| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2858429 | 2 | M | OH | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
|
Erythema, Swelling
Erythema, Swelling
|
Immunization: influenza (IIV3) vaccine - local skin reaction/erythema and swelling
Immunization: influenza (IIV3) vaccine - local skin reaction/erythema and swelling
|
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| 2858430 | 2 | F | AR | 09/12/2025 |
DTAP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JP227 3255P |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Dose administered to early, patient not due at time of vaccination. No adverse reaction noted.
Dose administered to early, patient not due at time of vaccination. No adverse reaction noted.
|
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| 2858431 | 1.33 | M | FL | 09/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
F9K3L |
Wrong product administered
Wrong product administered
|
TDap given instead of DTap
TDap given instead of DTap
|
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| 2858432 | 2 | M | AR | 09/12/2025 |
DTAP HEPA |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
9PT3F J4K4X |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Dose administered to early, patient not due at time of vaccination. No adverse reaction noted.
Dose administered to early, patient not due at time of vaccination. No adverse reaction noted.
|
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| 2858433 | 12 | F | KY | 09/12/2025 |
MMR |
MERCK & CO. INC. |
Y014094 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
The incorrect vaccination was administered. The patient experienced no adverse event.
The incorrect vaccination was administered. The patient experienced no adverse event.
|
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| 2858434 | 1.25 | M | AR | 09/12/2025 |
DTAP HEPA HIBV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
3CA55C1 J4K4X UK210AA Y013171 Y013346 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Dose administered to early, patient not due at time of vaccination. No adverse reaction noted. PCV15...
Dose administered to early, patient not due at time of vaccination. No adverse reaction noted. PCV15 given on same date Y010035 LD
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| 2858435 | 54 | F | MO | 09/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Burning sensation
Burning sensation
|
Feeling of having a sunburn
Feeling of having a sunburn
|
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| 2858436 | 0.5 | M | AK | 09/12/2025 |
HIBV |
MERCK & CO. INC. |
Y020468 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Vaccine was given at wrong time, he wasn't due for it yet.
Vaccine was given at wrong time, he wasn't due for it yet.
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| 2858437 | 17 | M | NC | 09/12/2025 |
MNQ |
SANOFI PASTEUR |
MENQUADFI |
Flushing, Loss of consciousness, Syncope
Flushing, Loss of consciousness, Syncope
|
APPROXIMATELY 1 MINUTE AFTER VACCINE ADMINISTRATION, WHILE SPEAKING TO MOTHER AND NURSE, PATIENT EXP...
APPROXIMATELY 1 MINUTE AFTER VACCINE ADMINISTRATION, WHILE SPEAKING TO MOTHER AND NURSE, PATIENT EXPERIENCED A SYNCOPAL EPISODE. PATIENT REGAINED CONSCIOUSNESS IN UNDER 1 MINUTE WHERE HE WAS THEN ALERT AND ORIENTED. FLUSING OF FACE WAS NOTED. PATIENT HAD NOT EATEN OR HAD FLUIDS PRIOR TO THIS APPOINTMENT.
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| 2858438 | 68 | F | OH | 09/12/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
my9550 407242 |
Back pain, Mobility decreased; Back pain, Mobility decreased
Back pain, Mobility decreased; Back pain, Mobility decreased
|
patient received vaccines and upon leaving the vaccination booth, she hunched over and she reported ...
patient received vaccines and upon leaving the vaccination booth, she hunched over and she reported a sharp pain in her back and that she could not move. the patient was assisted to a nearby bench. cold packs were applied. after 15 minutes that patient reported that she was feeling much better. the patient completed her shopping trip at store.
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| 2858439 | 0.58 | M | CT | 09/12/2025 |
PNC20 |
PFIZER\WYETH |
LP4946 |
Refusal of vaccination
Refusal of vaccination
|
Patient under-immunized. Discussion had today at well-visit with mom about the concerns/dangers of u...
Patient under-immunized. Discussion had today at well-visit with mom about the concerns/dangers of under-immunization. Patient on this day has only ever received 1 dose of DTaP, 1 dose of hepatitis B, 1 dose of HIB, 1 dose of Prevnar 20. Patient had no received IPV. Mom agreeable to only receive 1st IPV and 2nd HIB vaccines today. First vaccine was given, the prevnar 20, which was not one mom agreed to today. Provider immediately told mom, mom grabbed children and left room. Mom accused provider of doing it "on purpose." Provider apologized and stated she did not give Prevnar on purpose. Mom left office with children.
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| 2858440 | 59 | F | NC | 09/12/2025 |
PNC20 |
PFIZER\WYETH |
|
Arthralgia, Myalgia
Arthralgia, Myalgia
|
STARTING THE NEXT DAY SHE HAD "SHARP PAINS IN MUSCLE& JOINTS, SPECIFICALLY THE THUMBS, EXTR...
STARTING THE NEXT DAY SHE HAD "SHARP PAINS IN MUSCLE& JOINTS, SPECIFICALLY THE THUMBS, EXTREMETIES IN THIGHS AND UPPER ARMS FOR 2 WEEKS.
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| 2858441 | 54 | F | AR | 09/12/2025 |
COVID19 UNK |
MODERNA UNKNOWN MANUFACTURER |
|
Biopsy cervix abnormal, Lichen sclerosus, Smear cervix abnormal; Biopsy cervix a...
Biopsy cervix abnormal, Lichen sclerosus, Smear cervix abnormal; Biopsy cervix abnormal, Lichen sclerosus, Smear cervix abnormal
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Severe Chronic case of Lichen Sclerosis auto immune dissorder. There is no cure. Treated with a pres...
Severe Chronic case of Lichen Sclerosis auto immune dissorder. There is no cure. Treated with a prescription ointment.
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| 2858442 | 0.17 | F | TX | 09/12/2025 |
DTPPVHBHPB RV1 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS |
U8267AA 3Z34X |
Blood glucose normal, Infant irritability, Vomiting; Blood glucose normal, Infan...
Blood glucose normal, Infant irritability, Vomiting; Blood glucose normal, Infant irritability, Vomiting
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Parents gave her Tylenol this evening because she was fussy after receiving vaccines this morning. ...
Parents gave her Tylenol this evening because she was fussy after receiving vaccines this morning. Shortly after she got the Tylenol she vomited. She has since vomited 3 additional times. After her feeding, she vomited a large amount almost immediately.
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| 2858443 | 4 | M | PA | 09/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7FY52 |
Cellulitis, Injection site erythema, Injection site swelling, Injection site war...
Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
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Received vaccine 9/10/25 around 1700. 9/11/25 evening started with redness, warmth, mild swelling a...
Received vaccine 9/10/25 around 1700. 9/11/25 evening started with redness, warmth, mild swelling adjacent to immunization site. Diagnosed with cellulitis of right upper extremity and placed on antibiotics
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| 2858444 | 1.42 | M | TX | 09/12/2025 |
HIBV |
SANOFI PASTEUR |
UK304AA |
Extra dose administered, Product prescribing error
Extra dose administered, Product prescribing error
|
HIb given today per vaccine order , patient did not need a Hib Vaccine as he had this already, Docto...
HIb given today per vaccine order , patient did not need a Hib Vaccine as he had this already, Doctor informed me she tried reaching out to patient to inform her of this after they had left unable to reach mother.
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| 2858445 | 70 | F | PA | 09/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Coagulation test normal, Computerised tomogram head abnormal, Death, Haemorrhage...
Coagulation test normal, Computerised tomogram head abnormal, Death, Haemorrhage intracranial, Headache; Platelet count normal
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Intracranial hemorrhage, fatal. Patient had severe headache morning after COVID vaccine, symptoms sl...
Intracranial hemorrhage, fatal. Patient had severe headache morning after COVID vaccine, symptoms slightly improved and then suddenly worsened. Patient diagnosed with extensive intracranial hemorrhage 48 hours after receiving the COVID 19 vaccine. She had a history of prior intracranial hemorrhage a few years prior thought secondary to COVID infection.
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| 2858446 | 1 | M | OR | 09/12/2025 |
DTAP HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
3CA55C1 UK198AA |
Decreased appetite, Injection site swelling, Irritability, Pyrexia; Decreased ap...
Decreased appetite, Injection site swelling, Irritability, Pyrexia; Decreased appetite, Injection site swelling, Irritability, Pyrexia
More
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High fevers 104-104.8 F for 48 hours at the time of being seen; mild swelling at site of injection; ...
High fevers 104-104.8 F for 48 hours at the time of being seen; mild swelling at site of injection; fussiness, decreased appetite.
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| 2858447 | 4 | F | MN | 09/12/2025 |
MMRV |
MERCK & CO. INC. |
|
Extra dose administered, Fatigue
Extra dose administered, Fatigue
|
double dose was given to patient in error, child reported to seem a bit more tired over the weeken...
double dose was given to patient in error, child reported to seem a bit more tired over the weekend after this, but no other complaints or sequelae
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| 2858448 | 22 | F | NY | 09/12/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
#2L353 #2L353 |
Chest pain, Dyspnoea, Pharyngeal swelling, Pruritus, Swollen tongue; Urticaria
Chest pain, Dyspnoea, Pharyngeal swelling, Pruritus, Swollen tongue; Urticaria
|
Started as hives, itchiness, throat and tongue swelling, chest pain, shortness of breath
Started as hives, itchiness, throat and tongue swelling, chest pain, shortness of breath
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| 2858449 | 57 | F | AZ | 09/12/2025 |
FLU3 |
SEQIRUS, INC. |
406985 |
Contusion, Erythema, Immediate post-injection reaction, Peripheral swelling
Contusion, Erythema, Immediate post-injection reaction, Peripheral swelling
|
Immediately after giving the vaccination, patients arm was bruised, red and swollen about the size o...
Immediately after giving the vaccination, patients arm was bruised, red and swollen about the size of a golf ball. RPh asked patient to move arm and patient stated she had no pain at all. RPh aked patient if she wanted ice, take some OTC Motrin when she gets home and if it gets worse, go to the nearest Urgent Care. Patient states she gets a flu shot every year and this has never happened before. Patient reports feeling fine, arm is just swollen/red and bruised.
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| 2858450 | 0.5 | M | FL | 09/12/2025 |
DTAPHEPBIP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
B532G Y007178 LP4946 |
Diarrhoea, Eye swelling, Rash; Diarrhoea, Eye swelling, Rash; Diarrhoea, Eye swe...
Diarrhoea, Eye swelling, Rash; Diarrhoea, Eye swelling, Rash; Diarrhoea, Eye swelling, Rash
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Vaccines administered on 08/11/25, mother called on 08/12/2025 stating child had body rash, swelling...
Vaccines administered on 08/11/25, mother called on 08/12/2025 stating child had body rash, swelling eyes. Mom took him to Urgent care clinic on 08/11/25 where the doctor prescribed Benadryl and steroids. Pt had temp of 100.3. Mother also stated baby had x2 very loose stools today, still has rash that is now in his belly/trunk area. Attempted to call mother multiple times for follow up, no answer from parent.
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| 2858451 | 11 | F | OK | 09/12/2025 |
HPV9 PNC20 |
MERCK & CO. INC. PFIZER\WYETH |
|
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
Client came in for 2nd HPV vaccine. I inadvertently picked up the PCV 20 box and gave the vaccine ou...
Client came in for 2nd HPV vaccine. I inadvertently picked up the PCV 20 box and gave the vaccine out of this box. I discovered the mistake and informed the client and the mother, giving them the VIS on this vaccine and assuring that this vaccine was one that she has already had and would not harm her. I gave the patient the correct HPV vaccine with the mother permission.
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| 2858452 | 58 | F | NC | 09/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Ascending flaccid paralysis, Electric shock sensation, Fall, Feeling abnormal, M...
Ascending flaccid paralysis, Electric shock sensation, Fall, Feeling abnormal, Mobility decreased; Neck surgery
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I was doing my clinicals and i decied to take the shot. After i was feeling bad the following day an...
I was doing my clinicals and i decied to take the shot. After i was feeling bad the following day and i told my husband i told him i was gonna test myself to see if i have Covid. I went to lay back down on the bed and when i turned away i don't know what happen , the next moment my husband was yelling my name. He asked what happened i said i don't know. I told him to call my sister and she came over, and she asked me what's wrong i said idk i fell. And i told her i told feel good. My husband was gonna call EMS but i told him to call my son first and pray. My husband tried to touch me i told him not to because he shocked me, but he turned me over and it felt like every time he touched me he was shocking me. I could feel paralysis in my feet as my husband was calling EMS and it was coming up my legs and when it got to my waist i knew that something was happening. When it go to the top of my waist i told my sister to call 911 and hang up with my son. They came and they said they were gonna take me in but every time they touched me it felt like they were shocking me. They took me in and they put the cover on me but everything felt like a shock. They were asking me some questions when i got there and EMS told them not to touch me because i was feeling like everything i was shocking me when it touch's me. They didn't know what is going on so they put me on the floor and forget to put a neck brace on me but they did put one on me in the waiting room. The ER doctor said they were trying to get Neuro on the line. The Neurologist was able to do a visit and he asked me what was shocking me and i told him everything. And i had my hands up and i told him my hands were being shocked. The next thing i know he went off visit and they came in and told me they had to move me. They called a van and moved me and they told them everything that was going on. The specialist came in and i told him what was going on. And i told them that it felt like my body is shocking itself. And they took me to surgery on my neck and they put in the chart to not touch me and i stayed there for a couple of days because i couldn't move, they then put me in rehab for 30 days. I had to do therapy for 3.5 years. I think figured out that i think i have Guillen Burrier Syndrome
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| 2858453 | 64 | F | FL | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
U8823DA |
Chapped lips, Headache, Lip dry, Rash, Rash erythematous
Chapped lips, Headache, Lip dry, Rash, Rash erythematous
|
Patient called pharmacy 9/12 reporting possible side effects from a flu vaccine she got from 9/8/25....
Patient called pharmacy 9/12 reporting possible side effects from a flu vaccine she got from 9/8/25. She has experienced a rash (red and bumpy) upper belly button going up on left side to under her breast and dry, cracking lips. She has been using cortisone cream on the rash, and it has not been better. then patient called back after and said that her headaches also started on 9/9 until now. Patient said she doesn't usually got headaches. According to patient, she did not have anything new in her diet or new medication. I recommend patient to go to urgent care since it has been days and her symptoms still not going away. I will follow up with her again later today.
More
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| 2858454 | 12 | M | CA | 09/12/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8823AA 793PT |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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There was no adverse reaction to the vaccine. The patient was given the flu vaccine but actually wan...
There was no adverse reaction to the vaccine. The patient was given the flu vaccine but actually wanted to get the tdap vaccine instead. After finding this out they were given the tdap vaccine. Patient did not report any adverse reaction afterward
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| 2858455 | 32 | F | GA | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Hypertension
Hypertension
|
Hypertension. Treated with Losartan. Potential heart murmur and other cardiac complications
Hypertension. Treated with Losartan. Potential heart murmur and other cardiac complications
|
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| 2858456 | 82 | F | CO | 09/12/2025 |
PNC20 |
PFIZER\WYETH |
ln4930 |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
|
She stated a couple of days after getting the vaccine her arm started to swell and turn red then on ...
She stated a couple of days after getting the vaccine her arm started to swell and turn red then on 9/12 She contacted me stating her are was hot as well. I advised her to go to the doctor and they ended up prescribing antibiotics
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| 2858457 | 4 | F | TX | 09/12/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
u8198aa z008502 |
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 came with father to catch up on vaccines on 8/16. patient was showing past due for MMRV and ...
patient came with father to catch up on vaccines on 8/16. patient was showing past due for MMRV and DTAP/IPV. during appointment father said that patient had received shots earlier that week. Father did not know what shots were given or from where. This nurse went back to the computer to double check our records. Upon looking system was still showing that the vaccines were still past due and, at the time, no shots were seen haven been given that week. This nurse told this information to the father. Father consented to administering the vaccines and signed the consent form. This nurse was notified of adverse event on 9/9. This nurse spoke with Dr. on that day about possible adverse reactions to receiving second dose of vaccines. Dr informed this nurse that there should be no adverse reactions on patient. On same day this nurse called the father to inform of second vaccine shot and to inquire about where the vaccines on 8/13 were given. Father did not know and this nurse advised that they would look into the issue. on 9/11 this nurse spoke with both parents and advised about the second vaccine, the 8/13 shots not showing in the records, as well as there should be no adverse reactions from receiving second shot. Parents understood this and reported that the pt had not shown any adverse reactions to the second dose.
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| 2858458 | 71 | F | AL | 09/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
gj952 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
swollen red arm at injection site
swollen red arm at injection site
|
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| 2858459 | 74 | M | PR | 09/12/2025 |
PNC20 |
PFIZER\WYETH |
407245 |
Genital rash, Pruritus, Rash
Genital rash, Pruritus, Rash
|
Rash and itching on skin. Patient reported, skin in arms, legs abdomen and genitals as affected.
Rash and itching on skin. Patient reported, skin in arms, legs abdomen and genitals as affected.
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| 2858460 | 70 | F | FL | 09/12/2025 |
COVID19 FLU3 RSV |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
3042648 388459 52Z52 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
DISCOVERED A YEAR LATER BY PHARMACY. UNABLE TO REACH PATIENT REGARDING DUPLICATE VACCINE.
DISCOVERED A YEAR LATER BY PHARMACY. UNABLE TO REACH PATIENT REGARDING DUPLICATE VACCINE.
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| 2858461 | 15 | M | MO | 09/12/2025 |
COVID19 |
MODERNA |
NA0587 |
Blindness transient, Dizziness, Pallor
Blindness transient, Dizziness, Pallor
|
Patient stated he was unable to see for a few seconds and felt lightheaded. His mother took him to ...
Patient stated he was unable to see for a few seconds and felt lightheaded. His mother took him to the photo section to sit down. His complexion and lips appeared pale. This was within 15 minutes of the vaccine. When we got to him, he was seated and appeared pale. We got him water. He reported nothing like this happening in the past or with any other vaccines. After drinking about 200 mL pt color appeared back to normal per mom. Pt lips also no longer looked pale. At 30 minutes, pt was able to stand back up without incident.
More
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| 2858462 | 63 | F | MI | 09/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash, Swelling
Rash, Swelling
|
rash swelling
rash swelling
|
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| 2858463 | 26 | F | WA | 09/12/2025 |
RSV |
PFIZER\WYETH |
LL8398 |
Exposure during pregnancy, Inappropriate schedule of product administration, No ...
Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
More
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Abrysvo vaccine given prior to recommended gestational age of 32 weeks. Pt was 29 weeks 2 days at ti...
Abrysvo vaccine given prior to recommended gestational age of 32 weeks. Pt was 29 weeks 2 days at time of administration. EDD 11/24/25. No adverse effects.
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| 2858464 | 72 | M | FL | 09/12/2025 |
COVID19 FLU3 RSV |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
3042648 388459 52Z52 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
DISCOVERED A YEAR LATER BY PHARMACY. UNABLE TO REACH PATIENT REGARDING DUPLICATE VACCINE.
DISCOVERED A YEAR LATER BY PHARMACY. UNABLE TO REACH PATIENT REGARDING DUPLICATE VACCINE.
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| 2858465 | 51 | F | VA | 09/12/2025 |
FLU3 FLU3 FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U876488 U876488 |
Extra dose administered; Confusional state, Injection site pain, Wrong product a...
Extra dose administered; Confusional state, Injection site pain, Wrong product administered; Extra dose administered; Confusional state, Injection site pain, Wrong product administered
More
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I was given 2 doses of Flu instead of flu and covid.
I was given 2 doses of Flu instead of flu and covid.
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| 2858466 | 0.67 | M | IA | 09/12/2025 |
HEPA |
MERCK & CO. INC. |
Z003748 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Incorrect immunization administered to patient. No adverse reactions noted.
Incorrect immunization administered to patient. No adverse reactions noted.
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| 2858467 | M | CA | 09/12/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
|
Extra dose administered, Product administered to patient of inappropriate age; E...
Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age
More
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Extra dose; Out of age; Out of age; This non-serious case was reported by a pharmacist via call cent...
Extra dose; Out of age; Out of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. Concurrent medical conditions included hiv infection. On 05-JUN-2025, the patient received the 2nd dose of Menveo. In APR-2024, the patient received the 1st dose of Menveo. In APR-2024 after receiving Menveo and an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Out of age). On 05-JUN-2025, the patient experienced extra dose administered (Verbatim: Extra dose) and inappropriate age at vaccine administration (Verbatim: Out of age). The outcome of the extra dose administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The reporter called to get guidance on the vaccines series of Menveo for primary vaccination since the patient has a specific condition (HIV). She mentioned that according to the CDC, the time frame between the two doses was a minimum of 8 weeks for patients with HIV. The 58-year-old patient had the first dose back in April 2024 and he received the second dose on 5th June 2025, which led to inappropriate age at vaccine administration and extra dose administered. The reporter asked if a complete vaccination series or does he need a booster. The patient was planning to receive the booster dose at the time of reporting.
More
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| 2858468 | 18 | F | WA | 09/12/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
|
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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Patient was given vaccine on left deltoid, caregiver asked if she was ok after vaccine patient state...
Patient was given vaccine on left deltoid, caregiver asked if she was ok after vaccine patient stated she felt fine and got up to leave the room, I was going to help patient and mother set up record, as I was doing that patient was now in the hallway and mother outside the door mother started asking patient if she felt fine to which mother started saying patient had passed out and I immediately left the room and went to assist patient. Patient was on the floor I had 1 medical assistant, RN, resident, and PCP help assist with patient she was given crackers, apple juice, and water. Two sets of vitals were obtained one at 2:15 pm and another before she left 2:30 pm. Before patient left I asked if she felt fine she can leave, patient stated she felt fine and got up slowly and left.
More
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| 2858469 | 71 | F | AL | 09/12/2025 |
COVID19 |
JANSSEN |
|
Endoscopy, Gastric cancer stage III, Oesophageal carcinoma, Positron emission to...
Endoscopy, Gastric cancer stage III, Oesophageal carcinoma, Positron emission tomogram
More
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Esophageal Stomach Cancer stage1 to stage 3 in 1 month. Turbo Cancer
Esophageal Stomach Cancer stage1 to stage 3 in 1 month. Turbo Cancer
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| 2858470 | M | NY | 09/12/2025 |
DTAP DTAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
BH57H |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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Drug dose administration interval too long; Drug dose administration interval too long; This non-ser...
Drug dose administration interval too long; Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 5-year-old male patient who received DTPa (Infanrix) (batch number BH57H, expiry date 07-JUL-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (received first dose on 21-DEC-2021), PENTACEL (received first dose on 30-JUL-2020), PENTACEL (received second dose on 01-OCT-2020) and PENTACEL (received third dose on 10-DEC-2020). On 05-AUG-2025, the patient received the 3rd dose of Infanrix. On 18-JUL-2024, the patient received the 2nd dose of Infanrix. On 18-JUL-2024, not applicable after receiving Infanrix and an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 05-AUG-2025, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the drug dose administration interval too long and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-AUG-2025 The reporter reported that patient was given an additional dose of diphtheria, tetanus, and pertussis (Infanrix) which led to lengthening of vaccination schedule. No further information was obtained in this call.
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| 2858471 | 1 | M | GA | 09/12/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered by accident Kinrix to 2 patients that are 15 month old; This non-serious case was repor...
administered by accident Kinrix to 2 patients that are 15 month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Previously administered products included Pediarix (Dose given on June 28th 2024, batch number 9P329, expiry date March 6th 2026), Pediarix (Dose given on August 30th 2024, batch number X9ET5, expiry date March 9th 2026) and Pediarix (Dose given on October 29th 2024, batch number 5YB7L, expiry date November 29th 2026). On 08-AUG-2025, the patient received Kinrix. On 08-AUG-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered by accident Kinrix to 2 patients that are 15 month old). The outcome of the inappropriate age at vaccine administration 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: 18-AUG-2025 Nurse explained that on August 8th 2025 she administered by accident Kinrix to 2 patients that are 15 month old which led to inappropriate age at vaccine administration.; Sender's Comments: US-GSK-US2025106259:same reporter,different patient
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| 2858472 | 1 | F | GA | 09/12/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered by accident Kinrix to 2 patients that are 15 month old; This non-serious case was repor...
administered by accident Kinrix to 2 patients that are 15 month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Previously administered products included Pediarix (Dose given on June 24th 2024,batch number 9P329, expiry date March 6th 2026), Pediarix (Dose given on November 7th 2024, batch number 5YB7L, expiry date November 29th 2026) and Pediarix (Dose given on September 9th 2024, batch number X9ET5, expiry date March 9th 2026). On 08-AUG-2025, the patient received Kinrix. On 08-AUG-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered by accident Kinrix to 2 patients that are 15 month old). The outcome of the inappropriate age at vaccine administration 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: 18-AUG-2025 Nurse explained that on August 8th 2025 she administered by accident Kinrix to 2 patients that are 15 month old which led to inappropriate age at vaccine administration.; Sender's Comments: GSK-US2025106272:same reporter,different patient
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| 2858473 | 12 | F | CA | 09/12/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4BK3 |
Wrong product administered
Wrong product administered
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patient who was administered Bexsero instead of Menveo; This non-serious case was reported by a nurs...
patient who was administered Bexsero instead of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number X4BK3, expiry date 30-SEP-2026) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 15-AUG-2025, the patient received Bexsero. The patient did not receive Menveo. On 15-AUG-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient who was administered Bexsero instead of Menveo). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 18-AUG-2025 The patient inadvertently received Bexsero instead of Menveo, which led to wrong vaccine administered.
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| 2858474 | 47 | M | MO | 09/12/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
H39Z4 |
Underdose
Underdose
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Pediatric dose given; Pediatric dose given; This non-serious case was reported by a other health pr...
Pediatric dose given; Pediatric dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 47-year-old male patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. On 22-AUG-2025, the patient received the 2nd dose of Engerix B pediatric. On 22-AUG-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose given) and underdose (Verbatim: Pediatric dose given). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-AUG-2025 A medical assistant called to request data regarding the administration of a pediatric dose of Engerix-B, which had been given on 22th August 2025 as the second dose to a 45-year-old male patient.
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| 2858475 | 78 | F | NY | 09/12/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered at inappropriate site
Product administered at inappropriate site
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Administered in wrong area; This non-serious case was reported by a pharmacist via call center repr...
Administered in wrong area; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 78-year-old female patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (subcutaneous). On an unknown date, an unknown time after receiving Priorix, the patient experienced vaccine administered at inappropriate site (Verbatim: Administered in wrong area). The outcome of the vaccine administered at inappropriate site 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: 21-AUG-2025 and 22-AUG-2025 Pharmacist had called to request data regarding the validity of a Priorix dose that had been administered subcutaneously, although the pharmacist had stated it was given in the forearm.
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| 2858476 | F | MI | 09/12/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
K7JY3 |
Wrong product administered
Wrong product administered
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on August 26, 2025 a first dose of Bexsero was given to a patient by mistake, patient was supposed t...
on August 26, 2025 a first dose of Bexsero was given to a patient by mistake, patient was supposed to receive Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number K7JY3, expiry date 30-JUN-2028) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 26-AUG-2025, the patient received the 1st dose of Bexsero. The patient did not receive Menveo. On 26-AUG-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: on August 26, 2025 a first dose of Bexsero was given to a patient by mistake, patient was supposed to receive Menveo). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.
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| 2858477 | 56 | M | DC | 09/12/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Product storage error
Product storage error
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vaccine administration after a temperature excursion given that three vaccines involved in the excur...
vaccine administration after a temperature excursion given that three vaccines involved in the excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 56-year-old male patient who received HAV (Havrix) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 03-JUL-2025, the patient received Havrix. On 03-JUL-2025, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: vaccine administration after a temperature excursion given that three vaccines involved in the excursion). The outcome of the incorrect storage of drug 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:29-AUG-2025 This case is linked with US2025111571 reported by same reporter.; Sender's Comments: US-GSK-US2025111571:same reporter, different patient
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| 2858478 | F | 09/12/2025 |
COVID19 |
MODERNA |
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Malaise
Malaise
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The patient was "in bed" for a day or two and "not feeling well".; This spontane...
The patient was "in bed" for a day or two and "not feeling well".; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The patient was "in bed" for a day or two and "not feeling well".) 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 MALAISE (The patient was "in bed" for a day or two and "not feeling well".). At the time of the report, MALAISE (The patient was "in bed" for a day or two and "not feeling well".) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the patient was in bed for one or two days and no longer wished to receive the vaccine as a result of the experience. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789235 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789235:Master case
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