| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2824467 | 35 | M | MI | 02/04/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8274AA U8274AA |
Arthralgia, Electrocardiogram, Malaise, Myalgia, Pyrexia; SARS-CoV-2 test
Arthralgia, Electrocardiogram, Malaise, Myalgia, Pyrexia; SARS-CoV-2 test
|
Patient complined of malaise, fever of 101, extreme muscle and joint pain. He went to the ED wher...
Patient complined of malaise, fever of 101, extreme muscle and joint pain. He went to the ED where Tylenol and Motrin were advised. ketorolac (TORADOL) injection 60 mg was given in the ED.
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|
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| 2824468 | 17 | M | NJ | 02/04/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 |
Injection site pain
Injection site pain
|
Persistant L deltoid pain 11 days post-vaccine
Persistant L deltoid pain 11 days post-vaccine
|
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| 2824469 | 45 | M | 02/04/2025 |
VARCEL |
MERCK & CO. INC. |
X023717 |
Arthralgia, Injection site haemorrhage, Injection site pain, Muscle spasms, Myal...
Arthralgia, Injection site haemorrhage, Injection site pain, Muscle spasms, Myalgia
More
|
Patient reports 2 days later experiencing pain at injection site and pain in the left paraspinal mus...
Patient reports 2 days later experiencing pain at injection site and pain in the left paraspinal muscles at the T2 Level, left shoulder pain, and left elbow pain. Occasional muscle spasms of the left upper arm and left forearm. Patient evaluated 1 week after vaccine which still has an area of ecchymosis approximately 3 cm in diameter at the injection site.
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| 2824470 | 67 | F | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Asthenia, Mobility decreased
Asthenia, Mobility decreased
|
Pt reports that in the evening she had sudden onset weakness and unable to move her body except she ...
Pt reports that in the evening she had sudden onset weakness and unable to move her body except she was able to talk and breathe. She had 2 episodes of this during the night and each episode lasted 10 minutes. She had no residual effects after each episode.
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| 2824471 | 16 | M | VA | 02/04/2025 |
COVID19 |
MODERNA |
3044079 |
No adverse event, Underdose
No adverse event, Underdose
|
6m-11y Moderna vaccine given to a 17yo, no symptoms noted afterwards
6m-11y Moderna vaccine given to a 17yo, no symptoms noted afterwards
|
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| 2824472 | 71 | M | CO | 02/04/2025 |
RSV |
MODERNA |
|
Arthralgia, Balance disorder, Loss of personal independence in daily activities,...
Arthralgia, Balance disorder, Loss of personal independence in daily activities, Mobility decreased, Polymyalgia rheumatica
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within eight days I noticed sore shoulders and hips while execising. Four days later I could not ge...
within eight days I noticed sore shoulders and hips while execising. Four days later I could not get out of bed, lost balance, couldn't dress.
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|
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| 2824473 | 4 | M | PR | 02/04/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
34MF9 Y004115 Y011712 |
Eye swelling, Peripheral swelling; Eye swelling, Peripheral swelling; Eye swelli...
Eye swelling, Peripheral swelling; Eye swelling, Peripheral swelling; Eye swelling, Peripheral swelling
More
|
Swollen eyes, swollen arms
Swollen eyes, swollen arms
|
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| 2824474 | 70 | M | TX | 02/04/2025 |
COVID19 |
MODERNA |
027120A |
Rash
Rash
|
First vaccine no problem. When Ihad second vaccine rash broke. I was given. Steroid shot& it c...
First vaccine no problem. When Ihad second vaccine rash broke. I was given. Steroid shot& it clears up.when I the booster, it came back. Steroid shot not effective.
More
|
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| 2824475 | 90 | F | AL | 02/04/2025 |
RSV RSV RSV |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
HN8090 HN8090 HN8090 |
Blood gases, Dysphagia, Dysstasia, Endotracheal intubation, Gout; Guillain-Barre...
Blood gases, Dysphagia, Dysstasia, Endotracheal intubation, Gout; Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Laboratory test, Mobility decreased; Musculoskeletal disorder, Paralysis
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|
Unable to stand, Unable to control hand, if she raised her hand it would automatically fall down. U...
Unable to stand, Unable to control hand, if she raised her hand it would automatically fall down. Unable to move legs, then hands, become strangled when taking fluids, became paralyzed. Diagnosed with Guillain-Barre' Syndrome. Admitted to hospital, intensive care, was intubated for 7 days.. stayed in Medical Center for approx. 3 1/2 weeks transferred to Rehab. Patient there at present. Developed Gout. Never had prior
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โ | โ | ||||
| 2824476 | 83 | M | IN | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Death, SARS-CoV-2 test positive
COVID-19, Death, SARS-CoV-2 test positive
|
Patient was vaccinated 3/6/21 and 4/10/21, tested +ve for COVID19 on 12/5/24 and expired 2/2/25
Patient was vaccinated 3/6/21 and 4/10/21, tested +ve for COVID19 on 12/5/24 and expired 2/2/25
|
โ | |||||
| 2824477 | 66 | F | FL | 02/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
x357e |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received vaccine when not indicated for it as they received the TDAP back on 08/23/24. Patie...
Patient received vaccine when not indicated for it as they received the TDAP back on 08/23/24. Patient reported no adverse symptoms.
More
|
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| 2824478 | 55 | M | TX | 02/04/2025 |
FLU3 VARZOS |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
946612 KB2YT |
Cough, Oropharyngeal pain, Respiratory tract congestion; Cough, Oropharyngeal pa...
Cough, Oropharyngeal pain, Respiratory tract congestion; Cough, Oropharyngeal pain, Respiratory tract congestion
More
|
Patient reports congestion, cough, and a severe sore throat ("raw") developing the day aft...
Patient reports congestion, cough, and a severe sore throat ("raw") developing the day after the immunization.
More
|
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| 2824480 | 67 | M | 02/04/2025 |
COVID19 |
MODERNA |
|
COVID-19, Death, SARS-CoV-2 test positive
COVID-19, Death, SARS-CoV-2 test positive
|
Patient was vaccinated 8/24/21 and 12/21/21, tested +ve for COVID19 on 1/5/25 and expired 2/1/25
Patient was vaccinated 8/24/21 and 12/21/21, tested +ve for COVID19 on 1/5/25 and expired 2/1/25
|
โ | ||||||
| 2824481 | 1 | F | NY | 02/04/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y005808 Y005808 |
Crying, Immediate post-injection reaction, Increased viscosity of upper respirat...
Crying, Immediate post-injection reaction, Increased viscosity of upper respiratory secretion, Periorbital oedema, Vomiting; Wheezing
More
|
Patient received MMR, Varicella and Hep A vaccines after routine blood draw. Patient was crying, had...
Patient received MMR, Varicella and Hep A vaccines after routine blood draw. Patient was crying, had episode of milky emesis right after the first vaccine was administered. RN proceeded to give 2nd and third vaccine back to back, Patient continued to have intermittent episodes of emesis with thick mucous secretions. Patient placed on SpO2 monitor and was 100%. Remained awake and crying during event in father's arms. Mild periorbital edema and slight wheezes noted on reexamination. Epi given 0.15 mg x2 and albuterol 2.5 mg x1, remained on face mask on oxygen until EMS arrived to transport patient to ED.
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| 2824482 | 2 | F | OR | 02/04/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3043023 U8442BA |
Expired product administered; Expired product administered
Expired product administered; Expired product administered
|
Covid Vaccine was expired on 1/25/25
Covid Vaccine was expired on 1/25/25
|
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| 2824483 | 82 | F | FL | 02/04/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4F45Z 52Z52 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
Patient was administered the Arexvy vaccine on 4/2/24 and again on 1/30/25. The patient has not expe...
Patient was administered the Arexvy vaccine on 4/2/24 and again on 1/30/25. The patient has not experienced any negative symptoms from being administered the vaccine twice, 10 months apart.
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| 2824484 | 9 | M | MA | 02/04/2025 |
FLU3 FLU3 HPV9 HPV9 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
UT8506JA UT8506JA Y007197 Y007197 |
Crying, Head injury, Pain, Paraesthesia, Seizure; Syncope; Crying, Head injury, ...
Crying, Head injury, Pain, Paraesthesia, Seizure; Syncope; Crying, Head injury, Pain, Paraesthesia, Seizure; Syncope
More
|
The patient was given the vaccines. He had seemed to have done well after the vaccine & was chuc...
The patient was given the vaccines. He had seemed to have done well after the vaccine & was chuckling as both RN and mother praised him for receiving his vaccines. The RN stepped out about a minute after administering and heard screaming. RN came back in and patient had an episode of syncope that resulted in a head injury with the head making contact to the chair from the examination table. Patient seized for roughly 5 seconds with eyes closed. The patient opened his eyes startled & began to cry from the pain of the fall. The patient was then brought to the table and vitals were taken. Patient described tingling in both of his hands. The EMTs then arrived and assessed patient - RN relayed head injury and seizure activity.
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| 2824485 | 73 | F | MN | 02/04/2025 |
COVID19 |
MODERNA |
|
Adrenocortical insufficiency acute, Condition aggravated, Intensive care
Adrenocortical insufficiency acute, Condition aggravated, Intensive care
|
Adrenal Crisis with ICU care. This patient received the Covid-19 vaccine on 11/19/24. On 11/21/24 ...
Adrenal Crisis with ICU care. This patient received the Covid-19 vaccine on 11/19/24. On 11/21/24 she went into Adrenal Crisis which resulted in an ICU stay. The patient was in the ICU for two days and then returned to our facility.
More
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โ | โ | ||||
| 2824486 | 94 | F | CA | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
58160-723-03 |
Extra dose administered
Extra dose administered
|
Patient had already received RSV vaccine on 1/17/2024
Patient had already received RSV vaccine on 1/17/2024
|
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| 2824487 | 86 | F | CA | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
58160-723-03 |
Extra dose administered
Extra dose administered
|
Patient had already received a dose of RSV vaccine on 1/17/2024
Patient had already received a dose of RSV vaccine on 1/17/2024
|
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| 2824488 | 34 | F | MN | 02/04/2025 |
COVID19 |
MODERNA |
|
Lip swelling
Lip swelling
|
This patient reported a swollen upper lip three days after receiving the covid-19 vaccines. Benadry...
This patient reported a swollen upper lip three days after receiving the covid-19 vaccines. Benadryl 50mg was administered. The swelling resolved over the course of the day following the Benadryl.
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|
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| 2824489 | 90 | M | AR | 02/04/2025 |
COVID19 |
MODERNA |
022H22A |
COVID-19
COVID-19
|
COVID INFECTION WITH HOSPITALIZATION AFTER VACCINATION
COVID INFECTION WITH HOSPITALIZATION AFTER VACCINATION
|
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| 2824490 | 78 | M | AR | 02/04/2025 |
COVID19 |
MODERNA |
028A21A |
COVID-19
COVID-19
|
covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
|
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| 2824491 | 77 | M | MN | 02/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Chest pain, Computerised tomogram, Electrocardiogram abnormal, Fatigue, Myalgia;...
Chest pain, Computerised tomogram, Electrocardiogram abnormal, Fatigue, Myalgia; Scan with contrast normal, Troponin normal
More
|
The patient was evaluated for chest pain with EKG changes. They repeated EKG and found previous EKGs...
The patient was evaluated for chest pain with EKG changes. They repeated EKG and found previous EKGs which showed similar findings. Troponin was negative and not changing. Imaging including CTA chest/abdomen/pelvis was reassuring. They felt that patient's discomfort was likely musculoskeletal in etiology and recommended symptomatic measures for that. of note, patient recently had the Covid vaccine and it is possible that he is having myalgias and fatigue related to that in retrospect.
More
|
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| 2824492 | 64 | M | NY | 02/04/2025 |
COVID19 |
MODERNA |
3043930 |
Injection site pain
Injection site pain
|
Patient reports that he had his COVID vaccination booster (Dec 2024) and has had left arm pain at th...
Patient reports that he had his COVID vaccination booster (Dec 2024) and has had left arm pain at the injection site intermittently since then that began at the time of injection and has never gone away. Rates pain as minimal, comes and goes, notices it more than once a day as an "ache." Not severe enough to limit ROM or activity, no particular inciting motions or pressure that reproduces the ache, seems to be at random. No numbness, no tingling, no radiation of symptom. Never had bruising or redness. Has not ever been painful enough that he would consider taking a pain reliever, but since it has been ongoing, he wanted to mention it.
More
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| 2824493 | 71 | F | AR | 02/04/2025 |
COVID19 |
MODERNA |
3043823 |
COVID-19
COVID-19
|
covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
|
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| 2824494 | 70 | F | OH | 02/04/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
fj9a7 fj9a7 |
Dizziness, Erythema, Extra dose administered, Fatigue, Nausea; Rash, Swelling, V...
Dizziness, Erythema, Extra dose administered, Fatigue, Nausea; Rash, Swelling, Vomiting
More
|
patient went to physician reporting nausea/vomiting, dizziness, rash, swelling, redness and fatigue....
patient went to physician reporting nausea/vomiting, dizziness, rash, swelling, redness and fatigue. md discovered patient had received an unnecessary 3rd dose of shingrix.
More
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| 2824495 | 82 | F | AR | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6199 |
COVID-19
COVID-19
|
hospitalized with COVID
hospitalized with COVID
|
โ | |||||
| 2824496 | 5 | M | MI | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Child received COVID-19 vaccine, the vaccine expired on 1/30/2025. Manufacturer expiration date=...
Child received COVID-19 vaccine, the vaccine expired on 1/30/2025. Manufacturer expiration date= 12/31/2025, use by date in regards to thaw date was 1/30/2025. No immediate adverse reaction noted . PCP notified of incident ,pcp called and informed parent.
More
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| 2824497 | 78 | F | PR | 02/04/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Asthenia, Fatigue, Headache, Injection site pain, Injection site swelling; Myalg...
Asthenia, Fatigue, Headache, Injection site pain, Injection site swelling; Myalgia
More
|
Shingrix Vaccine, Headache, Exhaustion, muscle ache, weakness and swelling at site and soreness. Las...
Shingrix Vaccine, Headache, Exhaustion, muscle ache, weakness and swelling at site and soreness. Lasted about 5 days
More
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| 2824498 | 82 | M | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
no adverse effects noted. Patient received 2 doses of Arexvy (incorrect dosing interval) - 1st dose ...
no adverse effects noted. Patient received 2 doses of Arexvy (incorrect dosing interval) - 1st dose given 12/23/2023 and 2nd dose given 02/03/2025 .
More
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| 2824499 | 55 | F | OH | 02/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Injection site paraesthesia, Paraesthesia
Injection site paraesthesia, Paraesthesia
|
My left arm is tingling and numb from the injection site through my arm all the way down to my hand....
My left arm is tingling and numb from the injection site through my arm all the way down to my hand. It comes and goes hundreds of times a day, every day since the injection. (about a week today)
More
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| 2824500 | 39 | F | WA | 02/04/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Headache
Headache
|
Headache for over a week (still present today)
Headache for over a week (still present today)
|
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| 2824501 | 20 | F | TX | 02/04/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
3X937 |
Pruritus, Urticaria
Pruritus, Urticaria
|
Itching all over (not at injection site) onset approximately 10 hours after receiving injection. Hi...
Itching all over (not at injection site) onset approximately 10 hours after receiving injection. Hives noted to palms of hands the next morning at approximately 6am. Hives then began to spread over body.
More
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| 2824502 | 57 | M | GA | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n77j2 |
Rash
Rash
|
developed a rash that doesn't go away, the patient is unsure about the time line so the vaccine...
developed a rash that doesn't go away, the patient is unsure about the time line so the vaccine is unlikely to be the culprit but there is a possibility it was during the time after his second vaccine.
More
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| 2824503 | 7 | F | MT | 02/04/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9kb9g |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
The patient was given DTap when she should have received TD or TDap due to her age.
The patient was given DTap when she should have received TD or TDap due to her age.
|
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| 2824504 | 16 | F | NC | 02/04/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 |
Injection site pain
Injection site pain
|
lingering left deltoid soreness
lingering left deltoid soreness
|
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| 2824505 | 51 | F | TX | 02/04/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
|
Chest pain, Injection site pain, Injection site reaction, Injection site swellin...
Chest pain, Injection site pain, Injection site reaction, Injection site swelling, Insomnia; Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
More
|
Patient reports stiff swollen area at site of injection beginning day of injection and continuing to...
Patient reports stiff swollen area at site of injection beginning day of injection and continuing to time of report. Reports pain occasionally radiating to chest, reports pain in their arm with motion. Reports difficulty sleeping due to pain from injection site. Reports fever x4 days.
More
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| 2824506 | 80 | F | NV | 02/04/2025 |
FLU3 PNC20 RSV |
SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH |
|
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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Patient received the flu shot - she did not want it - no reaction or otherwise from the actual injec...
Patient received the flu shot - she did not want it - no reaction or otherwise from the actual injection itself.
More
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| 2824507 | 87 | F | FL | 02/04/2025 |
PNC21 RSV |
MERCK & CO. INC. PFIZER\WYETH |
|
Erythema, Hypersensitivity, Swelling; Erythema, Hypersensitivity, Swelling
Erythema, Hypersensitivity, Swelling; Erythema, Hypersensitivity, Swelling
|
pt had severe allergic reaction, redness and swelling . pt seen by her doctor and got prescribed M...
pt had severe allergic reaction, redness and swelling . pt seen by her doctor and got prescribed Medrol dose pack
More
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| 2824508 | 4 | M | OR | 02/04/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5g23d |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
|
This vaccine was administered subcutaneously instead of Intramuscular. There have been no adverse ...
This vaccine was administered subcutaneously instead of Intramuscular. There have been no adverse reactions from this administration. Provided was consulted and the necessary follow up actions were taken.
More
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| 2824509 | 1 | M | CO | 02/04/2025 |
HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
DN273 Y009430 Y010045 |
Flushing, Immediate post-injection reaction, Urticaria; Flushing, Immediate post...
Flushing, Immediate post-injection reaction, Urticaria; Flushing, Immediate post-injection reaction, Urticaria; Flushing, Immediate post-injection reaction, Urticaria
More
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Patient presents to clinic for 12month vaccine. verified patients full name and DOB. Parents of pati...
Patient presents to clinic for 12month vaccine. verified patients full name and DOB. Parents of patient stated reactions to influenza vaccines and Prevnar 20 in the past. Stated they were seen by an allergy specialist and determined it would be sufficient to continue age specific vaccination process. Spoke with the pediatrician who follows patient , here in clinic and concluded to move forward with vaccinating. Parents had prescribed EpiPen junior, and Benadryl. The benadryl was given 5-10 minutes prior to vaccine administration. After administering the MMR, Varicella, and Hep A, I noticed immediate flush skin throughout body and hives. Notified the pediatric provider team and administered the EpiPen, monitored vitals and observed patient. Hives immediately disappeared, vitals were stable and monitored patient in clinic for 1 hour.
More
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| 2824510 | 81 | F | LA | 02/04/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
|
Patient's daughter (caretaker) called us on 2/4/25 to report that on 2/4/25 patient started to ...
Patient's daughter (caretaker) called us on 2/4/25 to report that on 2/4/25 patient started to experience redness and itching at the injection site.
More
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| 2824511 | 6 | F | NE | 02/04/2025 |
COVID19 |
MODERNA |
B0002 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Adult dose given to child age 6 years.
Adult dose given to child age 6 years.
|
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| 2824512 | 62 | M | MA | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
T92HK |
Extra dose administered
Extra dose administered
|
Patient received one dose too many due to incomplete order from 2021 that should have been closed.
Patient received one dose too many due to incomplete order from 2021 that should have been closed.
|
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| 2824523 | U | TX | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
X026668 |
Product storage error
Product storage error
|
No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient afte...
No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024. Vaccine was administered after the excursion on 24DEC2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On 24-DEC-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) that underwent a temperature excursion that occurred on 02-DEC-2024. The temperature excursion was 46.7 degrees Fahrenheit for the time frame of 192 hours. There was no previous temperature excursion. No adverse event.
More
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| 2824524 | U | TX | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
X026668 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient afte...
No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024. Vaccine was administered during the excursion on 07DEC2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-DEC-2024, a temperature excursion occurred at 46.7 F for 192 hours. Later, on 07-DEC-2024, the patient was vaccinated with a improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No previous temperature excursion occurred. No additional adverse event was reported.
More
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| 2824525 | U | TX | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
X026668 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No adverse event; HCP called and reported inadvertent administration of GARDASIL 9 to a patient afte...
No adverse event; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024.; This spontaneous report was received from Other Health Professional and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 24-DEC-2024, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, dose description and route of administration were not provided) after a temperature excursion of 46.7 Fahrenheit for 192 hours 0 minutes 0 seconds, it was stated that no previous temperature excursion occurred. No additional adverse event occurred.
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| 2824526 | F | TX | 02/04/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943008 |
Interchange of vaccine products, No adverse event
Interchange of vaccine products, No adverse event
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First Dose Heplisav-B, Second Dose Twinrix; Initial report received on 03-Jan-2025. A pharmacist re...
First Dose Heplisav-B, Second Dose Twinrix; Initial report received on 03-Jan-2025. A pharmacist reported that a 59-year-old (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX as the second dose of the series. No medical history or concomitant medications were reported. On 24-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943008, expiration 30-Sep-2025, NDC # 43528-0003-05) intramuscularly in the left deltoid. On 29-Sep-2024, the patient received a dose of TWINRIX (hepatitis A/hepatitis B vaccine). Reporter stated that no adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2824527 | U | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Guillain-Barre syndrome
Guillain-Barre syndrome
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incidence of Guillian; This serious case was reported by a consumer via interactive digital media an...
incidence of Guillian; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: incidence of Guillian) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK receipt date: 24-JAN-2025 Reporter stated that patient had incidence of Gullian.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
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