| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829139 | 14 | M | NC | 03/03/2025 |
MMR |
MERCK & CO. INC. |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
We had a 14 yo male patient that was behind on his vaccines establish care with us on 2-24-25. The p...
We had a 14 yo male patient that was behind on his vaccines establish care with us on 2-24-25. The parents signed the consent for this patient to receive 7 vaccines. Once the consent was signed the nurse left the exam room and prepared the vaccines. When she returned to the room with the vaccines the patient became very combative. He screamed, elbowed his dad in the face, smacked his mother in the face, and smacked the nurse's arm away from him with an exposed needle in her hand. The patient's agitation continued to escalate and the nurse instructed the parents to return with the patient at a later date/time and we would try again. We placed all the vaccines in a basket and returned them to the refrigerator. We did not know if the patient would return that afternoon, we also didn't know if he would comply if he did return. In an effort not to waste vaccines we used 2 of the vaccines from the basket on another patient. The patient did return that afternoon and the nurse replaced the vaccines that were removed from the patients basket. Unfortunately one of the vaccines was an additional MMR II vaccine instead of the vaccine that needed to be replaced. The patient was mistakenly given two MMR II vaccines instead of one. The nurse realized the mistake as she was documenting the vaccines in the NCIR. She immediately notified the parents and we monitored the patient in-office for an hour and a half. The nurse educated the parents on what side effects and/or reverse reactions to watch for. The nurse continued to check on the patient throughout that evening, night, and the next day. The patient did not experience any reactions or adverse side effects. He will return in 28 days from 2-24-25 to get the vaccine that he was not given on 2-24-25.
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| 2829140 | 21 | M | 03/03/2025 |
YF |
SANOFI PASTEUR |
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Pruritus, Respiratory distress, Wheezing
Pruritus, Respiratory distress, Wheezing
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At 0750am, patient received yellow fever in his left deltoid and not subcutaneous as indicated. Pati...
At 0750am, patient received yellow fever in his left deltoid and not subcutaneous as indicated. Patient returned to the clinic around 0820 stating that his throat was " itchy and he felt like he wasn't breathing very well". The RN notified the Medical Officer on Duty to evaluate the patient who then took over the care of the patient. His VSS but upon assessment the patient was wheezing, and he was placed on supplemental oxygen and received a breathing treatment. EMS arrived shortly to take the patient to a local hospital to be evaluated further due to his respiratory distress.
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| 2829141 | 10 | M | OK | 03/03/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
1957407 1957407 |
Product storage error; No adverse event, Product storage error; Product storage ...
Product storage error; No adverse event, Product storage error; Product storage error; No adverse event, Product storage error
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MEDICATION OUT OF REFRIGERATOR RANGE FOR A PERIOD OF TIME
MEDICATION OUT OF REFRIGERATOR RANGE FOR A PERIOD OF TIME
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| 2829142 | 13 | M | 03/03/2025 |
HPV9 |
MERCK & CO. INC. |
|
Flushing, Rash, Rash pruritic
Flushing, Rash, Rash pruritic
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flush cheeks, generalized pruritic rash
flush cheeks, generalized pruritic rash
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| 2829143 | 2 | F | CA | 03/03/2025 |
HEPA HEPA HEPA HEPA HEPA HEPA |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y008483 Y008483 Y008483 Y008483 Y008483 Y008483 |
Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood alb...
Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase increased, Blood bicarbonate normal; Blood bilirubin normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood sodium decreased, Blood urea normal, C-reactive protein increased, Demyelinating polyneuropathy; Dysstasia, Gait disturbance, Haematocrit decreased, Haemoglobin normal, Magnetic resonance imaging spinal abnormal; Muscular weakness, Neuralgia, Platelet count normal, Protein total normal, Red blood cell sedimentation rate normal; White blood cell count normal
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Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking an...
Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
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โ | โ | ||||
| 2829144 | 23 | F | 03/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4D333 |
Underdose
Underdose
|
peds dose given to an adult
peds dose given to an adult
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| 2829145 | 4 | F | CA | 03/03/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Injection site pain, Injection site swelling, Injection site warmth
Injection site pain, Injection site swelling, Injection site warmth
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Mother of child reported (via telephone) swelling at the injection site and pain, injection site was...
Mother of child reported (via telephone) swelling at the injection site and pain, injection site was also hot to the touch
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| 2829146 | 46 | M | WA | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
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Dizziness, Electrocardiogram normal, Headache, Palpitations
Dizziness, Electrocardiogram normal, Headache, Palpitations
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Patient received the Prevnar vaccination at 1600, hemodialysis treatment ended at 1601, discharged f...
Patient received the Prevnar vaccination at 1600, hemodialysis treatment ended at 1601, discharged from dialysis clinic post hemostasis, presented to ER at 1839 with complaints of "feeling like heart is racing", headache and lightheadedness. Was treated with Benadryl, tylenol and pain medication. Per hospital EMR, EKG was normal, pt in otherwise in acute distress, was discharged.
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| 2829147 | 77 | M | IN | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Heart rate increased
Heart rate increased
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10 days after my shot, my resting heart rate went from 53 to 64, and now it is up to 73. My heart wa...
10 days after my shot, my resting heart rate went from 53 to 64, and now it is up to 73. My heart was tested coincidentally through an echo and was shown to be healthy on 01/10/2025. My heart rate has been around mid-50s since I take Matzim 240 for my Afib. It has never been in this range, and there were absolutely no other reasons except a reaction to the vaccine. My question is whether it will ever go down to my earlier ones? I always had Moderna and had no side effects of any sort. This time it was Pfizer which seems to have more cardiac side effects than Moderna
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| 2829148 | 54 | F | VA | 03/03/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Cellulitis, Erythema, Pruritus, Skin warm
Cellulitis, Erythema, Pruritus, Skin warm
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Arm is very red and hot to touch. Also itchy. Advised to see MD to determine if cellulitis.
Arm is very red and hot to touch. Also itchy. Advised to see MD to determine if cellulitis.
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| 2829149 | 13 | F | TX | 03/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y003462 |
Injection site pain, Pain, Swelling, Tenderness
Injection site pain, Pain, Swelling, Tenderness
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pt received vaccine and 2 days later noticed quarter swelling and pain. pt also started with pain a...
pt received vaccine and 2 days later noticed quarter swelling and pain. pt also started with pain all along left arm where vaccine was given. pt is able to move arm and use it. Tender to touch along arm. no redness
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| 2829150 | 50 | M | OK | 03/03/2025 |
PNC13 PNC13 |
PFIZER\WYETH PFIZER\WYETH |
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Chills, Extra dose administered, Hyperhidrosis, Pyrexia, Seizure; Tremor
Chills, Extra dose administered, Hyperhidrosis, Pyrexia, Seizure; Tremor
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convulsions/terrible tremors, shakes/convulsions tremors and shaking; alternating hot sweats and chi...
convulsions/terrible tremors, shakes/convulsions tremors and shaking; alternating hot sweats and chills/body sweats with fever; chills; body sweats with fever that would break; turned 50 gave 3rd pcv 13 shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 50-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2009 as dose 3, single (Batch/Lot number: unknown) at the age of 50 years, in arm for immunisation. The patient's relevant medical history included: "emergency splenectomy", start date: 1984 (unspecified if ongoing); "respiratory issues" (not ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, in 2009 (same date) for immunisation. Vaccination history included: Prevnar 13 (DOSE 1), administration date: 1999, when the patient was 40 years old, for Immunization; Prevnar 13 (DOSE 2), administration date: 2004, when the patient was 45 years old, for Immunization; Influenza vaccine (flu shot every year), for Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 2009, outcome "recovered", described as "alternating hot sweats and chills/body sweats with fever"; PYREXIA (non-serious) with onset 2009, outcome "recovered", described as "body sweats with fever that would break"; CHILLS (non-serious) with onset 2009, outcome "recovered"; SEIZURE (medically significant) with onset 2009, outcome "recovered", described as "convulsions/terrible tremors, shakes/convulsions tremors and shaking"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 2009, outcome "unknown", described as "turned 50 gave 3rd pcv 13 shot". Therapeutic measures were not taken as a result of seizure, hyperhidrosis, chills, pyrexia. Clinical course: In 1984, patient had an emergency splenectomy surgeon said would need to get flu and pneumonia shots, because patient did have respiratory issues, in his 30's he would get respiratory issues. When patient turned 40 and started going in for annual physicals and the doctor said we probably need to get a pcv 13 shot. Patient didn't have any respiratory issues beyond that and at his 45 y/o check up, they said the pneumonia shot can have every 5 years and gave patient another pcv 13 shot. Patient had no issues beyond that and when he turned 50 they said the pneumonia shot was up and gave another pcv 13 shot, that night patient had terrible tremors, shakes, convulsions, alternating hot sweats and chills, body sweats with fever that would break, it was a 5 or 6 hour occurrence. Fast forward to the next year, patient was at a health fair through his employment and they had the flu and pneumonia shots and he was visiting with a nurse taking this information, and they had a recap about the 3rd pcv 13 shot and she said, patient were only suppose to have [inaudible] pneumonia shot whole life. She said it could kill patient if I took the 4th, she said patient was only suppose to have two and then since he had side effects from the 3rd shot the 4th could kill patient. Patient asking if he's gonna be at risk or does it have a deadly reaction if he took Prevnar20 Vaccine. He has been 15 years nearly, his PVC would never give him that advise, he has a new PCP and it doesn't get him anywhere. As per caller (patient) he had an emergency where his spleen was removed that is why he needs to take a flu shot every year and pneumonia shots as per his doctor. When he was on his 30s he had some respiratory issues that attributed to his spleen and he took antibiotic about a year. As per caller during the third Prevnar 13 there was reaction that night that cause him to have convulsions tremors and shaking. No investigations. It was in 2009, and he was administered the shot during office hours and the reactions occurred after bedtime so maybe 5-10 hours afterwards 'this' close to duration". Immunizations on the same date with this Pfizer vaccine might be a flu shot. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2829152 | F | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
diagnosed with covid/ended up getting the covid; diagnosed with covid/ended up getting the covid; Th...
diagnosed with covid/ended up getting the covid; diagnosed with covid/ended up getting the covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 17-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Batch/Lot number: unknown) and on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The mother informed that her 17.5 year old daughter had no issues with the first vaccine, didn't believe she has gotten any others after the second dose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid/ended up getting the covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021655658 same patient/product, different events;
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| 2829153 | F | MI | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pain in extremity
Pain in extremity
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arm is still hurting/the pain was unbearable; This is a spontaneous report received from a Consumer ...
arm is still hurting/the pain was unbearable; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose 2, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose 3 booster, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm is still hurting/the pain was unbearable". Additional information: The patient called for the Pfizer covid vaccine which she received on 06Feb2025. She reported that her arm still his still hurting and she wanted to know if this is a normal side effect and if she could do something to get rid of it. The pain was unbearable. She claimed to have taken others, thinks this was her fourth shot and had no problems with the other shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2829154 | 63 | F | MD | 03/03/2025 |
RSV |
PFIZER\WYETH |
LN5490 |
Injection site pain, Injection site warmth, Pruritus
Injection site pain, Injection site warmth, Pruritus
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Itchy; pain/ sore where the injection/still tender and it still feels hot; pain/ sore where the inje...
Itchy; pain/ sore where the injection/still tender and it still feels hot; pain/ sore where the injection/still tender and it still feels hot; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Feb2025 as dose number unknown, single (Lot number: LN5490, Expiration Date: 31Oct2025) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (I have the last two years), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 13Feb2025, outcome "unknown", described as "Itchy"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 13Feb2025, outcome "unknown" and all described as "pain/ sore where the injection/still tender and it still feels hot". Additional information: Patient stated, She just wanted to know if it is normal. she had the Abrysvo RSV vaccines (Captured as: Abrysvo) two weeks ago and where they gave her the shot, it was still tender and it still feels hot and it was very itchy. I just wanted to know if that is normal, It's tender, it's sore where the injection was and it has been two weeks and it feels like a hot spot and it's very itchy on 13Feb2025 and Date of vaccination Abrysvo was on 13Feb2025. For Dose, route of administration and indication for Abrysvo: Patient stated, "The reason they gave it to me is I have asthma and diabetes. On Next day 14Feb2025 Consumer stated, "The itching feels like it is getting worse and the pain and the hotness is the same. No treatment was received. Time of vaccination (Abrysvo): Patient stated, she think it was 2:30 PM EST. and Vaccines did not administered on the same date of the Abrysvo vaccine Previous immunizations with the Pfizer vaccine Patient stated, she have taken your COVID vaccines. When probed for the details such as name, LOT# and expiration date of these COVID vaccines, consumer stated, Well she have the last two years because they do not keep them after that in a computer. They are gone. She do not have the COVID vaccine dates or anything with her, for Reassurance Patient stated Nope.
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| 2829155 | 03/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and ge...
sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". This product wasn't good for us. Any cures from this because I could not be off because of this. And this product was n't good for kids? Correct. We signed up for protection from Covid. Not to be followed and mocked without giving permission On God. I'm sick now because all got me on off What is why all plan with everyone acting out of these Covid protection shots on God. This was the family to go through this. No we were not the family to go through this On God. Why all misread the concept of head of household and breached access into our lives which totally unfair On God. Thing 1 and thing 2 shouldn't even be considered as a thought for any of Us here on earth On God. Aliens shouldn't have power to change my order of life to fit a science study that we waste even prepared for On God. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2829157 | 44 | F | NC | 03/03/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Injection site bruising, Injection site discolouration, Injection site erythema,...
Injection site bruising, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain; Injection site warmth, Swelling
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24 hours after the vaccine, the injection site was very inflamed, red, painful, and hot to the touch...
24 hours after the vaccine, the injection site was very inflamed, red, painful, and hot to the touch. Contacted doctor's office 5 days after vaccination to confirm course of action and was informed to continue treating with ice packs and anti-inflammatory (ibuprofen). After 14 days the swelling was finally reduced, no longer painful, and a bruise/skin discolouration is still visible at the injection site. It is now 39 days post vaccination and I still have a small lump and discolouration at the injection site (not otherwise painful or itchy).
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| 2829158 | 82 | F | MI | 03/03/2025 |
RSV |
PFIZER\WYETH |
LN5463 |
Blood test normal, Dizziness, Fatigue, Gait disturbance, Swelling face
Blood test normal, Dizziness, Fatigue, Gait disturbance, Swelling face
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She presented with complaints of extreme fatigue and swollen blood vessels on temples. Her husband ...
She presented with complaints of extreme fatigue and swollen blood vessels on temples. Her husband said she was walking with a tilt to the left. When I took her blood pressure it was 138/68. I was afraid of possible Guillian Barr muscle weakness/nerve involvement. She went to ER the next day and they told her to do the Epley Maneuver for dizziness she reported there. Her blood pressure at the hospital was 166/? as she reported to me. Her bloodwork was normal, but they saw a heart condition she had been diagnosed with years ago.
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| 2829159 | 11 | F | TX | 03/03/2025 |
MMR |
MERCK & CO. INC. |
X027903 |
Chest discomfort, Drooling, Lip swelling, Nausea
Chest discomfort, Drooling, Lip swelling, Nausea
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Pt received first dose of MMR vaccine, following clearance from specialist. Within 5 minutes of vacc...
Pt received first dose of MMR vaccine, following clearance from specialist. Within 5 minutes of vaccine pt reported lip swelling, chest tightness, nausea, and drooling. Epinephrine was administered 10 minute post vaccine due to progressive symptoms. 911 was called and pt was transports to ER. She received benadryl and an oral steroid in route. Pt was monitored and discharged same day.
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| 2829186 | 65 | M | GA | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
lg5577 |
Extra dose administered
Extra dose administered
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vaccine error, patient already received Prevnar-20 on 5/4/24
vaccine error, patient already received Prevnar-20 on 5/4/24
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| 2829187 | 69 | F | MI | 03/03/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
FF2590 FF2590 227C3 227C3 |
Biopsy artery abnormal, C-reactive protein normal, Eye irritation, Giant cell ar...
Biopsy artery abnormal, C-reactive protein normal, Eye irritation, Giant cell arteritis, Optic neuropathy; Red blood cell sedimentation rate normal, Vision blurred, Visual impairment, Vitreous floaters; Biopsy artery abnormal, C-reactive protein normal, Eye irritation, Giant cell arteritis, Optic neuropathy; Red blood cell sedimentation rate normal, Vision blurred, Visual impairment, Vitreous floaters
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Symptoms of irritation of right eye with floaters and blurred vision on 11/28/22. Was seen by ophth...
Symptoms of irritation of right eye with floaters and blurred vision on 11/28/22. Was seen by ophthalmologist, MD on 11/29/2022 who reported concerns for optic neuropathy and retinal hemorrhage OD. On 12/05/2022 suddenly developed worsening vision of left eye. Was seen by ophthalmologist, MD on 12/06/2022 who confirmed optic neuropathy involving left eye as well as right eye. Was seen by retinal specialist, MD on 12/07/22 who confirmed findings in both eyes. Started on oral prednisone 40mg/day. Was seen by neuro-ophthalmologist, MD at University on 12/09/2022 who confirmed findings and made provisional diagnosis of giant cell arteritis. Admitted to Univ Hospital on 12/09/22 and began IV solu-medrol x 3 days, followed by high dose (60mg/day) oral prednisone on discharge. Giant cell arteritis was confirmed by temporal artery biopsy performed on 12/20/2022. Since Jan 2023 has received monthly infusions of Actemra(tocilizumab) to present day.
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โ | โ | ||||
| 2829188 | 9 | F | AK | 03/03/2025 |
COVID19 |
MODERNA |
3044143 |
Immediate post-injection reaction, Syncope
Immediate post-injection reaction, Syncope
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Pt. fainted directly after injection.
Pt. fainted directly after injection.
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| 2829189 | 82 | F | CA | 03/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4h79y |
Blister, Eye discharge, Headache, Periorbital swelling
Blister, Eye discharge, Headache, Periorbital swelling
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pt came to pharmacy and stated that she called her dr stating she experienced a rite eye discharge...
pt came to pharmacy and stated that she called her dr stating she experienced a rite eye discharge, headache, puffy eyelid with blisters.
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| 2829190 | 85 | F | MN | 03/03/2025 |
PNC20 |
PFIZER\WYETH |
LP8151 |
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
More
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Had normal/uneventful vaccine administered on 2/25/25. Pt called 3/1/25 to ask about her vaccine; sh...
Had normal/uneventful vaccine administered on 2/25/25. Pt called 3/1/25 to ask about her vaccine; she said she took the band-aid off several days later and noticed a lump. She said at first there was redness/swelling/pain at the injection site; but redness/swellling/pain went away and now there is a lump. Pt. reports no fever/systemic side effects occurred. Injection site no longer red/painful. I told her I would call her Monday 3/3/25 to see how she was doing; she understood to go to ER if she developed fever. etc. or if injection site worsened. 3/3/25; pt. reports no other side effects just the lump. At first she said it was 1/2 the size (decreased), but then she said it is the same size. (1/2 of a marble); she reports no pain. She said she pressed on it hard, and there is no pain. We discussed vaccines can cause redness/swelliing at the injection site temporarily, but lumps are not as common/atypical response. I told her it could take some time for it to go away (several weeks?). I told her I would file a report and call her if I needed anymore informaton. She seemed satisfied with the follow-up efforts. She knows to go to the doctor if necessary, but declined on 3/1/25 Saturday, and did not seem interested in being seen on 3/3/25. She reports no history of any problems/side effects with vaccines. I have given her vaccines in the past with no responses like this.
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| 2829191 | 52 | F | WA | 03/03/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Injection site pain, Injection site rash, Neuralgia, Sleep disorder
Injection site pain, Injection site rash, Neuralgia, Sleep disorder
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pain and rash at the injection site, nerve pain like symptom, disrupt sleep. worst at 2 weeks mark, ...
pain and rash at the injection site, nerve pain like symptom, disrupt sleep. worst at 2 weeks mark, get little better overtime but still has significant pain that disrupt sleep. Has not seen by PCP yet even though patient was told to contact PCP asap
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| 2829192 | 61 | F | TX | 03/03/2025 |
MMR |
MERCK & CO. INC. |
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Abdominal pain upper, Fatigue, Musculoskeletal stiffness, Pyrexia
Abdominal pain upper, Fatigue, Musculoskeletal stiffness, Pyrexia
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Stomach cramps, severe neck and back stiffness, low grade fever, fatigue
Stomach cramps, severe neck and back stiffness, low grade fever, fatigue
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| 2829197 | 0.33 | MA | 03/03/2025 |
DTPPVHBHPB PNC20 RV1 |
MSP VACCINE COMPANY PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
U7947AA LG5574 7E942 |
Haematochezia, Occult blood positive; Haematochezia, Occult blood positive; Haem...
Haematochezia, Occult blood positive; Haematochezia, Occult blood positive; Haematochezia, Occult blood positive
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Blood in stool one week later - resolved within one week.
Blood in stool one week later - resolved within one week.
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| 2828946 | 71 | M | TX | 03/02/2025 |
TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness, Headache, Injection site pain; Dizziness, Headache, Injection site pa...
Dizziness, Headache, Injection site pain; Dizziness, Headache, Injection site pain
More
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Pain at injection sites, headache, dizziness
Pain at injection sites, headache, dizziness
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| 2828947 | 73 | F | TX | 03/02/2025 |
UNK |
UNKNOWN MANUFACTURER |
y013009 |
Erythema, Peripheral swelling
Erythema, Peripheral swelling
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patient's arm started swelling and getting red, the spot has only gotten bigger and traveling d...
patient's arm started swelling and getting red, the spot has only gotten bigger and traveling down her arm since 2/24 and is still red on 3/2
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| 2828948 | 61 | M | FL | 03/02/2025 |
FLU3 |
SEQIRUS, INC. |
946583 |
Guillain-Barre syndrome
Guillain-Barre syndrome
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Patient presented to hospital emergency room on Friday, February 14, 2025 and was diagnosed with Gui...
Patient presented to hospital emergency room on Friday, February 14, 2025 and was diagnosed with GuiGuillain Barre Syndrome secondary to the FLu vaccine he had received on January 1, 2025.
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| 2828949 | 7 | M | 03/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chemotherapy, Morphoea
Chemotherapy, Morphoea
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En Coupe de Sabre - looking through pictures, it began in February after the first covid 19 vaccine ...
En Coupe de Sabre - looking through pictures, it began in February after the first covid 19 vaccine was received in January. It got progressively worse, though we didn't notice it nor make the connection to the vaccine until later. He had a second covid 19 vaccine in June. The disease progressed exponentially after that point. Sadly, he was only diagnosed in late 2024, undergoing intensive steroid and chemotherapy treatment (at the age of 10). Despite treatment, the disease continues though there has been improvement. However, there is permanent damage to his face, with a deep gouge vertically through his forehead. Given that En Coup de Sabre is an autoimmune disease (a form of scleroderma), the doctors assume this was triggered by the covid 19 vaccine which has triggered many autoimmune responses.
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| 2828950 | 62 | M | NJ | 03/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Rash
Rash
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Patient states he developed a rash on his ankle.
Patient states he developed a rash on his ankle.
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| 2828951 | 52 | F | CO | 03/02/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMV8043A |
Wrong product administered
Wrong product administered
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wrong vaccine given, should have been MMR
wrong vaccine given, should have been MMR
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| 2828952 | 54 | F | WI | 03/02/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
TFAA2404 Y013009 |
Injection site erythema, Injection site pain; Injection site erythema, Injection...
Injection site erythema, Injection site pain; Injection site erythema, Injection site pain
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Pt's mother called with concern regarding redness,tenderness at injection site on right arm. pt...
Pt's mother called with concern regarding redness,tenderness at injection site on right arm. pt got flu and pneumonia vaccine in same arm on the same day.
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| 2828953 | 68 | F | FL | 03/02/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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Patient received an additional dose of vaccine as she had already received a dose on 11/8/23 and did...
Patient received an additional dose of vaccine as she had already received a dose on 11/8/23 and did not require an additional dose as per cdc recommendations.
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| 2828954 | 64 | F | 03/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Supraventricular tachycardia
Supraventricular tachycardia
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SVT
SVT
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| 2828955 | 67 | M | CA | 03/02/2025 |
COVID19 |
MODERNA |
013M20A |
Injection site pain
Injection site pain
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Deltoid Muscle myalgia -- began after exercise, thought just sore muscle but felt just like post inj...
Deltoid Muscle myalgia -- began after exercise, thought just sore muscle but felt just like post injection site pain. continued from November to present. Aches, muscle feels strained when used and achy.
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| 2828956 | 64 | F | KY | 03/02/2025 |
PNC20 PNC20 VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
lk6650 lk6650 x72d2 x72d2 |
Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Rash, Rash ...
Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Rash, Rash erythematous, Skin warm; Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Rash, Rash erythematous, Skin warm
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Patient reported reaction starting 2/27/25. That day she took her bandaid off from the vaccines and ...
Patient reported reaction starting 2/27/25. That day she took her bandaid off from the vaccines and started having a fever, redness and itchiness in her hair and on her arm. Patient reported to the pharmacy today where there is a visible red rash on her left arm that is swollen and hot to touch. she said the itching in her hair has gotten better, but no visible rash seen. she reports her arm is still painful as well. recommended that patient take some benadryl to help with the itchiness and reaction, tylenol for pain and fever and to ice her arm. i told her if after a few days if it didnt get better or got worse to seek care from her provider.
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| 2828957 | 39 | F | NJ | 03/02/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Menopause; Menopause; Menopause
Menopause; Menopause; Menopause
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4 months after vaccine I stopped getting a period. My doctor ran blood work after 8 months of no per...
4 months after vaccine I stopped getting a period. My doctor ran blood work after 8 months of no period and I was in full menopause. Prior to the vaccine I was getting periods and ovulating normally.
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| 2828958 | 72 | F | GA | 03/02/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
255T2 LL942 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient received a duplicate dose of the vaccine.
Patient received a duplicate dose of the vaccine.
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| 2828959 | 55 | F | VA | 03/02/2025 |
COVID19 |
PFIZER\BIONTECH |
Ew0175 |
Central nervous system lesion, Demyelination, Magnetic resonance imaging head ab...
Central nervous system lesion, Demyelination, Magnetic resonance imaging head abnormal
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Diagnosed with demyelinating disease on the left side of my Brain from the COVID vaccine shot. I hav...
Diagnosed with demyelinating disease on the left side of my Brain from the COVID vaccine shot. I have a lesion on the left side of my Brain which is causing me, health scare.
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| 2828960 | 56 | F | TX | 03/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Dysuria, Urinary incontinence
Dysuria, Urinary incontinence
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extreme burning and urinary incontinence for 12 hours
extreme burning and urinary incontinence for 12 hours
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| 2828961 | 49 | F | CO | 03/02/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
amx8043a |
Wrong product administered
Wrong product administered
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wrong vaccine administered. should have been MMR
wrong vaccine administered. should have been MMR
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| 2828962 | 30 | F | IL | 03/02/2025 |
UNK |
UNKNOWN MANUFACTURER |
324BY |
Dizziness, Loss of consciousness
Dizziness, Loss of consciousness
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Patient passed out after vaccine and was unconscious for about 15-20 seconds. Patient experienced li...
Patient passed out after vaccine and was unconscious for about 15-20 seconds. Patient experienced light headedness prior to that.
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| 2828963 | 56 | F | CO | 03/02/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
8081564 8081564 8081564 |
Carpal tunnel syndrome, Condition aggravated; Chest X-ray, Dysgraphia, Feeding d...
Carpal tunnel syndrome, Condition aggravated; Chest X-ray, Dysgraphia, Feeding disorder, Impaired driving ability, Impaired work ability; Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling; Carpal tunnel syndrome, Condition aggravated; Chest X-ray, Dysgraphia, Feeding disorder, Impaired driving ability, Impaired work ability; Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling
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Patient received a flu and COVID vaccine 1/30/2025. She reported to the pharmacy 2/28/2025 that the...
Patient received a flu and COVID vaccine 1/30/2025. She reported to the pharmacy 2/28/2025 that the COVID vaccine (right arm) may have caused her carpal tunnel to flair up the following day requiring two hospitalizations, a visit to her primary care physician, and a neurology referral. Her provider could not confirm if this incident was related to her vaccination. No issues were experienced in the other arm with her flu vaccination.
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| 2828964 | 55 | F | 03/02/2025 |
PNC21 |
MERCK & CO. INC. |
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Axillary pain, Oedema peripheral
Axillary pain, Oedema peripheral
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Underarm area of arm where vaccine was administered is sore/swollen. No bruising at admin site, pati...
Underarm area of arm where vaccine was administered is sore/swollen. No bruising at admin site, patient noticed the soreness 4 days after administration and has continued for more than 24 hours.
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| 2828965 | 19 | M | HI | 03/02/2025 |
FLU3 HEPAB MMR TDAP VARCEL |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
AW1611A 2553x Y003499 M7445 X010536 |
Syncope; Syncope; Syncope; Syncope; Syncope
Syncope; Syncope; Syncope; Syncope; Syncope
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Vasovagal syncope
Vasovagal syncope
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| 2829013 | 22 | M | GA | 03/02/2025 |
MMR |
MERCK & CO. INC. |
Y008077 |
Dysphagia, Enlarged uvula, Pruritus
Dysphagia, Enlarged uvula, Pruritus
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SWOLLEN EPIGLOTTIS (UVULA) SOMEWHAT DIFFICULTY TALKING AND SWALLOWING. DEEP NERVE ITCHING ON HANDS A...
SWOLLEN EPIGLOTTIS (UVULA) SOMEWHAT DIFFICULTY TALKING AND SWALLOWING. DEEP NERVE ITCHING ON HANDS AND FEETS
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| 2829014 | 67 | F | SC | 03/02/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
u8521da lj5284 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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advise patient to take otc Tylenol and check with her primary care dr and let us know if anything el...
advise patient to take otc Tylenol and check with her primary care dr and let us know if anything else happen
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| 2829015 | 1.42 | M | CA | 03/02/2025 |
COVID19 |
MODERNA |
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Blood immunoglobulin E increased, Urticaria
Blood immunoglobulin E increased, Urticaria
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Immunoglobulin E (IgE) levels is high which suggests a higher potential for allergic reaction. Pt ge...
Immunoglobulin E (IgE) levels is high which suggests a higher potential for allergic reaction. Pt gets hives and breaks out all over his body
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