| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2860753 | 28 | F | MO | 09/23/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
|
Laboratory test normal, Palpitations, Supraventricular extrasystoles; Laboratory...
Laboratory test normal, Palpitations, Supraventricular extrasystoles; Laboratory test normal, Palpitations, Supraventricular extrasystoles
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Onset of PAC in couplets or triplets; heart palpitations that will self-resolve but last up to 1.5 h...
Onset of PAC in couplets or triplets; heart palpitations that will self-resolve but last up to 1.5 hr at a time
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| 2860754 | 5 | F | CO | 09/23/2025 |
DTPPVHBHPB DTPPVHBHPB MMRV MMRV DTPPVHBHPB DTPPVHBHPB DTPPVHBHPB DTPPVHBHPB MMRV MMRV MMRV MMRV |
MSP VACCINE COMPANY MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MSP VACCINE COMPANY MSP VACCINE COMPANY MSP VACCINE COMPANY MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
U7969AA U7969AA Y017513 Y017513 U7969AA U7969AA Y017513 Y017513 |
Extra dose administered; Extra dose administered, No adverse event; Extra dose a...
Extra dose administered; Extra dose administered, No adverse event; Extra dose administered; Extra dose administered, No adverse event; Extra dose administered; Extra dose administered, No adverse event; Extra dose administered; Extra dose administered, No adverse event; Extra dose administered; Extra dose administered, No adverse event; Extra dose administered; Extra dose administered, No adverse event
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I administered these vaccines at her 5year old well child check, even though they were administered ...
I administered these vaccines at her 5year old well child check, even though they were administered at her 4 year old well child check. Athena did not transfer over those vaccines over to immune registry so when I had printed her immune registry it stated she was due for the vaccines that were administered on 09/22/2025. I did call the manufacture of the immunizations to get information on what can be done/ happen so I am able to notified mom. Merck did let me know that extra doses given to the patient is not harmful to them, I did call mom and did notify her about the information I was given and she did understand. Case Number from speaking with that manufacture
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| 2860755 | 74 | F | KS | 09/23/2025 |
COVID19 FLU3 FLU3 VARZOS |
MODERNA SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse reaction occurred. One of our pharmacists mistakenly gave two flu shots to this patient.
No adverse reaction occurred. One of our pharmacists mistakenly gave two flu shots to this patient.
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| 2860756 | 11 | M | AR | 09/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
JF7DM |
Wrong product administered
Wrong product administered
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Wrong vaccine was given, patient needed Tdap not Dtap.
Wrong vaccine was given, patient needed Tdap not Dtap.
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| 2860757 | 12 | M | AR | 09/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
JF7DM |
Wrong product administered
Wrong product administered
|
Dtap was given, needed Tdap
Dtap was given, needed Tdap
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| 2860758 | 58 | F | NY | 09/23/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052736 406997 |
Fall, Head injury, Syncope; Fall, Head injury, Syncope
Fall, Head injury, Syncope; Fall, Head injury, Syncope
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pt fell/fainted approximately 15 minutes after administration and hit her head, transported via ambu...
pt fell/fainted approximately 15 minutes after administration and hit her head, transported via ambulance for evaluation
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| 2860759 | 4 | F | NV | 09/23/2025 |
DTPPVHBHPB HEPA MMRV PNC20 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
U8313AA H3N97 Z008222 LN4932 |
Pyrexia; Pyrexia; Pyrexia; Pyrexia
Pyrexia; Pyrexia; Pyrexia; Pyrexia
|
Per Mom, child developed fever of 100.5 for 3 days then fever slight went up to 100.8. Mom was giv...
Per Mom, child developed fever of 100.5 for 3 days then fever slight went up to 100.8. Mom was giving fever-reducing med. Mom called clinic on 9/19/25 and was advised to seek med attention. Mom took child to urgent care and was advised to stop the medicine and informed that the fever will break eventually. T- 100.7 at the clinic. Follow-up call to Mom at 4:30 pm and mutually decided to give 1 vaccine at a time to determine which vaccine is causing the side effect.
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| 2860760 | 66 | F | CA | 09/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Dizziness, Headache, Nausea
Dizziness, Headache, Nausea
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dizziness, headache, nausea
dizziness, headache, nausea
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| 2860761 | 4 | M | KS | 09/23/2025 |
DTAPIPV FLU3 MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93H32 33CM4 4F9T5 |
Circumstance or information capable of leading to medication error, Scratch; Cir...
Circumstance or information capable of leading to medication error, Scratch; Circumstance or information capable of leading to medication error, Scratch; Circumstance or information capable of leading to medication error, Scratch
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As administrator went to administer a vaccine, the child's right hand came down and pulled the ...
As administrator went to administer a vaccine, the child's right hand came down and pulled the needle and syringe out of his leg. The syringe landed on the table. The vaccine was given fully. When the administrator assessed the child, he had a needle scratch on his right leg. The scratch and administration site were cleaned and bandaged appropriately, and the patient left the visit in stable condition.
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| 2860762 | 52 | F | GA | 09/23/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
B59DH B59DH |
Headache, Hypoaesthesia oral, Influenza like illness, Nystagmus, Pain; Vision bl...
Headache, Hypoaesthesia oral, Influenza like illness, Nystagmus, Pain; Vision blurred, Visual impairment
More
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PT called next day to inform us she had experience severe flu-like symptoms, bodyaches, severe heada...
PT called next day to inform us she had experience severe flu-like symptoms, bodyaches, severe headache, mouth numbness, right eye jittery w/ blurred vision and blind spot. No fever that she is aware of. Onset about 1 hour after shot.
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| 2860763 | 56 | M | NM | 09/23/2025 |
COVID19 VARZOS |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3051995 NR4TS |
Death; Death
Death; Death
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Patient passed away 9/21/25 at the hospital.
Patient passed away 9/21/25 at the hospital.
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โ | |||||
| 2860764 | 1 | F | 09/23/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
|
Abdominal X-ray, Febrile convulsion, Irritability, Laboratory test normal, Letha...
Abdominal X-ray, Febrile convulsion, Irritability, Laboratory test normal, Lethargy; Magnetic resonance imaging head normal, Pyrexia, Tremor, Unresponsive to stimuli, X-ray normal
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Febrile seizure, fever, unresponsive, slight tremors, lethargic, irritable
Febrile seizure, fever, unresponsive, slight tremors, lethargic, irritable
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| 2860765 | 78 | F | MO | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
u88598A |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Immunizing technician thought she was giving one flu shot and one Covid shot to patient, she actuall...
Immunizing technician thought she was giving one flu shot and one Covid shot to patient, she actually ended up giving the patient 2 flu shots.
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| 2860767 | 09/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Stress, Vaccination failure
Herpes zoster, Stress, Vaccination failure
|
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 79-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included shingles (had connection to stress). On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 17-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles, and it was awful and was told by doctor. It had a connection to stress. The patient had the shot but still got them and asked should the patient take another shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine, in a 79-year old patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2860768 | 71 | F | AL | 09/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793PT |
Dizziness, Malaise, Neuralgia
Dizziness, Malaise, Neuralgia
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Husband of pt called and stated pt has been feeling sick, lightheaded, and having nerve pain on her ...
Husband of pt called and stated pt has been feeling sick, lightheaded, and having nerve pain on her side under her breast
More
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| 2860769 | 5 | F | CA | 09/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Erythema, Pruritus, Skin warm, Swelling face
Erythema, Pruritus, Skin warm, Swelling face
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~1 hr after receiving vaccine, rapid onset of bright red skin discoloration on both elbows (extendin...
~1 hr after receiving vaccine, rapid onset of bright red skin discoloration on both elbows (extending mid forearm and mid tricep and wrapping around arm almost to pit of elbow) , both ears, multiple 6-8" diameter areas on abdomen. Skin discoloration was elevated in temperature to the touch, mild itching was reported by patient. Discoloration duration 4-6 hrs, gradually subsided in 1-2 hrs following. Uniform facial swelling, of entire face, lasting 4-6 hrs, after which right side subsided in 2-4 hrs but left side of face remained swollen for an additional 20 hours (24 hours total), then began to gradually subside over the following 12 hrs.
More
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| 2860770 | 43 | M | TX | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Patient given Fluzone HD despite not meeting criteria for this vaccine. Patient notified by this rep...
Patient given Fluzone HD despite not meeting criteria for this vaccine. Patient notified by this reporter, no adverse effects noted.
More
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| 2860771 | 65 | F | PA | 09/23/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
3052036 3052036 |
Injection site erythema, Injection site pain; Injection site bruising, Injection...
Injection site erythema, Injection site pain; Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain; Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
More
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redness and soreness at injection site. no pregnancy
redness and soreness at injection site. no pregnancy
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| 2860772 | 82 | M | OR | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
407248 |
Extra dose administered
Extra dose administered
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Clinic has visited the Senior Loving on 9/10/2025 for an influenza vaccine clinic. Patient received ...
Clinic has visited the Senior Loving on 9/10/2025 for an influenza vaccine clinic. Patient received influenza vaccination that was not documented properly in Alert. PCP Clinic and acting Local Public Health Authority went to Senior Living on 9/22/2025 to administer 2025 Fall Respiratory Vaccines - A staff persona stated patient may have received his influenza vaccination at the previous event held by Clinic. All actions were paused, staff called over to clinic to verify status of vaccination and was told that he received no vaccines via their on site clinic. The morning of 9/23/2025 clinic staff reached out to MA Manager, "Hey I heard there was some confusion regarding patient and the flu vaccine. I missed him on the list that staff did on 9/10. I just got his stuff entered into computer system so it should show on your end. I apologize for that, I didn't see him at the bottom of my list". The adverse event is that Patient received the influenza x2. One dose on 9/10/2025 and another dose on 9/22/2025.
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| 2860773 | 73 | F | GA | 09/23/2025 |
PNC20 |
PFIZER\WYETH |
lp4948 |
Extra dose administered
Extra dose administered
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Patient received the vaccine though they has already gotten prev in Dec 2023.
Patient received the vaccine though they has already gotten prev in Dec 2023.
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| 2860774 | 73 | F | WV | 09/23/2025 |
FLU3 VARZOS |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
407257 342XP |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue
More
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This was not an adverse event, it was an administration error. I gave the diluent by itself without ...
This was not an adverse event, it was an administration error. I gave the diluent by itself without mixing it with the antigen component. I then repeated the vaccine the correct way. The patient was fine after administration. I explained to her what had happened.
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| 2860775 | 32 | F | MI | 09/23/2025 |
COVID19 |
MODERNA |
409684 |
Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Injection site pain, Injection site reaction, Injection site warmth, Urticaria
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patient called to report she had a 2 inch diameter welt at injection site. She also had a warm and p...
patient called to report she had a 2 inch diameter welt at injection site. She also had a warm and painful with out rash at the site. Patient was adviced to apply a ice/warm compress and may take Tylenol and or ibuprofen. Patient called back 09/21/2025 to state that the swelling has decreased significantly, still warm but not as painful. She has been using icepacks and Tylenol along with her previously prescribed methocarbamol. She also said she has no further concerns.
More
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| 2860776 | 1 | F | MO | 09/23/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Eye movement disorder, Hypotonia, Influenza virus test negative, Loss of conscio...
Eye movement disorder, Hypotonia, Influenza virus test negative, Loss of consciousness, Musculoskeletal stiffness; Pallor, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Somnolence; Vomiting
More
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Patient went pale and slumped over in her high chair. I grabbed her and noticed she had a fever. Her...
Patient went pale and slumped over in her high chair. I grabbed her and noticed she had a fever. Her eyes rolled back in her head and she went stiff. She came to, but sleepy. I tried to give her tylenol. Her eyes rolled back in her head again and she threw up. She did this one more time before getting to the ED. They got her fever down with tylenol and motrin.
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| 2860777 | 43 | F | TX | 09/23/2025 |
MNQ MNQ MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Arthralgia, Back pain, Blood test, Chest X-ray, Drug hypersensitivity; Feeding d...
Arthralgia, Back pain, Blood test, Chest X-ray, Drug hypersensitivity; Feeding disorder, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Mobility decreased; Musculoskeletal pain, Neck pain, Pain in extremity, Pharyngeal swelling, Sleep disorder; Ultrasound scan
More
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Start off with just some light soreness in the arm and then over a couple hours. It turned in to sev...
Start off with just some light soreness in the arm and then over a couple hours. It turned in to severe pain throughout my left arm and the upper region, and then it moved down to the bottom region into my hands, and then it locked up my arm completely, and then it started, locking up my shoulder blade and going into the back of my neck And into the back of my back and then started going into my lower back and into my left hip and down my left leg, locking up my leg as well. My shot was done on Friday and since then the pain has continuously gotten worse, and I ve been to the hospital twice because of it And they were not able to help me and I m unable to sleep. I m unable to eat because they re swelling that is on the left side of my throat. I m unable to work or function correctly. I cannot lift anything at all with my left arm. I can t even pull my blankets up on me
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| 2860778 | 18 | F | CO | 09/23/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8779KA UT8779KA |
Blood test, Hemiparesis, Hypoaesthesia, Injection site pain, Magnetic resonance ...
Blood test, Hemiparesis, Hypoaesthesia, Injection site pain, Magnetic resonance imaging; Paraesthesia
More
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2 Hours after receiving Flu vaccine (Approximately at 1400) patient initially experienced soreness a...
2 Hours after receiving Flu vaccine (Approximately at 1400) patient initially experienced soreness at the site of the injection, followed by numbness and tingling to their left side, then weakness set in from the neck to their lower extremities on the left side of their body. At 1800 the patient sought treatment in the emergency department at (name withheld) Hospital. An MRI was conducted which ruled out a Stroke. Pt. was admitted to the hospital for observation and was discharged on 9/17/25 with an unknown diagnosis possible Auto immune disorder.
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| 2860779 | 29 | F | WA | 09/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
HR4RB |
Wrong product administered
Wrong product administered
|
Patient presented to clinic for Flu vaccine. Pulled vaccine from the Flublock box, had double checke...
Patient presented to clinic for Flu vaccine. Pulled vaccine from the Flublock box, had double checked for vaccine and expiration, was verified. Gave vaccine to patient and when removing label noticed it was Hep A vaccine. Immediately notified patient, gave her information sheet for vaccine, patient was ok with getting this vaccine. She is a dental hygenist. Immediately reported to supervisor and relayed information from patient. Also let him know that I would do reporting of incident. Patient to return to clinic next week for TB testing and if any adverce reactions.
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| 2860780 | 0.17 | M | GA | 09/23/2025 |
RV5 |
MERCK & CO. INC. |
2124039 |
Diarrhoea, Infant irritability
Diarrhoea, Infant irritability
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Extreme irritability and diarrhea per mom for the rest of the day after administered
Extreme irritability and diarrhea per mom for the rest of the day after administered
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| 2860781 | 46 | F | NJ | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
AX4606A |
Erythema, Eye swelling, Ocular hyperaemia, Peripheral swelling, Pruritus
Erythema, Eye swelling, Ocular hyperaemia, Peripheral swelling, Pruritus
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On September 18, 2025, at approximately 1630, patient reported the onset of itchiness and redness on...
On September 18, 2025, at approximately 1630, patient reported the onset of itchiness and redness on both hands, along with itching of both ears. Redness progressed to her eyes and nose. She denied shortness of breath or any respiratory distress. Although encouraged by her family to seek evaluation at urgent care or the ER, the patient declined medical attention unless her condition got worse. On Friday, September 19, 2025, she noted swelling of both eyes and hands. She self-administered Benadryl (25 mg tablet), and after the second dose, she experienced relief of symptoms. No shortness of breath or respiratory distress reported.
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| 2860782 | 67 | M | OH | 09/23/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8764CB U8764CB |
Erythema multiforme, Full blood count normal, Herpes zoster, Increased tendency ...
Erythema multiforme, Full blood count normal, Herpes zoster, Increased tendency to bruise, Injection site reaction; Rash, Skin lesion
More
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Erythema multiforme Rash Noted to injection site with 7 lesions, painful to light touch, pt was seen...
Erythema multiforme Rash Noted to injection site with 7 lesions, painful to light touch, pt was seen on the Sept 18th- Differential: Shingles- Mupirocin and Triamcinolone ordered. Pt returned to office on Sept 22nd, with rash spread throughout the body- Medrol Dose pack ordered
More
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| 2860783 | 66 | F | OK | 09/23/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052736 U8764DB |
Haematochezia, Rectal haemorrhage; Haematochezia, Rectal haemorrhage
Haematochezia, Rectal haemorrhage; Haematochezia, Rectal haemorrhage
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Bleeding in stool/ rectum
Bleeding in stool/ rectum
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| 2860784 | CA | 09/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Respiratory syncytial virus infection, Vaccination failure
Respiratory syncytial virus infection, Vaccination failure
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Respiratory syncytial virus infection; suspected vaccination failure; This serious case was reported...
Respiratory syncytial virus infection; suspected vaccination failure; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) (serious criteria hospitalization). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 10-SEP-2025 The patient who received Arexvy approximately two years ago, in 2023. The patient was recently hospitalized for respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, unknown time after receiving Arexvy, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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โ | |||||||
| 2860785 | 16 | F | KS | 09/23/2025 |
HPV9 |
MERCK & CO. INC. |
Y020464 |
Extra dose administered
Extra dose administered
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Patient received a 3rd HPV vaccine in addition to 16 yo immunizations. Patient had already previousl...
Patient received a 3rd HPV vaccine in addition to 16 yo immunizations. Patient had already previously been treated with two HPV vaccines at age 11 and 12.
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| 2860786 | 1.33 | F | TN | 09/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
42DM9 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Patient received second Hepatitis A vaccine on July 1, 2025 at 16 months old-only 4 months after fir...
Patient received second Hepatitis A vaccine on July 1, 2025 at 16 months old-only 4 months after first Hepatitis A vaccine that was administered on March 7, 2025 at 12 months old. No adverse reaction or symptoms reported.
More
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| 2860787 | 5 | M | KS | 09/23/2025 |
MMR |
MERCK & CO. INC. |
Y015551 |
Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
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While administering an MMR vaccine, the patient moved, and the full vaccine was not administered. No...
While administering an MMR vaccine, the patient moved, and the full vaccine was not administered. No needlestick or exposures occurred. Patient left clinic in stable condition.
More
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| 2860788 | 75 | F | WA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8800DA |
Injection site erythema, Injection site inflammation, Injection site pruritus
Injection site erythema, Injection site inflammation, Injection site pruritus
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Pt states Left arm around the injection site was red and inflamed. which has never happen before. Pt...
Pt states Left arm around the injection site was red and inflamed. which has never happen before. Pt. iced it once at night. Pt. states it was very itchy.
More
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| 2860789 | 45 | F | MI | 09/23/2025 |
HPV9 |
MERCK & CO. INC. |
Z002399 |
Arthralgia, Dyskinesia, Mobility decreased, Pain
Arthralgia, Dyskinesia, Mobility decreased, Pain
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PT states she felt a shooting pain after vaccine was given. Pain radiated down arm and in to finger ...
PT states she felt a shooting pain after vaccine was given. Pain radiated down arm and in to finger tips. A few days later strange movement started to happen in thumb. 4 days post vaccine shoulder pain was still present. Can not life arm.
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| 2860790 | 29 | M | MI | 09/23/2025 |
COVID19 |
MODERNA |
3052583 |
Immediate post-injection reaction, Syncope
Immediate post-injection reaction, Syncope
|
Syncopal episode lasting less than 5 seconds immediately after receiving the vaccine.
Syncopal episode lasting less than 5 seconds immediately after receiving the vaccine.
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| 2860791 | 50 | F | OR | 09/23/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LP4948 37R35 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
More
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redness, warmth, itchiness, and pain at injection site. Redness going down arm.
redness, warmth, itchiness, and pain at injection site. Redness going down arm.
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| 2860792 | 13 | F | PA | 09/23/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
y015560 y015560 y015560 y015560 y015560 y015560 Y011560 Y011560 Y011560 Y011560 Y011560 Y011560 |
Blood iron normal, Dizziness, Full blood count normal, Gait disturbance, Liver f...
Blood iron normal, Dizziness, Full blood count normal, Gait disturbance, Liver function test normal; Loss of personal independence in daily activities, Metabolic function test normal, Muscular weakness, Postural orthostatic tachycardia syndrome, Presyncope; Thyroid function test normal, Urine analysis normal; Angiogram normal, Blindness transient, Blood test, Cardiac monitoring abnormal, Dizziness; Echocardiogram normal, Electrocardiogram, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Orthostatic hypotension; Postural orthostatic tachycardia syndrome, Syncope, Urine analysis; Blood iron normal, Dizziness, Full blood count normal, Gait disturbance, Liver function test normal; Loss of personal independence in daily activities, Metabolic function test normal, Muscular weakness, Postural orthostatic tachycardia syndrome, Presyncope; Thyroid function test normal, Urine analysis normal; Angiogram normal, Blindness transient, Blood test, Cardiac monitoring abnormal, Dizziness; Echocardiogram normal, Electrocardiogram, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Orthostatic hypotension; Postural orthostatic tachycardia syndrome, Syncope, Urine analysis
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48 hrs after the immunization patient experienced lightheadedness, weakness of the legs, feeling lik...
48 hrs after the immunization patient experienced lightheadedness, weakness of the legs, feeling like she was going to pass out. Symptoms did not abate so pt was evaluated in the ER with no definitive diagnosis; symptoms are daily and pt who is a swim athlete cannot swim. After primary care evaluation Salt therapy was started but was ineffective so a Cardiology eval was done who started Florinef for presumed POTS; No change in symptom severity and the frequency of symptoms has greatly increased; Neurology is being consulted since she can hardly walk
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| 2860793 | 63 | F | TX | 09/23/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8832DA Z006076 |
Joint swelling, Pain in extremity, Peripheral swelling; Joint swelling, Pain in ...
Joint swelling, Pain in extremity, Peripheral swelling; Joint swelling, Pain in extremity, Peripheral swelling
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SWOLLEN ARM AND ELBOW AND PAIN ON THE RIGHT ARM.
SWOLLEN ARM AND ELBOW AND PAIN ON THE RIGHT ARM.
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| 2860794 | 17 | M | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
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Cold sweat, Feeling cold, Loss of consciousness, Syncope
Cold sweat, Feeling cold, Loss of consciousness, Syncope
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The young man stated after the vaccine that he didn't do well with shots. He then fainted but d...
The young man stated after the vaccine that he didn't do well with shots. He then fainted but did not fall. He was cool, clammy, and had a heart rate of 45. BP was 90/52 but he was very athletic and on the tennis team. He was laid on a mat, legs raised and monitored. He quickly regained consciousness and was given a drink of water. His pulse increased and his BP. There were no further issues, and he returned to class.
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| 2860795 | 64 | M | CA | 09/23/2025 |
FLU3 RSV VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8800CA 9BE5H 2HJ99 |
Unevaluable event; Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event; Unevaluable event
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NA
NA
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| 2860796 | 25 | F | PA | 09/23/2025 |
FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8523CA U8523CA U8523CA U8523CA |
Exposure during pregnancy, Incorrect route of product administration, No adverse...
Exposure during pregnancy, Incorrect route of product administration, No adverse event; Expired product administered, No adverse event; Exposure during pregnancy, Incorrect route of product administration, No adverse event; Expired product administered, No adverse event
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No adverse reaction. Pt 36w1d pregnant date of given vaccine.
No adverse reaction. Pt 36w1d pregnant date of given vaccine.
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| 2860797 | 80 | F | SC | 09/23/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0589 U8859BA |
Injection site pruritus, Injection site warmth; Injection site pruritus, Injecti...
Injection site pruritus, Injection site warmth; Injection site pruritus, Injection site warmth
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patient has had on and off itching and fever in the injection site and it is improving but she is st...
patient has had on and off itching and fever in the injection site and it is improving but she is still having
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| 2860798 | 1.33 | F | WA | 09/23/2025 |
HPV9 |
MERCK & CO. INC. |
Y015760 |
Lethargy, Pyrexia
Lethargy, Pyrexia
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Fever, lethargic
Fever, lethargic
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| 2860799 | 4 | M | CA | 09/23/2025 |
DTAPIPV FLU3 MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
U8623AA UT8779KA Z010731 |
Eye swelling, Periorbital swelling, Rash, Rash papular, Rash pruritic; Eye swell...
Eye swelling, Periorbital swelling, Rash, Rash papular, Rash pruritic; Eye swelling, Periorbital swelling, Rash, Rash papular, Rash pruritic; Eye swelling, Periorbital swelling, Rash, Rash papular, Rash pruritic
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Patient returned to clinic approximately 10 minutes after being immunized with new onset pruritic ra...
Patient returned to clinic approximately 10 minutes after being immunized with new onset pruritic rash over neck and torso as well as slight lower right eye swelling. Denied any cough lip or tongue swelling respiratory distress vomiting or diarrhea. Exam notable for pinpoint erythematous papules over torso and bilateral proximal upper extremities as well as very slight right inferior periocular swelling. Reassuring repeat vitals with administration of Benadryl 1 mg/kg. After 20-minute reevaluation, right periocular swelling had decreased significantly with rash still stable/persistent notable on the torso and proximal bilateral upper extremities. As patient was doing well, mother comfortable with continued following at this time and would recommend repeat Benadryl in 6 hours with utilization as needed thereafter. Discussed ED return precautions and red flag symptomatology for which to continue monitoring to include recurrent facial swelling, lip/tongue swelling, respiratory distress, cough, vomiting, diarrhea. Patient has tolerated these immunizations in the past however as this does seem suspicious for class I hypersensitivity reaction, will place consultation to allergist for recommendations in regards to future immunizations. Mother verbalized understanding/agreement of plan.
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| 2860800 | M | TX | 09/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4DS4N |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Twnrix late second dose; This non-serious case was reported by a physician via call center represent...
Twnrix late second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received first dose on unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twnrix late second dose). The outcome of the drug dose administration interval too long 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: 11-SEP-2025 The reporter wanted to know how to proceed after a patient received the second dose of Twinrix 5 months after the first dose, which led to lengthening of vaccine schedule.
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| 2860801 | 38 | F | MO | 09/23/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
na0587 406984 |
Dizziness, Flushing, Nausea; Dizziness, Flushing, Nausea
Dizziness, Flushing, Nausea; Dizziness, Flushing, Nausea
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pt felt flushed, dizzy and nauseous. She had walked just 1/2 to the front of the store and sat down...
pt felt flushed, dizzy and nauseous. She had walked just 1/2 to the front of the store and sat down when she felt the symptoms and asked staff for help. She declined us calling 911. After a few minutes, she walked back to the chairs with store manager and rph. We gave her water and waited with her until she felt better. after about 15 minutes, she was no longer flushed and left the store.
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| 2860802 | M | NY | 09/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Atrial fibrillation, Electrocardiogram abnormal, Herpes zoster, Lip swelling, Mu...
Atrial fibrillation, Electrocardiogram abnormal, Herpes zoster, Lip swelling, Muscular weakness; Pneumonia, Rash, Transient ischaemic attack
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TIA(minor stroke); left lower lobe pneumonia; he was in Afib.; 00he developed shingles on his left c...
TIA(minor stroke); left lower lobe pneumonia; he was in Afib.; 00he developed shingles on his left chest; He also developed lower leg weakness; developed severe swelling of upper and lower lip; This serious case was reported by a nurse via call center representative and described the occurrence of transient ischemic attack in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In MAR-2025, the patient received the 1st dose of Shingrix. In JUL-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: 00he developed shingles on his left chest) (serious criteria hospitalization). On an unknown date, the patient experienced transient ischemic attack (Verbatim: TIA(minor stroke)) (serious criteria hospitalization and GSK medically significant), lower lobe pneumonia (Verbatim: left lower lobe pneumonia) (serious criteria hospitalization and GSK medically significant), atrial fibrillation (Verbatim: he was in Afib.) (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (Verbatim: He also developed lower leg weakness) and lip swelling (Verbatim: developed severe swelling of upper and lower lip). The patient was treated with apixaban (Eliquis). The outcome of the transient ischemic attack, lower lobe pneumonia, atrial fibrillation, shingles, lower extremities weakness of and lip swelling were not reported. It was unknown if the reporter considered the transient ischemic attack, lower lobe pneumonia, atrial fibrillation, shingles, lower extremities weakness of and lip swelling to be related to Shingrix. The company considered the transient ischemic attack, lower lobe pneumonia, atrial fibrillation and shingles to be unrelated to Shingrix. It was unknown if the company considered the lower extremities weakness of and lip swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 Retired Nurse reported that her husband in March 2025 received the Shingrix vaccine and within 30 hrs of getting the vaccine he developed severe swelling of upper and lower lip and they both became the size of my thumb, so he was a with, and he was told he cannot take the 2nd Shingrix vaccine. He then 3 months ago he developed shingles on his left chest, the shingles caused believe not only the shingles the rash on the chest, but he was brought to the emergency because he showed signs of having a stoke at home and when called to doctor they came to the home they examined his chest and heart , they did an EKG and he was in Afib. So, he was immediately brought to the emergency room at the hospital in where he stayed for 3.5 days and he had a diagnosis of shingles left lower lobe pneumonia and TIA (minor stroke). He was treated and but on Eliquis, after the viral drug. He was continued at home and Eliquis twice a day. Reporters concern was, he can get shingles again. However, in state, don't know what we do because he can't have shingles but there was a question to what do know because the Zostavax was not available. So, her concern was where do go from here, so he does not get shingles again and worse outcome. He also developed lower leg weakness and doing physical therapy.; Sender's Comments: A case of Transient ischaemic attack, Pneumonia, Atrial fibrillation and Herpes zoster, an unknown time after receiving Shingrix, in a 85-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.
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| 2860803 | F | CA | 09/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Late 2dn and 3rd dose; This non-serious case was reported by a pharmacist via call center representa...
Late 2dn and 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 44-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received in October 2017). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: Late 2dn and 3rd dose). The outcome of the incomplete course of vaccination 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: 17-SEP-2025 The reporter contacted us regarding a patient who had received the first dose of the Twinrix vaccine a couple of years ago. The reporter wanted to confirm whether the patient only needed to receive the second and third doses to complete the vaccination schedule. During the call, the healthcare professional (HCP) did not provide any specific patient information. They only mentioned that the patient had received the first dose of Twinrix. The HCP stated that the first dose was administered in October 2017 but did not specify the exact date. For documentation purposes, we recorded the date as 01-OCT-2017, as the system format does not allow the date field to be left blank
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