfort, left external ear dysesthesia (bug crawling sensation), left temple...
Left ear canal pain, discomfort, left external ear dysesthesia (bug crawling sensation), left temple headache. All symptoms persisting as of the date of this report, 2+ months.
More
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| 2833944 | 2 | F | OH | 04/01/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y013350 Y013350 |
Dry skin, Injection site erythema, Injection site papule, Injection site rash, I...
Dry skin, Injection site erythema, Injection site papule, Injection site rash, Injection site reaction; Skin exfoliation
More
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3/21/25 - 2 weeks after vaccine, mother notified office of rash that developed to posterior aspect o...
3/21/25 - 2 weeks after vaccine, mother notified office of rash that developed to posterior aspect of right leg and sent photos. mom notes not bothersome but seems to be worsening instead of improving. Pictures seem to show clustered erythematous papules, not able to discern vesicles. on 3/21/25 nursing staff called to triage and obtain more information, Mom states does not appear to be fluid filled; initially looked like a pimple, but now is more reddish in color. She sent another picture which shows erythematous papules with dry peeling skin almost like eczema. This provider recommended otc hydrocortisone 1% and evaluation with dermatology. On 4/1/25 mom sent update that she saw dermatology who informed mother that rash is from the varicella vaccine. Dermatology advised mom to use hydrocortisone.. Mother reported 4/1/25 that topical hydrocortisone is not working and rash is worsening. Advised mom to reach out to dermatology. This office will request dermatology records as not currently viewable. This provider also entered consult to pediatric infectious disease for further vaccine recommendations.
More
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| 2833945 | 15 | M | NY | 04/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0168 EW0168 |
Tremor; Tremor
Tremor; Tremor
|
I have had chronic tremors or shaking in both my right and left hand
I have had chronic tremors or shaking in both my right and left hand
|
β | |||||
| 2833946 | 1.42 | M | 04/01/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Pneumococcal Dtap/ipv/Hib (Left thigh for |
Crying, Injection site erythema, Injection site mass, Injection site pain; Cryin...
Crying, Injection site erythema, Injection site mass, Injection site pain; Crying, Injection site erythema, Injection site mass, Injection site pain; Crying, Injection site erythema, Injection site mass, Injection site pain
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When baby arrived home from vaccination he was fine but the following day by the morning when I was ...
When baby arrived home from vaccination he was fine but the following day by the morning when I was going to change his diaper there was a huge red lump/bump on the left thigh bigger than a golf size ball. I tried putting cold compress but baby would not let me touch it. For that weekend he was just on diapers because we couldn't put any pants shorts or other garment due to the size of the bump he would cry every time he would accidentally touched the area. He continued to be in pain and Tylenol was given. I stopped Tylenol because I did not wanted for the baby to be on medicine all the time.
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| 2833947 | 65 | F | TN | 04/01/2025 |
FLU3 |
SANOFI PASTEUR |
UT8473DA |
Injection site pain, Pain, Sleep disorder
Injection site pain, Pain, Sleep disorder
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Per pt report "Got Flu vaccine at pharmacy at the end of Jan and has been having pain in her le...
Per pt report "Got Flu vaccine at pharmacy at the end of Jan and has been having pain in her left upper arm since then. Hurts more when trying to raise left arm and when sleeping." Pt was seen at Center for complaint above. Pt was assessed by provider and ordered to receive Physical Therapy on the arm as well as high dose NSAIDS (Meloxicam). Pt to begin PT on 04/02/2025
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| 2833948 | 63 | M | NY | 04/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N3Y |
Injection site erythema, Injection site rash
Injection site erythema, Injection site rash
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Patient started to develop a red area around where the injection was given the night of 3/27/25. As...
Patient started to develop a red area around where the injection was given the night of 3/27/25. As of today's date, the redness is enveloping his entire upper arm and has a rash associated with it in the same area.
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| 2833949 | 4 | M | PA | 04/01/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5G23D Y017207 |
Injected limb mobility decreased, Injection site erythema, Injection site pain, ...
Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder; Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder
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Patient is a 4 year old male with a past medical history of asthma presenting with left arm swelling...
Patient is a 4 year old male with a past medical history of asthma presenting with left arm swelling s/p vaccines. Patient received his 4 year old vaccinations yesterday at 1000 (Dtap/IPV/MMR). He returned to school after vaccines with no issue or concerns from patient's school. Last evening, parents noted significant upper arm swelling, redness, and tenderness. Symptoms worsened over night and into this morning. He was in pain all night and was given tylenol without significant improvement. Reportedly waking up every 30 mins. Dad became concerned when patient stopped using his left arm today, which prompted him to come to ED. Of note, parents report a similar reaction after vaccines when patient was around 1 year old. However, dad notes the reaction was more localized that time and resolved without antibiotics. Patient had 1 reported low grade temp (around 100F), for which he received tylenol. No recent falls or trauma to left arm. No past skin or soft tissue infection. Family has a 2-year old cat at home but deny concern for recent scratch or bite. No known bug bites prior to onset of symptoms. No recent travel. Denies rash, cough, congestion, swollen lymph nodes, decrease PO intake or UOP, AMS, lethargy. Routine immunizations up to date. Older brother and sister at home, no recent sick contacts.
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| 2833950 | 31 | F | OK | 04/01/2025 |
DTAP DTAP VARCEL VARCEL |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
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Injection site pain, Injection site swelling, Nausea, Rash, Rash maculo-papular;...
Injection site pain, Injection site swelling, Nausea, Rash, Rash maculo-papular; Vomiting; Injection site pain, Injection site swelling, Nausea, Rash, Rash maculo-papular; Vomiting
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nausea vomiting, injection site swelling redness and tenderness diffuse rash maculopapular rash all ...
nausea vomiting, injection site swelling redness and tenderness diffuse rash maculopapular rash all started within 24 hours or less of vaccine administration
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| 2833951 | 59 | F | CO | 04/01/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL9264 EL9264 EL9264 EL9264 EL9264 EN6198 EN6198 EN6198 EN6198 EN6198 EL9264 EL9264 EL9264 EL9264 EL9264 EN6198 EN6198 EN6198 EN6198 EN6198 |
Abdominal pain, Chest discomfort, Chest pain, Chest wall operation, Computerised...
Abdominal pain, Chest discomfort, Chest pain, Chest wall operation, Computerised tomogram abdomen abnormal; Costochondritis, Diverticulitis, Dizziness, Eye contusion, Eye disorder; Hypoaesthesia, Lacrimal disorder, Limb discomfort, Magnetic resonance imaging abnormal, Malaise; Mammogram, Motion sickness, Muscle mass, Pain in extremity, Paraesthesia; Pulmonary function test normal, Tinnitus; Abdominal pain, Chest discomfort, Chest pain, Chest wall operation, Computerised tomogram abdomen abnormal; Costochondritis, Diverticulitis, Dizziness, Eye contusion, Eye disorder; Hypoaesthesia, Lacrimal disorder, Limb discomfort, Magnetic resonance imaging abnormal, Malaise; Mammogram, Motion sickness, Muscle mass, Pain in extremity, Paraesthesia; Pulmonary function test normal, Tinnitus; Abdominal pain, Chest discomfort, Chest pain, Chest wall operation, Computerised tomogram abdomen abnormal; Costochondritis, Diverticulitis, Dizziness, Eye contusion, Eye disorder; Hypoaesthesia, Lacrimal disorder, Limb discomfort, Magnetic resonance imaging abnormal, Malaise; Mammogram, Motion sickness, Muscle mass, Pain in extremity, Paraesthesia; Pulmonary function test normal, Tinnitus; Abdominal pain, Chest discomfort, Chest pain, Chest wall operation, Computerised tomogram abdomen abnormal; Costochondritis, Diverticulitis, Dizziness, Eye contusion, Eye disorder; Hypoaesthesia, Lacrimal disorder, Limb discomfort, Magnetic resonance imaging abnormal, Malaise; Mammogram, Motion sickness, Muscle mass, Pain in extremity, Paraesthesia; Pulmonary function test normal, Tinnitus
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Sick for several days after the 1st shot, global chest pain, pressure, started within a few days, Af...
Sick for several days after the 1st shot, global chest pain, pressure, started within a few days, After the 2nd shot the pain and pressure I was feeling intensified, and I finally called my doctor in March, 2021. The pain and pressure morphed into my arms and legs feeling numb and tingling. I also developed problems with my eyes and tinnitus in my right ear. Started to develop pain in my abdomen - thought it was gall bladder and/or spleen area. CT of abdominal area. A shadow was seen in the upper right chest. Had another CT. They thought I had a tumor. 7/15/22 surgery for tumor. It was just a mass of muscle tissue, benign. I went to more PT to help with the pain in chest and arms. Went to pain management doc. I had a steroid injection. I had a reaction to the steroid, it did not help. 4/20/23: Went to ENT for tinnitus, no explanation for having tinnitus. Hearing is good. 10/10/23 bruising around eye - no explanation, 10/13/23 had a pulmonary function test due to centrilobular emphysema markings seen on MRI - asymptomatic, no COPD rare but not unusual the doctor said 1/25/24 diagnosed with diverticulitis, Sent for more pain management - Doctors offered steroid injections, I declined due to negative reaction and no relief from the last one. 3/21/25 had a mammogram and it resulted in sharp shooting pains in my chest for about 5 days. Pain and pressure in chest, arms, underarms continues. Tingling and numbness feeling in arms and legs continue. Throughout I have experienced some dizziness and lightheadedness, particularly in moving vehicles.
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| 2833952 | 72 | F | WI | 04/01/2025 |
COVID19 |
MODERNA |
3043838 |
Extra dose administered
Extra dose administered
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The patient requested a covid shot after getting one 9/17/24 and 3/14/25. Vaccine was administered 4...
The patient requested a covid shot after getting one 9/17/24 and 3/14/25. Vaccine was administered 4/1/25 and realized after the fact that the patient was up to date. The patient was confused and wanted a Shingles shot but stated on her paperwork she was asking for a Covid shot.
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| 2833953 | 0.25 | M | MI | 04/01/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7921AA Y005465 2032352 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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First dose Rotateq given to infant at 15 weeks 5 days old. No symptoms or side effects at this time.
First dose Rotateq given to infant at 15 weeks 5 days old. No symptoms or side effects at this time.
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| 2833955 | 18 | M | OH | 04/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
52N4S |
Abdominal pain, Nausea, Vomiting
Abdominal pain, Nausea, Vomiting
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pt started to feel nauseated after receiving the bexero vaccine on 3/28/25. this has continued for 4...
pt started to feel nauseated after receiving the bexero vaccine on 3/28/25. this has continued for 4 days. he has vomited 5 times in the past 4 days. also has had abdominal pain since receiving the vaccine.
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| 2833956 | 4 | M | CT | 04/01/2025 |
FLU3 |
SEQIRUS, INC. |
319439 |
Henoch-Schonlein purpura, Rash
Henoch-Schonlein purpura, Rash
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Henoch-SchοΏ½nlein purpura first symptoms of the rash in early February. No other illness or allerg...
Henoch-SchοΏ½nlein purpura first symptoms of the rash in early February. No other illness or allergies.
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| 2833957 | 10 | F | MI | 04/01/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Incorrect dose administered
Incorrect dose administered
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Patient is 10 years old and was given a 12> COVID dose
Patient is 10 years old and was given a 12> COVID dose
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| 2833958 | 11 | M | TX | 04/01/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMXB064A |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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Nurse drew up the dilutant and administered it to the patient. The nurse never took the dilutant and...
Nurse drew up the dilutant and administered it to the patient. The nurse never took the dilutant and reconstituted the vaccine. The patient did not receive the actual vaccine during his visit. There is no evidence to suggest an adverse reaction, but the patient did get an injection without receiving the intended medication.
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| 2833959 | 33 | M | FL | 04/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Syncope
Syncope
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Patient briefly fainted after vaccination was given.
Patient briefly fainted after vaccination was given.
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| 2833960 | 10 | F | MO | 04/01/2025 |
HEP HEPA IPV TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
95BJ9 Y011731 X1D141M U8274AA |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Catch-up dose was given too soon. IPV dose #2 was administered on 01/07/2025. IPV dose #3 was admin...
Catch-up dose was given too soon. IPV dose #2 was administered on 01/07/2025. IPV dose #3 was administered on 04/01/2025. There were no adverse reactions. This vaccine was administered along with Tdap, Hep A and Hep B on 04/01/2025.
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| 2833961 | 29 | F | FL | 04/01/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Adjustment disorder with depressed mood, Back pain, Hypomenorrhoea, Irritability...
Adjustment disorder with depressed mood, Back pain, Hypomenorrhoea, Irritability, Menstruation irregular; Mood swings, Pain, Premenstrual syndrome
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The next day after I received the shot, I used the bathroom and got up from the toilet to wash my ha...
The next day after I received the shot, I used the bathroom and got up from the toilet to wash my hands and my middle back started hurting like never before. I could hardly stand up straight, it was almost like a constant sharp pain. This pain lasted for about 3 days, across the middle of my back when I moved my arms or did anything. Then 2 days after the vaccine I got my period!! I already had my period on January 10th. But on January 24th I started my period again. It was an irregular period as well with dark blood and light bleeding. I also had TERRIBLE mood swings and PMS on January 23rd, very very irritable and depressed.
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| 2833962 | 18 | F | MA | 04/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
B4J4B |
Arthralgia
Arthralgia
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Patient reports pain, in left shoulder, pain with raising arm. Seen in ER possible bruising or vacci...
Patient reports pain, in left shoulder, pain with raising arm. Seen in ER possible bruising or vaccine induced tendinitis.
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