| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851640 | 11 | M | NM | 07/29/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
42DM9 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
patient was given Hep A instead of HPV9. Patient tolerated vaccine well with no adverse reaction not...
patient was given Hep A instead of HPV9. Patient tolerated vaccine well with no adverse reaction noted. I have called and spoke to mother to check on the child and his well being. She states he is doing well and will return to clinic for the correct vaccine.
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| 2851641 | 20 | F | OR | 07/29/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
T9TL9 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Pt did not experience any adverse SE's. Was mistakenly given Havrix -Adult instead of Hepilisav...
Pt did not experience any adverse SE's. Was mistakenly given Havrix -Adult instead of Hepilisav- B on Friday July 25th, pt called by this RN to report incident and need to return to clinic for administration of second Heplisav-B required by her nursing school on 7/28/25 when error was discovered during count. Pt returned later that day, denies difficulty with Havrix.
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| 2851642 | 68 | F | NC | 07/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
332l4 |
Contusion, Pain in extremity
Contusion, Pain in extremity
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Bruise with rash and sore arm. Occurred the next morning of vaccine. The bruise and rash still prese...
Bruise with rash and sore arm. Occurred the next morning of vaccine. The bruise and rash still present 1 week later. No fever
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| 2851643 | 1 | M | MD | 07/29/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
72AB2 |
Circumstance or information capable of leading to medication error
Circumstance or information capable of leading to medication error
|
During administration the child's parent was not holding them still. The child began to fight t...
During administration the child's parent was not holding them still. The child began to fight the Medical Assistant and parent causing the needle to come out of the skin prematurely during administration. Due to this there was concern that the child did not receive the full dose of the vaccine.
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| 2851644 | 41 | F | IN | 07/29/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
p2443 |
Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling
|
Patient reported redness and swelling about a quarter size and seems to be growing, hot to the touch...
Patient reported redness and swelling about a quarter size and seems to be growing, hot to the touch. Patient seen in urgent care 07/28/25 and was instructed to apply Benadryl cream. Patient reports full mobility but soreness and improvement in redness post application of Benadryl cream (07/29/25).
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| 2851645 | 70 | F | GA | 07/29/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
|
Asthenia, Dysphagia, Feeling abnormal, Incontinence, Pain; Pyrexia, Respiratory ...
Asthenia, Dysphagia, Feeling abnormal, Incontinence, Pain; Pyrexia, Respiratory tract congestion, Vomiting
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pt states that evening after being vaccinated she was a little off and was feeling funny. She became...
pt states that evening after being vaccinated she was a little off and was feeling funny. She became congested and felt like couldn't swallow. She tried to eat a little something but she automatically vomited it up. She was achy, feverish, and weak. She only wanted to lie still and rest then she became incontinent. She felt unsettled and unsure what was going on. She took some Tylenol Cold and Flu over a weeks time to help her get through her symptoms. She has never had any reaction to other flu vaccines in the past and was concerned as she lives alone. She is now getting stronger and starting to feel back to normal. She called the clinic to let them know she had this reaction to the vaccine.
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| 2851646 | 0.5 | F | 07/29/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7446AA |
Expired product administered
Expired product administered
|
Patient was given an expired vaccine Vaxelis (Dtap/Hep B/HIB/IPV). This vaccine expired 6/25/2025.
Patient was given an expired vaccine Vaxelis (Dtap/Hep B/HIB/IPV). This vaccine expired 6/25/2025.
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| 2851647 | 29 | M | TX | 07/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Gaze palsy, Seizure
Gaze palsy, Seizure
|
Approximately 1?2 minutes after receiving the vaccine, the patient?s eyes rolled back and he began s...
Approximately 1?2 minutes after receiving the vaccine, the patient?s eyes rolled back and he began sliding out of his chair. Patient was experiencing a seizure. He remained conscious and communicative throughout, lying on the floor for approximately five minutes. When asked, both he and his partner declined EMS assistance or contacting anyone. I advised them to remain in the waiting area for additional observation.
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| 2851648 | 2 | F | OR | 07/29/2025 |
DTPPVHBHPB DTPPVHBHPB MMR MMR VARCEL VARCEL |
MSP VACCINE COMPANY MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
U7535AA U7535AA X018904 X018904 Y014181 Y014181 |
Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bear...
Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty; Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty; Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty
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Parents report that after the last vaccines in 4/17/25, patient was not feeling well for a couple w...
Parents report that after the last vaccines in 4/17/25, patient was not feeling well for a couple weeks post vaccination. She had a sore leg for 3 days (due to vaccination struggles and safety concerns, all 3 doses were given in 1 leg). Mom notes patient avoided putting weight on her legs for about 3 days. Her sleep was disturbed, waking up intermittently (every 2 hrs) outside of her normal, grumpy (modified temperament) for a 2-3 weeks, and not interacting with her normal play activities. She also developed a low grade fever that resolved with Tylenol. I discussed with the parents that her response was likely due to the pain of all 3 vaccines given in the single leg. After further discussion, we have agreed on a modified schedule moving forward.
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| 2851649 | 76 | F | MD | 07/29/2025 |
RSV RSV RSV RSV RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
255T2 255T2 255T2 255T2 255T2 255T2 |
Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site r...
Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site reaction, Mobility decreased, Oropharyngeal pain, Pain in extremity; Arthralgia, Dyspnoea, Injection site swelling; Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site reaction, Mobility decreased, Oropharyngeal pain, Pain in extremity; Arthralgia, Dyspnoea, Injection site swelling
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pt states when she received the vaccine it was painful. She had a huge red mark at the injection. B...
pt states when she received the vaccine it was painful. She had a huge red mark at the injection. By the next day her hands and every joint in her body hurt. Her fingers were hurting so bad she could not lift anything and she couldn't bend her fingers. Her throat was very sore and it became hard to swallow. Her voice sounded different with a high pitch sound. She became very tired and had extreme fatigue. By the second day she could not raise her arms above her head. She started taking Tylenol and antihistamine to help with the symptoms. These symptoms lasted about a week. At this point she remains very tired but the pain is getting better. She went to her PCP on 7/24. He checked her lymph glands and was told everything seemed to be okay but to keep him posted.
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| 2851650 | 19 | F | TX | 07/29/2025 |
HEP TDAP |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
946060 793pt |
Anxiety, Feeling hot, Flushing, Syncope, Vomiting; Anxiety, Feeling hot, Flushin...
Anxiety, Feeling hot, Flushing, Syncope, Vomiting; Anxiety, Feeling hot, Flushing, Syncope, Vomiting
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During Hep B vaccine, Pt reported feeling warm and looked anxious immediately after recieving the va...
During Hep B vaccine, Pt reported feeling warm and looked anxious immediately after recieving the vaccine. I waited a few minutes for the patient to calm down and she told me when she was ready to revieve the next vaccine. During the Tdap vaccine, Pt experienced brief syncope and vomited after the vaccination. Pt reported feeling very warm and her cheeks were flushed. This happened within a minute after the Tdap vaccine. Her boyfriend who was with her caught her and she regained consciousness within that brief moment. Her blood pressure was taken and she was given oral fluids (Gatorade). After several minutes of observation by myself and my supervising Pharmacist, she was advised not to recieve the last vaccine she asked for (MMR) until the following day. She went home and reported feeling no further symptoms the following day.
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| 2851653 | 18 | F | OK | 07/29/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
xx33p u7852ab |
Nausea, Presyncope, Vomiting; Nausea, Presyncope, Vomiting
Nausea, Presyncope, Vomiting; Nausea, Presyncope, Vomiting
|
pre-syncope including nausea/vomiting within 10 minutes, resolved after 20 minutes
pre-syncope including nausea/vomiting within 10 minutes, resolved after 20 minutes
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| 2851654 | 11 | F | TN | 07/29/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
EK7DG |
Injection site reaction, Injection site swelling, Injection site warmth, Rash pr...
Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
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rash slowly got bigger, swollen itchy, and warm to the touch L upper arm- first time pt ever receive...
rash slowly got bigger, swollen itchy, and warm to the touch L upper arm- first time pt ever received MCV4. Pt mother reported trying cold compresses, Benadryl, Tylenol and Ibuprofen.
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| 2851655 | 54 | M | WI | 07/29/2025 |
PNC20 PNC20 PNC20 VARZOS VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LN4928 LN4928 LN4928 332L4 332L4 332L4 |
Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reac...
Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Chills, Computerised tomogram thorax; Dyspnoea exertional, Fatigue, Pleuritic pain, Pulmonary embolism, Pulmonary infarction; Pyrexia, Scan with contrast; Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Chills, Computerised tomogram thorax; Dyspnoea exertional, Fatigue, Pleuritic pain, Pulmonary embolism, Pulmonary infarction; Pyrexia, Scan with contrast
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Patient developed subjective fever/chills in day 2-3 post vaccination and subsequently developed rig...
Patient developed subjective fever/chills in day 2-3 post vaccination and subsequently developed right sided pleuritic pain about 1 week after with ongoing relapsing/remitting low grade fever, fatigue, and dyspnea on exertion. He never was hypoxic. He was subsequently evaluated and diagnosed with sub-seqmental pulmonary embolism, largest in the right lower lobe with associated subsegmental pulmonary infarction. He was started on oral anti-coagulation on 7/29/25.
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| 2851656 | 16 | F | MA | 07/29/2025 |
MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR |
U8369BA U8369BA |
Abdominal pain, Blood glucose normal, Dizziness, Dysmenorrhoea, Hyperhidrosis; P...
Abdominal pain, Blood glucose normal, Dizziness, Dysmenorrhoea, Hyperhidrosis; Pallor, Syncope
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Near syncopal episode while standing at checkout. Became very pale and dizzy, sweating. BP 92/62, HR...
Near syncopal episode while standing at checkout. Became very pale and dizzy, sweating. BP 92/62, HR 62, 100%. Then proceeded to start with severe lower abdominal cramping and menstrual cramping and needed to use the restroom for a BM. Remained sweaty and dizzy while on the toilet. No LOC. No vomiting. Rested in room and had sips of juice and bites of a cookie. Dizziness improved but then continued with lower abdominal cramping.
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| 2851657 | 13 | F | MO | 07/29/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8370AA X449Y |
Rash, Rash papular; Rash, Rash papular
Rash, Rash papular; Rash, Rash papular
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Per patient's mother, patient has a slightly raised rash "all over entire body" but m...
Per patient's mother, patient has a slightly raised rash "all over entire body" but mostly concentrated on arms and legs. She states it resembles "goose bumps". Mother denies any signs of anaphylaxis. States rash is not painful or itching. She administered Benadryl.
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| 2851658 | 4 | F | MI | 07/29/2025 |
VARCEL |
MERCK & CO. INC. |
Y015108 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient came in for an appointment on 7/25/25 for a preschool form to be filled out. patient was due...
Patient came in for an appointment on 7/25/25 for a preschool form to be filled out. patient was due for vaccines. Patient was due for Kinrix and Proquad. Patient was given Kinrix and MMR on 7/25/25. Upon putting in the vaccines in the patients chart it was noticed that patient did not receive Proquad (MMR and Varicella combo vaccine), patient only received the MMR portion of the vaccine that could have been a combo. Patients mom was contacted and mom stated she would bring the patient back in for the varicella portion of the vaccine. Patient came in today (7/29/25) and got varicella. Patients immunization registration flagged that the varicella was invalid. Health department contacted and stated the live virus vaccines can be given on the same day separately but if given on separate days then they need to be 28 days apart. Patients mom was contacted and informed that patient will need the varicella vaccine again in October as the dose given today (7/29/25) was invalid. Correct vaccines were given but in the wrong time frame.
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| 2851659 | 0.33 | M | VA | 07/29/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5h95b |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Vaccination was given as an off label use. Regional Immunization Nurse Consultant contacted. Mother ...
Vaccination was given as an off label use. Regional Immunization Nurse Consultant contacted. Mother of the patient contacted, denied any symptoms of an adverse reaction.
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| 2851660 | 18 | M | AL | 07/29/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
Z39XM U8558BA |
Cold sweat, Hypotonia, Loss of consciousness, Pallor; Cold sweat, Hypotonia, Los...
Cold sweat, Hypotonia, Loss of consciousness, Pallor; Cold sweat, Hypotonia, Loss of consciousness, Pallor
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Patient received 2 vaccines- one in each arm. No complaints during vaccination. Patient was seated...
Patient received 2 vaccines- one in each arm. No complaints during vaccination. Patient was seated during vaccine administration. Following vaccine administration, nurse sat at her desk to document vaccines and patient passed out and slumped over in his chair. Skin was noted to be pale and clammy. The chair had arms so patient remained in chair and no injury occured. , feet were elevated in another chair, cool rag aplied to his neck, B/P monitored and WNL. Patient was alert and orientented x 3 within about 10 seconds. He was monitored x 15 minutes and denied any dizziness, headache, blurred vision. He stated he felt completely normal and was discharged in stable condition.
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| 2851661 | 4 | M | KY | 07/29/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U7931AB Z008501 |
Injection site erythema, Injection site swelling, Injection site warmth, Vaccina...
Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site eschar; Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site eschar
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Within hours after receiving vaccine child's arm became red, hot, and doubled in size from shou...
Within hours after receiving vaccine child's arm became red, hot, and doubled in size from should down to mid forearm. Side effect persisted over the weekend. Today (4/5 days after the date) it is onlky a little warm and red over the deltoid. He had fragile tissue and got a little eschar when the band aid was removed that is healing now.
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| 2851663 | 63 | M | GA | 07/29/2025 |
COVID19 FLU3 PNC20 |
MODERNA SANOFI PASTEUR PFIZER\WYETH |
B0002 UT8408NA HH1326 |
No adverse event; No adverse event; No adverse event
No adverse event; No adverse event; No adverse event
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No symptoms of adverse event reported by patient.
No symptoms of adverse event reported by patient.
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| 2851664 | 49 | F | MN | 07/29/2025 |
HEP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
4BX39 LN4930 |
Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm; Erythem...
Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
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left arm started to swell and get red and hot on 7/26/25; she now has reported swelling size of a ba...
left arm started to swell and get red and hot on 7/26/25; she now has reported swelling size of a baseball, hard, warm and very painful arm. She has used ice but this is not helping.
More
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| 2851665 | 12 | F | AK | 07/29/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y00799 U8375AA 4K7JP |
Photopsia, Syncope; Photopsia, Syncope; Photopsia, Syncope
Photopsia, Syncope; Photopsia, Syncope; Photopsia, Syncope
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Patient tolerated IM vaccine administration, she sat for 3 minutes in chair prior to standing. She h...
Patient tolerated IM vaccine administration, she sat for 3 minutes in chair prior to standing. She had what appeared to be a Vasovagal syncope event. Eyes opened the entire time and gently guided to the floor. She blinked and then began talking within few seconds of lying down. Patient admitted to feeling like she was seeing stars when she stood up and tried walking. Patient requested to be sitting rather than lying down and sat for about 10minutes and stood with stand by assist. She denied any symptoms of dizziness or concerns. She left clinic with parent and no other concerning symptoms.
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| 2851666 | 10 | F | MA | 07/29/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8558AA 4CA04C1 |
Product preparation issue; Product preparation issue
Product preparation issue; Product preparation issue
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Both Tdap and Menquadfi where drawn up into the same syringe accidentally and given to patient.
Both Tdap and Menquadfi where drawn up into the same syringe accidentally and given to patient.
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| 2851667 | 68 | F | MN | 07/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
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Patient called today 7/29 stating that she has had small red bumps/ itchy rash on both arms starting...
Patient called today 7/29 stating that she has had small red bumps/ itchy rash on both arms starting 1 week or so after second vaccine in the series. No problems reported from the first vaccine in the series. We consulted her to call her MD and can use topical cortisone to possible help with the itchiness.
More
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| 2851668 | 64 | M | MI | 07/29/2025 |
ADEN_4_7 ADEN_4_7 |
TEVA PHARMACEUTICALS TEVA PHARMACEUTICALS |
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Balance disorder, Computerised tomogram head, Deafness unilateral, Ear discomfor...
Balance disorder, Computerised tomogram head, Deafness unilateral, Ear discomfort, Electrocardiogram; Full blood count, Metabolic function test, Tinnitus, Walking aid user
More
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1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a can...
1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a cane to help keep me from falling over. Loud ringing in right ear. Low grade fever of 100. I still can't even hear a smoke alarm going off. A feeling of pressure in ear
More
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✓ | |||||
| 2851669 | 18 | F | WA | 07/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
TH9NR |
Syncope
Syncope
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Patient had syncope episode after receiving the vaccines. She was laid down on the table and was coh...
Patient had syncope episode after receiving the vaccines. She was laid down on the table and was coherent after 20 seconds. Legs were bent at the knees. Nurse was brought into the room and did vitals. Patient was given juice and crackers. Vitals were monitored while the doctor was brought into the room.
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| 2851670 | 56 | F | MI | 07/29/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
H4279 PJ353 |
Pain in extremity, Peripheral swelling, Skin warm; Pain in extremity, Peripheral...
Pain in extremity, Peripheral swelling, Skin warm; Pain in extremity, Peripheral swelling, Skin warm
More
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PROGRESSIVE SWELLING OF THE ARM FROM SHOULDER TO ELBOW,HOT TO TOUCH AND PAINFUL
PROGRESSIVE SWELLING OF THE ARM FROM SHOULDER TO ELBOW,HOT TO TOUCH AND PAINFUL
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| 2851671 | 51 | F | NC | 07/29/2025 |
HEPAB VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P2443 PJ353 |
Injection site erythema, Injection site inflammation, Injection site pain, Injec...
Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth; Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
More
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Patient has a very red inflamed spot on her arm where the vaccine for shingrix was administered, and...
Patient has a very red inflamed spot on her arm where the vaccine for shingrix was administered, and a 4 in diameter of red inflamed area around it and feels very warm and tender to touch. patient continues to have full range of motion on this arm . She is on day 6 today since vaccination and it is not improved
More
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| 2851672 | 66 | M | ND | 07/29/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
JB4K2 |
Underdose
Underdose
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Hep B pediatric was given instead of Hep B adult.
Hep B pediatric was given instead of Hep B adult.
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| 2851674 | 57 | F | NJ | 07/29/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z003579 93N4J |
Pruritus, Urticaria; Pruritus, Urticaria
Pruritus, Urticaria; Pruritus, Urticaria
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Patient said they had hives and itchiness in left arm two days after getting both vaccines. They tr...
Patient said they had hives and itchiness in left arm two days after getting both vaccines. They tried Benadryl but it did not help, so she went to the emergency room. She is better today.
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| 2851675 | 54 | M | CO | 07/29/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
57DD5 |
Product preparation issue
Product preparation issue
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Administered the diluent only, forgot to mix in the freeze dried vaccine. New type of brand of vacci...
Administered the diluent only, forgot to mix in the freeze dried vaccine. New type of brand of vaccine and was first time giving it.
More
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| 2851676 | 16 | F | OK | 07/29/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
XL223 XL223 |
Depressed level of consciousness, Hypotonia, Immediate post-injection reaction, ...
Depressed level of consciousness, Hypotonia, Immediate post-injection reaction, Nausea, Pallor; Seizure, Somnolence, Unresponsive to stimuli
More
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Patient had brief seizure (<30 seconds) which involved her eyes and all 4 extremities immediately...
Patient had brief seizure (<30 seconds) which involved her eyes and all 4 extremities immediately after the vaccine was given. Afterward, she was sleepy and had a decreased level of consciousness (unable to respond to questions) for several minutes and had to lie on the table for about 30 minutes before she could leave the office. She appeared limp and pale and felt nauseous but did not vomit. 7/21/2021, she received her first meningococcal vaccine (Menactra lot #U6951AA) along with HPV9 and Tdap (all on the same day). She had an identical reaction at that time which was thought to be due to the HPV vaccine. With her second HPV vaccine, she had no reaction however so the original culprit must have been the meningococcal vaccine.
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| 2851677 | 73 | F | MS | 07/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95n |
Arthralgia, Injection site rash
Arthralgia, Injection site rash
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Rash at site of injection, shoulder joint pain. She said that the reaction lasted a few days.
Rash at site of injection, shoulder joint pain. She said that the reaction lasted a few days.
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| 2851678 | 50 | F | NC | 07/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
CD44A |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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3RD an final Bexsero to be administered 6 months or after from Day 0, per guidelines. This patient ...
3RD an final Bexsero to be administered 6 months or after from Day 0, per guidelines. This patient received her first dose on 01/31/25, 2nd dose 03/28/2025 and 3rd dose due on or after 07/31/2025. In this case, Bexsero 3rd dose administered on 07/25/2025, six days prior to recommended dosing schedule. Notified nursing and pharmacist, and requested that the pharmacist reach out to the HCP and notify them of the above.
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| 2851681 | F | FL | 07/29/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013469 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
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Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years o...
Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years old but received their second dose at age 46 years old on 7-MAR-2025. Caller states patient is now requesting their 3rd dose to complete the series bu; Information has been received from Business Partner/CRO on 08-Jul-2025. This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), dose number 1, (indication, expiration date, and lot # were not reported). On 07-Mar-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (lot #Y013469, expiration date: 10-Oct-2026), dose number 2, for an unknown indication (Inappropriate schedule of vaccine administered).
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| 2851682 | KY | 07/29/2025 |
VARCEL |
MERCK & CO. INC. |
Y006523 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; Pharmacist calling to report inadvertently administering VARIVAX to patients after...
no adverse event; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; This spontaneous report was received from a Pharmacist 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 25-Sep-2024, the patient was inadvertently vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y006523, expiration date: 25-Mar-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). It was mentioned that the vaccine was "issued" to the facility on 09-AUG-2024 and was inadvertently stored in the refrigerated throughout administrations. The temperature excursion was: Temperature 2 to 8�C, the time frame was and previous temperature excursion was Unknown. No adverse events reported.; Reporter's Comments: Keywords :
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| 2851683 | VA | 07/29/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; VARIVAX was administered following the excursion; This spontaneous report was rece...
No additional AE; VARIVAX was administered following the excursion; This spontaneous report was received from a nurse 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 10-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y019318, expiration date: 21-Nov-2026 (dose number, route of administration, and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiration date were not reported). On an unknown date, before administration, the vaccine underwent a temperature excursion of 52.2 degrees Fahrenheit (F), time frame was unknown by reporter. No symptoms or side effects, no additional adverse events were reported.
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| 2851684 | CA | 07/29/2025 |
HPV9 |
MERCK & CO. INC. |
Z005469 |
Syringe issue
Syringe issue
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HCP calling to report a PQC for GARDASIL 9. Caller states "the syringe broke" following t...
HCP calling to report a PQC for GARDASIL 9. Caller states "the syringe broke" following the administration of a GARDASIL 9 dose to a patient. Caller states the "glass part" near the plunger broke for one of the syringes of GARDASIL 9.; Syringe broken; No adverse event; This spontaneous report was received from Other health professional 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 an unknown date, "the syringe broke" following the administration of a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis to the patient. The primary reporter stated that the "glass part near the plunger" near the plunger broke for one of the syringes of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The break was noticed after the administration and the needle was removed from the patient's arm. Caller states the break occurred prior to placing the needle cover. Even with the break, the HCP administering the vaccine was able to cover the needle with the safety cover. The patient received the full dose. Other doses from the box have been administered with no issues. No adverse event reported.; Reporter's Comments
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| 2851685 | GA | 07/29/2025 |
MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z007213 Y013580 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered...
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter.
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| 2851686 | 17 | CA | 07/29/2025 |
MMRV |
MERCK & CO. INC. |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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HCP reporting PROQUAD administered to a 17 year old patient.; No additional AE; This spontaneous rep...
HCP reporting PROQUAD administered to a 17 year old patient.; No additional AE; This spontaneous report was received from a nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, at the age of 17 years old, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). No additional adverse event was reported. Lot# is being requested and will be submitted if received.
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| 2851687 | 1 | IA | 07/29/2025 |
MMR MMR MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y018703 Z005153 |
Extra dose administered, Inappropriate schedule of product administration, No ad...
Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event
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Patient is not symptomatic. No additional AE; Received their first dose of MMR-II on 08/17/2023. Adm...
Patient is not symptomatic. No additional AE; Received their first dose of MMR-II on 08/17/2023. Administration of MMR-II on 07/25/25; HCP calling to report the inadvertent administration of PROQUAD and MMR-II today (07/25/25).; This spontaneous report was received from a registered nurse (R.N.) and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 17-AUG-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both administered for prophylaxis (dose, formulation, route of administration, anatomical site of injection, lot number and expiration date were not reported), which were both reconstituted with sterile diluent (MERCK STERILE DILUENTE) (lot number and expiration date not provided). On 25-JUL-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y018703 has been verified to be valid for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live [M-M-R II], expiration date 11-NOV-2026) (Inappropriate schedule of product administration), and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) dose number 1 (lot number Z005153 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 25-AUG-2026); both vaccines were administered for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided) and both were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported). The administered vaccines were giving inadvertently on the same date (Accidental overdose). The patient was no symptomatic and no additional adverse event was reported. No other information provided This is one of two reports from the same reporter.
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| 2851688 | WV | 07/29/2025 |
MMRV |
MERCK & CO. INC. |
Y002374 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No additional AE reported; PROQUAD was administered to a 22-year-old consumer; This spontaneous repo...
No additional AE reported; PROQUAD was administered to a 22-year-old consumer; This spontaneous report was received from a/an Other health professional and refers to a 22-year-old patient of unknown gender. The patient's previous adverse drug reaction history and family adverse drug reactions were not reported. The patient's concomitant therapies, medical histories and drug allergies were not applicable. On 07-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y002374, expiration date: 14-Jul-2025) (strength, formulation route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) for Prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (Product administered to patient of inappropriate age). No additional AE reported. No PQC reported. No additional information provided.
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| 2851689 | GA | 07/29/2025 |
MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z007213 Y013580 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered...
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter.
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| 2851690 | GA | 07/29/2025 |
MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z007213 Y013580 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered...
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter.
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| 2851693 | 11 | M | IA | 07/29/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB064A |
Product preparation error
Product preparation error
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Wrong solution used in drug reconstitution; Wrong solution used in drug reconstitution; This non-ser...
Wrong solution used in drug reconstitution; Wrong solution used in drug reconstitution; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 14-JUL-2025, the patient received Menveo (intramuscular, left deltoid). On 14-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong solution used in drug reconstitution) and inappropriate dose of vaccine administered (Verbatim: Wrong solution used in drug reconstitution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter stated that a male patient received the Lyophilized Conjugate component only of Menveo reconstituted with a Merck diluent that is used for the Proquad Vaccine instead of reconstituted with the Liquid conjugate for Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with case US2025091804, reported by the same reporter.; Sender's Comments: US-GSK-US2025091804:same reporter, different patient, 2 of 2
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| 2851694 | M | FL | 07/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose; This non-serious case was...
he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The reporter was an older male who stated that he received dose one of Shingrix in 2019 and had not yet had the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. This case US2025AMR094554 was reporter by same reporter.; Sender's Comments: US-GSK-US2025AMR094554:Same reporter,different patient
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| 2851695 | 07/29/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B); This...
the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B); This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 2 doses on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Twinrix. The patient had incomplete course of vaccination (Verbatim: the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B)). 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: 21-JUL-2025 The pharmacist reported that the patient was given the first two doses of Twinrix but the third dose was only the Hepatitis B vaccine (not the A and B). The Hepatitis B vaccine that was administered was Dynavax and the drug name the Heplisav. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine (Hepatis A antigen), which led to incomplete course of vaccination.
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| 2851696 | 14 | F | MO | 07/29/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Extra dose administered
Extra dose administered
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inadvertently given menveo 1 year apart and once at 13 and once at 14 years old; This non-serious ca...
inadvertently given menveo 1 year apart and once at 13 and once at 14 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a child female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (received 1st dose at age of 13 years old). On 23-JUL-2025, the patient received the 2nd dose of Menveo (intramuscular) .5 ml. On 23-JUL-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: inadvertently given menveo 1 year apart and once at 13 and once at 14 years old). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 The reporter reported that they have inadvertently given Menveo 1 year apart which was once at 13 and once at 14 years old, which led to extra dose administered. The reporter asked was there any side effects or problems that they should know about, and she will still need another at 16 years, correct
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| 2851697 | 07/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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was not able to get 2nd shot in 6 months due to pandemic recently got the second dose; This non-seri...
was not able to get 2nd shot in 6 months due to pandemic recently got the second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in MAR-2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: was not able to get 2nd shot in 6 months due to pandemic recently got the second dose). The outcome of the social problem was not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. Patient got first Shingrix vaccine in March 2020 but was not able to get 2nd shot in 6 months due to pandemic. Patient got the 2nd Shingrix vaccine, but it has been 5 years since 1st one. Patient wanted to know if they need to get 3rd vaccine.
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