| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2864008 | 65 | F | 10/07/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Syringe issue, Underdose
Syringe issue, Underdose
|
Our pharmacy intern claimed that the patient did not get a full dose because of the device malfunct...
Our pharmacy intern claimed that the patient did not get a full dose because of the device malfunction-either the pre-filled syringe or the needle. The syringe plunger was hard to press and did not reach the end completely. According to MERCK, dose repeat is recommended. The patient is aware of the situation and she is willing to get a repeat dose. No adverse effect was found, per patient.
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| 2864009 | 74 | F | TX | 10/07/2025 |
FLU3 |
SEQIRUS, INC. |
407263 |
Fatigue, Injection site pustule, Pain in extremity
Fatigue, Injection site pustule, Pain in extremity
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Husband called store on 10/7/25 at 12pm stating that wife has several severe symptoms after vaccine ...
Husband called store on 10/7/25 at 12pm stating that wife has several severe symptoms after vaccine 3 days ago. This includes pus coming out of vaccine entrance, resembling a pustule "or small pimple. Also stated her arm was in pain and she was very fatigued. Referred patient to PCP for treatment.
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| 2864011 | 90 | F | ID | 10/07/2025 |
COVID19 FLU3 PNC13 |
PFIZER\BIONTECH SEQIRUS, INC. PFIZER\WYETH |
|
Chills, Pain, Pneumonia, Pyrexia; Chills, Pain, Pneumonia, Pyrexia; Chills, Pain...
Chills, Pain, Pneumonia, Pyrexia; Chills, Pain, Pneumonia, Pyrexia; Chills, Pain, Pneumonia, Pyrexia
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Penumonia, Fever, Chills, Body Aches,
Penumonia, Fever, Chills, Body Aches,
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โ | |||||
| 2864012 | 59 | F | NC | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8848AA |
Pain, Product administered at inappropriate site
Pain, Product administered at inappropriate site
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Vaccine administered high. Soreness and pain
Vaccine administered high. Soreness and pain
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| 2864013 | 66 | M | FL | 10/07/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
00069-2528-10 00069-2528-10 00069-2528-10 |
Arthralgia, Chills, Condition aggravated, Defaecation urgency, Dizziness; Fatigu...
Arthralgia, Chills, Condition aggravated, Defaecation urgency, Dizziness; Fatigue, Head injury, Injection site pain, Joint stiffness, Loss of consciousness; Myalgia, Presyncope, Skin laceration, Sleep disorder
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Within 30 minutes my right deltoid (injection site) was very sore (8 of 10), which is much greater t...
Within 30 minutes my right deltoid (injection site) was very sore (8 of 10), which is much greater than my normal pain factor for vaccine injection sites (3 of 10). From 11 PM (11 hours after the injection) until 2 AM the next day I experienced severe rigors and was unable to sleep until about 7 AM. I woke at 10 AM with severe universal joint stiffness (substantially greater than my baseline OA) and attempted to shower. While in the shower I experienced vasovagal cooling in my abdomenal area and became lightheaded, so sat on a seat in our shower. Some time later (unknown to me) I regained consciousness laying on the floor of the shower with a bump on my left temporal area and cut on my left knee. After laying on the floor for some minutes and regaining strength I had bowel urgency and carefully moved to a commode, resulting in a large loose stool. I went back to bed and slept until 2 PM. The remainder of the day I had severe fatigue and muscle/joint soreness. Today I am recovering fairly well and am at 70% of baseline strength and alertness.
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| 2864014 | 71 | M | IA | 10/07/2025 |
FLU3 |
SEQIRUS, INC. |
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Arthralgia, Radiculopathy
Arthralgia, Radiculopathy
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left shoulder pain and left arm radiculopathy
left shoulder pain and left arm radiculopathy
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| 2864015 | 48 | F | NH | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8836DA |
Incorrect dose administered
Incorrect dose administered
|
High dose was given to patient instead of regular dose influenza.
High dose was given to patient instead of regular dose influenza.
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| 2864017 | 23 | F | MA | 10/07/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
B59DH B59DH |
Anaphylaxis treatment, Dysphonia, Electrocardiogram, Rash, Rash macular; Tachyca...
Anaphylaxis treatment, Dysphonia, Electrocardiogram, Rash, Rash macular; Tachycardia, Throat tightness
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She received flu vaccine and the minutes after developed throat tightness and full body rash. On in...
She received flu vaccine and the minutes after developed throat tightness and full body rash. On initial exam prior to epinephrine she was having noticeable hoarseness and widespread macular rash on face, upper and lower extremities and torso. Exam after epinephrine aside from tachycardia normalized. Hoarseness resolved.
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| 2864019 | 77 | F | VA | 10/07/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Headache, Injection site erythema, Injection site inflammation, Injection site p...
Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus; Injection site swelling, Injection site warmth, Nausea, Pain
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pt says a couple of days after the vaccine she had achiness, headache and felt nauseated. By that ni...
pt says a couple of days after the vaccine she had achiness, headache and felt nauseated. By that night below the injection site above the elbow, she developed a grapefruit size area of inflammation. It was hot to the touch and was very painful. She went to the pharmacy and was told it was not a normal reaction and to use cortisone cream which did not help. By the next day it was very red and itchy. Went back to the pharmacy and was told it needed to be reported. It is now 5 days post vaccine and the arm is still very tender and the swelling has gone down some but it it still red. She feels like it is finally getting better as it is no longer itching.
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| 2864020 | 12 | M | MA | 10/07/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052579 ax4142a |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
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no adverse event had. gave pediatric moderna, as when patient registered for clini they were 11 yea...
no adverse event had. gave pediatric moderna, as when patient registered for clini they were 11 years old. Paper said 11, so pediatric vaccine was given. However, pt DOB was the day before clinic, but registration was made prior to this. At th time of vaccination, pt was 12 years old (1 day of 12 years old) Technically should have received Regular adult formuation
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| 2864021 | 0.08 | F | VA | 10/07/2025 |
DTPPVHBHPB FLU3 PNC20 RV5 |
MSP VACCINE COMPANY SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
2C853C1 UT8770MA MA2488 2142138 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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We accidentally gave patient a Flu Vaccine at her 2 month visit today though it was intended for her...
We accidentally gave patient a Flu Vaccine at her 2 month visit today though it was intended for her mother. She has not shown any side effects. Just want to report this incident as the vaccine was given too early.
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| 2864022 | 71 | F | TX | 10/07/2025 |
PNC21 |
MERCK & CO. INC. |
z006076 |
Injection site erythema, Injection site swelling, Pruritus
Injection site erythema, Injection site swelling, Pruritus
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Patient came in with redness and swelling at the site of injection 6 days after the dose was given. ...
Patient came in with redness and swelling at the site of injection 6 days after the dose was given. She complained of itching and proceeded to go the doctor for further care.
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| 2864023 | 25 | F | OR | 10/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
|
Arrhythmia, Blood test, Dizziness, Dyspnoea, Electrocardiogram; Fatigue, Hyperte...
Arrhythmia, Blood test, Dizziness, Dyspnoea, Electrocardiogram; Fatigue, Hypertension, Injection site pain, Insomnia, Palpitations; Pyrexia, Syncope
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Day of vaccine (10/2): Fever of 101 - 102, soreness at site of vaccine, tiredness but with insomnia....
Day of vaccine (10/2): Fever of 101 - 102, soreness at site of vaccine, tiredness but with insomnia. Day two (10/3): continued fever and soreness - began heart palpitations, shortness of breath, and arrythmia. Day three (10/4): continued heart palpitations, shortness of breath, and arrythmia. Began noticing high blood pressure (taken via an at-home cuff 134/95) and dizziness. Day 4 (Sat, 10/5): symptoms continued and wend to urgent care, I was sent home and told to follow up with another clinician. Day 5 (Sun, 10/6): Symptoms continued and I went to the ED. They noted the arrythmia and I experience a convulsing syncope.
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| 2864024 | 44 | M | NH | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8830DA |
Incorrect dose administered
Incorrect dose administered
|
none
none
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| 2864025 | 54 | F | NH | 10/07/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052586 u8881ca |
Arthralgia, Injection site pain, Pain; Arthralgia, Injection site pain, Pain
Arthralgia, Injection site pain, Pain; Arthralgia, Injection site pain, Pain
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Shoulder pain HPI: 54 yo member presents with CC of left upper arm pain S/P Covid-19 & Flu vacci...
Shoulder pain HPI: 54 yo member presents with CC of left upper arm pain S/P Covid-19 & Flu vaccine administration. She reports she has not had similar symptoms in the past post-vaccination. She reports the pain is not at the injection site, it's below the injection site. She reports tenderness to palpation to her left lower deltoid. History of trauma? Denies, s/p Covid-19 & Flu vaccine Onset: 9/22/25 Location: Left deltoid Duration: 14 days Characterisitics? Achy, pain with lifting arm up, pain to touch Aggravating factors? Left arm abduction Radiating pain? Denies Treatment? NSAIDs Denies fevers, edema, warmth, ecchymosis, body aches, chills.
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| 2864026 | 72 | F | MA | 10/07/2025 |
PNC20 |
PFIZER\WYETH |
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Mobility decreased, Pain, Product administered at inappropriate site
Mobility decreased, Pain, Product administered at inappropriate site
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patient had vaccine at store. she noticed that the injection was given almost at shoulder level. s...
patient had vaccine at store. she noticed that the injection was given almost at shoulder level. she reported that she has had increased pain and now decreased rom on that extremity, no redness, warmth or swelling noted. she has tried otc pain relief and ice and will be seeing an orthopedic next thursday
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| 2864028 | 94 | F | AZ | 10/07/2025 |
COVID19 |
MODERNA |
3052087 |
Rash
Rash
|
PATIENT IS COMPLAING SHE HAD SEVERAL BUMPS ON HER BODY STARTED LATER DAY IN THE EVENING. SAID SLOWL...
PATIENT IS COMPLAING SHE HAD SEVERAL BUMPS ON HER BODY STARTED LATER DAY IN THE EVENING. SAID SLOWLY REDUCE THE SYMPTOPMS
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| 2864029 | 62 | M | AK | 10/07/2025 |
FLU3 |
SEQIRUS, INC. |
|
Arthralgia, Sleep disorder, Wrong technique in product usage process
Arthralgia, Sleep disorder, Wrong technique in product usage process
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pt reported that rph injected the vaccine and left needle inside his arm for more than 20 seconds. T...
pt reported that rph injected the vaccine and left needle inside his arm for more than 20 seconds. The following day pt noticed shoulder wasn't feeling better. Range of motion limited without pain. Sleeping is nearly impossible as pt could not find a comfortable position on account of sore shoulder. Putting pressure on it helps. Pt has not taken any medications for pain. A week out from vaccination, pain is about the same, no worse/better.
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| 2864030 | 67 | F | VA | 10/07/2025 |
COVID19 |
MODERNA |
3052734 |
Urticaria
Urticaria
|
Within 48 hours I had two bumps on my right check and three on my left. These bumps were not hot, i...
Within 48 hours I had two bumps on my right check and three on my left. These bumps were not hot, itchy or sore (like a pimple). They had no visible pus in them nor were they hard. They were just red welps. Each day I continued to have more breakouts and by the following Thursday, October 2nd, my left cheek was 75% covered with these welps and my right check at 50%. I visited Urgent Care on Friday, October 3rd and was prescribed a 6-day dose of Prednisone 20 mg. Within 24 hours, the welps were clearing. Today is day five of prednisone and most of the welps have disappeared on my right check and still some linger on my left cheek.
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| 2864033 | 18 | M | 10/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Wrong patient
No adverse event, Wrong patient
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Vaccine administered to wrong patient. Vaccine not indicated for patient that received the vaccine. ...
Vaccine administered to wrong patient. Vaccine not indicated for patient that received the vaccine. No adverse effects noted. Patient aware and provider notified.
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| 2864034 | 62 | F | AR | 10/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
023M20A 045A21A 939909 |
Condition aggravated, Macular degeneration, Malaise, Vision blurred; Condition a...
Condition aggravated, Macular degeneration, Malaise, Vision blurred; Condition aggravated, Macular degeneration, Malaise, Vision blurred; Condition aggravated, Macular degeneration, Malaise, Vision blurred
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Sick for several days after each injection. Severe worsening of macular degeneration, resulting in ...
Sick for several days after each injection. Severe worsening of macular degeneration, resulting in blurry vision and difficulty communicating with my deaf daughter through sign language, first noticed in next eye exams and continuing to now.
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โ | |||||
| 2864035 | 55 | F | AZ | 10/07/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site swelling, Pyrexia
Injection site erythema, Injection site swelling, Pyrexia
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4 day delayed reaction, erythema swelling to injection site days 5-8 after injection, fevers day 5-9...
4 day delayed reaction, erythema swelling to injection site days 5-8 after injection, fevers day 5-9 after injection
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| 2864037 | 68 | F | 10/07/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Cardiac dysfunction, Fatigue, Lethargy, Malaise, Pain in extremity; Cardiac dysf...
Cardiac dysfunction, Fatigue, Lethargy, Malaise, Pain in extremity; Cardiac dysfunction, Fatigue, Lethargy, Malaise, Pain in extremity
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a couple of tests were done and found out that only 20% of her left bundle was functioning; she didn...
a couple of tests were done and found out that only 20% of her left bundle was functioning; she didn't feel well; lethargic; had pain from both shots in both arms; was very tired; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. The patient's past medical history included Implantable cardioverter defibrillator insertion (ICD implanted in the chest since April of 2023.) in April 2023. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Dose 1, Lot/Batch Number: 026L20A, Expiration Date: 28JUN2021) on 22-Jan-2021, Spikevax NOS (Dose 2, Lot/Batch Number: 013L20A, Expiration Date: 08JUL2021) on 20-Feb-2021, Spikevax NOS (Dose 3 Booster, Lot/Batch Number: 038C21A, Expiration Date: 27OCT2021) on 26-Oct-2021, Spikevax NOS (Dose 4 and Lot/Batch Number: 007M21A) on 02-Apr-2022. Past adverse reactions to the above products included No adverse effect with Spikevax NOS, Spikevax NOS, Spikevax NOS and Spikevax NOS. Concurrent medical conditions included Heart disease, unspecified (over with heart issues). In October 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning) (seriousness criterion medically significant), MALAISE (she didn't feel well), LETHARGY (lethargic), PAIN IN EXTREMITY (had pain from both shots in both arms) and FATIGUE (was very tired). At the time of the report, CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning), MALAISE (she didn't feel well), LETHARGY (lethargic), PAIN IN EXTREMITY (had pain from both shots in both arms) and FATIGUE (was very tired) had resolved with sequelae. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. The patient was asking about further details regarding mNEXSPIKE for 65 years and older with heart issues when receiving the mNEXSPIKE as she just had gotten an ICD implanted in the chest the meaning of which she did not elaborate, but she shared that she had it since Apr-2023. The patient stated that she should be concerned about getting the product as it is a lower dosage but had precautions for seniors with heart issues. She also desired to get it, having booked an appointment at Walgreens. The patient added she was concerned because she had never had this "heart thing" which she added had just happened. The patient verbalized that she had not realized she had a heart issue, but when she thought she had heartburn, a couple of tests were done and found out that only 20% of her left bundle was functioning. She was then on medicine and a life vest, but the condition didn't improve and that was when the cardiologist along with her primary HCP decided that she needed to have the implant but still she feels the same way as before. It was further stated that she was a regular recipient of the COVID-19 vaccines since 2020 except last year because her husband was ill. She added that in Oct-2023, she received both Moderna COVID-19 vaccine with the flu shot on the same day while she was going to a street fair. She recalled that she had not felt well, was very tired, had pain from both shots in both arms, very lethargic and that her arms were killing her. It was reported that the patient was going to her Primary HCP in 2 weeks specifically on 01-Oct-2025 for her annual physical exam. She added that she would have her next dose with Moderna COVID-19 vaccine on a Tuesday afternoon, but it was unknown to her yet if it would be Spikevax or mNEXSPIKE hence her calling Moderna. It was also reported that the patient had not received any other brands of Moderna COVID-19 vaccine. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789734 (E2B Linked Report). This case was linked to MOD-2025-789733 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789734:Reporter's husband case
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| 2864038 | 0.33 | M | FL | 10/07/2025 |
DTAPIPVHIB PNC20 RV5 |
SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
uk329aa MA2523 Z007564 |
Laboratory test normal, Rash; Laboratory test normal, Rash; Laboratory test norm...
Laboratory test normal, Rash; Laboratory test normal, Rash; Laboratory test normal, Rash
More
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Mom noticed rash in evenng 9/18/25 following immunizations. She took patient to ER in 2m 9/19/25 aft...
Mom noticed rash in evenng 9/18/25 following immunizations. She took patient to ER in 2m 9/19/25 after noting rash had spread head to toe. Complete work up done--all labs negative. 9/23/25 Mother called back--she tried Kendamil formula again and patient threw up and broke out in hives.
More
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| 2864039 | 0.42 | F | MI | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817KA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
The patient did not meet the minimum age requirement for this seasonal vaccine. No adverse symptoms ...
The patient did not meet the minimum age requirement for this seasonal vaccine. No adverse symptoms occurred from the vaccination.
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| 2864040 | 17 | M | MA | 10/07/2025 |
FLU3 FLU3 FLU3 MENB MENB MENB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
FH4YR FH4YR FH4YR LW8911 LW8911 LW8911 |
Activated partial thromboplastin time, Arnold-Chiari malformation, Computerised ...
Activated partial thromboplastin time, Arnold-Chiari malformation, Computerised tomogram head abnormal, Crying, Differential white blood cell count; Full blood count, Headache, Impaired driving ability, International normalised ratio, Metabolic function test; Mononucleosis heterophile test, Muscle spasms, Musculoskeletal stiffness, Neutrophil count increased, White blood cell count increased; Activated partial thromboplastin time, Arnold-Chiari malformation, Computerised tomogram head abnormal, Crying, Differential white blood cell count; Full blood count, Headache, Impaired driving ability, International normalised ratio, Metabolic function test; Mononucleosis heterophile test, Muscle spasms, Musculoskeletal stiffness, Neutrophil count increased, White blood cell count increased
More
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Received vaccines at yearly physical around 4:00pm on 10/7/25. While driving home, had sudden onset ...
Received vaccines at yearly physical around 4:00pm on 10/7/25. While driving home, had sudden onset headache, neck stiffness, bilateral cramping in the ankles and knees, and was hysterically crying. He had to pull over and asked Dad to drive. Dad brought him to Urgent Care who recommended the ER. In the ER he had a head CT without contrast which showed a Borderline Chiari malformation. They also did labs which showed elevated white count and neutrophils and is most likely due to an immune system response to the vaccines. They gave him a dose of Tylenol which provided great relief of his headache. He was discharged home in stable condition.
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| 2864041 | 0.33 | M | MN | 10/07/2025 |
COVID19 |
MODERNA |
0353253 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
NO ADVERSE REACTION-- Patient received vaccination prior to 6mo of age
NO ADVERSE REACTION-- Patient received vaccination prior to 6mo of age
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| 2864043 | 60 | M | TX | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
|
Injury associated with device
Injury associated with device
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Needlestick injury to provider of vaccine
Needlestick injury to provider of vaccine
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| 2864044 | 36 | F | WV | 10/07/2025 |
HPV9 |
MERCK & CO. INC. |
meallma.s02823. |
Peripheral swelling, Pruritus
Peripheral swelling, Pruritus
|
raised area on arm and itching
raised area on arm and itching
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| 2864045 | 64 | M | NJ | 10/07/2025 |
COVID19 |
MODERNA |
|
Amnesia, Brain fog, Disorientation
Amnesia, Brain fog, Disorientation
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On 10\3\25 I had a COVID Vaccine (Moderna) at (withheld name) Pharmacy. On 10\4 I was disoriented an...
On 10\3\25 I had a COVID Vaccine (Moderna) at (withheld name) Pharmacy. On 10\4 I was disoriented and had severe memory loss one day after vaccine. I felt in a fog most of the day, but lost a complete period of time when my wife and I were giving a tour of the downstairs of our house to friends. I don't recall it at all. Also during that time, as my wife explained to them about concrete work for a patio we were planning out back I didn't know anything about this even though I had spray painted the outline on the ground and met with 3 contractors previously. In hindsight, we believe the same thing happened in 2020 (?) after the vaccine when I checked myself into the hospital for a heart problem and called my wife to ask her why I was there. I believe my wife brought this to Dr (withheld name attention when they were both in the hospital with me. I believe these incidents were possibly from autoimmune encephalitis. A Rare Adverse Effect of the COVID-19 Vaccine on Autoimmune Encephalitis (withheld)
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| 2864048 | 48 | F | CA | 10/07/2025 |
PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. |
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Cardiac ablation, Dizziness, Electrocardiogram ambulatory abnormal, Heart rate i...
Cardiac ablation, Dizziness, Electrocardiogram ambulatory abnormal, Heart rate irregular, Intensive care; Ventricular tachycardia
More
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I began feeling faint while working out in the yard. Initially, I thought I was over heated or neede...
I began feeling faint while working out in the yard. Initially, I thought I was over heated or needed to eat or drink. It got progressively worse and I began feeling faint frequently. I waited a long time to go to the doctor because I thought it was an issue that would correct itself but eventually, I could tell that my heart wasn't beating properly. I went to the clinic in September of 2017, they put a Holter Monitor on me and when it was analyzed by the clinic, I was called and told to come to the hospital immediately and not to drive myself. I spent 4 days in ICU at hospital before being transferred to another hospital where I spent another 3 days. I was given Magnesium intravenously, which seemed to help but I was discharged with a Metoprolol prescription which helped to regulate my irregular heartbeat for a few months. The plan was to have a heart ablation procedure to correct the my irregular heartbeat. I had the heart ablation done January 22, 2018 in the basement of the hospital and it corrected the ventricular tachycardia. I was discharged the next day.
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โ | |||||
| 2864049 | 8 | M | TX | 10/07/2025 |
COVID19 |
MODERNA |
8146367 |
Incorrect dose administered
Incorrect dose administered
|
Patient was erroneously administered .5mL dose indicated for ages 12+
Patient was erroneously administered .5mL dose indicated for ages 12+
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| 2864051 | 67 | F | CA | 10/07/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407266 2006889 |
Erythema, Pain, Skin warm, Swelling; Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling; Erythema, Pain, Skin warm, Swelling
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The day after the shot she had an an area that was red and bump 2-5 inchs with pain of 5 and heat.
The day after the shot she had an an area that was red and bump 2-5 inchs with pain of 5 and heat.
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| 2864053 | 8 | F | TX | 10/07/2025 |
COVID19 |
MODERNA |
8146367 |
Incorrect dose administered
Incorrect dose administered
|
Erroneously administered .5mL dose indicated for ages 12+
Erroneously administered .5mL dose indicated for ages 12+
|
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| 2864055 | 0.33 | F | MD | 10/07/2025 |
PNC20 |
PFIZER\WYETH |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
There were no adverse effects
There were no adverse effects
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| 2864057 | 37 | F | CA | 10/07/2025 |
FLU3 HEP |
GLAXOSMITHKLINE BIOLOGICALS DYNAVAX TECHNOLOGIES CORPORATION |
9JC49 946910 |
Dyspnoea, Malaise, Pruritus, Urticaria; Dyspnoea, Malaise, Pruritus, Urticaria
Dyspnoea, Malaise, Pruritus, Urticaria; Dyspnoea, Malaise, Pruritus, Urticaria
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The patient received the influenza and hepatitis B (Heplisav-B) vaccines at the end of her visit tod...
The patient received the influenza and hepatitis B (Heplisav-B) vaccines at the end of her visit today. She left the office in return shortly after stating that she did not feel well, complaining of shortness of breath and generalized itching and with two small hives appearing on the face. The patient states that she has has had the flu vaccine in the past with no adverse reaction. She believes she had the hepatitis B vaccine as a child but reports no adverse reaction. The only known allergy is to penicillin which causes a rash. Initially, her blood pressure was elevated with normal pulse rate and normal SpO2. Repeat vital signs 3 minutes later showed normal blood pressure and normal heart rate with normal SpO2. I offered a steroid injection but the patient declined. I advised her that the symptoms of allergic reaction will likely get worse. She declined to go to urgent care or emergency room. She is driving herself. I have sent in prescriptions for a Medrol Dosepak and diphenhydramine every 4 hours as needed. I advised the patient to go to the ER with any worsening symptoms. Will place a referral to allergist. Will avoid a second hepatitis B vaccine.
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| 2864058 | F | 10/07/2025 |
COVID19 |
MODERNA |
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COVID-19, Pain in extremity, Pyrexia
COVID-19, Pain in extremity, Pyrexia
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covid 19; sore arm all the time from this vaccine; Fever; This spontaneous case was reported by a co...
covid 19; sore arm all the time from this vaccine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neurological disorder NOS and Pericarditis. Concurrent medical conditions included Systemic lupus erythematosus and Coronary artery disease. Concomitant products included Belimumab (Benlysta) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm all the time from this vaccine) and PYREXIA (Fever). At the time of the report, COVID-19 (covid 19), PAIN IN EXTREMITY (sore arm all the time from this vaccine) and PYREXIA (Fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. It was reported that patient had more so considering SPIKEVAX due to her medical problems (lupus and coronary artery disease, and some neurologic - a physical mass). When she had COVID-19 back in 2022, and she was fully vaccinated, it nearly put her in hospital. She was sick for 8 weeks. Due to this, was looking at the mNEXSPIKE and was wondering if patient might be better off with SPIKEVAX. It was stated that the Moderna website said it was an alternative, but that patient did not feel like being a guinea pig. Patient received SPIKEVAX every 6 months. Her next vaccine was due in the fall and now patient was looking more and more seriously at SPIKEVAX vs mNEXSPIKE because it had got a higher dose of mRNA. It was stated that that seems to be a little more scientifically global. As far as patient was aware, for mNEXSPIKE this was not known yet. It was hesitant of mNEXSPIKE because it was a lower dose and believed that a lower dose might not always work out for a person who might or might not be able to achieve the ability to have their immune system fight it off to begin with, they might not achieve the proper efficacy. It was stated again that patient also has coronary artery disease which would be a very severe outcome, which already knew, because patient already had COVID-19 and was almost hospitalized back in 2022 which was scary. Due to this, patient masked up as did want to be dealing with that again. Patient was never shown anything for an antibody after getting the SPIKEVAX that she gotten in the past. It was believed it was probably going to come down to the preference of the person in the doctor's office. The doctor might think maybe a higher one might be better, because then they knew for sure that it would be help. No treatment information was reported. It was stated she had a history of pericarditis but still decided to get SPIKEVAX anyway, and she had been fine ever since, even when she got those vaccines, because they checked, and she was constantly at the doctor's office anyway. It was stopped going to patient rheumatologist which she could not understand as the doctor wanted her on Benlysta which she thought would probably be a good thing for patient. When you get vaccinated for influenza and you were over the age of 65 (which the patient was). Patient got it all the time. She got fevers and sore arm all the time from this vaccine. For her, it was only for one whole day, and it was not that inconvenient as knew that when she went out in the public, patient did not have to worry as much and it was worth it. It was stated that another reason for the low dose might be due to the system being messed up with the CDC and everything. Patient was happy she could get through to someone quickly but that the music she heard for a short amount of time was very loud. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-789767 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789767:Case for multiple patient
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| 2864060 | 35 | F | WA | 10/07/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
948402 948402 |
Asthenia, Burning sensation, Dizziness, Dysarthria, Heart rate increased; Hypoae...
Asthenia, Burning sensation, Dizziness, Dysarthria, Heart rate increased; Hypoaesthesia, Injection site warmth, Pallor, Paraesthesia, Peripheral coldness
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After receiving a flu shot, patient experienced several concerning symptoms within 15 minutes, inclu...
After receiving a flu shot, patient experienced several concerning symptoms within 15 minutes, including numbness and tingling down her left arm, warmth at the injection site, pale complexion, elevated heart rate, dizziness, slurred speech, and weakness. Me (Registered Nurse) and the clinic manager (Medical Assistant) evaluated her and decided to call paramedics as her symptoms appeared to be worsening. By the time the paramedics arrived, patient's condition had improved somewhat, and she declined ambulance transport to the emergency department. Instead, a friend picked her up from the office, and she was able to walk to the car without assistance. As of today, patient continues to experience numbness, tingling, burning sensations, and cold fingertips. She also had another episode of dizziness and elevated heart rate during a follow-up doctor visit on 10/6/25. Her doctor has recommended she take frequent breaks throughout the day, though specifics regarding frequency and duration were not provided. Her doctor submitted a referral for a nerve conduction study to further evaluate her symptoms.
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| 2864061 | 71 | F | FL | 10/07/2025 |
FLU3 HEP |
SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION |
u8859da 946064 |
Asthenia, Dizziness; Asthenia, Dizziness
Asthenia, Dizziness; Asthenia, Dizziness
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Patient felt dizzy and weak after 1 hour of walking and shopping at store. Patient needed to sit dow...
Patient felt dizzy and weak after 1 hour of walking and shopping at store. Patient needed to sit down for 10 minutes to start feeling better. Paramedic was called to evaluate patient. Patient was feeling better when paramedics arrived.
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| 2864062 | 76 | F | CA | 10/07/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Abdominal distension, Angiogram, Atrial fibrillation, Blood test, Cardiac monito...
Abdominal distension, Angiogram, Atrial fibrillation, Blood test, Cardiac monitoring; Chest X-ray, Chest pain, Computerised tomogram abdomen, Dyspnoea, Echocardiogram; Electrocardiogram, Gait disturbance, Heart rate increased, Heart rate irregular, Hypertension; Magnetic resonance imaging, Magnetic resonance imaging heart, Neck pain, Oedema, Pericardial effusion; Peripheral swelling, Plethysmography, Pulmonary function test, Red blood cell sedimentation rate, Scan with contrast; Swelling, Total lung capacity, Ultrasound Doppler; Abdominal distension, Angiogram, Atrial fibrillation, Blood test, Cardiac monitoring; Chest X-ray, Chest pain, Computerised tomogram abdomen, Dyspnoea, Echocardiogram; Electrocardiogram, Gait disturbance, Heart rate increased, Heart rate irregular, Hypertension; Magnetic resonance imaging, Magnetic resonance imaging heart, Neck pain, Oedema, Pericardial effusion; Peripheral swelling, Plethysmography, Pulmonary function test, Red blood cell sedimentation rate, Scan with contrast; Swelling, Total lung capacity, Ultrasound Doppler
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Symptoms: chest pain, neck pain, high blood pressure, difficulty breathing, high erratic pulse, swel...
Symptoms: chest pain, neck pain, high blood pressure, difficulty breathing, high erratic pulse, swelling of feet, legs, abdomen and chest, difficulty walking. Diagnoses: pericardial effusion, atrial fibrolation, edema. Admissions to Hospital: 10/17/2024 - 10/21/2024, 10/24/2024 - 10/27/2024, and 01/09/2025 - 01/12/2025. Treatments: (1) Medicines (amiodarone, apixaban, colchicine, furosemide, potassium chloride, prednisone, and diltiazem, and (2) physical therapy at home.
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| 2864063 | 22 | F | TX | 10/07/2025 |
HPV9 |
MERCK & CO. INC. |
2005469 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Patient is an obstetric EDD: 02/20/2026. Patient was given a Gardasil 9 vaccine versus a flu vacci...
Patient is an obstetric EDD: 02/20/2026. Patient was given a Gardasil 9 vaccine versus a flu vaccine when she was 15weeks and 6days. HPV vaccine is not recommended during pregnancy. She was notified of vaccine error. She has no adverse at this time. She was advised to notify the office immediately if any adverse.
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| 2864064 | 74 | F | OH | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0739 |
Needle issue, Underdose
Needle issue, Underdose
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When administering the vaccine to the patient the dose squirted out the side of the needle. Since t...
When administering the vaccine to the patient the dose squirted out the side of the needle. Since the patient did not get the full dose, she is coming in the next day to repeat the vaccine.
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| 2864065 | 83 | M | OH | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8764DB |
Platelet count decreased
Platelet count decreased
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Patient had platelet lab drawn on 9/29/25 and 517,000 was the result. He got the flu vaccine only on...
Patient had platelet lab drawn on 9/29/25 and 517,000 was the result. He got the flu vaccine only on 10/1/25. On October 6, 2025 when he got his next platelet count it was 33,000. On 10/7/25 it went to 1 platelet and he is in the hospital on steroids and going to be given platelets.
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| 2864066 | 64 | F | PA | 10/07/2025 |
PNC21 |
MERCK & CO. INC. |
Z009681 |
Erythema, Mobility decreased, Peripheral swelling, Pruritus, Skin warm
Erythema, Mobility decreased, Peripheral swelling, Pruritus, Skin warm
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PT HAD SWOLLEN RED ARM , WAS ITCHING A LOT AND HOT TO TOUCH .PT COUDN'T MOVE ARM UP OR DOWN
PT HAD SWOLLEN RED ARM , WAS ITCHING A LOT AND HOT TO TOUCH .PT COUDN'T MOVE ARM UP OR DOWN
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| 2864067 | 80 | F | CA | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash erythematous, Rash pruritic
Rash erythematous, Rash pruritic
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pt indicates had Shingrix vaccine 10-04-2025 and began having wam itchy red rash on 10-06-2025. was ...
pt indicates had Shingrix vaccine 10-04-2025 and began having wam itchy red rash on 10-06-2025. was adviced to see MD
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| 2864068 | 56 | F | 10/07/2025 |
PNC20 |
PFIZER\WYETH |
lj5283 |
Arthralgia, Mobility decreased, Tenderness
Arthralgia, Mobility decreased, Tenderness
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pain in arm , very tender , not able to lift
pain in arm , very tender , not able to lift
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| 2864070 | 73 | F | NY | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8855da |
Fatigue, Headache, Pain
Fatigue, Headache, Pain
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Patient had at first a Headache, then body-aches. Patient was also tired. Headaches disapeared by ...
Patient had at first a Headache, then body-aches. Patient was also tired. Headaches disapeared by 10/6/25 but patient still feels a little tired.
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| 2864071 | 7 | M | TX | 10/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9JC49 |
Joint swelling, Peripheral swelling, Rash, Rash erythematous, Skin discolouratio...
Joint swelling, Peripheral swelling, Rash, Rash erythematous, Skin discolouration
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Pt received the vaccine on 10/1/2025 intramuscularly in his left thigh. On 10/3/25 pts mom called of...
Pt received the vaccine on 10/1/2025 intramuscularly in his left thigh. On 10/3/25 pts mom called office stating "He usually gets the flu shot in his arm but they swell. We did it on his leg this time and swelling still happened and is around his knee." Pts mom was advised to get an appointment with an allergist and keep us up to date. Pt came in to the office on 10/6/25 due to rash and swelling on other parts of legs. He was referred to an allergist and told to get an appointment ASAP. On 10/7/25 mom called again stating "I got a call from his school nurse saying that his rash has spread and is discolored." Mom was advised to bring pt. in. They arrived at the office at 3:50pm temp was taken, no fever. Pulse ox was also used SPO2 was 98% and HR was 75. He was seen by Dr. (withheld name) who diagnosed him with a vaccine reaction and to follow up with an allergist. Rash was darker red on this date. Pt denies itching or pain at site of rash.
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| 2864072 | M | 10/07/2025 |
COVID19 |
MODERNA |
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Near death experience
Near death experience
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dying from the shot you guys gave me; This spontaneous case was reported by a consumer and describes...
dying from the shot you guys gave me; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (dying from the shot you guys gave me) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (dying from the shot you guys gave me) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (dying from the shot you guys gave me) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. Patient was dying from the shot. Patient mentioned that it was poison. Treatment information was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2864073 | 0.33 | F | MN | 10/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
Uk308AA |
Incorrect dose administered
Incorrect dose administered
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Patient weighs 10lbs 15oz and was given the 100mg Beyfortus
Patient weighs 10lbs 15oz and was given the 100mg Beyfortus
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