| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2832551 | 39 | F | IN | 03/21/2025 |
HPV9 |
MERCK & CO. INC. |
y014059 |
Lymphadenopathy, Mass
Lymphadenopathy, Mass
|
Lump in left arm with lymphadenopathy on same side starting on day of injection, worsening until tod...
Lump in left arm with lymphadenopathy on same side starting on day of injection, worsening until today 3/21. Will treat moving forward with medrol dose pack and if needed antibiotics if infection suspected after steroids.
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| 2832552 | 75 | F | GA | 03/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration, Injection site reaction
Inappropriate schedule of product administration, Injection site reaction
|
Patient was contacted by the pharmacy to inform her that her second dose was sooner than the recomm...
Patient was contacted by the pharmacy to inform her that her second dose was sooner than the recommendation by the CDC. She was informed that because of an early dose, she is more likely to experience side effects or adverse events. At this time, patient stated that she did experience side effects that she didn?t have on dose one. She stated that she developed a rash on her arm. It was larger than just at the injection site. She stated that it did not hurt or itch and so she did not seek medical attention. It resolved within a couple of days on its own.
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| 2832553 | 11 | F | KY | 03/21/2025 |
HEPA |
MERCK & CO. INC. |
X021563 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient had received first dose 9/13/24 therefore the 2nd dose was given 5 days too soon. No signs/s...
Patient had received first dose 9/13/24 therefore the 2nd dose was given 5 days too soon. No signs/symptoms of any adverse affects post vaccination administration
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| 2832554 | 4 | F | KS | 03/21/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Vaccination site erythema, Vaccination site swelling
Vaccination site erythema, Vaccination site swelling
|
Large area of erythema and small amount of swelling localized around the vaccine site starting 1 day...
Large area of erythema and small amount of swelling localized around the vaccine site starting 1 day after vaccination.
More
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| 2832555 | 31 | F | CA | 03/21/2025 |
VARCEL |
MERCK & CO. INC. |
YO1 3073 |
Contraindication to vaccination, No adverse event
Contraindication to vaccination, No adverse event
|
Applicant has history of LUpus and reveived Varicella vaccine. No adverse reactions noted at this ti...
Applicant has history of LUpus and reveived Varicella vaccine. No adverse reactions noted at this time. Instructed to monitor for next 21 days. Instructed to notify primary care provider and work clinic of any adverse reactions. ie.e fever,rash.
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| 2832556 | 66 | M | GA | 03/21/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8524DA 52F7M |
Asthenia, Neuromyelitis optica spectrum disorder; Asthenia, Neuromyelitis optica...
Asthenia, Neuromyelitis optica spectrum disorder; Asthenia, Neuromyelitis optica spectrum disorder
More
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Patient has Neuromyelitis Optica Spectrum Disorder that is well managed at this time and at the time...
Patient has Neuromyelitis Optica Spectrum Disorder that is well managed at this time and at the time of vaccine. Patient states that he soon started experiencing weakness in both legs and had 2 serious falls r/t the weakness. Patient states that he spoke with his neurologist at that time and has a follow-up appointment in 1 week. Patient states that he returned to baseline after 2 weeks.
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| 2832557 | 8 | M | SC | 03/21/2025 |
COVID19 FLU3 HEPA IPV TDAP |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
3042999 391439 T5727 W1C831M 3RE73 |
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; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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First MMR 9/22/2023 Second MMR 11/9/2023 Third MMR 3/18/25 - dose given inadvertently. No adverse re...
First MMR 9/22/2023 Second MMR 11/9/2023 Third MMR 3/18/25 - dose given inadvertently. No adverse reaction noted.
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| 2832558 | 64 | M | FL | 03/21/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered, Pain in extremity
Extra dose administered, Pain in extremity
|
Patient received an additional dose of Prevnar 20. His initial dose was 9/7/2023 and pharmacist on d...
Patient received an additional dose of Prevnar 20. His initial dose was 9/7/2023 and pharmacist on duty provided additional dose on 3/20/2025 not meeting timeline CDC guidelines. Patient states his arm is sore from injection but no other symptoms.
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| 2832559 | 66 | F | TN | 03/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Extra dose administered, Pain in extremity
Extra dose administered, Pain in extremity
|
Patient received additional dose of Boostrix on 3/20/2025, previous dose was on 5/15/2024. CDC guide...
Patient received additional dose of Boostrix on 3/20/2025, previous dose was on 5/15/2024. CDC guidelines not met of 8-10 year apart from 1st dose. Patient arm was sore but no other symptoms.
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| 2832561 | 1.83 | F | ID | 03/21/2025 |
MMRV |
MERCK & CO. INC. |
Y015357 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No adverse effect at this time. Patient was younger than recommended age.
No adverse effect at this time. Patient was younger than recommended age.
|
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| 2832563 | F | TN | 03/21/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
BH57H |
Injection site pruritus, Injection site rash, Injection site swelling
Injection site pruritus, Injection site rash, Injection site swelling
|
RASH AND SWELLING TO INJECTION SITE, ITCHY. GAVE ORAL BENADRYL AND SENT RX FOR BENADRYL ONITMENT
RASH AND SWELLING TO INJECTION SITE, ITCHY. GAVE ORAL BENADRYL AND SENT RX FOR BENADRYL ONITMENT
|
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| 2832564 | 13 | M | FL | 03/21/2025 |
HEPA HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
DN273 Y014510 |
Dizziness, Pallor; Dizziness, Pallor
Dizziness, Pallor; Dizziness, Pallor
|
Pt here today for immunizations. Pt received havrix and gardasil. After vaccines were administered p...
Pt here today for immunizations. Pt received havrix and gardasil. After vaccines were administered pt began to turn pale and reported dizziness and this medical assistant helped pt into a supine position to avoid a fall and or injury. As soon as pt was laid down pt immediately reported feeling better and regained color in his face. After providing verbal reassurance pt was instructed to remain lying down and vitals were as followed: 114/64 BP, 86 HR, 18 RR, 98% O2. After 30 minutes pt was A&O x 4 and reported feeling better and expressed wanting to go home. Pt was then discharged.
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| 2832565 | 29 | F | CA | 03/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
2A755 |
Rash
Rash
|
Patient developed a rash. Provider verified it was a reaction to the vaccine.
Patient developed a rash. Provider verified it was a reaction to the vaccine.
|
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| 2832566 | 44 | M | WA | 03/21/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
044B21A 044B21A 044B21A 044B21A 044B21A 044B21A 044B21A 044B21A 044B21A 006C21A 006C21A 006C21A 006C21A 006C21A 006C21A 006C21A 006C21A 006C21A |
Aldolase, Arthralgia, Autoimmune disorder, Blood calcium, Blood creatine phospho...
Aldolase, Arthralgia, Autoimmune disorder, Blood calcium, Blood creatine phosphokinase; Blood magnesium, Blood phosphorus, Blood test, Bone densitometry, C-reactive protein; Chest X-ray, Chest pain, Computerised tomogram heart, Differential white blood cell count, Echocardiogram; Electrocardiogram, Exercise tolerance decreased, Eye haemorrhage, Fibrin D dimer, Full blood count; Glycosylated haemoglobin, Immunoassay, Impaired work ability, Injection site pain, Lipids; Loss of consciousness, Loss of personal independence in daily activities, Low density lipoprotein, Magnetic resonance imaging spinal, Magnetic resonance imaging thoracic; Mast cell activation syndrome, Metabolic function test, Muscle spasms, Muscle twitching, Myalgia; Petechiae, Platelet count, Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Scan myocardial perfusion; Scan with contrast, Serum ferritin, Spinal X-ray, Thrombosis; Aldolase, Arthralgia, Autoimmune disorder, Blood calcium, Blood creatine phosphokinase; Blood magnesium, Blood phosphorus, Blood test, Bone densitometry, C-reactive protein; Chest X-ray, Chest pain, Computerised tomogram heart, Differential white blood cell count, Echocardiogram; Electrocardiogram, Exercise tolerance decreased, Eye haemorrhage, Fibrin D dimer, Full blood count; Glycosylated haemoglobin, Immunoassay, Impaired work ability, Injection site pain, Lipids; Loss of consciousness, Loss of personal independence in daily activities, Low density lipoprotein, Magnetic resonance imaging spinal, Magnetic resonance imaging thoracic; Mast cell activation syndrome, Metabolic function test, Muscle spasms, Muscle twitching, Myalgia; Petechiae, Platelet count, Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Scan myocardial perfusion; Scan with contrast, Serum ferritin, Spinal X-ray, Thrombosis
More
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The week following both vaccinations, I had an extremely sore arm/shoulder at the injection site. O...
The week following both vaccinations, I had an extremely sore arm/shoulder at the injection site. Once my arm soreness subsided, I did not have any noticeable serious health issues until July 6th of 2022. On that date, following swimming at the gym, I developed severe chest pain that lasted about 10 to 15 minutes. This symptom re-occurred several times during physical activity. I went to urgent care following my third chest pain incident. Nothing was found at that time, but I was referred to a cardiologist. The cardiologist gave me a clean bill of health and advised I go back to full exercise. I continued to have chest pain with exercise and limited my activity significantly. In October 2022, I was walking slowly on a treadmill and had a bout of severe case of chest pain, muscle spasms all around my torso, passed out, had petechiae in my face and a burst vessel in my eye. I consulted with my primary care doctor, who had no idea what was happening and referred me to a sports medicine doctor. The sports medicine doctor did not find anything wrong with me to explain my symptoms, neither did a neurosurgery doctor. My symptoms continued to worsen with escalating muscle twitching, soreness, spasms, and occasional chest pain (from physical activity). The muscle twitching and soreness did not correlate to any known physical activity. I was beginning to have a hard time working, sitting in a chair, and doing the most basic of everyday tasks. I met with a vaccine injury and long-COVID care clinic doctor and after several visits and tests was advised I very likely have a vaccine injury. I have been diagnosed with autoimmune disease, including MCAS, and widespread fibrin micro-blood clotting. My symptoms have improved over the past two years with the help of many therapies/protocols, including continued medication, supplementation, and life-style changes, but my twitching and muscle soreness continues to be a constant struggle with more acute flare-ups periodically.
More
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โ | |||||
| 2832567 | 68 | F | FL | 03/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
wcf3021 |
Dyspnoea, Hypotension
Dyspnoea, Hypotension
|
Resident was given epinephrine x 1 dose IM .and place on oxygen due to shortness of breath. Resident...
Resident was given epinephrine x 1 dose IM .and place on oxygen due to shortness of breath. Resident had symptoms of SOB, and low BP.
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| 2832568 | 15 | F | MD | 03/21/2025 |
MMR |
MERCK & CO. INC. |
Y003499 |
Hyperhidrosis, Pallor, Syncope, Tinnitus
Hyperhidrosis, Pallor, Syncope, Tinnitus
|
Patient experienced diaphoresis, syncope, and pallor. Patient complains of head ringing. Pt had syn...
Patient experienced diaphoresis, syncope, and pallor. Patient complains of head ringing. Pt had syncopal episode lasting about 2 minutes. Client feet elevated and provided water once alert and oriented to person, place, time, and situation. Client admits to fasting prior to vaccine administration. Patient's mother requested ambulance to be made aware, EMS called arrived on scene about 5-8 mins after call. Upon EMS arrival patient alert and oriented to person, place, time and situation, VS and FS obtained by EMS. Patient's mother declined hospital transport, signed with EMS. Client ambulated from clinic alert and oriented to person, place, time and situation with steady gait.
More
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| 2832569 | 23 | M | TX | 03/21/2025 |
TDAP |
SANOFI PASTEUR |
u8122aa |
Syncope
Syncope
|
Fainted---monitored, gave water, offered medical attention---patient refused medical attention, sai...
Fainted---monitored, gave water, offered medical attention---patient refused medical attention, said he felt better and left with the person he arrived with.
More
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| 2832570 | 73 | M | NJ | 03/21/2025 |
CHIK HEPA IPV TDAP TYP |
VALNEVA USA, INC. MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
24B011 Y017625 Y1A201M U8352AA W1A991M |
Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration; Angiog...
Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration; Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration; Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration; Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration; Angiogram, Concussion, Diarrhoea, Loss of consciousness, Skin laceration
More
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This client was seen at facility on Fri 2/7. He elected to receive Ixchiq, Hep A #1, Typhoid Vi, TDA...
This client was seen at facility on Fri 2/7. He elected to receive Ixchiq, Hep A #1, Typhoid Vi, TDAP and polio on that day. He was fine over the weekend. Took his normal morning walk on Monday morning. Monday evening, he had laid down on the couch. When he went to get up, he passed out. He tried to get up again and passed out and hit his head on a lamp which broke glass and cut his forehead. He crawled into bed and went to sleep. He was in and out of it on Tuesday, feeling "concussed" with diarrhea. His family caught up with him on Wednesday and took him to the ER.
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| 2832571 | 76 | F | FL | 03/21/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient did not have an adverse reaction. She just received a second dose of Prevnar 20 when she had...
Patient did not have an adverse reaction. She just received a second dose of Prevnar 20 when she had already received a dose two years ago.
More
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| 2832572 | 66 | F | PA | 03/21/2025 |
COVID19 |
MODERNA |
3043823 |
Expired product administered
Expired product administered
|
Administration error. Vaccine was 3 days past expiration date
Administration error. Vaccine was 3 days past expiration date
|
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| 2832573 | 18 | F | MI | 03/21/2025 |
COVID19 |
MODERNA |
B0005 |
Expired product administered
Expired product administered
|
The use by date was 3/13/25. The patient was given the vaccine on 3/17/25.
The use by date was 3/13/25. The patient was given the vaccine on 3/17/25.
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| 2832574 | 59 | M | MN | 03/21/2025 |
PNC20 |
PFIZER\WYETH |
HN5978 |
Back pain, Gait disturbance, Hypoaesthesia, Hypoaesthesia oral
Back pain, Gait disturbance, Hypoaesthesia, Hypoaesthesia oral
|
8/2/24 started to notice numbness of lower extremities, gradually worsened spreading upward, because...
8/2/24 started to notice numbness of lower extremities, gradually worsened spreading upward, because unable to ambulate easily and was having low back pain, numbness continued to spread to involve the upper extremities and down around the lips.
More
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โ | |||||
| 2832575 | 29 | F | VA | 03/21/2025 |
FLU3 |
SANOFI PASTEUR |
ut8514ka |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Member given extra dose of flu shot. Member given flu shot outside of facility on 2/05/25 and given ...
Member given extra dose of flu shot. Member given flu shot outside of facility on 2/05/25 and given again today in our office 3/21/25. No adverse reactions noted.
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| 2832576 | 9 | F | KY | 03/21/2025 |
HEPA |
MERCK & CO. INC. |
X021563 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient was given the vaccine 5 days too early, no signs or symptoms or any adverse affects noted
Patient was given the vaccine 5 days too early, no signs or symptoms or any adverse affects noted
|
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| 2832577 | 8 | M | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
lm2045 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Gave this vaccine after the Beyond use date by accident. No adverse event reported
Gave this vaccine after the Beyond use date by accident. No adverse event reported
|
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| 2832578 | 6 | F | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
UT8496MA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED.
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED.
|
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| 2832579 | 10 | M | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
NO ADVERSE EVENT. EXPIRED VACCINE GIVEN
NO ADVERSE EVENT. EXPIRED VACCINE GIVEN
|
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| 2832580 | 7 | M | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
LM20458 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED
|
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| 2832581 | 11 | M | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
UT8408KA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
NO ADVERSE EVENT. EXPIRED VACCINE GIVEN
NO ADVERSE EVENT. EXPIRED VACCINE GIVEN
|
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| 2832582 | 10 | F | UT | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED
NO ADVERSE EVENT. EXPIRED VACCINE ADMINISTERED
|
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| 2832583 | 17 | M | PA | 03/21/2025 |
MENB |
PFIZER\WYETH |
LF5302 |
Urticaria
Urticaria
|
Urticaria/Hives-diffuse. Treated with diphenhydramine, Cetirizine. Prednisone
Urticaria/Hives-diffuse. Treated with diphenhydramine, Cetirizine. Prednisone
|
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| 2832584 | 45 | F | 03/21/2025 |
IPV |
SANOFI PASTEUR |
X1C891M |
Wrong product administered
Wrong product administered
|
Polio received instead of MMR
Polio received instead of MMR
|
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| 2832585 | 70 | F | TX | 03/21/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Body temperature increased, Breath sounds abnormal, Cough, Dyspnoea, Oedema peri...
Body temperature increased, Breath sounds abnormal, Cough, Dyspnoea, Oedema peripheral; Painful respiration, Skin discolouration
More
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I got the shot and then a day later my shoulder swelled. 2-3 days later i got a black and blue mark...
I got the shot and then a day later my shoulder swelled. 2-3 days later i got a black and blue mark it was painful but im on blood thinners so i didnt think much of it . 2 weeks ago i got a cough but its pollen season but then i started having issues breathing and a temp at night every night. And so i have an appointment next tues but i had so much trouble breathing i went yesterday they check my oxygen level i was at 91, they listened to my lungs and they heard no air flow at the bottom of my lungs but the top wasn't doing well either, They put me on oxygen for 20 mins and it went up to 94%, they put me on two meds. I still feel like today i cant get a full breath, everything hurts in the lung area but i have only had 2 pills so far.
More
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| 2832586 | 3 | F | NJ | 03/21/2025 |
HEPA |
MERCK & CO. INC. |
Y008338 |
Extra dose administered
Extra dose administered
|
Patient was given third dose of Hepatitis A in error. Provider believed pt needed her second dose, b...
Patient was given third dose of Hepatitis A in error. Provider believed pt needed her second dose, but she had already received two doses on 04-07-2023 and 10-23-2023. Dose given on 3/20/25 was extra dose. Pt is doing well
More
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| 2832587 | 59 | M | PA | 03/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
Unknown |
Urticaria
Urticaria
|
The first SHINGRIX vaccine was administered 10/23/2024. I did not notice any changes. A few days aft...
The first SHINGRIX vaccine was administered 10/23/2024. I did not notice any changes. A few days after 12/27/2024 SHINGRIX vaccine I noticed hives in areas I don't normally get hives. The were presented on thighs and ankles. I read this is not uncommon. It was on 1/17/2025 that I noticed I had NOT gotten any of my usual dermatographia hives since the second dose. On 1/20/2025 I saw my first dermatographia hive in the usual places. I still see hives on occasion but only about once ever 2 weeks. This is a decrease from the multiple times a week prior to the SHINGRIX vaccine. I made note in doctor site portal but did not visit medical staff.
More
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| 2832588 | 59 | F | WY | 03/21/2025 |
MMR |
MERCK & CO. INC. |
Y010372 |
Flushing, Skin warm, Throat irritation
Flushing, Skin warm, Throat irritation
|
Advised patient to report to the emergency room for moderate facial flushing, hot ears and scratchy ...
Advised patient to report to the emergency room for moderate facial flushing, hot ears and scratchy throat.
More
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| 2832589 | 11 | M | AR | 03/21/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
7gf79 CX4H2 |
Mass, Rash, Swelling; Mass, Rash, Swelling
Mass, Rash, Swelling; Mass, Rash, Swelling
|
Received TdaP and menveo one day prior to onset. Localized swelling, mass and lump, unspecified.. I...
Received TdaP and menveo one day prior to onset. Localized swelling, mass and lump, unspecified.. It began yesterday. It is of moderate intensity. This is the first episode. The typical duration of an episode is the majority of the day. There are no obvious aggravating factors. Nothing relieves the symptoms. Associated symptoms include rash. He denies abdominal pain, arthralgias, chest pain, chills, constipation, cough, diarrhea, dysuria, fever, headache, hematuria, jaundice, melena, myalgias, nausea, palpitations, paresthesias, red bloody stools, sore throat, sweats, tachycardia, vomiting or weight loss.
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| 2832590 | 7 | F | IL | 03/21/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9pt2f |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
patient is 7 and was mistakenly given Dtap instead of Tdap
patient is 7 and was mistakenly given Dtap instead of Tdap
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| 2832591 | 54 | M | KS | 03/21/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Fatigue, Lymphadenopathy, Pain in extremity
Fatigue, Lymphadenopathy, Pain in extremity
|
Patient had a sore arm the next day but noticed the swollen lymph nodes 2 days after receiving the v...
Patient had a sore arm the next day but noticed the swollen lymph nodes 2 days after receiving the vaccine. He has also been fatigued.
More
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| 2832592 | 1 | F | WA | 03/21/2025 |
HIBV |
SANOFI PASTEUR |
UK111AA |
Extra dose administered
Extra dose administered
|
Combo vaccine Vaxelis administered as well which contains HIB. Additional HIB vaccine given at the s...
Combo vaccine Vaxelis administered as well which contains HIB. Additional HIB vaccine given at the same time.
More
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| 2832603 | 1 | GA | 03/21/2025 |
VARCEL |
MERCK & CO. INC. |
Y015101 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/...
HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; Information has been received from Business Partner/CRO on 19-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) 12-month-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 19-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection (lot #Y015101, expiration date: 06-Sep-2026), dose number 1, (1st dose),. On 19-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), Solution for injection (1st dose), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of prophylaxis. On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.. On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.. At the reporting time, the outcome of HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. and HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. was unknown. The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
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| 2832606 | F | VA | 03/21/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Influenza like illness, Injection site erythema, Injection site pain, Injection ...
Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a l...
HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; Patient also complained of flu like symptoms; This spontaneous report has been received from a pharmacist regarding a 78-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), as a single dose, administered intramuscularly in the left deltoid as immunization (lot number reported as Y013009, which has been verified as valid, expiration date reported and validated as 17-NOV-2025) (strength, dose, and vaccination scheme were not reported). On 08-MAR-2025, the patient developed a large area of redness and warmth around the injection site (Vaccination site erythema, Vaccination site warmth). The reporter stated there was minimal swelling and mild tenderness (Vaccination site swelling, Vaccination site pain). On an unknown date in March 2025, patient also complained of flu like symptoms (Influenza-like illness). The outcome of all events was not reported. The causal relationship between the aforementioned events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
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| 2832607 | WI | 03/21/2025 |
HPV9 |
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 to report that a 74-year-old patient was administered a dose of GARDASI...
No additional AE; HCP called to report that a 74-year-old patient was administered a dose of GARDASIL 9; This spontaneous report was received from a Pharmacist regarding a 74-year-old patient of unknown gender. The reporter refused to provide information about the patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (formulation, dose, vaccination scheme frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported) (Product administered to patient of inappropriate age). No additional adverse event reported for the patient (it was also reported it was unknown if side effects or symptoms were reported, conflicting information). No additional information provided.
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| 2832608 | ID | 03/21/2025 |
VARCEL |
MERCK & CO. INC. |
Y013350 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/No PQC.; HCP calling reporting that a patient has received an improperly stored VAR...
No additional AE/No PQC.; HCP calling reporting that a patient has received an improperly stored VARIVAX. Reference TE case #02773596. HCP reported that the VARIVAX underwent a TE on 03/13/2025. HCP reported that the date of the administration was 03/17/2025. No symptoms or; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-MAR-2025, the patient received improperly stored varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection, lot #Y013350 and expiration date 02-AUG-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown). The excursion lasted for 45 minutes in temperature of 16.1 Fahrenheit degrees. There was previous excursion that lasted 1 hour in temperature of ๏ฟฝ 13.6 Fahrenheit degrees (product storage error). No additional adverse event/ Product Quality Complaints reported (no adverse event).
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| 2832609 | 1 | KS | 03/21/2025 |
MMR |
MERCK & CO. INC. |
W001598 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r...
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 13-month-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 11-JUL-2023 at 10:04, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # W001598, expiration date: 14-JAN-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.
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| 2832610 | 8 | KS | 03/21/2025 |
MMR |
MERCK & CO. INC. |
W001598 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r...
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to an 8-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 06-NOV-2023 at 11:48, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # W001598, expiration date: 14-JAN-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.
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| 2832611 | 1 | KS | 03/21/2025 |
MMR |
MERCK & CO. INC. |
X011441 |
No adverse event, Product storage error
No adverse event, Product storage error
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MMR II was administered after a temperature excursion; No additional AE reported; This spontaneous r...
MMR II was administered after a temperature excursion; No additional AE reported; This spontaneous report was received from a nurse and refers to a 20-months-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 15-JUL-2024, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments:
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| 2832612 | M | CA | 03/21/2025 |
HPV4 HPV4 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Axillary mass; Axillary mass; Axillary mass; Axillary mass
Axillary mass; Axillary mass; Axillary mass; Axillary mass
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the son developed a big lump under the armpit; received the first dose of either GARDASIL or GARDASI...
the son developed a big lump under the armpit; received the first dose of either GARDASIL or GARDASIL 9 as a teenager approximately 10-12 years ago; received the second dose of the vaccine series, never received the third dose in the series.; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On an unknown date (reported as approximately 10-12 years ago), the patient was vaccinated either with the first dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); or with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On an unknown date, the patient was vaccinated either with the second dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); or with the second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On an unspecified date (reported as after received the second dose of the vaccine either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL), the patient experienced big lump under the armpit (axillary mass). It was stated that the patient never received the third dose of the previous mention vaccine either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) (inappropriate schedule of product administration) At the time of the reporting, the outcome of the event of axillary mass was not reported. The causal relationship between the event of axillary mass with the suspect vaccines either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) was not provided.
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| 2832613 | M | 03/21/2025 |
TDAP |
UNKNOWN MANUFACTURER |
UNK |
Autism spectrum disorder
Autism spectrum disorder
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now he has autism; This serious case was reported by a consumer via call center representative and d...
now he has autism; This serious case was reported by a consumer via call center representative and described the occurrence of autism in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced autism (Verbatim: now he has autism) (serious criteria GSK medically significant). The outcome of the autism was not resolved. It was unknown if the reporter considered the autism to be related to Tdap Vaccine. The company considered the autism to be unrelated to Tdap Vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 The patient's mother reported this case. The patient (son) received Tdap vaccine many years ago and now he had autism.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK Tdap Vaccine.
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| 2832614 | 03/21/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Death
Death
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I would never take a vax again after losing a couple friends within a shot time of receiving the ja...
I would never take a vax again after losing a couple friends within a shot time of receiving the jab; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: I would never take a vax again after losing a couple friends within a shot time of receiving the jab) (serious criteria death and GSK medically significant). The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to RSV vaccine. The company considered the unknown cause of death to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date : 19-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that she looked into what was in them, she would never took a vaccine again after losing a couple friends within a shot time of received the jab.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.; Reported Cause(s) of Death: Unknown cause of death
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