| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2832178 | 0.58 | F | TX | 03/19/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
2R3BY |
Device connection issue, Underdose
Device connection issue, Underdose
|
glass little part that you screw in the needle tto, that little glass part is loose/syringe popped o...
glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off; Product Complaint; needle stuck; not all the liquid not all the vaccine went in to the patient's leg"; This non-serious case was reported by a nurse via call center representative and described the occurrence of needle stick/puncture in a 8-month-old female patient who received Hib (Hiberix) (batch number 34L24) and (batch number 2R3BY, expiry date 15-JUL-2026) for prophylaxis. This case was associated with a product complaint. On 04-MAR-2025, the patient received Hiberix. On 04-MAR-2025, an unknown time after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: needle stuck) and incomplete dose administered (Verbatim: not all the liquid not all the vaccine went in to the patient's leg"). On an unknown date, the patient experienced device connection loose (Verbatim: glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture was not reported and the outcome of the incomplete dose administered, device connection loose and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the needle stick/puncture and device connection loose to be related to Hiberix. It was unknown if the company considered the needle stick/puncture and device connection loose to be related to Hiberix. Additional Information: GSK Receipt Date: 04-MAR-2025 The nurse reported that in the prefilled syringe in the glass little part that you screw in the needle too, that little glass part was loose. So the nurse was assuming that when she put the pressure it went through and it popped-off in that part, she when she was injecting it with the pressure of the injection popped it off and not all the liquid not all the vaccine went in to the patient's leg. The nurse reported that once the Hiberix was mixed and the needle was placed in the patient's left leg the syringe popped off and the needle stuck in the babies left leg. The defect was discovered during administration. The product was only partially administered which led to incomplete dose adminstred. Syringe was involved in the complaint. There was no defect or damage on the syringe noticed. When removing the cap, it was screwed off.
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| 2832179 | M | 03/19/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
B532G |
Extra dose administered
Extra dose administered
|
extra dose/Inappropriate schedule; This non-serious case was reported by a other health professional...
extra dose/Inappropriate schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G, expiry date 11-APR-2027) for prophylaxis. Previously administered products included Pediarix (Patient received first dose on an unknown date), Pediarix (Patient received second dose on 09-OCT-2024) and Pediarix (patient received third dose on an unknown date). On 02-FEB-2025, the patient received the 4th dose of Pediarix. On 02-FEB-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: extra dose/Inappropriate schedule). The outcome of the extra dose administered 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: 05-MAR-2025 Medical Assistant reported that a 6 month old patient completed Diphtheria, Tetanus, Pertussis Vaccine 2 doses on October ninth twenty twenty-four, they went to after that and the patient got vaccinated again for Diphtheria, Tetanus, Pertussis Vaccine there, the pharmacy was not aware of that. So, on February second patient received the 3rd Diphtheria, Tetanus, Pertussis Vaccine dose as recommended by the profile. Medical Assistant wanted to know as for the parent๏ฟฝs concern on the child๏ฟฝs health. Patient received fourth dose of Pediarix, which led to extra dose administered.
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| 2832180 | 11 | F | 03/19/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
73SX2 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
patient was given Infanrix instead of Tdap; given to an 11 year old; This non-serious case was repor...
patient was given Infanrix instead of Tdap; given to an 11 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 73SX2, expiry date 24-MAR-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On 03-MAR-2025, the patient received Infanrix. On an unknown date, the patient did not receive Tdap Vaccine. On 03-MAR-2025, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced wrong vaccine administered (Verbatim: patient was given Infanrix instead of Tdap) and inappropriate age at vaccine administration (Verbatim: given to an 11 year old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 13-MAR-2025 The staff member stated a patient was given Infanrix instead of Tdap which led to, wrong vaccine administered and inappropriate age at vaccine administration.
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| 2832181 | 50 | F | NJ | 03/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site mass, Injection site pain
Injection site mass, Injection site pain
|
lump on the injection site; pain in injection site; This non-serious case was reported by a pharmaci...
lump on the injection site; pain in injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-JAN-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site lump (Verbatim: lump on the injection site) and injection site pain (Verbatim: pain in injection site). The outcome of the injection site lump and injection site pain were unknown. It was unknown if the reporter considered the injection site lump and injection site pain to be related to Shingrix. It was unknown if the company considered the injection site lump and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date : 13-MAR-2025 A patient had this vaccine last January twenty-twenty five, patient complained about a lump on the injection site and pain in injection site. The reporter questioned how much was this gonna last.
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| 2832182 | M | FL | 03/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered
Extra dose administered
|
Extra Dose Administered; This non-serious case was reported by a pharmacist via call center represen...
Extra Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 14-MAR-2025 The pharmacist reported that a patient who was unsure if they got the Arexvy vaccine twice, which led to extra dose administered. So, ask question was if they were vaccinated twice, whether, what should they do. The pharmacist did not have lot number of the vaccines and patient was not sure whether he received the Arexvy vaccine twice. Patient age was approximated by the health care professional between 75-76 years old.
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| 2832183 | F | 03/19/2025 |
COVID19 |
JANSSEN |
|
Death, Internal haemorrhage, Lung neoplasm malignant, Thrombosis
Death, Internal haemorrhage, Lung neoplasm malignant, Thrombosis
|
stage 4 lung cancer; internal bleeding; head to toe Blood clots; death; This spontaneous report rece...
stage 4 lung cancer; internal bleeding; head to toe Blood clots; death; This spontaneous report received from a consumer concerned a female patient of unspecified age. received via JnJ managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced death. On an unspecified date, the patient experienced stage 4 lung cancer and was hospitalized on an unspecified date. On an unspecified date, the patient experienced internal bleeding and was hospitalized on an unspecified date. On an unspecified date, the patient experienced head to toe blood clots and was hospitalized on an unspecified date. (dose series 1) The patient had internal bleeding. One month in the hospital with no answers and then they said she developed head to toe blood clots and stage 4 lung cancer. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was unknown cause of death. The patient died on an unspecified date. The outcome of stage 4 lung cancer, internal bleeding and head to toe blood clots was not reported. This report was serious (death and caused/prolonged hospitalization).; Sender's Comments: V0; Death, Lung neoplasm malignant, Internal haemorrhage and Thrombosis; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
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โ | โ | ||||||
| 2832184 | 1.75 | M | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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The adverse event was that the medication was expired at the time it was given. No adverse reaction...
The adverse event was that the medication was expired at the time it was given. No adverse reaction by patient.
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| 2832185 | 1.75 | M | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Medication given pass the expiration date. No other adverse reactions noted or reported by pt parent...
Medication given pass the expiration date. No other adverse reactions noted or reported by pt parents.
More
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| 2832186 | 1.5 | F | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Medication given pass the expiration date. No other adverse reactions noted or reported by pt parent...
Medication given pass the expiration date. No other adverse reactions noted or reported by pt parents.
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| 2832187 | 70 | F | DC | 03/19/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Provider ordered Abrysvo outside of administration window. Administering medical assistant inadverte...
Provider ordered Abrysvo outside of administration window. Administering medical assistant inadvertently grabbed Beyfortus as Abrysvo was no longer available at the site. Beyfortus was administered to the patient. Provider contacted patient and informed her of the inadvertent administration. Patient reported no adverse side effects.
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| 2832188 | 47 | F | NJ | 03/19/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8506JA UT8506JA |
Dizziness, Dysphagia, Dysphonia, Lip erythema, Lip pruritus; Lip swelling, Pruri...
Dizziness, Dysphagia, Dysphonia, Lip erythema, Lip pruritus; Lip swelling, Pruritus, Sensation of foreign body, Throat irritation
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Ball feeling in throat, having difficulty swallowing. fluid pooling in mouth . itchy right shoulder....
Ball feeling in throat, having difficulty swallowing. fluid pooling in mouth . itchy right shoulder. lips swollen, itchy, & red. lightheadness. voice going horse. buring sensation down back of throat.
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| 2832189 | 91 | M | IA | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
3043159 |
Death
Death
|
Deceased, anticipated and on hospice care.
Deceased, anticipated and on hospice care.
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โ | |||||
| 2832190 | 6 | F | OH | 03/19/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2438 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
FluBlok given instead of Fluzone; no adverse reactions
FluBlok given instead of Fluzone; no adverse reactions
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| 2832191 | 0.92 | F | MI | 03/19/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient was due for Dtap and polio according to the system. Medical assistant seen that we had a com...
Patient was due for Dtap and polio according to the system. Medical assistant seen that we had a combination immunization in the VFC stock for children for the 2 immunizations due and administered the combination medication. After the combination immunization was administered and patient left the medical assistant was putting it into epic when it gave an alert that the child was not yet old enough for that particular immunization combination. After further investigation the immunization combination that was administered was found to be for children 4 to 6 years of age and the patient in question is 11 months old. The health department was contacted and notified of the adverse event and gave guidance on how to handle the situation and what all steps needed to be taken. The patients' parent was contacted and told about the adverse event and re-educated on the adverse reactions to look out for and when to contact our office if they do present or if the patient's parent has any further questions. The medical assistant was re-educated on immunization administration, additional learning was assigned, and new safeguards were put in place.
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| 2832192 | 64 | F | KY | 03/19/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
kh2bd |
Rash
Rash
|
Patient came to pharmacy asking to get mmr vaccine due to recent out break. Patient takes medication...
Patient came to pharmacy asking to get mmr vaccine due to recent out break. Patient takes medication (Actemra) for arthritis. The medication lowers the immune systems response. This was accidently over looked and the vaccine was administered. Patient had a rash that popped up later that evening into the the next morning on her arms and back. The patient was advised to go get checked out by ER or family dr at the least. The patient decided that she would go get checked if the condition worsened. She said at the time she was not in pain and was only curious if having the rash was normal after receiving the mmr vaccine. Patient does not fill the Actemra at this pharmacy and was advised to reach out to the pharmacy that fills the Actemra for a second opinion and additional info about possible side effects with the medicine and the live vaccine. She was also advised to ask her rheumatologist when to stop or continue with the next dose of her Actemra. Pharmacist did call once each day for 3 days following the identification of the event to check on patient and reiterate importance of checking with rheumatologist, other pharmacy and ER or family dr of second opinions about Actemra and possible other side effects.
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| 2832193 | 63 | F | OH | 03/19/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Arthralgia, Loss of personal independence in daily activities, Pain, Pain in ext...
Arthralgia, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder; X-ray limb; Arthralgia, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder; X-ray limb
More
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My (R) arm and shoulder started hurting and aching that night making it extremely hard to sleep. I ...
My (R) arm and shoulder started hurting and aching that night making it extremely hard to sleep. I have to sleep on my left side with a pillow propped under my right arm to stop the arm from throbbing and aching. Movements such as moving my arm forward or back or to the side cause excruciating pain! I am very limited in my everyday chores and if I accidentally move it in a certain way, it is very jarring and takes me to my knees. It is even difficult to get dressed and undressed every day. I saw Dr., PA-C on 01/14/2024 and informed her of my situation and the pain I was experiencing since having the Flu and Pneumonia shot on 12/18/2024. She then ordered the x-ray and prescribed me Naproxen 500mg Naproxen 500mg for the pain and put in an order for me to go to Physical Therapy. I have not scheduled any physical therapy because I currently am without health insurance.
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| 2832194 | 1.5 | F | NH | 03/19/2025 |
MMR |
MERCK & CO. INC. |
X007688 |
Expired product administered
Expired product administered
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Vaccine was in the freezer, pulled vaccine and did not check date. Gave client vaccine without check...
Vaccine was in the freezer, pulled vaccine and did not check date. Gave client vaccine without checking expiration date. Noticed vaccine was expired when I put it into the chart for documentation.
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| 2832195 | 10 | M | MI | 03/19/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5H773 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient was due for Dtap/Tdap/TD according to system which is a outside immunization data base for p...
Patient was due for Dtap/Tdap/TD according to system which is a outside immunization data base for patients that have received immunizations outside of state. The medical assistant pulled and administered Dtap for the child however since the child 10 years old and the Dtap immunization is recommended for children less than 7 years of age, this particular child should have received the Tdap immunization instead. The parents were notified of the adverse event and are aware that the patient's school may require the child to receive the Tdap immunization in the fall if they do not accept the Dtap immunization. The medical assistant was re-educated on Immunization administration as well as assigned additional learning modules and new safeguards were placed to prevent future adverse events.
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| 2832196 | 17 | F | 03/19/2025 |
HPV9 |
MERCK & CO. INC. |
X005044 |
Expired product administered
Expired product administered
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Vaccine was administered past expiration date.
Vaccine was administered past expiration date.
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| 2832197 | 2 | M | MI | 03/19/2025 |
HEPA PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
DN273 LG5578 |
No adverse event; No adverse event
No adverse event; No adverse event
|
No known adverse event
No known adverse event
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| 2832198 | 17 | F | NC | 03/19/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
A5AD4 |
Injection site cellulitis, Injection site erythema, Injection site swelling, Inj...
Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
More
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Redness, swelling, heat at injection site that extended to elbow. Diagnosed with cellulitis via tele...
Redness, swelling, heat at injection site that extended to elbow. Diagnosed with cellulitis via telemedicine visit. Treated with Amoxicillin BID X 10 days.
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| 2832199 | 23 | F | CT | 03/19/2025 |
CHIK CHIK CHIK TYP TYP TYP YF YF YF |
VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
|
Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positi...
Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, C-reactive protein; Chills, Complement factor C3, Complement factor C4, Differential white blood cell count normal, Double stranded DNA antibody; Full blood count normal, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor; Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, C-reactive protein; Chills, Complement factor C3, Complement factor C4, Differential white blood cell count normal, Double stranded DNA antibody; Full blood count normal, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor; Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, C-reactive protein; Chills, Complement factor C3, Complement factor C4, Differential white blood cell count normal, Double stranded DNA antibody; Full blood count normal, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor
More
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Experienced high fever (103) with chills that were not relieved much by ibuprofen for 7 days. After ...
Experienced high fever (103) with chills that were not relieved much by ibuprofen for 7 days. After around 3-5 days fever-free, joint pain in the knees, ankles, wrists, and PIP joints similar to the symptoms of chikungunya persisted. Acute joint pain is still being experienced 5 months later. Leading theory from rheumatologist is that the vaccine predisposed the patient (me) to an autoimmune condition. Patient has been on and off prednisone, and is now seeking treatment using methotrexate and hydroxychloroquine to find relief.
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| 2832200 | 53 | F | GA | 03/19/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
79S54 |
Interchange of vaccine products
Interchange of vaccine products
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N/A - PATIENT RECIEVED HEPLISAV-B ON 1/2/25 AND RECIEVED ENGERIX-B ADULT AS A SECOND DOSE INSTEAD OF...
N/A - PATIENT RECIEVED HEPLISAV-B ON 1/2/25 AND RECIEVED ENGERIX-B ADULT AS A SECOND DOSE INSTEAD OF RECIEVING HEPLISAV-B
More
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| 2832201 | 4 | M | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832202 | 25 | M | UT | 03/19/2025 |
TD TD TD |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U8303A4 U8303A4 U8303A4 |
Anti-aquaporin-4 antibody negative, Antinuclear antibody increased, Antinuclear ...
Anti-aquaporin-4 antibody negative, Antinuclear antibody increased, Antinuclear antibody positive, Blood test normal, CSF myelin basic protein increased; Headache, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal, Neck pain, Optic neuritis; Scan with contrast abnormal, Sleep disorder, Vision blurred, Visual impairment
More
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Bilateral Optic Neuritis following Td Vaccination no significant medical history or concomitant med...
Bilateral Optic Neuritis following Td Vaccination no significant medical history or concomitant medications. No personal or family history of autoimmune disease. January 19, 2025: Received Td vaccine (Td Adult, absorbed, PMC, Lot U83003A4) from provider: Around 2 weeks later noted some pain around right temporal area at night which was worse when sleeping on his side and required sleeping on his back. February 19 noted blurred vision especially in lower visual field of right eye. Progressed to inability to make out any details with right eye and severe blurred vision of left eye over the following days with headache. February 24: Seen in the emergency room and bilateral optic nerve swelling was observed. Cerebral MRI with and without contrast showed findings consistent with bilateral optic neuritis but no vascular or parenchymal abnormalities. CSF and blood panels show elevation of myelin basic protein consistent with optic neuritis. Aquaporin-4 receptor antibody negative. Spine cervical MRI with and without contrast negative for white matter lesions. Spine thoracic MRI with and without contrast negative for white matter lesions. Admitted to the hospital overnight and discharged on February 25 Received 5 days of intravenous steroids from February 24 through March 1. Experienced headache and some neck pain intermittently. March 3: Visited neurologist. Evaluation negative for multiple sclerosis. Gradual improvement of vision but right eye continues impaired as of March 19, 2025.
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โ | โ | ||||
| 2832203 | 76 | M | GA | 03/19/2025 |
PNC20 |
PFIZER\WYETH |
LA6406 |
Dysgeusia, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Dysgeusia, Erythema, Pain in extremity, Peripheral swelling, Pruritus
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Funny taste in mouth (metallic) immediately following vaccine administration. Encouraged to wait in ...
Funny taste in mouth (metallic) immediately following vaccine administration. Encouraged to wait in building for 30 minutes. No further problems noted. Encouraged patient to call 911 or visit ER for signs/symptoms of anaphylaxis. Patient reported back to health department on 3/19/2025 with complaints of further issues. 3/13/25 left arm was sore and began to swell a little on 3/14/2025. Swelling lasted a few days and went down. Redness spread down arm the past couple of days. It also itches a little. Encouraged topical anti-inflammatory cream for itching and to follow up with primary physician.
More
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| 2832204 | 2 | M | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832205 | 10 | F | CA | 03/19/2025 |
MNQ MNQ TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8194AA U8194AA U8231AA U8231AA |
Cough, Fatigue, Influenza B virus test positive, Nasal congestion, Oropharyngeal...
Cough, Fatigue, Influenza B virus test positive, Nasal congestion, Oropharyngeal pain; Pain, Pyrexia, Syncope; Cough, Fatigue, Influenza B virus test positive, Nasal congestion, Oropharyngeal pain; Pain, Pyrexia, Syncope
More
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developed a fever, body aches, sore throat and nasal congestion starting the day after her TDaP and ...
developed a fever, body aches, sore throat and nasal congestion starting the day after her TDaP and MenQuadFi Vaccines . Parents suspected this was related to the vaccines . She fainted x 1. My suspicion is that she developed a viral infection coinciding with the vaccines. She ultimately tested positive for Influenza B. She remained febrile for around 4 days and then at the time of this report still has fatigue and cough.
More
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| 2832206 | 70 | F | IA | 03/19/2025 |
PNC21 |
MERCK & CO. INC. |
YO13009 |
Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
|
Patient experienced red, itchy rashes all over her body, including the inside of her throat. Patien...
Patient experienced red, itchy rashes all over her body, including the inside of her throat. Patient has experienced similar reactions from multiple flu vaccinations as well as the shingles vaccination
More
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| 2832207 | 1.5 | F | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832208 | 0.5 | F | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832209 | 2 | F | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832211 | 4 | M | CA | 03/19/2025 |
DTAPIPV FLU3 MMRV |
SANOFI PASTEUR SEQIRUS, INC. MERCK & CO. INC. |
U7838AA 946602 Y006767 |
Pruritus, Throat irritation; Pruritus, Throat irritation; Pruritus, Throat irrit...
Pruritus, Throat irritation; Pruritus, Throat irritation; Pruritus, Throat irritation
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Pt. received Sanofi Pasteur Quadracel, Merck ProQuad and Sequirus Flucelvax at his routine 4 year we...
Pt. received Sanofi Pasteur Quadracel, Merck ProQuad and Sequirus Flucelvax at his routine 4 year well. Within minutes of receiving the vaccine, he described throat itching. His skin became itchy but he did not develop hives. The physician was immediately notified and assessed the patient. He did not develop any respiratory distress. He was given oral Diphenhydramine and oral Dexamethasone and observed in the office until all his symptoms had resolved. Physician followed up by phone later in the day and the patient had no further symptoms.
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| 2832212 | 29 | M | PA | 03/19/2025 |
HEP |
MERCK & CO. INC. |
944915 |
Dizziness, Feeling abnormal, Syncope
Dizziness, Feeling abnormal, Syncope
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Per patient, he verbalized after receiving vaccination it was time to pick up his kid from school. ...
Per patient, he verbalized after receiving vaccination it was time to pick up his kid from school. Patient was asked to wait up to 15mins before exiting center. Patient left after 5 min stating that he needed to get to his son school on time. Patient arrived to work this morning to report that he fainted while getting of the train. Patient verbalize that right before his train was to arrive at his destination he felt off and dizzy. He got up and once he exit train he fainted. He stated that he woke up to a lot of strangers standing over him in concerns and disbelief. Patient did not sustain any injury to head nor body upon passing out. No bruising or cuts upon nursing assessment. Vitals were stable. At this time no other issues or concern per Patient. Patient was advice to report any changes to staff. Also to seek out further evaluation if he ever finds himself at home feeling dizzy. Patient understood and will follow up with any changes.
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| 2832213 | 6 | M | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832214 | 7 | F | MD | 03/19/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7302 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
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| 2832215 | 5 | M | MA | 03/19/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
4L454 4L454 Y017512 Y017512 |
Agitation, Erythema, Fatigue, Hyperhidrosis, Retching; Swelling face, Urticaria;...
Agitation, Erythema, Fatigue, Hyperhidrosis, Retching; Swelling face, Urticaria; Agitation, Erythema, Fatigue, Hyperhidrosis, Retching; Swelling face, Urticaria
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About 10-15 minutes post vaccines, patient developed hives, somewhat diaphoretic and pretty agitated...
About 10-15 minutes post vaccines, patient developed hives, somewhat diaphoretic and pretty agitated. Facial swelling. He was pretty red overall, EXCEPT at the injection sites. He was given 12.5 mg of Benadryl and observed. O2 sat about 93-94% and quite tired. He did have a bit of gagging, but never vomited. He was observed for about 1 hour. By the time he left, he was very chatty, though he was still a bit red. Mom cautioned that if there is any return of sx, she should go to the closest ER for further evaluation.
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| 2832216 | 46 | F | CO | 03/19/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
012m20a 012m20a Unknown Unknown 939905 939905 |
Blood test, Chest discomfort, Chest pain, Chills, Feeding disorder; Myocarditis,...
Blood test, Chest discomfort, Chest pain, Chills, Feeding disorder; Myocarditis, Pain, Pericarditis, Pyrexia; Blood test, Chest discomfort, Chest pain, Chills, Feeding disorder; Myocarditis, Pain, Pericarditis, Pyrexia; Blood test, Chest discomfort, Chest pain, Chills, Feeding disorder; Myocarditis, Pain, Pericarditis, Pyrexia
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Was very sick after first vaccine shot. After second shot, was even sicker and had chest pain/pressu...
Was very sick after first vaccine shot. After second shot, was even sicker and had chest pain/pressure from pericarditis/myocarditis. After 3rd shot, even sicker for longer. Chills, fever, aches & pains and chest pain.
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| 2832217 | 7 | M | WA | 03/19/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Vaccine was given to a patient outside of age range
Vaccine was given to a patient outside of age range
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| 2832218 | 63 | F | NC | 03/19/2025 |
PNC21 PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y019157 Y019157 Y019157 Y019157 |
Amnesia, Asthenia, Blood glucose normal, Blood test, Cheilitis; Dizziness, Elect...
Amnesia, Asthenia, Blood glucose normal, Blood test, Cheilitis; Dizziness, Electrocardiogram normal, Fall, Head injury, Injection site erythema; Injection site inflammation, Injection site pain, Injection site warmth, Lip injury, Lip pain; Pallor, Syncope, Vision blurred
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Developed redness, pain, inflammation and warmth at the injection site which is still present as of ...
Developed redness, pain, inflammation and warmth at the injection site which is still present as of 1pm 3/19/205. On 3/18/2025 around 7:15, 13 hours after administration of the vaccine, I experienced lightheadedness and weakness upon getting up from bed. I went back to bed for about 35-40 minutes. I then got up to get ready for the day; I checked my blood sugar (98), brushed teeth and walked to the kitchen. Around 8:05AM, I was standing and started experiencing lightheadedness, weakness, blurred vision and went to seat. I called my husband who stated I was paled. He helped me to walk to the soda but I fainted and fell to the carpet hitting my head and bitting my lip. I do not remember any of that but my lip is still hurting and inflamed. He gave me a glass of water which I drank. He took my blood pressure but the machine didn?t register any reading the first two times he tried. He tried it on him to make sure the machine was working correctly and it was. On the third attempt @8:16 BP:65/44, HR:46 @8:22 BP:85/46, HR:55 @8:28 BP:99/50, HR:57 @9:38 BP:91/48, HR:63
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| 2832219 | 63 | F | CO | 03/19/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3334Y 3334Y |
Bursitis, Injected limb mobility decreased, Injection site erythema, Injection s...
Bursitis, Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site swelling; Pyrexia
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Patient reported having a 101 degree temperature for over 7 days, severe reaction at the injection s...
Patient reported having a 101 degree temperature for over 7 days, severe reaction at the injection site to include redness and swelling extending to the elbow, three weeks post administration still unable to rotate right shoulder and has been diagnosed with bursitis treated with tramadol and ibuprofen
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| 2832220 | 26 | F | AZ | 03/19/2025 |
HPV9 |
MERCK & CO. INC. |
W026150 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was given 3rd dose approximately 10 weeks after 2nd dose. Per ACIP guidelines the recommenda...
Patient was given 3rd dose approximately 10 weeks after 2nd dose. Per ACIP guidelines the recommendation is to give the 3rd dose at least 12 weeks after the 2nd dose.
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| 2832221 | 4 | F | NE | 03/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Foot deformity, Gait disturbance, Pain
Foot deformity, Gait disturbance, Pain
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She?s having trouble walking normal , her toes are pointed inward as she walks, it was hurting her ...
She?s having trouble walking normal , her toes are pointed inward as she walks, it was hurting her bad to walk, she needed help walking after the vaccines, she?s walking better now, walking on her own , but her feet are still pointed sideways inward and she walks on her heels now !
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| 2832222 | 24 | F | MN | 03/19/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Head injury, Loss of consciousness, Pallor, Visual impairment
Head injury, Loss of consciousness, Pallor, Visual impairment
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After giving 2 injections (HPV & Tdap) to patient, IM left deltoid. Patient turned pale and stat...
After giving 2 injections (HPV & Tdap) to patient, IM left deltoid. Patient turned pale and stated she was seeing white spots, within 30 sec-one minute, patient passed out and hit her head on the table. Within 20-30 seconds patient came to and sat up. She did indicate that she has a history of passing out but did not inform before vaccines given.
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| 2832223 | 1.58 | M | TN | 03/19/2025 |
DTAP HEPA HIBV VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
47y5m dn273 y013470 y014868 |
Induration; Induration; Induration; Induration
Induration; Induration; Induration; Induration
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dime sized induration palpable
dime sized induration palpable
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| 2832224 | 5 | M | AZ | 03/19/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
FT1551 2YB4G |
Unresponsive to stimuli; Unresponsive to stimuli
Unresponsive to stimuli; Unresponsive to stimuli
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staring spell about 20 min after receiving the immunizations: pt had episode outside clinic buildin...
staring spell about 20 min after receiving the immunizations: pt had episode outside clinic building of sitting awake but unresponsive for several minutes before spontaneously returning to baseline. They did not seek care for the episode and no recurrence or further associated event ensued.
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| 2832225 | 52 | F | KS | 03/19/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342RC |
Lymphadenopathy, Rash
Lymphadenopathy, Rash
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Patient had swollen post cervical lymph node noticed 3/18/2025. Rash that started 3/18/2025 on torso...
Patient had swollen post cervical lymph node noticed 3/18/2025. Rash that started 3/18/2025 on torso, back, and face.
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| 2832226 | 3 | M | MI | 03/19/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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The patient inadvertently received Kinrix (DTaP-IPV), which is not approved for his age/dose, instea...
The patient inadvertently received Kinrix (DTaP-IPV), which is not approved for his age/dose, instead of DTaP. The patient did not have any adverse reaction to the vaccine and does not require treatment. The patient's parents have been notified of the administration error and report that the patient has not any adverse reactions. The dose does appear to count in the Registry towards the patient's DTaP and IPV series.
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| 2832227 | 0.25 | M | FL | 03/19/2025 |
DTPPVHBHPB PNC15 RV1 |
MSP VACCINE COMPANY MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
U7899AA Y010032 HP495 |
Crying, Infant irritability, Vomiting projectile; Crying, Infant irritability, V...
Crying, Infant irritability, Vomiting projectile; Crying, Infant irritability, Vomiting projectile; Crying, Infant irritability, Vomiting projectile
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Mother of client contacted clinic around 3:00 EST. Mom states that ever since arriving home this mor...
Mother of client contacted clinic around 3:00 EST. Mom states that ever since arriving home this morning patient has been fussy (around 10 EST). Mom attempted to give a bottle at 12:00 PM and patient projectile vomited. A 1.25 ml dose of infants tylenol was given around 12:30pm. According to mom, around 1 PM, patient began to cry inconsolably. Nothing she tried seemed to help. Mom informed APRN that patient seemed to have an episode where he stopped breathing for approx. 20 seconds. Mom states child is now resting and seems to be okay. Reassurance given and adivsed mom if any further issues or if baby has difficulty breathing, to contact emergency services.
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| 2832228 | 74 | M | FL | 03/19/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received the vaccine too soon since last dose. Received first dose on 08/30/2024 and a secon...
Patient received the vaccine too soon since last dose. Received first dose on 08/30/2024 and a second dose on 03/18/2025
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