| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856863 | 70 | F | OH | 09/04/2025 |
FLU3 |
SEQIRUS, INC. |
407242 |
Injection site pain, Pain, Pain in extremity
Injection site pain, Pain, Pain in extremity
|
Patient said they experiences a shooting pain in their arm and hand during and after the immunizatio...
Patient said they experiences a shooting pain in their arm and hand during and after the immunization. Followed up with patient next day still experiences some pain in the arm more than a usual vaccines in the past. Referred patient to call doctor if they felt it was more pain than past shots. Do not know if the patient called the Doctor's office.
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| 2856864 | 13 | M | TN | 09/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
There was no adverse reaction. Dose was not needed. First Tdap was 2/8/2023. Tdap given on 8/4/20...
There was no adverse reaction. Dose was not needed. First Tdap was 2/8/2023. Tdap given on 8/4/2025 was not needed.
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| 2856865 | 81 | M | TX | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
No adverse event
No adverse event
|
There was no adverse reaction.
There was no adverse reaction.
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| 2856866 | 4 | M | PR | 09/04/2025 |
DTAPIPV MMR VARCEL |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Pain in extremity, Peripheral swelling, Pyrexia, Skin warm; Pain in extremity, P...
Pain in extremity, Peripheral swelling, Pyrexia, Skin warm; Pain in extremity, Peripheral swelling, Pyrexia, Skin warm; Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
More
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Started with Right arm swelling, pain, warmth and fever day after vaccine. Came to the clinic two da...
Started with Right arm swelling, pain, warmth and fever day after vaccine. Came to the clinic two days later and arm was significantly swollen, red, warm and could not move it. Concerns for cellulitis vs septic arthritis vs inflammatory arthritis and referred to the ER for further evaluation
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| 2856867 | 0.75 | M | NE | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No reaction to expired vaccine that was given by (LPN)
No reaction to expired vaccine that was given by (LPN)
|
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| 2856868 | 5 | M | TN | 09/04/2025 |
DTAP IPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. |
47Y5M Y1A201M Z005151 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
Patient received duplicate doses of dtap,ipv, and mmrv. On 8/11/25, database screen did not show th...
Patient received duplicate doses of dtap,ipv, and mmrv. On 8/11/25, database screen did not show that child had received his second MMR and Varicella IMM or his last doses needed in his DTAP or IPV series. Patient was 5 y/o at time of visit. Threfore I procedded to admin these imm. Database now is showing that patietn had these shot previously at 4 y/o on 10/05/23.
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| 2856869 | 12 | M | TN | 09/04/2025 |
MNQ |
SANOFI PASTEUR |
u8194AA |
Extra dose administered
Extra dose administered
|
Menquadfi was given on 8/4/2025. It was not due as the pt had already received a dose on 6/3/2024 a...
Menquadfi was given on 8/4/2025. It was not due as the pt had already received a dose on 6/3/2024 and is not over 16. I did not see it on the vaccine record and gave an extra dose.
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| 2856870 | 0.17 | M | MI | 09/04/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8383AB |
Wrong product administered
Wrong product administered
|
The two month old patient was given the Quadracel vaccine instead of the recommended Vaxelis vaccine...
The two month old patient was given the Quadracel vaccine instead of the recommended Vaxelis vaccine in error. This error was discovered a couple weeks after the vaccine was given. The patient came back in for a visit a couple weeks later after the error was discovered. The provider explained the error to the patient and any known risks associated with giving Quadracel out of the recommended age range. The provider also inquired about any symptoms the parent noticed after the vaccine was given in error. Mom stated that the patient handled the vaccine well with no fevers, excessive fussiness or increased swelling at the injection site.
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| 2856871 | 15 | M | 09/04/2025 |
HIBV |
MERCK & CO. INC. |
X003664 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
There were no adverse events, wrong vaccine was given.
There were no adverse events, wrong vaccine was given.
|
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| 2856872 | 12 | F | OR | 09/04/2025 |
HPV9 |
MERCK & CO. INC. |
Y015560 |
Dizziness, Pallor, Vomiting
Dizziness, Pallor, Vomiting
|
5 minutes after injection Pt became pale and light headed, I had her lie down and while mom stayed w...
5 minutes after injection Pt became pale and light headed, I had her lie down and while mom stayed with her I got her apple juice. Unclear if she lost consciousness as she was lying down with her eyes closed. She drank apple juice and did feel slightly better, she then vomited about 10min after injection. after vomiting she stated that her stomach felt better. I had her continue to lie down and Dr did come in and examine her.
More
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| 2856873 | 39 | M | NC | 09/04/2025 |
COVID19 |
MODERNA |
|
Abdominal distension, Brain fog, Dyspnoea, Fatigue
Abdominal distension, Brain fog, Dyspnoea, Fatigue
|
Brain fog shortness of breath fatigued
Brain fog shortness of breath fatigued
|
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| 2856874 | 7 | M | TN | 09/04/2025 |
DTAP MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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I administered a 3rd dose of MMR and a 6th dose of DTap mistakenly. The child had no adverse effect...
I administered a 3rd dose of MMR and a 6th dose of DTap mistakenly. The child had no adverse effect.
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| 2856875 | 0.5 | F | TN | 09/04/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Administered a 3rd dose of Rotarix by mistake. No adverse reaction occurred.
Administered a 3rd dose of Rotarix by mistake. No adverse reaction occurred.
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| 2856876 | 11 | F | MA | 09/04/2025 |
HPV9 |
MERCK & CO. INC. |
Y013768 |
No adverse event, Syringe issue, Underdose
No adverse event, Syringe issue, Underdose
|
As I was administrating the vaccine, it came to point where I was unable to "push" the plu...
As I was administrating the vaccine, it came to point where I was unable to "push" the plunger any further, I then pulled the needle out assuming all vaccine was administered, as I was going to dispose of the needle I noticed some of the vaccine was present and not all was administered, patient and mom were notified of the event, patient had no adverse reaction and appeared fine
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| 2856877 | 4 | F | VA | 09/04/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
L4EA4 |
Circumstance or information capable of leading to medication error
Circumstance or information capable of leading to medication error
|
WHILE ADMINISTERING HEP-A VAX, CHILD JERKED ARM AND NEEDLE CAME OUT OF ARM. VAX WAS DISCARDED. NEW H...
WHILE ADMINISTERING HEP-A VAX, CHILD JERKED ARM AND NEEDLE CAME OUT OF ARM. VAX WAS DISCARDED. NEW HEP-A VAX ADMINISTERED.
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| 2856878 | 1 | F | KY | 09/04/2025 |
HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
3255P Y018962 Z008427 |
Breath holding, Cyanosis, Hypotonia; Breath holding, Cyanosis, Hypotonia; Breath...
Breath holding, Cyanosis, Hypotonia; Breath holding, Cyanosis, Hypotonia; Breath holding, Cyanosis, Hypotonia
More
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During administration of first vaccine, child began to hold her breath as all injections were given....
During administration of first vaccine, child began to hold her breath as all injections were given. She then became limp and light purple in color. Patient's mother picked her up from the exam table, still limp. The provider was called to the exam room and got the baby which then began to cry without intervention but remained slightly limp. Patient was observed with provider at bedside for the next 20 mins. Upon discharge, was walking, in no acute distress with no visible local reaction at injection site.
More
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| 2856879 | 79 | F | ME | 09/04/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2215 UT8437DA |
Arthralgia, Shoulder injury related to vaccine administration, X-ray; Arthralgia...
Arthralgia, Shoulder injury related to vaccine administration, X-ray; Arthralgia, Shoulder injury related to vaccine administration, X-ray
More
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Patient developed SIRVA following the Covid-19 vaccination on 8/29/2024. The SIRVA was detected when...
Patient developed SIRVA following the Covid-19 vaccination on 8/29/2024. The SIRVA was detected when the patient came into the office on 7/25/25 for right shoulder pain.
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| 2856880 | 68 | M | 09/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
|
Inappropriate additional dose. Patient received Arexvy on 12/21/23.
Inappropriate additional dose. Patient received Arexvy on 12/21/23.
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| 2856881 | 83 | F | FL | 09/04/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
L5229 EK225 |
Injection site pruritus; Injection site pruritus
Injection site pruritus; Injection site pruritus
|
Patient started getting itching occur after receiving vaccines. There was no rash just itching near ...
Patient started getting itching occur after receiving vaccines. There was no rash just itching near and right below the injection sites. She complains of no other problems and continues to have no pain or reduction in range of motion. It has almost been 1 month of having slight itching in the arm.
More
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| 2856882 | 66 | M | KY | 09/04/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8764DB 37F34 |
Swollen tongue, Tongue pruritus; Swollen tongue, Tongue pruritus
Swollen tongue, Tongue pruritus; Swollen tongue, Tongue pruritus
|
Tongue and lips swollen and itching a few hours after vaccines administered. Patient states he took...
Tongue and lips swollen and itching a few hours after vaccines administered. Patient states he took benadryl and it subsided.
More
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| 2856883 | 26 | M | SC | 09/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Astrocytoma malignant, Brain neoplasm, Computerised tomogram head abnormal, Cran...
Astrocytoma malignant, Brain neoplasm, Computerised tomogram head abnormal, Craniotomy, Magnetic resonance imaging head abnormal; Pathology test, Seizure; Astrocytoma malignant, Brain neoplasm, Computerised tomogram head abnormal, Craniotomy, Magnetic resonance imaging head abnormal; Pathology test, Seizure
More
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Roughly two years after receiving both does of the vaccine, I had a seizure on 1/21/2023. The CT and...
Roughly two years after receiving both does of the vaccine, I had a seizure on 1/21/2023. The CT and MRI scans that were taken of my brain on that same day showed a tumor growing in my brain. The following week I had to undergo a craniotomy to remove this tumor at (withheld name) Medical Center in (withheld state). The tissue was sent to the pathology department at the same hospital, which determined that it was a Grade II Oligodendroglioma and would only require surveillance scans every 6 months. A month passes and the neurosurgeon called and urgently summoned me into the hospital and proceeded to explain that they sent the tissue sample to (withheld) University for a second opinion and their conclusion was a Grade IV Astrocytoma. The pathology departments at The University of (withheld) and (withheld) hospital in (withheld state) both came to the same conclusion as (withheld) upon conducting their own studies of the tissue. I have now been a patient at (withheld) since this misdiagnosis occurred. This is an impossible type of cancer to beat.
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โ | โ | โ | |||
| 2856885 | 4 | F | IL | 09/04/2025 |
MMR |
MERCK & CO. INC. |
Y019930 |
Rash, Urticaria
Rash, Urticaria
|
Patient left the office following her MMR-11 & Varivax immunizations without adverse effects. Ap...
Patient left the office following her MMR-11 & Varivax immunizations without adverse effects. Approximately 3 hours later, patient's mother called the immunization extention and informed the nurse that the patient was in the emergency department with hives and a rash.
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| 2856886 | 76 | F | UT | 09/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Injection site bruising, Injection site pain
Injection site bruising, Injection site pain
|
Patient experienced a bruise-like mark on arm soon after vaccine was given and still has a dark mark...
Patient experienced a bruise-like mark on arm soon after vaccine was given and still has a dark mark on skin and tenderness at injection site 5 months after vaccine was administered.
More
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| 2856887 | 30 | F | NY | 09/04/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
MD9SL |
Dizziness, Exposure during pregnancy, Vision blurred
Dizziness, Exposure during pregnancy, Vision blurred
|
30 y.o. female with PMH hypothyroidism (on levothyroxine) and current pregnancy (EDD 09/26/25) prese...
30 y.o. female with PMH hypothyroidism (on levothyroxine) and current pregnancy (EDD 09/26/25) presented for 2nd dose of Engerix-B hepatitis b vaccine. Vaccine was administered at approximately 8:50 AM and pt remained in clinic for 15 minutes following vaccine administration to be observed for side effects, per facility policy. No side effects observed, and pt reported feeling well when she left clinic after 15 minutes. Pt reports onset of blurry vision and lightheadedness at around 9:30 AM while working on her computer and starting to eat breakfast. She initially attributed these symptoms to low blood sugar - as she usually eats breakfast at 7:30 AM, but hadn't eaten until 9:30 AM today. She then became concerned symptoms might be a side effect of the vaccine, so she returned to clinic at 9:40 AM. BP 128/85, HR 95, SpO2 99%, BG 104. Pt reported normal fetal movement. Pt reported feeling better immediately following vital signs. 911 was called. Pt was evaluated by EMS. She declined transport to the emergency room. Pt's OB office was called and her OB was informed of her symptoms. Pt was advised to monitor for symptoms, given emergency precautions, and advised to follow up with OB at scheduled appointment next week, or sooner should she develop symptoms. VS were repeated and WNL. Pt reported feeling well, and she left clinic.
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| 2856888 | 6 | F | 09/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Extra dose administered
Extra dose administered
|
Administered 3rd dose of MMR.
Administered 3rd dose of MMR.
|
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| 2856889 | 11 | M | TX | 09/04/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Z005486 U8562AA 4CA04C1 |
Petechiae, Rash, Rash erythematous; Petechiae, Rash, Rash erythematous; Petechia...
Petechiae, Rash, Rash erythematous; Petechiae, Rash, Rash erythematous; Petechiae, Rash, Rash erythematous
More
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Parent reported (9/3/2025) via Online message that patient developed a red rash area near his right ...
Parent reported (9/3/2025) via Online message that patient developed a red rash area near his right shoulder. It came on suddenly today (9/3/2025). Did not bother him. No scratch or sting. Today, 9/4/25, looks less red, more pink. No pain or bothering him. Recently seen by pediatrician on 8/29/25 who noted petechiae over right shoulder.
More
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| 2856890 | 2 | F | OR | 09/04/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Fatigue, Lethargy, Myalgia; Fatigue, Lethargy, Myalgia
Fatigue, Lethargy, Myalgia; Fatigue, Lethargy, Myalgia
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Extremely tired, lethargic, uncomfortable muscle soreness. Lots of rests and observation
Extremely tired, lethargic, uncomfortable muscle soreness. Lots of rests and observation
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| 2856891 | 41 | F | MD | 09/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Injected limb mobility decreased, Injection site pain, Ultrasound scan
Injected limb mobility decreased, Injection site pain, Ultrasound scan
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R upper arm pain lasting 3 weeks with muscle tenderness and limited range of motion secondary to pai...
R upper arm pain lasting 3 weeks with muscle tenderness and limited range of motion secondary to pain.
More
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| 2856892 | 1.5 | M | CA | 09/04/2025 |
DTAP HEPA MMRV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
JF7DM MB599 Z008866 LP4946 |
Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia; Febrile convulsion, Py...
Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia
More
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Fever to 104, GTC seizure x 30 seconds, self-resolved, went to ER, diagnosed with febrile seizure
Fever to 104, GTC seizure x 30 seconds, self-resolved, went to ER, diagnosed with febrile seizure
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| 2856893 | 1 | F | NH | 09/04/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5h95b z007853 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
Wrong vaccines given at 12 month check up.
Wrong vaccines given at 12 month check up.
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| 2856894 | 26 | F | MI | 09/04/2025 |
FLU3 |
SANOFI PASTEUR |
U8767BA |
Injection site pain, Injection site swelling, Injection site warmth
Injection site pain, Injection site swelling, Injection site warmth
|
patient states her arm swelled up at the site. it is hot to the touch, it is the size of a ping pon...
patient states her arm swelled up at the site. it is hot to the touch, it is the size of a ping pong ball. patient states that it is hot and it hurts.
More
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| 2856895 | 76 | M | CA | 09/04/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U08800BA Z006889 |
Infection; Infection
Infection; Infection
|
Patient called pharmacy to say infection occurred a day or 2 after injection
Patient called pharmacy to say infection occurred a day or 2 after injection
|
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| 2856896 | 1.42 | M | ID | 09/04/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
|
No adverse event
No adverse event
|
No symptoms at this time
No symptoms at this time
|
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| 2856897 | 18 | F | CA | 09/04/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
find out from find out from |
Asthma, Attention deficit hyperactivity disorder, Dermatitis allergic, Eczema, F...
Asthma, Attention deficit hyperactivity disorder, Dermatitis allergic, Eczema, Food allergy; Rash erythematous
More
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My daughter was given vaccines as recommended by healthcare provider from time of birth up to age 12...
My daughter was given vaccines as recommended by healthcare provider from time of birth up to age 12 and has sever ADHD and allergies including skin and Asthma
More
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โ | |||||
| 2856898 | 45 | F | TX | 09/04/2025 |
FLU3 |
SEQIRUS, INC. |
AX4606A |
Rash, Urticaria
Rash, Urticaria
|
Rash and hives on anterior/posterior trunk, groin, and bilateral upper extremities. Treatments incl...
Rash and hives on anterior/posterior trunk, groin, and bilateral upper extremities. Treatments included: steroid cream (triacinolone), steroid shot (8/21/25), 8/22-8/26 steroid pills, pepcid 8/29/25, 9/2/25 IV steroid and anti-histamine, 9/3/25-9/10/25 steroid pills
More
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| 2856899 | 1 | M | MO | 09/04/2025 |
DTAP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
JF7DM 742G5 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
More
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swelling and redness of legs reported by parent day after receiving vaccines. 9/4 child refused to w...
swelling and redness of legs reported by parent day after receiving vaccines. 9/4 child refused to walk or put any weight onto legs. Came into office, no redness or swelling present in office. Child sent to ER from office d/t pain level and being inconsolable
More
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| 2856900 | 0.33 | M | 09/04/2025 |
PNC21 |
MERCK & CO. INC. |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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pt was given Kinrix per manufacturer Kinrix is for 4yr-6yr old and should be the 5th Dtap and the 4t...
pt was given Kinrix per manufacturer Kinrix is for 4yr-6yr old and should be the 5th Dtap and the 4th IPV - Pt was 4 months. Pt case was made, and supervisors. Immunization coordinator and provider deems not necessary to revaccinate patient at this time and no safety concern.
More
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| 2856901 | 4 | M | PA | 09/04/2025 |
FLU3 |
SEQIRUS, INC. |
407003 |
Induration, Peripheral swelling, Skin reaction
Induration, Peripheral swelling, Skin reaction
|
Patient was seen on 9/4/25 and given an influenza vaccine in his left deltoid. He was fine immediate...
Patient was seen on 9/4/25 and given an influenza vaccine in his left deltoid. He was fine immediately after the vaccine and cleared to leave the office. Mom called the office around 3:30pm and stated patient's left arm was "very swollen, hard, and red". No signs of distress or trouble breathing. He was brought back into the office to be seen at 4:45pm. Dr. evaluated him.
More
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| 2856902 | 70 | F | NC | 09/04/2025 |
FLU3 |
SEQIRUS, INC. |
AW3225B |
Injection site pain, Pain
Injection site pain, Pain
|
SHE NOTICED ME ON 12/12/24 ABOUT SORENESS AT THE INJECTION SITE AND THE DISCOMFORT WHEN RAISING HER ...
SHE NOTICED ME ON 12/12/24 ABOUT SORENESS AT THE INJECTION SITE AND THE DISCOMFORT WHEN RAISING HER ARM ABOVE HER HEAD. I SPOKE TO HER TWICE AND ANOTHER PHARMACIST SPOKE TO HER AS WELL REASSURING HER THAT IT WAS UNLIKELY THAT HER ISSUES WERE CAUSED BY THE VACCINE 2 MONTHS EARLIER.
More
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| 2856903 | 80 | F | IL | 09/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4ZL72 |
Asthenia, Dysstasia
Asthenia, Dysstasia
|
THAT EVENING SHE EXPERIENCED GENERAL WEAKNESS AND HAD A HARD TIME GOING TO THE BATHROOM AND KITCHEN....
THAT EVENING SHE EXPERIENCED GENERAL WEAKNESS AND HAD A HARD TIME GOING TO THE BATHROOM AND KITCHEN. SHE IS PARTIALLY PARALYZED POST STROKE, AND USES AN ELECTRIC WHEELCHAIR, BUT FINDS EXTREME WEAKNESS SINCE THE VACCINE. SHE STATED SHE CANNOT MOVE LEFT LEG, AND SHE NEEDS TO PARK HER WHEELCHAIR VERY CLOSE TO THE BATHROOM DOOR BECAUSE SHE STRUGGLES STANDING UP TO WALK IN. NO NUMBNESS OR TINGLING, BUT HARD TO ASSESS DUE TO PARTIAL PARALYSIS. THIS HAS CONTINUED SINCE DAY 1 OF VACCINE. I ADVISED PATIENT TO SEEK MEDICAL TREATMENT AND TO GO TO HOSPITAL TO GET EXAMINED. SHE IS STRUGGLING WITH TRANSPORTATION AT THE MOMENT DUE TO HER WEAKNESS, AND HER DOCTOR TODAY ADVISED HER TO USE THE LOCAL BUS TO GET TO THE CLINIC TOMORROW. I ADVISED TO CALL EMS AND TO GET SEEN IN HOSPITAL TODAY.
More
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| 2856904 | 5 | F | WA | 09/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PG3RP |
Wrong product administered
Wrong product administered
|
Gave wrong Dtap to pt. I gave Tdap
Gave wrong Dtap to pt. I gave Tdap
|
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| 2856905 | 14 | M | MN | 09/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Given Twinrix which is not age-appropriate -- approved for 18 years and older, and patient was 14 ye...
Given Twinrix which is not age-appropriate -- approved for 18 years and older, and patient was 14 years old. Confirmed with patient's mother he tolerated the vaccine, no unusual signs or symptoms since vaccination.
More
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| 2856906 | 68 | M | WI | 09/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
AE435 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
No adverse effect. Patient just told us that he has already received Abrysvo in 9/27/2023 and now go...
No adverse effect. Patient just told us that he has already received Abrysvo in 9/27/2023 and now got an extra RSV vaccine Arexvy
More
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| 2856907 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Myalgia, Pyrexia
Myalgia, Pyrexia
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muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence o...
muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and PYREXIA (Fever) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches) and PYREXIA (Fever). At the time of the report, MYALGIA (muscle aches) and PYREXIA (Fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The patient had recently turned 65 years. The patient did not have medical history and did not receive any vaccines within the past 4 weeks prior to the last dose of Moderna COVID-19 vaccine. No concomitant medications were reported. It was reported that the patient inquired about the availability of the Spikevax (Moderna COVID-19 vaccine), specifically near her location, as she planned to travel and wanted to receive another dose of the vaccine. Her last dose was in September 2024. She found that only one pharmacy offered the Pfizer vaccine, and other pharmacies that she contacted did not have the Moderna vaccine. It was asked if she should consider getting the Pfizer vaccine since it was available. Additionally, she inquired about the duration or longevity of protection from her previous Moderna dose. During the call, it was reported that the patient experienced muscle aches and fever after receiving her Moderna COVID-19 vaccine, although she did not remember the exact date of when these symptoms began. She got all these vaccines, but they were slight side effects such like the typical ones like muscle aches or might had run a fever a little bit. It was added that she didn't remember having any side effects in September of 2024. Those symptoms were very mild, which lasted for one day and that was not anything to be of concern. Her last dose of the Moderna COVID-19 vaccine was administered in fall, but her doctor recorded in September 2024. Additionally, she mentioned visiting her doctor but did not specify the reason for the visit. The patient received very first Moderna COVID-19 shot in 2021 during a mass vaccination event at a college or university. For all subsequent Moderna COVID-19 shots, she went to the pharmacy, which was closed. Towards the end of the call, she asked if Spikevax 2024-2025 formula was for a booster dose and which variant did it target. No treatment information was provided. This case was linked to MOD-2025-788720 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2025: Non-significant follow-up received included reference numbers were added.
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| 2856908 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Immune system disorder, Rash macular
Immune system disorder, Rash macular
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immune-type problems after COVID vaccination; skin blotted; This spontaneous case was reported by a ...
immune-type problems after COVID vaccination; skin blotted; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) and RASH MACULAR (skin blotted) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) and RASH MACULAR (skin blotted). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) and RASH MACULAR (skin blotted) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Medical History (vaccines within the past 4 weeks, medical conditions) was reported unknown. The patient had immune-type problems after COVID vaccination. She showed pictures of her skin blotted and to be on prednisone. It was unknown if the patient experienced any additional symptoms/events. This case created for 1 female patient out of 3 female patients. This case was linked to US-MODERNATX, INC.-MOD-2025-788968 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788968:Patient 1 of 3
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| 2856909 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Immune system disorder
Immune system disorder
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immune-type problems after COVID vaccination; This spontaneous case was reported by a consumer and d...
immune-type problems after COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination). At the time of the report, IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Medical History (vaccines within the past 4 weeks, medical conditions) was reported unknown. No concomitant medication was reported. The patient had immune-type problems after COVID vaccination. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. Reporter causality was not reported. This case created for 2nd female patient out of 3 female patients. This case was linked to US-MODERNATX, INC.-MOD-2025-788968 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788968:Patient 2 of 3
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| 2856910 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Immune system disorder
Immune system disorder
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immune-type problems after COVID vaccination; This spontaneous case was reported by a consumer and d...
immune-type problems after COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination). At the time of the report, IMMUNE SYSTEM DISORDER (immune-type problems after COVID vaccination) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Medical History (vaccines within the past 4 weeks, medical conditions) was reported unknown. The patient had immune-type problems after COVID vaccination. It was unknown if the patient experienced any additional symptoms/events. This case created for 3rd female patient out of 3 female patients. This case was linked to US-MODERNATX, INC.-MOD-2025-788968 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788968:Patient 3 of 3
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| 2856911 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Myalgia, Pyrexia
Myalgia, Pyrexia
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muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence o...
muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and PYREXIA (fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, MYALGIA (muscle aches) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Patient had recently turned 65 years. Patient did not have medical history and did not receive any vaccines within the past 4 weeks prior to the last dose of Moderna COVID-19 vaccine. Concomitant medication was not reported It was reported that the patient inquired about the availability of the Spikevax (Moderna COVID-19 vaccine), specifically near patient's location, as she planned to travel and wanted to receive another dose of the vaccine. Her last dose was in September 2024. She found that only one pharmacy offered the Pfizer vaccine, and other pharmacies that she contacted did not have the Moderna vaccine. It was asked if she should consider getting the Pfizer vaccine since it was available. Additionally, she inquired about the duration or longevity of protection from her previous Moderna dose. During the call, it was reported that the patient experienced muscle aches and fever after receiving her Moderna COVID-19 vaccine, although she did not remember the exact date of when these symptoms began. Patient got all these vaccines, but they were slight side effects such like the typical ones like muscle aches or might had run a fever a little bit. It was added that she didn't remember having any side effects in September of 2024. These symptoms were very mild which lasted for one day and that wasn't anything to be of concern. Her last dose of the Moderna COVID-19 vaccine was administered in fall, but her doctor recorded in September 2024. Additionally, she mentioned visiting her doctor but did not specify the reason for the visit. The patient received very first Moderna COVID-19 shot in 2021 during a mass vaccination event at a college or university. For all subsequent Moderna COVID-19 shots, she went to pharmacy, which was closed. Towards the end of the call, she asked if Spikevax 2024-2025 formula was for a booster dose and which variant did it target. Treatment medication was not reported. This case was linked to MOD-2025-788919 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2025: Non-significant follow-up received included reference numbers were added.
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| 2856912 | 77 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Bronchiectasis
Bronchiectasis
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Bronchiectasis; This spontaneous case was reported by a consumer and describes the occurrence of BRO...
Bronchiectasis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIECTASIS (Bronchiectasis) in a 77-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BRONCHIECTASIS (Bronchiectasis) (seriousness criterion medically significant). At the time of the report, BRONCHIECTASIS (Bronchiectasis) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had bronchiectasis and was immunocompromised. She had always received the Moderna vaccines and was happy with it. No treatment medications were reported. It was unknown if the patient experienced any additional symptoms or events.; Reporter's Comments: The event BRONCHIECTASIS is assessed as not related due to nature of the event and lack of biological plausibility. Additionally, no temporal relationship was established, and the patient had a history of immunocompromise, which may predispose to respiratory conditions independently of vaccination. The benefit-risk relationship of product is not affected by this report.
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| 2856913 | F | MS | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they ...
they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID; they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Transferring agent stated, "I have a patient on my backline, and they said that they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID and then, they have been prescribed the medication (Clarified as Paxlovid) due to them having COVID again. Well, the patient said that they had COVID and that they took the Pfizer vaccine for them for it." Consumer stated, "I have got the COVID again, but my best friend had it three times. We did take our Pfizer shots. We would not take the Moderna, we waited for the Pfizer and got it and I took two vaccines and I got the COVID about a year or later, but I am immune suppressed in 70s and stuff like that and I could understand that, but it was really wild, I did not know I was in the world when I have got it now and it is nothing like the first time I got it." Consumer stated, "I am 73 now as of a couple of weeks ago. I would have been 71. I almost died the first time. I was sick for like 10 days really sick. I just ran a really high fever and threw up constantly. I did not know I was in the world for three days, honestly, yes. The first time, that was bad." Consumer stated, "I can get it for you. We got our booster there too because we had to wait for Pfizer shot to come because everybody ran and got the Moderna and blah, get in line, go through the thing, it was wild. Other medical conditions and concomitant medications: Consumer stated, "I am, I have NPH now. It's called Normal pressure hydrocephalus which is fluid on my brain. I cannot walk, I am immobilized." When clarified if NPH occurred after taking Pfizer COVID-19 Vaccine, consumer stated, "After taking the disease, they say it is a side effect of long COVID." Treatment of NPH: Consumer stated, "There is no treatment, but surgery and they put a shot in your brain and being 73 years old, I do not want to have brain surgery." Lab work: Consumer stated, "Yes, I did. I got lab work. I do not know if it was two weeks. They did not draw blood this past time. They drew blood on the 16th. It is not in the last two weeks. I had blood work done the 16th and I had an extended panel done on the 16Jul2025." If took Paxlovid before or the first time: Consumer stated, "Yes, I took the Paxlovid before and I believe that saved my damn life, I was so sick. Yes so, my doctors called and wanted me to come to the hospital." Start date, stop date, dose, route of administration, formulation and frequency of Paxlovid: consumer stated, "300 and 100, whatever that is." the first Paxlovid in 2023.Date and time of vaccination, anatomical location, route of administration and site of administration: Consumer stated, "We got our vaccines always in the left arm and (Withheld) (patient name could not be phonetically clarified) still has problems with her left arm hurting and I have another friend that has it in her 'leg' (further clarification UNKNOWN. Hence, split not made)." If any other vaccination on the same day or 4 weeks prior: Consumer stated, "No, we are both good and my arm never even swelled up that hard and theirs did. I did not even have a local reaction." During an inbound call for financial assistance, the patient, (Name Withheld), stated, "I have Covid "Later, (Name Withheld) advised, "I can barely hear you. I got you turned up all the way, but I still can't hear you very well. You gotta remember. I'm old. I'm old, and my ears are stopped up anyway. My best friend poured a jug of water in them a few weeks ago, and I still haven't gotten it all out yet. I'm using my caretaker's phone. She's got the damn COVID, too. We both got sick. I can't get out. Because I got the NPH, the Normal pressure hydrocephalus. (Name Withheld) got my disease back in May, I got mine in Mar a year ago, from the vaccine and the disease, long covid, and it makes fluid accumulate in your brain, so when that happens, you can't walk and you have bladder incontinence. But I cannot walk But I'm immunosuppressed and elderly, so you know what I'm saying...It's been a headache for me. I was not like this forever. It's hard to deal with it." Later, after going online to check her eligibility, (Name Withheld) stated, " I'm glad I took the damn Pfizer Shot, whether I got the COVID or not, right?" (Name Withheld) also stated, "I think I might start back sneezing. Oh Lord, I can feel it coming At least this COVID is better than the first one. It was a son of a bitch. I'm telling you. I didn't know where I was for three days. I just sat up in the bed with a high fever, threw up everywhere, and laid back down in it like a nasty person. I never knew I was even alive. It was bad that first one. I'm glad this strain isn't as bad. " While confirming the card details, (Name Withheld) stated, ". I'm choking to death. " Toward the end of the call, (Name Withheld) advised, ". And I've never done without the medication. I took the Paxlovid very, very quickly when I had the other, because I was so definitely ill. They just knew I wasn't gonna make it. My age and all that immune system crap. Of course, I didn't know I was in the world for three days, but whatever. I still survived it." (Name Withheld) also stated, "If I wasn't so hoarse. I can go get my meds, I can go get my meds. And be sure to tell this company. I do appreciate it. I did take their vaccine voluntarily. I was not forced. Both of us. So we both got repercussions. Because, I guess it was such a strong thing and that is a lottery thing. vaccines are just like the lottery. When you take it, it's not 100% guarantee on anything, and we're just glad to have the opportunity that we lived through it. " When asked to confirm if she had taken the Pfizer vaccine previously, (Name Withheld) stated, "I did." Note to DSU: This call was warm transferred to DSU agent (Name Withheld) , reference number (Withheld) ; however, the reportable safety information provided to (Name Withheld) was incomplete. Sending this source document to include: (Name Withheld) stated in Mar a year ago that she took the Pfizer Vaccine. Stated from the Pfizer Vaccine, she got Long COVID, NPH, Normal pressure hydrocephalus, and it makes fluid accumulate in the brain. She went on to explain that when that happens, you can't walk, and you have bladder incontinence, and she cannot walk. The patient also stated that she took Paxlovid during that previous bout of COVID. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
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