| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842748 | 11 | M | VA | 05/27/2025 |
HPV9 HPV9 MNQ MNQ |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
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Immunoglobulin therapy, Insomnia, Lumbar puncture, Magnetic resonance imaging, M...
Immunoglobulin therapy, Insomnia, Lumbar puncture, Magnetic resonance imaging, Meningoencephalitis viral; Movement disorder, Psychotic disorder, Seizure, Sleep study, Speech disorder; Immunoglobulin therapy, Insomnia, Lumbar puncture, Magnetic resonance imaging, Meningoencephalitis viral; Movement disorder, Psychotic disorder, Seizure, Sleep study, Speech disorder
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Day after Vaccines, had seizure. IVIG and steroids administered following week. Experience psychosis...
Day after Vaccines, had seizure. IVIG and steroids administered following week. Experience psychosis with insomnia. Viral meningoencephalitis but cause still unknown to date. Months later beginning 2/2025 developed movement disorder and speech impediment.
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โ | โ | โ | |||
| 2842749 | 11 | M | IN | 05/27/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8124AB 8274AA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Received an email notification from patient's father stating that the school reported that the ...
Received an email notification from patient's father stating that the school reported that the above vaccinations were due. Immunizations given to patient. No side effects were noted after the vaccination. After patient left, I recorded the vaccination information and noticed that these vaccinations were given in a different facility on 2/14/25. My collaborative physician was notified; patient's father was notified. No adverse side effects noted.
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| 2842750 | 63 | F | FL | 05/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Eosinophil count increased, Joint swelling, Night sweats, Oedema peripheral, Pai...
Eosinophil count increased, Joint swelling, Night sweats, Oedema peripheral, Pain; Pain in extremity, Paraesthesia, Peripheral swelling, Rheumatoid arthritis, Skin discolouration
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Within two weeks fingers would swell after a couple hours of sleep - would go away in morning. Prog...
Within two weeks fingers would swell after a couple hours of sleep - would go away in morning. Progressed to completely swollen at all times. Fingers turned purple/red. Bottom of feet and lower legs throbbing/tingling/painful. Night sweats. Weird colors in lower legs. Edema Back of hands purplelish Eosiphinals were tripled. After about 4-6 month eosiphinals returned to normal and bumps came up on lower wrist followed by joint swelling in hands and feet
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| 2842751 | 11 | M | IN | 05/27/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8124AB U8274AA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Received an email notification from patient's father stating that the school is requiring patie...
Received an email notification from patient's father stating that the school is requiring patient to have the above vaccinations. Patient came to the office with grandparents. Vaccinations given. Patient tolerated well. Patient had no adverse events. Patient left. Documentation completed. Once information was entered, I identified that patient had received the same immunizations on 2/14/25 at another facility. Father, was notified via email and phone conversation.
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| 2842752 | 30 | F | RI | 05/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y015180 |
Injection site pain
Injection site pain
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Patient came in stating her arm is still sore to the tough in that area.
Patient came in stating her arm is still sore to the tough in that area.
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| 2842753 | 49 | M | NY | 05/27/2025 |
FLU3 |
SANOFI PASTEUR |
|
Anaphylactic reaction
Anaphylactic reaction
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Anaphylaxis
Anaphylaxis
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โ | โ | ||||
| 2842754 | 57 | F | GA | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
EP7534 |
Endocrine pancreatic disorder, Faecal elastase test
Endocrine pancreatic disorder, Faecal elastase test
|
Exocrine pancreatic insufficiency
Exocrine pancreatic insufficiency
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โ | |||||
| 2842755 | 67 | F | VT | 05/27/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3046731 3046731 |
Headache, Hyperhidrosis, Mobility decreased, Nausea, Pain; Pyrexia
Headache, Hyperhidrosis, Mobility decreased, Nausea, Pain; Pyrexia
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Patient sent mychart message " I have been ill for 2 days with severe headache, pains and diffi...
Patient sent mychart message " I have been ill for 2 days with severe headache, pains and difficulty getting up. I had a fever of over 102 and nausea. It?s the 23rd of May and I?m still sweating through my shirts."
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| 2842757 | 31 | F | GA | 05/27/2025 |
HPV9 |
MERCK & CO. INC. |
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Arthralgia, Emotional distress, Mobility decreased, Pain in extremity, Sleep dis...
Arthralgia, Emotional distress, Mobility decreased, Pain in extremity, Sleep disorder
More
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I had terrible shoulder and arm pain for over two weeks and still, ongoing. I could not move my arms...
I had terrible shoulder and arm pain for over two weeks and still, ongoing. I could not move my arms and experienced difficulty sleeping and mental stress due to the horrible pain.
More
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| 2842758 | 66 | M | GA | 05/27/2025 |
COVID19 PNC20 |
PFIZER\BIONTECH PFIZER\WYETH |
LM2214 LC5485 |
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
|
PT STATED THAT HE LOST RANGE OF MOTION AND WAS IN A LOT OF PAIN IN HIS RIGHT ARM. HE STATED THAT HE ...
PT STATED THAT HE LOST RANGE OF MOTION AND WAS IN A LOT OF PAIN IN HIS RIGHT ARM. HE STATED THAT HE DID NOT SEE THE DOCTOR ABOUT THIS PROBLEM.
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| 2842760 | 20 | F | ID | 05/27/2025 |
HEP |
MERCK & CO. INC. |
Y009551 |
No adverse event
No adverse event
|
No adverse event reported
No adverse event reported
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| 2842761 | 87 | F | IL | 05/27/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9L944 9L944 |
Arthralgia, Culture negative, Cyst, Incisional drainage, Injection site discolou...
Arthralgia, Culture negative, Cyst, Incisional drainage, Injection site discolouration; Injection site pain, Product administered at inappropriate site, Suture insertion
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05/01/25 Patient received Vaccination in the left arm, witness to the vaccine and patient stated it ...
05/01/25 Patient received Vaccination in the left arm, witness to the vaccine and patient stated it was administered about 1 finger width(approximately 5/8) below the shoulder bone into the left deltoid. Symptoms started 3 hours post administration. Pt experienced severe pain in the left shoulder. Symptoms progressed to pain in the left arm from the shoulder down to the elbow and arm turned blue. 05/01/25 3 hours 45 minutes post vaccine administration pt calls 911 and is transported by ambulance to the emergency room -
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โ | |||||
| 2842762 | 62 | F | ID | 05/27/2025 |
COVID19 |
MODERNA |
304383 |
Diarrhoea, Vomiting
Diarrhoea, Vomiting
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Diarrhea and vomiting. Hydration and rest.
Diarrhea and vomiting. Hydration and rest.
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| 2842763 | 12 | F | OH | 05/27/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Z005469 U8124AB U8232AA |
Disorientation, Pallor, Syncope, Unresponsive to stimuli; Disorientation, Pallor...
Disorientation, Pallor, Syncope, Unresponsive to stimuli; Disorientation, Pallor, Syncope, Unresponsive to stimuli; Disorientation, Pallor, Syncope, Unresponsive to stimuli
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At 10:45am, RN heard thud against documentation desk and mother shout for help from clinic room 3. R...
At 10:45am, RN heard thud against documentation desk and mother shout for help from clinic room 3. RN entered to see client unresponsive and breathing on clinic floor. Ten seconds after RN entered room as RN assessing client, client roused spontaneously. Client disoriented to syncopal event, though alert and oriented. Client recognized mother immediately and responded appropriately to her. Client supported by RN while sitting on clinic floor. Client's skin pale, lips pink, and mucous membranes moist. Client stated being thirsty; water and teddy grahams provided. RN asked client if felt lightheaded or dizzy before event; client denied feeling lightheadedness/dizziness before syncopal episode. Client stated everything "suddenly went black." Asked if client ate breakfast before coming to visit; client denied eating breakfast this morning, which mother was unaware of because mother stated is atypical that client doesn't eat breakfast. Client able to tolerate water and grahams. After sitting on floor for 15 minutes, client stated feeling better; denied lightheadedness/dizziness. However, no change to skin condition. Mother assisted client slowly to standing. Had client stand for two minutes; client denied lightheadedness/dizziness. Client proceeded to slowly ambulate from clinic room 3 with assistance of mother and RN. Client ambulated to outside DON office before RN noticed signs client becoming lightheaded (client looking down at ground and balance wavering). RN had client stop ambulating, asked client if needed to sit down. Client at first denied needing to sit and denied lightheadedness, but then after 30 seconds asked to sit down against the hall wall. After client sitting, client asked for more water; water provided. Mother made arrangements for another adult to meet her at home to assist with watching client. After 15 minutes, no change to skin condition. RN asked client if feeling better. Client stated feeling marginally better and denied lightheadedness, but client does not feel able to ambulate from clinic to private vehicle. RN offered to escort client from clinic to private vehicle via wheelchair. Client and mother agreeable. Client able to stand to sit in wheelchair with minimal assistance and able to get out of wheelchair to private vehicle with minimal assistance. Gave final instructions to mother. Client left premises with mother via private vehicle at 11:23am.
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| 2842764 | 52 | F | WA | 05/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0183 EW0183 |
Fluid retention, Laboratory test, Positive airway pressure therapy, Pulmonary oe...
Fluid retention, Laboratory test, Positive airway pressure therapy, Pulmonary oedema, Respiratory disorder; Weight increased
More
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pt states she started having water retention. She was gaining 10 pounds of water weight every month ...
pt states she started having water retention. She was gaining 10 pounds of water weight every month after getting the second vaccine for nine months straight. She gained a total of 95 pounds. She started seeing an internal med specialist and she was told it was from the vaccine. He is treating her with diuretics and potassium. She only looses a few pounds and it comes right back. She now has respiratory fluid that she is dealing with. She spent a couple of days at hospital for respiratory problems. She is on a C-Pap machine at night and a portable O2 machine. She needed the C-Pap machine prior to the vaccine but not the O2. She was seen by a cardiologist and pulmonologist for her heart and lungs all test were good. These test were performed at Tacoma Kaiser location. She continues treatment with her internal med Dr. She says it has ruined her life.
More
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โ | โ | โ | |||
| 2842765 | 84 | F | OK | 05/27/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Patient indicated she had extreme swelling, redness and pain at the injection site. She does not re...
Patient indicated she had extreme swelling, redness and pain at the injection site. She does not remember that ever happening with an other vaccine in the past. It began fairly quickly and lasted several days, but has gotten better recently (about 7 days later).
More
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| 2842766 | 50 | F | AZ | 05/27/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
EM9E4 |
No adverse event
No adverse event
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Unable to note any adverse events as the error was discovered after client left office.
Unable to note any adverse events as the error was discovered after client left office.
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| 2842767 | 0.58 | M | MA | 05/27/2025 |
COVID19 |
MODERNA |
3043023 |
Expired product administered
Expired product administered
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given vaccine with expiration date 5/19/2025
given vaccine with expiration date 5/19/2025
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| 2842768 | 4 | F | AZ | 05/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y013407 |
Injection site pain, Product administered to patient of inappropriate age
Injection site pain, Product administered to patient of inappropriate age
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A 4-year-old female was inadvertently administered the first dose of the HPV vaccine (Gardasil 9) du...
A 4-year-old female was inadvertently administered the first dose of the HPV vaccine (Gardasil 9) during a routine well-child visit. The error was identified immediately after administration when staff noticed the vaccine was not indicated for the patient age group (approved for ages 9 and older). The patient experienced no adverse effects. She remained alert and active during the post-vaccination observation period, No fever, rash, or behavioral changes were reported by parent. Pt did have arm pain at the injection site which resolved the same day. Dr. called mom on 5/26/26 to check on patient. mom stated patient was doing well with no adverse reaction.
More
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| 2842769 | 54 | F | OH | 05/27/2025 |
PNC20 |
PFIZER\WYETH |
|
Cough, Productive cough
Cough, Productive cough
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Severe coughing with foamy phlegm
Severe coughing with foamy phlegm
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| 2842770 | 72 | F | 05/27/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793PT |
Injection site erythema, Injection site induration, Injection site pruritus, Inj...
Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
More
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Red, swollen injection site, itchy, warm and hard to touch for 3 days after injection
Red, swollen injection site, itchy, warm and hard to touch for 3 days after injection
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| 2842771 | 29 | M | WA | 05/27/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Computerised tomogram heart, Diarrhoea, Echocardiogram, Laboratory test, Myocard...
Computerised tomogram heart, Diarrhoea, Echocardiogram, Laboratory test, Myocarditis; Myopericarditis, Nausea, Pericarditis, Pleuritic pain, Ultrasound Doppler abnormal; Vomiting
More
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Myopericarditis. hospitalization and ambulance transportation to hospital. nausea and vomiting, diar...
Myopericarditis. hospitalization and ambulance transportation to hospital. nausea and vomiting, diarrhea, and pleuritic chest pain. admited for likely pericarditis with mild myocarditis.
More
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| 2842772 | 2 | F | GA | 05/27/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK216AB |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
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Parent brought child in 2 days after the immunization. Her left leg was red, Swollen and painful wi...
Parent brought child in 2 days after the immunization. Her left leg was red, Swollen and painful with no tenderness. Patient with Benedry, Claritin and Clindamycin. Also, she was advised to apply a cool compress to site. On 5/27/25 spoke with mom and she stated that patient is doing well, No longer has swelling, or redness.
More
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| 2842773 | 9 | F | CT | 05/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y007197 |
Urticaria
Urticaria
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Pt took HPV #1 on 5/19. On 5/21 she developed hives to neck and back. Unclear if related to vaccine ...
Pt took HPV #1 on 5/19. On 5/21 she developed hives to neck and back. Unclear if related to vaccine or not. No other new exposures
More
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| 2842774 | 0.17 | M | NC | 05/27/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Crying, Injection site pain, Rash, Screaming, Seizure
Crying, Injection site pain, Rash, Screaming, Seizure
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Crying/screaming for hours at a time for multiple days, generally irritated - didn't want to be...
Crying/screaming for hours at a time for multiple days, generally irritated - didn't want to be held and would cry out if held, leg hurt where injected, skin rashes all over, and had a seizure about a month after the injection.
More
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| 2842775 | 55 | M | CT | 05/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Biopsy skin normal, Dermatitis contact, Dry skin, Haemorrhage, Skin exfoliation;...
Biopsy skin normal, Dermatitis contact, Dry skin, Haemorrhage, Skin exfoliation; Skin fissures; Biopsy skin normal, Dermatitis contact, Dry skin, Haemorrhage, Skin exfoliation; Skin fissures
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2 months post vaccine I began to develop a small patch on my left palm of what I thought was dryness...
2 months post vaccine I began to develop a small patch on my left palm of what I thought was dryness from washing hands with alcohol gel. This continued and red patch developed into dry flaky, cracking and bleeding. This spread to the right palm and exhibited same contact dermatitis as the left. Dr. could not determine what this was so she did a biopsy and it did not come back as virus. Treatment of a steroid was prescribed and had zero affect after 6 months. Next treatment was .1% Tacrolimus Ointment, and have been on this for >6 months. Had little or no affect, so stopped using and now just apply Eucerin to keep the palms from drying out.
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| 2842776 | 72 | F | OH | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Expired product administered
Expired product administered
|
No symptoms or signs at the time of visit. Patient was given an expired covid 19 vaccine.
No symptoms or signs at the time of visit. Patient was given an expired covid 19 vaccine.
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| 2842777 | 64 | F | IL | 05/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8733 ER8733 ER8733 ER8733 |
Arthralgia, Hemiparesis, Inflammation, Injection site pain, Injection site parae...
Arthralgia, Hemiparesis, Inflammation, Injection site pain, Injection site paraesthesia; Injection site swelling, Joint swelling, Magnetic resonance imaging abnormal, Osteoarthritis, Pain; Pain in extremity, Paraesthesia, Peripheral swelling, Rheumatoid arthritis, Rheumatoid factor positive; Ultrasound Doppler, X-ray abnormal
More
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First injection: 04/03/2021 led to pain and soreness in upper left arm. Two days later, swelling an...
First injection: 04/03/2021 led to pain and soreness in upper left arm. Two days later, swelling and tingling in the area. Second injection: 04/25/2025 led to pain in my left hip three weeks later, in May 2025. In June and July 2025, I developed pain and weakness down the left side of my body. In August 2025, I developed pain and tingling in my left foot. By mid-September 2025, I developed heavy swelling and pain in my left knee, all the way down to my heavily swollen left foot. I finally went to the doctor on 10/07/2025. Bloodwork showed I had become serum positive for RA. I then developed swelling and pain in my right knee as well. My body has been messed up ever since I elected to get the covid vaccinations. I wish I had never done so. I also developed osteoarthritis as well. I was in robust health and very active before the injections
More
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โ | |||||
| 2842778 | 18 | F | AZ | 05/27/2025 |
MNQ |
SANOFI PASTEUR |
U7996BB |
No adverse event, Vaccination error
No adverse event, Vaccination error
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Menquadfi (MCV 4) vaccine was administered by mistake. This nurse was unable to note any adverse r...
Menquadfi (MCV 4) vaccine was administered by mistake. This nurse was unable to note any adverse reaction due to patient left office prior to discovery of vaccine error.
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| 2842779 | 85 | F | IA | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F95YS |
Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
More
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Redness, swelling, itching, warmth localized to injection site. Swelling/induration and redness cove...
Redness, swelling, itching, warmth localized to injection site. Swelling/induration and redness covered entirety of left deltoid
More
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| 2842780 | 39 | M | AZ | 05/27/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
92DJ3 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Client received several vaccines on that day and forgot to grab the adult Hep B instead of the pedia...
Client received several vaccines on that day and forgot to grab the adult Hep B instead of the pediatric box. I attempted to contact client once it was discovered; However, his phone line is disconnected.
More
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| 2842781 | 47 | F | NC | 05/27/2025 |
UNK |
UNKNOWN MANUFACTURER |
Moderna |
Brain fog, Fatigue, Fear, Memory impairment
Brain fog, Fatigue, Fear, Memory impairment
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I wrote all of this on the first page under medical issues. It?s quite long?
I wrote all of this on the first page under medical issues. It?s quite long?
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| 2842782 | 67 | M | IN | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Limb mass, Pruritus
Limb mass, Pruritus
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Patient states he has small, tiny, itchy bumps on the tops both of his arms. He states that it is no...
Patient states he has small, tiny, itchy bumps on the tops both of his arms. He states that it is not spreading any further and seems to be resolving
More
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| 2842783 | 0.67 | F | ND | 05/27/2025 |
MMR |
MERCK & CO. INC. |
|
Conjunctivitis, Ear infection, Rash, Uveitis
Conjunctivitis, Ear infection, Rash, Uveitis
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Child developed bilateral uveitis and conjunctivitis, requiring antibiotic eye drops. Child also dev...
Child developed bilateral uveitis and conjunctivitis, requiring antibiotic eye drops. Child also developed full body rash, ear infection requiring amoxicillin.
More
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| 2842785 | 21 | M | CA | 05/27/2025 |
TDAP |
SANOFI PASTEUR |
U8564AA |
Erythema, Pruritus
Erythema, Pruritus
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The person who received the vaccine experienced redness on their bilateral arms and back as well as ...
The person who received the vaccine experienced redness on their bilateral arms and back as well as itchiness.
More
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| 2842786 | 86 | F | MA | 05/27/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Chills, Cough, Decreased appetite, Fatigue, Headache; Hyperhidrosis, Oropharynge...
Chills, Cough, Decreased appetite, Fatigue, Headache; Hyperhidrosis, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Somnolence
More
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Patient had Booster #6 had extremely sore arm, extremely tired, sleepy, sweating, headache for 4 da...
Patient had Booster #6 had extremely sore arm, extremely tired, sleepy, sweating, headache for 4 days, chills for 2 days, sore throat, runny nose, not much of an appetite and mild cough
More
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| 2842787 | 62 | F | OH | 05/27/2025 |
MMR PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y015995 y011819 |
Injection site erythema, Injection site induration, Injection site pain; Injecti...
Injection site erythema, Injection site induration, Injection site pain; Injection site erythema, Injection site induration, Injection site pain
More
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pt complains of experiencing soreness at injection site for >7 days, says initially the area was ...
pt complains of experiencing soreness at injection site for >7 days, says initially the area was red, sore and sort of hard, that has resolved, but is still sore, recommended the patient monitor for a few more days since she states it is getting better, also may use pain reliever of choice and ice may help
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| 2842788 | 62 | F | WA | 05/27/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Injection site induration, Injection site mass, Injection site pruritus
Injection site induration, Injection site mass, Injection site pruritus
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Patient presented at clinic for triage of allergic reaction on 5/27/2025. HISTORY: - Patient repo...
Patient presented at clinic for triage of allergic reaction on 5/27/2025. HISTORY: - Patient reported she received the pneumococcal vaccine on Thursday 5/22/2025, which she believes is the cause of her allergic reaction. - On Saturday night, she developed severe itching on her left arm where the vaccine was administered. Her left arm also became hard, turned red, and developed bumps which were suspected to be hives. - Patient reported severe itching has persisted since Saturday night. She is unable to wear long sleeve shirts due to this. She took expired Benadryl this morning and has been applying Gold Bond anti-itch lotion which did not help. ASSESSMENT: - Left arm visualized. Moderate erythema > 3 inches visualized. No swelling, hives, open wounds, or warmth. Patient denied fevers, chills, shortness of breath, chest pain, nausea, vomiting. NEXT STEPS: Given allergic reaction, consulted with provider of day. She advised patient to stop taking Benadryl due to potential for drowsiness and instead take cetirizine (Zyrtec) twice daily (once in the morning, once at night) and apply hydrocortisone ointment or cream twice daily (once in the morning, once at night). Patient was also advised to return to the clinic if symptoms worsen despite recommended home treatment with OTC medications. Patient confirmed understanding and agreed to plan, no further questions or concerns at this time.
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| 2842837 | 48 | F | KS | 05/27/2025 |
MMR |
MERCK & CO. INC. |
Y018702 |
Exposure via skin contact, No adverse event, Syringe issue, Underdose
Exposure via skin contact, No adverse event, Syringe issue, Underdose
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No other information provided. No additional AEs reported; Caller reported dose of MMR II leaked out...
No other information provided. No additional AEs reported; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; This spontaneous report was received from a Pharmacist and refers to a(n) 48-year-old female patient. The patient's medical history, concurrent condition, concomitant therapies were not reported. On 22-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y018702, expiration date reported 11-NOV-2026, but upon internal validation established as 26-Apr-2026), with sterile diluent (MERCK STERILE DILUENT) (lot #2031274, expiration date: 10-Dec-2026) for prophylaxis. During administration, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) leaked out onto the patient's arm. The reporter states he thinks he did not secure the needle tightly to the PFS (not fully secured by the administered Registered Pharmacist) (Incorrect dose administered; Product preparation error; Exposure via skin contact; Device leakage). No adverse event. The patient was told to return 28 days after event to re-vaccinate.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02793444-02793443 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZANKIYA5|02052025230031|5173 , Central date : 2025-05-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2279609 , MNSC case number : 02793444 , MNSC interaction number : 02793443 , Integration log UniqueID : 500UW00000ZANKIYA5|02052025230031|5173 , Service cloud CaseID : 500UW00000ZANKIYA5
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| 2842839 | 13 | CO | 05/27/2025 |
MMRV |
MERCK & CO. INC. |
Y013579 |
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; HCP calling to report PROQUAD administered to a 13-year-old patient on 04/18/2025....
no additional AE; HCP calling to report PROQUAD administered to a 13-year-old patient on 04/18/2025. Confirmed no symptoms. Unable to collect expiration date for PROQUAD. No other information presented at the moment. No additional AE/PQC.; This spontaneous report was received from a medical Assistant and refers to a(n) 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013579, expiration date: 03-Feb-2026) administered by Unknown route for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), administered by Unknown route (indication, expiration date, and lot # were not reported) (Product administered to patient of inappropriate age). No adverse event was reported.
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| 2842841 | PA | 05/27/2025 |
HEPA |
MERCK & CO. INC. |
Y015027 |
Underdose
Underdose
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Caller did not report an symptoms/No AE/PQC reported.; Specialist transferred pharmacist reporting a...
Caller did not report an symptoms/No AE/PQC reported.; Specialist transferred pharmacist reporting an adult patient received a pediatric dose of VAQTA. Caller did not report an symptoms. Permission to contact HCP was granted. No additional information provided. No AE/PQC reported.; This spontaneous report was received from a pharmacist and refers to an adult 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 12-May-2025, the was vaccinated with pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #Y015027, expiration date: 06-Feb-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (vaccine underdose). Caller did not report any symptoms (no adverse event).
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| 2842842 | F | FL | 05/27/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
N009800 |
Antibody test negative; Antibody test negative
Antibody test negative; Antibody test negative
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"non-responsive" to MMR-II; patient's MMR titers showed no immunity to measles, mumps...
"non-responsive" to MMR-II; patient's MMR titers showed no immunity to measles, mumps, and rubella; patient received 3 doses of MMR-II in a year; This spontaneous report was received from a medical student and refers to a(n) female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2019, the patient was vaccinated with 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (inappropriate schedule of product administration), (lot #N009800, expiration date: 24-Mar-2019), administered by Unknown route for Prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). In April 2025 (Reported as "about a month ago"), the patient's MMR titers showed no immunity to measles, mumps and rubella, the patient was non-responsive to the vaccine At the reporting time, the outcome of the events was unknown. Causality assessment was not provided.
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| 2842843 | M | FL | 05/27/2025 |
MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
N009800 N009800 N009800 |
Inappropriate schedule of product administration, Therapy non-responder; Inappro...
Inappropriate schedule of product administration, Therapy non-responder; Inappropriate schedule of product administration, Therapy non-responder; Inappropriate schedule of product administration, Therapy non-responder
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HCP called to report a husband and a wife who were "non-responsive" to MMR-II. See AE case...
HCP called to report a husband and a wife who were "non-responsive" to MMR-II. See AE case #02805024 for documentation of the wife and this AE case #02805008 is for documentation of the husband. Patient received 3 doses of MMR-II in the year 2018.; patient's MMR titers showed no immunity to measles, mumps, and rubella; Patient received 3 doses of MMR-II in the year 2018; This spontaneous report was received from a medical student and refers to a 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. In an unspecified date in 2018, the patient was vaccinated with the first, second, and third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #N009800, expiration date: 24-Mar-2019)for prophylaxis, diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Inappropriate schedule of product administration). In an unspecified date in April 2025 (also reported as about a month ago), patient's MMR titers showed no immunity to measles, mumps, and rubella. Reporter stated the patient was "non-responsive" to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. This is one of two reports from the same reporter.
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| 2842844 | 11 | NY | 05/27/2025 |
HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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no adverse event; HCP called to report that a 11 yr old patient received an extra 2nd dose of GARDAS...
no adverse event; HCP called to report that a 11 yr old patient received an extra 2nd dose of GARDASIL 9, 18 days after the actual 2nd dose had been administered. First dose of GARDASIL 9 was administered in January 2024, with the 2nd dose being administered on May 1; HCP called to report that a 11 yr old patient received an extra 2nd dose of GARDASIL 9, 18 days after the actual 2nd dose had been administered. First dose of GARDASIL 9 was administered in January 2024, with the 2nd dose being administered on May 1; This spontaneous report was received from a Physician and refers to a 11-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 Jan-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, 0.5 mL (lot # and expiration date were not reported). On 01-May-2025, the patient received a second dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported) which was a delayed 2nd dose not administered according to the schedule in the PI (inappropriate schedule of vaccine administered). On 19-May-2025, the patient received a third dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL (lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). No adverse event was reported.
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| 2842845 | PA | 05/27/2025 |
DTPPVHBHPB HEP |
MSP VACCINE COMPANY MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No symptomatic adverse events were reported; patient inadvertently received RECOMBIVAX HB and VAXELI...
No symptomatic adverse events were reported; patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day; This spontaneous report was received from a Licensed 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 20-May-2025, the patient inadvertently vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),, dose number 1, (lot # and expiration date were not reported) and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus(VAXELIS), dose number 1, (lot # and expiration date were not reported) (accidental overdose). No adverse event was reported.; Reporter's Comments:
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| 2842846 | 13 | VA | 05/27/2025 |
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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no additional AE; HCP called and reported inadvertent administration of a first dose of PROQUAD to a...
no additional AE; HCP called and reported inadvertent administration of a first dose of PROQUAD to a 13-year-old patient on 23MAY2025. Patient demographics not provided. No additional information was known by reporter at time of call. No additional AE/PQC.; This spontaneous report was received from a Physician and refers to a 13-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 23-MAY-2025, at the age of 13 years old, the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose number 1, (dose, strength, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age) together with sterile diluent (no details provided). No additional adverse event was reported (no adverse event). Lot # is being requested and will be submitted if received.
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| 2842847 | 05/27/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Bell's palsy, Ear pain, Facial pain, Facial paralysis, Feeling abnormal; He...
Bell's palsy, Ear pain, Facial pain, Facial paralysis, Feeling abnormal; Herpes zoster, Pyrexia, Vaccination failure
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Bell-palsy; I thought I went through a stoke; Suspected vaccination failure; shingles included, the ...
Bell-palsy; I thought I went through a stoke; Suspected vaccination failure; shingles included, the only thing I needed was to have the clusters; That weird feeling of the shingles; Fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In MAR-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell-palsy) (serious criteria GSK medically significant), stroke (Verbatim: I thought I went through a stoke) (serious criteria GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles included, the only thing I needed was to have the clusters), weird feeling (Verbatim: That weird feeling of the shingles) and fever (Verbatim: Fever). The outcome of the bell's palsy, stroke, vaccination failure, shingles, weird feeling and fever were not reported. The reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the reporter considered the stroke, vaccination failure, shingles, weird feeling and fever to be related to Shingles vaccine. The company considered the bell's palsy, stroke and vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, weird feeling and fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 The case was received from the patient via interactive digital media. The reporter had taken the shingles vaccine. The reporter thought he/she went through a stoke. His/her right side of face dropped completely, my eye closed, the pain throughout my right side of my face, and behind my ear it was so painful. The reporter thought the stroke took place behind the ear. That weird feeling of the shingles included, the only thing he/she needed was to have the clusters, oh also with fever. The reporter reported, never again would take a vaccine. His/her mouth went to the left side of face. The reporter reported that you need 2 vaccines to get protected for 7 years, he/she was protected for 31/2 years. It was called Bell-palsy from the shingles vaccine. This symptoms can last upto 8 months. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Cerebrovascular accident and Bell's palsy is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2842848 | M | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain
Injection site pain
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feel some injection site pain that resolved in a couple days; This non-serious case was reported by ...
feel some injection site pain that resolved in a couple days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: feel some injection site pain that resolved in a couple days). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 21-MAY-2025 Patient was the reporter and stated that he received the first Shingrix vaccine in February of 2025, unknown arm. Patient felt some injection site pain that resolved in a couple days. For tolerance of 2nd dose please refer linked case.
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| 2842849 | F | NJ | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash pruritic, Skin discharge
Rash pruritic, Skin discharge
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Rash fluid discharge itchy; Rash fluid discharge itchy; This non-serious case was reported by a othe...
Rash fluid discharge itchy; Rash fluid discharge itchy; This non-serious case was reported by a other health professional and described the occurrence of pustular rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension and blood cholesterol abnormal. On 09-MAY-2025, the patient received Shingrix (intramuscular) .5 ml. On 09-MAY-2025, less than a day after receiving Shingrix, the patient experienced pustular rash (Verbatim: Rash fluid discharge itchy) and itchy rash (Verbatim: Rash fluid discharge itchy). The outcome of the pustular rash and itchy rash were not resolved. It was unknown if the reporter considered the pustular rash and itchy rash to be related to Shingrix. It was unknown if the company considered the pustular rash and itchy rash to be related to Shingrix. Additional Information: GSK receipt date: 23-MAY-2025 The patient was gardening as well rash fluid discharge itchy. No additional information was reported.
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| 2842850 | F | ND | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pyrexia
Pyrexia
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Ongoing fevers; This non-serious case was reported by a pharmacist via sales rep and described the o...
Ongoing fevers; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Ongoing fevers). The outcome of the fever was resolved. It was unknown if the reporter considered the fever to be related to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 23-MAY-2025 The pharmacist reported that ongoing fevers in the evening for two weeks following the second dose of Shingrix. The pharmacist reported that this was from a woman in her late 50s/early 60s. The fever was only in the evenings and lasted for a few weeks before dissipating.
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