| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2849682 | 23 | F | TX | 07/14/2025 |
HEP MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
MD9SL Y015022 Y017915 |
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus...
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
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Per patient "On the morning of 07/12/2025, I noticed rednes, swollenes and itchiness on my left...
Per patient "On the morning of 07/12/2025, I noticed rednes, swollenes and itchiness on my left arm. By the afternoon I had a small bump that was turning more red and had become more hard."
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| 2849683 | 5 | F | TN | 07/14/2025 |
MMRV |
MERCK & CO. INC. |
|
Excessive eye blinking
Excessive eye blinking
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After receiving the vaccine we noticed involuntary rapid eye blinking that resembles a facial tic. T...
After receiving the vaccine we noticed involuntary rapid eye blinking that resembles a facial tic. The involuntary blinking has persisted and the child has asked why they continue to involuntarily blink and if there is something wrong.
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| 2849684 | 9 | M | WA | 07/14/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Student intern administered the adult (12+) vaccine to the 9 year old patient. No immediate advers...
Student intern administered the adult (12+) vaccine to the 9 year old patient. No immediate adverse event was noted, patient stayed in store/near pharmacy for 20 minutes following administration. The had received multiple doses of the pediatric Pfizer vaccine previously.
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| 2849685 | 35 | F | OK | 07/14/2025 |
HPV9 |
MERCK & CO. INC. |
|
Fatigue, Headache, Injection site mass, Injection site pain, Pain
Fatigue, Headache, Injection site mass, Injection site pain, Pain
|
Headache, body ache, fatigue, knot at injection site lasting 3+ weeks, pain at injection site lastin...
Headache, body ache, fatigue, knot at injection site lasting 3+ weeks, pain at injection site lasting 6+weeks
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| 2849699 | 76 | F | OH | 07/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
NDC49281-0124-6 NDC49281-0124-6 |
Dysgraphia, Dyspnoea, Headache, Hypoaesthesia, Muscle disorder; Nervous system d...
Dysgraphia, Dyspnoea, Headache, Hypoaesthesia, Muscle disorder; Nervous system disorder, Pain in extremity, Sleep disorder
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Muscles - arms - legs - hands- feet - neck - shoulders low back Nerves - arms - legs - hands feet ne...
Muscles - arms - legs - hands- feet - neck - shoulders low back Nerves - arms - legs - hands feet neck - shoulders low back Left headache - right @ times Fingers complete numb - cant write sometimes (right hand) More trouble breathing/sleeping @ night Started day after flu shot, still having problems today! Problems-fill out this form=pain - hand
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| 2849700 | 12 | F | NY | 07/14/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8369AA U8252AA |
Injection site erythema, Injection site pruritus; Injection site erythema, Injec...
Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus
More
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2 minutes after injection, mother reported that patient complained of itchy and site have flat redne...
2 minutes after injection, mother reported that patient complained of itchy and site have flat redness that was covering the left shoulder where Tdap had been given. She applied ice to the site when they arrived home and after 30 minutes the itchy and redness resolved.
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| 2849520 | 91 | M | GA | 07/13/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
No adverse event
No adverse event
|
A second dose of Prevnar-20 was administered upon patient request. First dose was given in 2023. Pat...
A second dose of Prevnar-20 was administered upon patient request. First dose was given in 2023. Patient experienced no adverse effect from the second vaccination.
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| 2849521 | 50 | F | AR | 07/13/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Dyspnoea, Feeling abnormal, Pain in extremity
Dyspnoea, Feeling abnormal, Pain in extremity
|
Patient called to inform the pharmacy she already received the pneumonia vaccine in November 2024 an...
Patient called to inform the pharmacy she already received the pneumonia vaccine in November 2024 and believed she was having an allergic reaction. She stated her arm was sore, she felt bad, and she was short of breath the evening of 7/12/25. She stated she was taking Benadryl and pain relievers to help with the reaction. Pharmacist explained ibuprofen or Tylenol will help with pain and Benadryl with swelling, but any shortness of breath is a medical emergency and she would need to be seen if she was experiencing that.
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| 2849522 | 23 | F | ME | 07/13/2025 |
ANTH HEP |
EMERGENT BIOSOLUTIONS GLAXOSMITHKLINE BIOLOGICALS |
300216A |
Bell's palsy, Facial paralysis, Malaise; Bell's palsy, Facial paralysi...
Bell's palsy, Facial paralysis, Malaise; Bell's palsy, Facial paralysis, Malaise
More
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At facility for deployment completing Hep B serries and Starting Anthrax serries. Revived vaccines a...
At facility for deployment completing Hep B serries and Starting Anthrax serries. Revived vaccines around 1000. Around 800 PM started to not feel well and noticed facial droop. Diagnosed with bell's palsy that evening.
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| 2849523 | 57 | F | MO | 07/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9n2r2 |
Injection site pain, Injection site pruritus, Injection site rash
Injection site pain, Injection site pruritus, Injection site rash
|
Patient called Sunday (7.13) to report a 4 inch raised rash by the injection site. Patient states it...
Patient called Sunday (7.13) to report a 4 inch raised rash by the injection site. Patient states it is itchy and burns. I counseled patient to use OTC measures for the itching and pain. She had already taken famotidine before calling.
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| 2849524 | 67 | M | 07/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Extra dose administered
Extra dose administered
|
A patient was given a shingrix vaccine but he had already finished the two dose series, in fact this...
A patient was given a shingrix vaccine but he had already finished the two dose series, in fact this was a fourth dose according to database which was checked later when we thought we were giving him a second dose.
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| 2849525 | 22 | F | SC | 07/13/2025 |
TDAP |
SANOFI PASTEUR |
U8231AA |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Reviewed wrong record patient was last given TDap in 12May2021. Patient was not due for booster unti...
Reviewed wrong record patient was last given TDap in 12May2021. Patient was not due for booster until 2031 patient received TDap 4 years after last vaccine.
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| 2849526 | 62 | F | CA | 07/13/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site erythema, Injection site mass, Injection site warmth
Injection site erythema, Injection site mass, Injection site warmth
|
Hard lump about 1 inch in diameter where vaccine administered for 2-3 days. Currently hot to touch ...
Hard lump about 1 inch in diameter where vaccine administered for 2-3 days. Currently hot to touch and redness that seems to be spreading toward elbow. advised to ice, take Benadryl or other antihistamine, and to seek either regular PCP or urgent care.
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| 2849527 | 89 | F | KY | 07/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MD3414 MD3414 |
Computerised tomogram head normal, Computerised tomogram neck normal, Computeris...
Computerised tomogram head normal, Computerised tomogram neck normal, Computerised tomogram thorax normal, Dysphonia, Laryngoscopy abnormal; Vocal cord paralysis
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Hoarseness onset 6/14/25. No response to antibiotic and prednisone.
Hoarseness onset 6/14/25. No response to antibiotic and prednisone.
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✓ | |||||
| 2849528 | 50 | F | NE | 07/13/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5yc8zyb3r2 5eghwx4mh7 |
Arthralgia, Headache, Swelling; Arthralgia, Headache, Swelling
Arthralgia, Headache, Swelling; Arthralgia, Headache, Swelling
|
Swelling, joint pain, headaches
Swelling, joint pain, headaches
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| 2849529 | 74 | F | CO | 07/13/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
Contusion, Discomfort, Pain, Swelling, Tenderness
Contusion, Discomfort, Pain, Swelling, Tenderness
|
patient presented with a baseball size bruise, slight swelling, tenderness, and mild/moderate pain. ...
patient presented with a baseball size bruise, slight swelling, tenderness, and mild/moderate pain. Profound Bruising and patient was in discomfort and wanted to ensure we were aware.
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| 2849530 | 55 | F | CO | 07/13/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Injection site erythema, Injection site reaction, Injection site swelling, Malai...
Injection site erythema, Injection site reaction, Injection site swelling, Malaise
More
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Patient came to the pharmacy to ask what to do with the redness and swelling in her arm. She receive...
Patient came to the pharmacy to ask what to do with the redness and swelling in her arm. She received the Prevnar 20 vaccine on 7/10/25 and felt sick on the 11th and 12th and still has redness and swelling today 7/13. Upon inspection of the right upper arm, the injection site appears red with about 1 inch margins around the injection site. Patient stated she feels 'ok' today, but still has redness and itching on her arm which appears to be worsening.
More
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| 2849531 | 75 | M | NV | 07/13/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
G22GH |
Expired product administered
Expired product administered
|
DISCOVERED VACCINE WAS EXPIRED POST ADMINISTRATION; PATIENT AWARE; WILL CONTACT GSK TO DETERMINE WHE...
DISCOVERED VACCINE WAS EXPIRED POST ADMINISTRATION; PATIENT AWARE; WILL CONTACT GSK TO DETERMINE WHETHER PATIENT NEEDS TO BE RE-VACCINATED
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| 2849554 | 70 | F | FL | 07/13/2025 |
MMR |
MERCK & CO. INC. |
ME6072 |
Eczema, Rash, Rash pruritic
Eczema, Rash, Rash pruritic
|
Eczematous, extremely itchy rash of upper extremities, neck that started on forearms and spread to s...
Eczematous, extremely itchy rash of upper extremities, neck that started on forearms and spread to shoulders, neck starting 7/6/2025. (Primarily sun exposed areas)Seen in urgent care 7/10/2025, dexamethasone 8mg IM injection given with little or no relief. Using OTC 1% cortisone cream, diphenhydramine gel OTC, Loratadine 10mg/d, pepcid 20mg OTC/d. Rash and itching have persisted, although slightly less 7 days later. I'm not sure this was due to the COVID vaccination, but it is the only new thing I can think of recently.
More
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| 2849563 | 67 | F | FL | 07/13/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z002626 FT95N |
Injection site rash; Injection site rash
Injection site rash; Injection site rash
|
Rash below area of injection that occurred 2 days after immunization given.
Rash below area of injection that occurred 2 days after immunization given.
|
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| 2849502 | 5 | M | WA | 07/12/2025 |
MMR |
MERCK & CO. INC. |
Y008591 |
Lethargy, Rash erythematous, Rash papular, Urticaria
Lethargy, Rash erythematous, Rash papular, Urticaria
|
5 days after vaccination my son started getting what looked like hives around his armpits,chest, tum...
5 days after vaccination my son started getting what looked like hives around his armpits,chest, tummy and back of thighs. They were red circles and slightly raised. We gave him Benadryl but that did nothing. The next day it appeared worse and my son started getting lethargic. No fever. By the Thursday day the hives started spreading to his neck and face, both arms, hands, legs on his chest, tummy and back. Daycare did not allow him to go because they were very concerned. The doctor did prescribe antihistamines for our son. They would work initially, but after about 12 hours we would see the hives come back
More
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| 2849503 | 25 | F | LA | 07/12/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
|
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti...
Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth; Urticaria
More
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Cellulitis at injection site (Left Deltoid). Warm, erythematous, painful welp formed within 24 hours...
Cellulitis at injection site (Left Deltoid). Warm, erythematous, painful welp formed within 24 hours of injection. Warmth and erythema spread with poorly defined borders down to antecubital region. Augmentin started. Ongoing treatment.
More
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| 2849504 | 71 | F | MI | 07/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N9K4G |
Injection site bruising, Injection site swelling, Injection site warmth
Injection site bruising, Injection site swelling, Injection site warmth
|
Very swollen area of injection, warm to the touch and she states it feels like a deep bruise. She ha...
Very swollen area of injection, warm to the touch and she states it feels like a deep bruise. She has been using a pain reliever and icing it.
More
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| 2849505 | 65 | F | FL | 07/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
pj353 pj353 |
Back pain, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain; Pain ...
Back pain, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain; Pain in extremity
More
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Patient states she was unable to move her arm for over 3 days and had pain radiating to her back and...
Patient states she was unable to move her arm for over 3 days and had pain radiating to her back and neck. She states now which is 10 days after vaccine administration she is feeling a little better and can lift her arm but her neck is a little stiff and her reach is limited. Patient was counseled to follow up with primary doctor if symptoms worsen and to apply cold compress to arm in addition to using OTC analgesics.
More
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| 2849506 | 77 | M | NC | 07/12/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
H4279 |
Wrong product administered
Wrong product administered
|
Pt requested Twinrix, received Boostrix in error
Pt requested Twinrix, received Boostrix in error
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| 2849507 | 1 | M | NY | 07/12/2025 |
DTPPVHBHPB PNC20 VARCEL |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7788AA MF0416 x026326 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
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Vaxelis administered in error by staff, last dose administered 4/03/2025 - administered too soon - p...
Vaxelis administered in error by staff, last dose administered 4/03/2025 - administered too soon - patient was supposed to only have Varicella/Prevnar at visit and return at later date for additional vaccination. Error made at administration providing incorrect immunization resulting in additional dose to patient. Without further c/o vaccine reaction from patient/mom.
More
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| 2849508 | 31 | F | MD | 07/12/2025 |
TDAP TDAP TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y3Z9P Y3Z9P |
Mobility decreased, Muscular weakness, Pain in extremity, Restless arm syndrome;...
Mobility decreased, Muscular weakness, Pain in extremity, Restless arm syndrome; Arthralgia, Exposure during pregnancy, Injection site pain, Mobility decreased; Mobility decreased, Muscular weakness, Pain in extremity, Restless arm syndrome; Arthralgia, Exposure during pregnancy, Injection site pain, Mobility decreased
More
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Chronic pain in my arm now since I got the shot. Restless arm feeling, loss of strength and loss of...
Chronic pain in my arm now since I got the shot. Restless arm feeling, loss of strength and loss of motion in arm
More
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| 2849509 | 56 | F | FL | 07/12/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
ek225 ek225 |
Contusion, Injection site erythema, Injection site infection, Injection site war...
Contusion, Injection site erythema, Injection site infection, Injection site warmth, Limb discomfort; Pain in extremity
More
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Start heavy arm some pain then 2nd day red on injection site hot on the site the redness got bigger ...
Start heavy arm some pain then 2nd day red on injection site hot on the site the redness got bigger inflammation in the arm achy and hotter. Bruising started 5 days after the injection. Pain in the arm for 2 weeks. The pain still there and bruise is slowly getting better.
More
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| 2849510 | 18 | M | KY | 07/12/2025 |
MNQ |
SANOFI PASTEUR |
u8193aa |
Loss of consciousness
Loss of consciousness
|
pt got vaccine and then after a few minutes he lost consciousnesses. after only a few seconds he reg...
pt got vaccine and then after a few minutes he lost consciousnesses. after only a few seconds he regained consciousnesses and was able to speak and tell me his name. he mentioned he had not eaten at all that day. the pt has lost consciousnesses before at school but never after a vaccine. after several minutes pt was able to walk and was feeling better after a snack
More
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| 2849511 | 25 | F | KY | 07/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Exposure during pregnancy, Neonatal disorder
Exposure during pregnancy, Neonatal disorder
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I was pregnant at time of vaccine and my baby was born with two birth defects. Duane syndrome type 1...
I was pregnant at time of vaccine and my baby was born with two birth defects. Duane syndrome type 1 in her left eye which is incurable. And also webbed toes on both feet.
More
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| 2849512 | 1.17 | F | CT | 07/12/2025 |
VARCEL |
MERCK & CO. INC. |
|
Pyrexia, Rash, Varicella
Pyrexia, Rash, Varicella
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Fever day 8-11, rash started day 11, woke up with full blown chickenpox rash on day 12 on scalp, for...
Fever day 8-11, rash started day 11, woke up with full blown chickenpox rash on day 12 on scalp, forehead, neck, chest, belly and back.
More
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| 2849513 | 80 | F | GA | 07/12/2025 |
RSV |
PFIZER\WYETH |
hy1813 |
Extra dose administered
Extra dose administered
|
Patient received an additional RSV vaccine
Patient received an additional RSV vaccine
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| 2849514 | 89 | F | FL | 07/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3J2S2 |
Injection site pain, Mobility decreased, Pain in extremity
Injection site pain, Mobility decreased, Pain in extremity
|
The patient initially experienced pain at the injection site for the first few days. Subsequently, t...
The patient initially experienced pain at the injection site for the first few days. Subsequently, the pain migrated to the forearm. While the pain at the injection site has subsided, the patient continues to report forearm pain and difficulty grasping objects with her hand.
More
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| 2849515 | 69 | M | SC | 07/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Pain in extremity
Pain in extremity
|
Sore arm, no other side effects, pt received a dose on 10/7/2023. pt was not supposed to receive ano...
Sore arm, no other side effects, pt received a dose on 10/7/2023. pt was not supposed to receive another dose on 7/12/25
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| 2849516 | 86 | M | 07/12/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
|
Peripheral swelling, Skin discharge
Peripheral swelling, Skin discharge
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Patient called and complained that his arm was swollen and it had clear liquid leaking from it
Patient called and complained that his arm was swollen and it had clear liquid leaking from it
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| 2849517 | 22 | F | PA | 07/12/2025 |
COVID19 |
MODERNA |
|
Erythema, Mechanical urticaria, Pruritus, Urticaria
Erythema, Mechanical urticaria, Pruritus, Urticaria
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Hives all over body starting 11 days after the vaccine lasting several days and may last longer. I h...
Hives all over body starting 11 days after the vaccine lasting several days and may last longer. I have been taking Allegera and Benadryl to control it, neither of which are helping. Have developed dermatographism. Hives are extremely itchy and red. Appear all over body, disappearing and reappearing. Have had three prior covid vaccines, none of which caused this.
More
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| 2849518 | 75 | F | CA | 07/12/2025 |
HEP VARZOS |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
946062 2HJ99 |
Injection site pain, Mobility decreased; Injection site pain, Mobility decreased
Injection site pain, Mobility decreased; Injection site pain, Mobility decreased
|
PATIENT IS HAVING PAIN AT THE INJECTION SITE IN LEFT ARM SINCE THE VACCINATION WAS ADMINISTERED. SHE...
PATIENT IS HAVING PAIN AT THE INJECTION SITE IN LEFT ARM SINCE THE VACCINATION WAS ADMINISTERED. SHE COMPLAINS OF LIMITED MOVEMENT IN THAT ARM. SHE DESCRIBE THE PAIN AS IT IS BETWEEN NERVE AND BONE. AND SOMETIMES THE PAIN IS AT THE SCALE OF 10 (ON 1-10 SCALE). SHE ALSO STATES THAT PAIN IS GETTING WORSE AND INJECTION SITE IS PAINFUL TO TOUCH. SHE STATES THAT SHE TAKES IBUPROFEN FOR THE PAIN, BUT IT ONLY HELPS FOR A SHORT DURATION. PATIENT WAS RECOMMENDED TO MAKE APPOINTMENT WITH HER PRESCRIBER. I CALLED AND LEFT MESSAGE WITH HER DOCTOR'S OFFICE AS WELL AND INFORMED ABOUT THE SITUATION. LATER TODAY PATIENT CONFIRMED SHE HAD MADE APPOINTMENT WITH HER DOCTOR TODAY.
More
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| 2849335 | 1 | AL | 07/11/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y020301 Z003766 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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No additional AE reported; FBE stated patient should have received MMR II and VARIVAX; This spontane...
No additional AE reported; FBE stated patient should have received MMR II and VARIVAX; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-Jun-2025, the patient was inadvertently administered with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003766, expiration date: 30-Jan-2027), dose number 1 (anatomical location and administration route were not reported) and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y020301, expiration date: 09-Jun-2026), dose number 1, (anatomical location and administration route were not reported) administered during their wellness visit as prophylaxis. It was stated that the patient should have received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate and solvent for solution for injection (M-M-R II), instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). No side effects were reported.
More
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| 2849336 | F | OK | 07/11/2025 |
PPV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Allergy to vaccine; Allergy to vaccine
Allergy to vaccine; Allergy to vaccine
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allergy to vaccine; This spontaneous report was received from a Physician and refers to a 58-year-ol...
allergy to vaccine; This spontaneous report was received from a Physician and refers to a 58-year-old female patient. 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 was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (25MCG/0.5) (strength, dose, dose number, route, lot #, expiration date and anatomical location were not reported) for Prophylaxis. On an unknown date, the patient experienced allergy to those vaccines. At the reporting time, the outcome of allergy to vaccine was unknown. The reporter considered the event of allergy to vaccine to be related to both vaccines. This is one of two reports received from the same patient (2301380).
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| 2849337 | M | 07/11/2025 |
HPV9 |
MERCK & CO. INC. |
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Syncope
Syncope
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fainted; This spontaneous report was received from a Nurse via company representative and refers to ...
fainted; This spontaneous report was received from a Nurse via company representative and refers to an Adolescent male 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 (recently), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced fainted after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) at the office. At the reporting time, the outcome of fainted was unknown. The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown (They were not certain that it was associated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) and the patient had not eaten that morning). Upon internal review, the event(s) of fainted was determined to be medically significant.
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| 2849338 | 16 | M | GA | 07/11/2025 |
HEP |
MERCK & CO. INC. |
|
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 other AE/No PQC.; HCP called stating that a male 16 year old patient was inadvertently given the ...
No other AE/No PQC.; HCP called stating that a male 16 year old patient was inadvertently given the adult formulation 1mL dose of RECOMBIVAX HB "last week". No further information provided. No other AE/No PQC. 1 mL RECOMBIVAX - last week male 00006-4094-02; This spontaneous report was received from a Physician and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On an unknown date in July 2025 (reported as last week), the patient was inadvertently vaccinated with an adult formulation of Hepatitis B Vaccine (Recombinant) 10MCG/1.0ML Injection, at a dose of 1mL, prefilled syringe, administered as prophylaxis (route of administration, anatomical site of injection, lot number and expiration date were not reported) (Accidental overdose). No additional adverse event was reported for the patient. No further information provided.
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| 2849339 | 28 | M | PA | 07/11/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C. Capv...
No additional AE; the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C. Capvaxive was administered to a patient on 07/03/2025; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 28-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. From 27-JUN-2025 through 09-JUN-2025, a temperature excursion occurred for Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). On 03-JUL-2025, the patient was vaccinated with an improperly stored dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, prefilled syringe, strength: 168 mcg/ml, 0.5 ml, once, administered as prophylaxis (lot number Z002626 has been verified to be valid for Pneumococcal 21-valent Conjugate Vaccine [CAPVAXIVE], expiration date not reported but upon internal validation was established as 04-SEP-2026; anatomical site of injection, route of administration and vaccination scheme frequency were not provided). The reporter stated that the administered vaccine was exposed to a minimum temperature of 0 degree Celsius (C) and a maximum of 9 degree C (Product storage error), but was unable to confirm the exact dates of the excursions and indicated that is unknown if there were any previous excursions. The reporter confirmed the patient did not report any adverse issues or side effects from the administrated dose (No adverse event). This is one of three reports from the same reporter.
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| 2849340 | 12 | M | CA | 07/11/2025 |
MNQ |
SANOFI PASTEUR |
|
Rash
Rash
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he had a rash the next day after the vaccine was administered; Initial information received on 09-Ju...
he had a rash the next day after the vaccine was administered; Initial information received on 09-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to this case US-SA-2025SA194402 This case involves a 18 years old male patient who was administered with Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] and had rash the next day. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date In 2019, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, Solution for injection, Strength:standard (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested corresponding to the one at time of event occurrence On an unknown date In 2019 the patient had a rash the next day after the vaccine was administered (rash) (unknown latency). Reportedly,The patient's mother claims there was a reaction to MENACTRA in 2019, and since then she didn't give the booster. Now, her child's school is requesting the booster shot, is it a contraindication to give MENQUADFI the patient's mother called them 4 days after the vaccine was administered and claimed that he had a rash the next day after injection. He didn't have anaphylaxis, didn't have shortness of breath, and didn't go to the emergency room. Parent gave Benadryl and the rash lasted 4 days after injection. The physician confirmed that it was MENACTRA to which the patient had a reaction Action taken was not applicable. The patient was treated with DIPHENHYDRAMINE (BENADRYL [DIPHENHYDRAMINE]) for Rash. At time of reporting, the outcome was Unknown for the event he had a rash the next day after the vaccine was administered.; Sender's Comments: US-SA-2025SA194402:
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| 2849357 | 35 | F | MA | 07/11/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
Underdose
Underdose
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an adult who received a pediatric dose of Hep B vaccine/ she only had half a dose; an adult who rece...
an adult who received a pediatric dose of Hep B vaccine/ she only had half a dose; an adult who received a pediatric dose of Hep B vaccine/Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 30-JUN-2025, the patient received Engerix B pediatric. On 30-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult who received a pediatric dose of Hep B vaccine/ she only had half a dose) and adult use of a child product (Verbatim: an adult who received a pediatric dose of Hep B vaccine/Unapproved age). The outcome of the underdose and adult use of a child product 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: 30-JUN-2025 Nurse had a patient, an adult who received a pediatric dose of Hep B vaccine, which led to an adult use of a child product and underdose. Nurse questioned what was and what they do because she only had half a dose. Did they have to came her back for a second pediatric dose to equal to 1 ml.
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| 2849358 | 41 | SC | 07/11/2025 |
IPV |
SANOFI PASTEUR |
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No adverse event, Off label use
No adverse event, Off label use
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intentional off label prescription by hcp: imovax is prescribed with off label diagnosis encounter f...
intentional off label prescription by hcp: imovax is prescribed with off label diagnosis encounter for general adult medical examination without abnormal findings with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 41 years old and unknown gender patient who had an intentional off label prescription by HCP (healthcare professional): IPV (VERO) [IMOVAX POLIO] was prescribed with off label diagnosis encounter for general adult medical examination without abnormal findings with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an intentional off label prescription by HCP: 1 ml dose once of IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for diagnosis encounter for general adult medical examination without abnormal findings (Physical examination) with no reported adverse event (off label use) (same day latency). Information on the batch number could not be requested corresponding to the one at time of event occurrence Action taken was not applicable.
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| 2849359 | TN | 07/11/2025 |
YF |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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received a booster dose of YF-vax prior to the 10-year interval., with no reported adverse event; In...
received a booster dose of YF-vax prior to the 10-year interval., with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown gender child patient who received a booster dose of Yellow Fever Vaccine - Us [Yf-Vax] prior to the 10-year interval, with no reported adverse event. This case was linked to US-SA-2025SA194574 The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - US, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site due to upcoming travel requirement (immunization) prior to the 10-year interval, with no reported adverse event (inappropriate schedule of product administration) (latency same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, a family of 5 came in to get YF-vax due to upcoming travel requirements; that the family told the Pharmacy that they had not gotten a YF-vax before; that it was not until after administration the pharmacy was alerted that 2-of the family members had had the vaccine 6-years prior. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA194574:
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| 2849360 | 1.33 | F | CO | 07/11/2025 |
DTAP DTAP HIBV HIBV PNC20 PNC20 UNK UNK |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Pyrexia; Febrile convulsion, Injection site bruising, Injection site erythema; P...
Pyrexia; Febrile convulsion, Injection site bruising, Injection site erythema; Pyrexia; Febrile convulsion, Injection site bruising, Injection site erythema; Pyrexia; Febrile convulsion, Injection site bruising, Injection site erythema; Pyrexia; Febrile convulsion, Injection site bruising, Injection site erythema
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DTAP, HiB, PCV20 given day of reaction. Fever associated self-limited ~2min seizure. Report by ED pr...
DTAP, HiB, PCV20 given day of reaction. Fever associated self-limited ~2min seizure. Report by ED provider, lot number of vaccines unknown. Patient back to baseline.
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| 2849422 | 1 | M | MO | 07/11/2025 |
VARCEL |
MERCK & CO. INC. |
Y015108 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported...
No additional AE; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided. On 27-JUN-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine Live (Oka/Merck) (VARIVAX) , for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, valid lot number Y015108 with an expiration date on 06-SEP-2026) which was reconstituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot number and expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 6.3 degrees Fahrenheit for 16 minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. Follow up information was received from the nurse on 07-JUL-2025 regarding the 12-month-old male patient. The nurse had saw a note here where the parents reported the patient had a reaction to the Band-Aids but nothing else was reported. The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was given in the left thigh. On 27-JUN-2025, the patient was also vaccinated with dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y013130, expiration date 30-JUL-2026) in the right thigh for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same date, the patient also received dose of Hepatitis a vaccine (lot number J4K4X, expiration date 28-DEC-2026) in the left thigh. No vaccines were given in the 4 weeks prior. No illness at time of vaccination. No past medical history. No concomitant medications. No adverse events reported after vaccination.
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| 2849423 | F | 07/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Neuropathy peripheral
Neuropathy peripheral
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permanent neuropathy issues; This serious case was reported by a consumer via interactive digital me...
permanent neuropathy issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced neuropathy (Verbatim: permanent neuropathy issues) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported. The reporter considered the neuropathy to be related to Shingles vaccine. The company considered the neuropathy to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a patient via interactive digital media. The reporter said that probably not as bad as the permanent neuropathy issues his/her daughter have gotten from taking Shingles vaccine. This case is linked with US2025AMR088680, reported by same reporter.; Sender's Comments: A case of Neuropathy peripheral, an unknown time after receiving Shingles vaccine, in a female subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR088680:Same reporter
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| 2849424 | 07/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Neuropathy peripheral
Neuropathy peripheral
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Permanent neuropathy issues many others have gotten from taking it; This serious case was reported b...
Permanent neuropathy issues many others have gotten from taking it; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced neuropathy (Verbatim: Permanent neuropathy issues many others have gotten from taking it) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported. The reporter considered the neuropathy to be related to Shingles vaccine. The company considered the neuropathy to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a patient via interactive digital media. The reporter said that probably not as bad as the permanent neuropathy issues many others have gotten from taking Shingles vaccine. This case is linked with US2025AMR085363, reported by same reporter.; Sender's Comments: A case of Neuropathy peripheral, an unknown time after receiving Shingles vaccine, in a female subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR085363:Same reporter
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