| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2863425 | 74 | F | FL | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8820AA |
Cellulitis
Cellulitis
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Patient given Clindamycin 300mg every 6 hours for 5 days for possible cellulitis
Patient given Clindamycin 300mg every 6 hours for 5 days for possible cellulitis
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| 2863426 | 61 | F | IN | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
406994 |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
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Swelling, red and hot. affected area continues to grow after 72 hours. Impacted area still red and...
Swelling, red and hot. affected area continues to grow after 72 hours. Impacted area still red and hot. Using ice but symptoms have not diminished.
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| 2863427 | 57 | F | GA | 10/06/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
u8832da g2ha7 |
Dizziness postural, Injection site reaction, Injection site warmth, Pyrexia, Ras...
Dizziness postural, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous; Dizziness postural, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
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Px received 2 vaccines, both in left arm, 10/4/25. She reported to pharmacy upon opening on 10/6/25 ...
Px received 2 vaccines, both in left arm, 10/4/25. She reported to pharmacy upon opening on 10/6/25 to report that she experienced red rash that felt hot to the touch at the injection site. She stated that the rash started 10/4/25 and began getting bigger. It went from dime sized to half-dollar size by Monday morning. i asked her if she had any other symptoms. She said she did not. I advised her how to treat the site, monitor for worsening symptoms, and seek medical care if necessary. The px marked her arm to monitor the site. She stated that after another 2 hours, the site was enlarging, she now had a low-grade fever, and she felt dizzy upon standing. She was advised to seek medical help immediately. The px was taken to the local ER for treatment.
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| 2863428 | 81 | F | MI | 10/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. |
3052583 3052583 407246 407246 |
Injected limb mobility decreased, Injection site erythema, Magnetic resonance im...
Injected limb mobility decreased, Injection site erythema, Magnetic resonance imaging abnormal, Pain in extremity, Peripheral swelling; Tendon injury; Injected limb mobility decreased, Injection site erythema, Magnetic resonance imaging abnormal, Pain in extremity, Peripheral swelling; Tendon injury
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Patient reports significant pain at time of injection, within 24 hours there was significant swellin...
Patient reports significant pain at time of injection, within 24 hours there was significant swelling and pain. Pain continued past swelling resolution and an MRI was eventually conducted that showed tendon injury and free fluid. The injection site (as reproted by patient) is a red bump and there is movement restriction and pain in the arm.
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| 2863429 | 80 | M | VA | 10/06/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052736 407245 |
Injection site haemorrhage, Injection site induration, Injection site swelling; ...
Injection site haemorrhage, Injection site induration, Injection site swelling; Injection site haemorrhage, Injection site induration, Injection site swelling
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injection site bled and quickly swelled to a hard bump the size of a nickel
injection site bled and quickly swelled to a hard bump the size of a nickel
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| 2863430 | 86 | F | PA | 10/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. |
MY9548 MY9548 407245 407245 |
Injection site discolouration, Injection site pain, Injection site warmth, Magne...
Injection site discolouration, Injection site pain, Injection site warmth, Magnetic resonance imaging, Pain in extremity; Scan with contrast, Skin discolouration, Skin warm, Ultrasound scan, X-ray; Injection site discolouration, Injection site pain, Injection site warmth, Magnetic resonance imaging, Pain in extremity; Scan with contrast, Skin discolouration, Skin warm, Ultrasound scan, X-ray
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Patient's left arm turned completely purple starting from left deltoid traveling around entire ...
Patient's left arm turned completely purple starting from left deltoid traveling around entire diameter of arm and down past elbow. It is hot to the touch and very painful. Facility obtained x-ray to ensure no breaks occured, ice and elevation. However, family requested doppler and ultrasound to ensure that bloodflow was not compromised, vascular checks routinely. Attending physician ordered MRI with contrast; facility scheduled this several weeks out from administration date. Family requested a sooner appointment - was obtained 10/2 without success due to patients inability to remain still; family requesting a repeat. Per nursing supervisor, CRNP will "order a drug similar to Valium" to assist with anxiousness and ability to ramain still in the MRI machine.
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| 2863431 | 70 | F | WI | 10/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
3052671 3052671 U8855CA U8855CA |
Chills, Dizziness, Fatigue, Headache, Hyperhidrosis; Musculoskeletal stiffness, ...
Chills, Dizziness, Fatigue, Headache, Hyperhidrosis; Musculoskeletal stiffness, Myalgia, Pain, Pyrexia; Chills, Dizziness, Fatigue, Headache, Hyperhidrosis; Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
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Body and muscle aches/stiffness, dizziness, headache, fatigue, sweating, chills, fever. Patient too...
Body and muscle aches/stiffness, dizziness, headache, fatigue, sweating, chills, fever. Patient took Tylenol. Symptoms started improve after 48 hours.
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| 2863432 | 5 | F | CA | 10/06/2025 |
COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
NA0846 NA0846 NA0846 UT8779KA UT8779KA UT8779KA |
Chills, Ear pain, Fatigue, Hyperacusis, Influenza A virus test negative; Influen...
Chills, Ear pain, Fatigue, Hyperacusis, Influenza A virus test negative; Influenza B virus test negative, Nasal congestion, Nausea, Pain, Photophobia; Productive cough, Pyrexia, Rash, SARS-CoV-2 test negative, Vomiting; Chills, Ear pain, Fatigue, Hyperacusis, Influenza A virus test negative; Influenza B virus test negative, Nasal congestion, Nausea, Pain, Photophobia; Productive cough, Pyrexia, Rash, SARS-CoV-2 test negative, Vomiting
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Fever started ~24 hours after injection and has continued for 8 days. Additional symptoms include na...
Fever started ~24 hours after injection and has continued for 8 days. Additional symptoms include nasal congestion, productive cough, chills, aches, ear pain, nausea and vomiting, sensitivity to light and sound, fatigue, and rash on face and body.
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| 2863433 | 65 | F | PA | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Injected limb mobility decreased, Loss of personal independence in daily activit...
Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Product administered at inappropriate site, Sleep disorder
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Pt received vaccine on 9/24/25. Pt presented to pharmacy on 10/6/25 to report lingering arm pain, li...
Pt received vaccine on 9/24/25. Pt presented to pharmacy on 10/6/25 to report lingering arm pain, limited mobility in left arm after having first ever dose of 65 over Fluad. "can't play tennis, can't sleep on it." Pt made a point to confirm it was "that kid," our adult temp nurse helping provide vaccinations, as the person who administered the vaccine. Pt states the shot was given "way too high" and gestured to upper portion of deltoid muscle approaching shoulder blade. Pt was advised to let pharmacy know by other people/MD. Visualized pt can move arm in some capacity. Pt states she can't "lift it over her head." No formal diagnosis was provided other than pt was referred to see "orthopedic" and "had to see her chiropractor."
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โ | |||||
| 2863434 | 73 | F | ME | 10/06/2025 |
COVID19 |
MODERNA |
|
Condition aggravated, Hypoacusis, Post-acute COVID-19 syndrome, Vestibular neuro...
Condition aggravated, Hypoacusis, Post-acute COVID-19 syndrome, Vestibular neuronitis
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vestibular neuritis; long covid; her hearing got back to the way it normally was, which was about on...
vestibular neuritis; long covid; her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%; her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%/ condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR NEURONITIS (vestibular neuritis), HYPOACUSIS (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%) and CONDITION AGGRAVATED (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%/ condition aggravated) in a 73-year-old 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 Near death experience (tested for horses, collapsed when she was near one, died in process, they had to bring her back to life). Concurrent medical conditions included Allergic to horses (fatally allergic to horses), Hearing decreased (partially), Hearing aid wearer and Immunosuppression. In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid). In 2022, the patient experienced HYPOACUSIS (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%) (seriousness criterion medically significant) and CONDITION AGGRAVATED (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%/ condition aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced VESTIBULAR NEURONITIS (vestibular neuritis) (seriousness criterion medically significant). The patient was treated with Prednisone for Vestibular neuritis, at an unspecified dose and frequency and Nirmatrelvir, Ritonavir (Paxlovid) for Long COVID, at an unspecified dose and frequency. At the time of the report, VESTIBULAR NEURONITIS (vestibular neuritis) and POST-ACUTE COVID-19 SYNDROME (long covid) was resolving and HYPOACUSIS (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%) and CONDITION AGGRAVATED (her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40%/ condition aggravated) had resolved. Concomitant medication was not provided. Patient had the Moderna COVID-19 vaccine in 2023 and said it was fine. It was mentioned that she was partially deaf. She had been wearing hearing aids and had a CapTel phone for a long time because she uses the phone in work. After she had the shot and after she had long covid, she had a condition called vestibular neuritis where the nerve that goes from the ear to the brain was damaged. The words she would hear got to her brain garbled. She could not understand what people were saying. And then she went to an ENT doctor 2 years later, and the ENT gave her prednisone which decreased the inflammation of that nerve. So, then her hearing got back to the way it normally was, which was about only 72% of word recognition, but it went down to 40% during COVID. So, something affected her hearing, but it was back to where it was. While speaking to her she can understand because she can hear it. It was really kind of a non-issue, but she was affected either by covid or by the shot with her hearing. She had a Moderna COVID-19 vaccine in 2023, in 2022, she had all the ones she was supposed to, and it was always Moderna because she had always called about the gelatin. She was stuck with Moderna. Patient did not have the vaccine last year. She was very immune suppressed. it didn't kill her all the times she got the vaccine, and it could do her some good. Long covid happened after her first Moderna covid-19 vaccine, she contracted covid after the shot. It had been 3 years. It was a debilitating fatigue and vertigo. She had Sacro cranial treatment which helped and acupuncture. Sacro cranial helps unblock the lymph system, the lymph system can get blocked, and it takes the vertigo right away. Patient used LifeWave patches that help build your own stem cells and help the immune system. She had done a lot of things that had helped, but it was not easy to be like this. She had to pace herself every day and then she was okay.; Reporter's Comments: Patients hearing difficulties are confounder for the event hypoacusis (condition aggravated). The benefit-risk relationship of product is not affected by this report.
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| 2863436 | 0.17 | M | MD | 10/06/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
TE499 UK166AA LP4948 Z007562 |
Bowel movement irregularity, Faeces discoloured, Mucous stools; Bowel movement i...
Bowel movement irregularity, Faeces discoloured, Mucous stools; Bowel movement irregularity, Faeces discoloured, Mucous stools; Bowel movement irregularity, Faeces discoloured, Mucous stools; Bowel movement irregularity, Faeces discoloured, Mucous stools
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Significant and persistent changes in consistency and frequency of bowel movements. Stringy, mucusy,...
Significant and persistent changes in consistency and frequency of bowel movements. Stringy, mucusy, very dark brown, pasty. Stool went from yellow and seedy to thick, dark brown, very sticky (needing to peel off skin), and is stooling only once every several days, instead of several times a day like normal. This has persisted TWO months after vaccine.
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| 2863437 | 52 | F | MA | 10/06/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
TFAA2545 5N79Z |
Balance disorder, Contusion, Fall, Loss of consciousness, Skin laceration; Balan...
Balance disorder, Contusion, Fall, Loss of consciousness, Skin laceration; Balance disorder, Contusion, Fall, Loss of consciousness, Skin laceration
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I blacked out for 10 minutes -- I was standing in my bathroom and felt a sudden, overwhelming need t...
I blacked out for 10 minutes -- I was standing in my bathroom and felt a sudden, overwhelming need to lie down (completely off-balance and like my I was being pushed down from the top of my head); I woke up on my living room floor and saw by the clock that 10 minutes had passed. My head caught the edge of a square table causing a cut beside my right eye as well as I have a bruise by that eye and on the part of my head and the side of my leg that landed on the floor. I was completely recovered/back to normal by early afternoon. I have never had any reaction to the Flu vaccine (this is my 20th flu vaccine).
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| 2863438 | 65 | M | ME | 10/06/2025 |
COVID19 |
JANSSEN |
|
Cerebrovascular accident
Cerebrovascular accident
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"split skull brain stroke"
"split skull brain stroke"
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| 2863439 | 26 | F | FL | 10/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8146367 U8790AA |
Blood glucose normal, Fall, Head injury; Blood glucose normal, Fall, Head injury
Blood glucose normal, Fall, Head injury; Blood glucose normal, Fall, Head injury
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Patient fel from the chair and banged her head to the table. We checked her blood sugar levels and i...
Patient fel from the chair and banged her head to the table. We checked her blood sugar levels and it was found to be 64 post brandial.
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| 2863440 | 69 | F | OH | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ba |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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No adverse event reported. Patient was expecting Fluzone HD and was given Flublok.
No adverse event reported. Patient was expecting Fluzone HD and was given Flublok.
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| 2863441 | 73 | M | WA | 10/06/2025 |
HEP HEP HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945662 945662 946065 946065 |
Alopecia, Antinuclear antibody, Blood iron, Blood thyroid stimulating hormone, F...
Alopecia, Antinuclear antibody, Blood iron, Blood thyroid stimulating hormone, Full blood count; Human chorionic gonadotropin, Reflex test, Syphilis test; Alopecia, Antinuclear antibody, Blood iron, Blood thyroid stimulating hormone, Full blood count; Human chorionic gonadotropin, Reflex test, Syphilis test
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acute sudden hair loss started after 2nd dose in August.
acute sudden hair loss started after 2nd dose in August.
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| 2863442 | 81 | M | FL | 10/06/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
ut8820ca z009681 |
Erythema, Pain in extremity; Erythema, Pain in extremity
Erythema, Pain in extremity; Erythema, Pain in extremity
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On the day of the administration the patient had pain in the left arm. The pain increased the next d...
On the day of the administration the patient had pain in the left arm. The pain increased the next day. Patient took tylenol for the pain. On tuesday redness occurred. The next day on friday the redness got better than worse.
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| 2863443 | 50 | F | NM | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55K90 |
Cellulitis, Incorrect route of product administration
Cellulitis, Incorrect route of product administration
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PATIENT WAS GIVEN SHOT SQ . CELULLITIS PROGRESSED.
PATIENT WAS GIVEN SHOT SQ . CELULLITIS PROGRESSED.
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| 2863444 | 73 | M | 10/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
|
Atrial fibrillation, Mental status changes, Pyrexia; Atrial fibrillation, Mental...
Atrial fibrillation, Mental status changes, Pyrexia; Atrial fibrillation, Mental status changes, Pyrexia
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New onset atrial fibrillation with rapid ventricular response, fever, altered mental status
New onset atrial fibrillation with rapid ventricular response, fever, altered mental status
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โ | โ | |||||
| 2863445 | 73 | F | PA | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3T74X |
Nausea, Vomiting
Nausea, Vomiting
|
NAUSEA AND VOMITTING
NAUSEA AND VOMITTING
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| 2863446 | 26 | M | PA | 10/06/2025 |
FLU3 HEP HPV9 |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Arthralgia, Bursitis, Injected limb mobility decreased, Shoulder injury related ...
Arthralgia, Bursitis, Injected limb mobility decreased, Shoulder injury related to vaccine administration, X-ray limb normal; Arthralgia, Bursitis, Injected limb mobility decreased, Shoulder injury related to vaccine administration, X-ray limb normal; Arthralgia, Bursitis, Injected limb mobility decreased, Shoulder injury related to vaccine administration, X-ray limb normal
More
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On September 3, 2025, I received three vaccines (Hepatitis B, HPV, and Influenza) in my right arm at...
On September 3, 2025, I received three vaccines (Hepatitis B, HPV, and Influenza) in my right arm at Pharmacy. The same day, I began experiencing severe shoulder pain and very limited range of motion. The pain worsened over the next several days. I went to the Hospital Emergency Room twice for evaluation due to the ongoing pain and inability to lift my arm. Later, I was seen by Orthopedic Group, where I was diagnosed with chemical bursitis / SIRVA (shoulder injury related to vaccine administration). An X-ray was performed to rule out other injuries. As of now, I am still in pain and have limited movement in my right arm
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| 2863447 | 30 | M | OH | 10/06/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8790AA U8764BB |
Extra dose administered, Product administered to patient of inappropriate age, W...
Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
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THE TECHICIAN CHOSE THE SHOTS TO BE ADMINSTERED. SHE THOUGHT SHE CHOSE FLU AND COVID IMMUNIZATIONS. ...
THE TECHICIAN CHOSE THE SHOTS TO BE ADMINSTERED. SHE THOUGHT SHE CHOSE FLU AND COVID IMMUNIZATIONS. AFTER ADMINISTERING THE SHOTS SHE WAS SCANNING IN THE INFORMATION AND DISOVERED HER ERROR. I LOOKED ON THE CDC WEBSITE FOR CONFIRMATION OF POTENTIAL SIDE EFFECTS. THE PHARMACIST CALLED THE PATIENT ABOUT 1/2 LATER AND EXPLAINED TO THE PATIENT AND HE WAS FINE. HE SAID "NO PROBLEM. MISTAKES HAPPEN" I EXPLAINED POTENTIAL SIDE EFFECTS- SORENESS AT SITE, TIREDNESS, FEVER"
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| 2863448 | 47 | F | IN | 10/06/2025 |
COVID19 |
MODERNA |
8146367 |
Chills, Nausea, Pyrexia
Chills, Nausea, Pyrexia
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It started Friday morning (10/3/25) with nausea then about 10am the chills, fever, abdominal crampin...
It started Friday morning (10/3/25) with nausea then about 10am the chills, fever, abdominal cramping and vomiting started. By 8pm Friday night the patients I-watch started alarming low heart rate in the 55-59 range she double checked it and it was accurate and then she woke up in the middle of the night Friday into Saturday with it alarming between 47-49 through Sunday (10/5/25) at 10 am. She treated with tylenol, motrin and zofran. Symptoms were resolved by Sunday (10/5/25) morning.
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| 2863449 | 42 | F | GA | 10/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JE74J |
Eye pain, Eye pruritus, Eye swelling, Hypersensitivity
Eye pain, Eye pruritus, Eye swelling, Hypersensitivity
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Employee reports having allergic reaction to flu vaccine. Received flu vaccine on 10/1/25 and within...
Employee reports having allergic reaction to flu vaccine. Received flu vaccine on 10/1/25 and within 1-2 hours of receiving vaccine both eyes were swollen, itching and mild pain behind eyes. Reports she took Benadryl and itching was relieved, left eye no longer swollen. Right eye remains slightly swollen and mild pain. States have not had reactions to flu vaccines in the past. No other identified allergy triggers.
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| 2863450 | 77 | F | OH | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Immediate post-injection reaction, Injected limb mobility decreased, Injection s...
Immediate post-injection reaction, Injected limb mobility decreased, Injection site warmth, Pain in extremity
More
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Patient states immediately after administration of vaccine she felt that the area in the arm felt wa...
Patient states immediately after administration of vaccine she felt that the area in the arm felt warm. She stated that she could not use her arm for 24 hours. She was able to move her arm after that time period but stated it still felt sore. She did not have any swelling or discoloration at any time. She states that it's better now but still sore. She is able to move the arm.
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| 2863451 | 75 | F | TX | 10/06/2025 |
COVID19 UNK |
MODERNA UNKNOWN MANUFACTURER |
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Arthralgia, Joint dislocation; Arthralgia, Joint dislocation
Arthralgia, Joint dislocation; Arthralgia, Joint dislocation
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About 15 mins after i got the vaccine, I got off the bus to walk home and it felt like my right hip ...
About 15 mins after i got the vaccine, I got off the bus to walk home and it felt like my right hip came out of joint. That only happened once when i sat in a chair. I had to walk in pain home and take small steps. Ive been a while and it was 90% improved and then i had a flare up around 5pm and i called pharmacy but i could not understand the man. So I called the next day and i was fine.
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| 2863452 | 43 | F | WI | 10/06/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
7345R 7345R |
Inflammation, Injection site induration, Injection site pain, Paraesthesia, Peri...
Inflammation, Injection site induration, Injection site pain, Paraesthesia, Peripheral swelling; Tendonitis
More
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Few hours after vaccine she developed swelling in her left arm and hardness near the inject site. By...
Few hours after vaccine she developed swelling in her left arm and hardness near the inject site. By the next morning her arm was swollen from the left hand to the shoulder with tingling and burning at the inject site.
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| 2863453 | 69 | M | OH | 10/06/2025 |
COVID19 |
MODERNA |
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Headache, Influenza like illness
Headache, Influenza like illness
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flu like symptoms/achy; flu-like symptoms/a severe headache" described as "kind of a crush...
flu like symptoms/achy; flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) in a 69-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 in 2023. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice). In 2024, INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) had resolved. No concomitant medication was reported. It was reported that patient always had side effects for 36 hours after each one, he had flu-like symptoms, achy, a severe headache described as kind of a crushing headache that headache kind of feel was felt like his head was in a vice. That would last for like 36 hours and once he hit the 36-hour mark, it was just like somebody flipped the switch, disappeared. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789726 (E2B Linked Report). This case was linked to MOD-2025-789721, MOD-2025-789723, MOD-2025-789724 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789726:female patient case
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| 2863454 | 54 | M | UT | 10/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
027H21B 027H21B 027H21B 027H21B |
Blepharospasm, Blindness unilateral, Blood test, Chills, Computerised tomogram; ...
Blepharospasm, Blindness unilateral, Blood test, Chills, Computerised tomogram; Conjunctival haemorrhage, Disturbance in attention, Dizziness, Echocardiogram, Headache; Impaired work ability, Intensive care, Iris hypopigmentation, Magnetic resonance imaging, Neoplasm malignant; Ocular discomfort, Retinal vein occlusion, Speech disorder, Ultrasound chest, Visual acuity tests abnormal
More
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pt says he became really sick following the 3rd covid vaccine. He became dizzy, developed a headache...
pt says he became really sick following the 3rd covid vaccine. He became dizzy, developed a headache, had chills, could not concentrate or barely talk so he had to go home and missed 2 days of work. After returning to work he started having fluttering in the right eye. He had vision loss in the right eye that would come and go. In May 2022 he had lost pigmentation in the right eye and had blood around the pupil. August 17th, 2022 he ended up in the ER. He was diagnosed with a blood clot behind his right eye and was given a blood thinner then admitted to the ICU. His vision in his 2000/20 and his left eye is 20/20. So, he is now blind as the dead center of his eye is gone from loss of blood. Doctors have no clue where the clot came from . He continues to see doctors to check his eyes to make sure there are no new vessels growing. He feels like he has constant pressure in his eye. He has to have his heart checked and is now taking medication for cancer.
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| 2863455 | 72 | M | TX | 10/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Memory impairment, Sluggishness
Memory impairment, Sluggishness
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Patient states that the day after he received the vaccine, he felt sluggish and memory issues. He al...
Patient states that the day after he received the vaccine, he felt sluggish and memory issues. He also stated that he had a stent put in on 08/25/2025 and a flu vaccine administered on 08/28/2025. He was not sure what these side effect's attributed to exactly (he is not sure if it was the vaccine or procedure).
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| 2863456 | 45 | F | WI | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
407251 |
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 received the 65+ flu vaccine, not the under 65 flu vaccine
patient received the 65+ flu vaccine, not the under 65 flu vaccine
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| 2863458 | 11 | F | 10/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
CD44A |
Wrong product administered
Wrong product administered
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Provider ordered Men B instead of the required dose of Menveo. Patient will receive required dose in...
Provider ordered Men B instead of the required dose of Menveo. Patient will receive required dose in November 2025 visit.
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| 2863459 | 5 | M | AZ | 10/06/2025 |
FLU3 MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
UT8779MA Z011863 |
Erythema, Full blood count, Skin warm, Swelling; Erythema, Full blood count, Ski...
Erythema, Full blood count, Skin warm, Swelling; Erythema, Full blood count, Skin warm, Swelling
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increased redness and swell, skin hot to touch reported to hospital >24 hours following vaccinati...
increased redness and swell, skin hot to touch reported to hospital >24 hours following vaccination.
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| 2863460 | 86 | M | AZ | 10/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2863461 | 68 | F | IL | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8847BA |
Feeling hot, Flushing, Insomnia, Limb discomfort, Pain in extremity
Feeling hot, Flushing, Insomnia, Limb discomfort, Pain in extremity
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Pt called, 10/06/2025- states "I wanted to report, I believe I had a reaction to the flu vaccin...
Pt called, 10/06/2025- states "I wanted to report, I believe I had a reaction to the flu vaccine, and I have never had a reaction before." Patient reported that she received a high-dose flu vaccine on 10/02/2025 at the (withheld name) flu vaccine clinic, by that evening she had a sore arm, that felt heavy to raise, her face was flushed, her body felt hot, but temperature was normal, and she had difficulty sleeping Thursday and Friday. She states, "I woke up Saturday morning and felt normal, the symptoms were gone, since I had never felt like this before, I thought I should let someone know."
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| 2863462 | 8 | M | VA | 10/06/2025 |
COVID19 |
MODERNA |
3052553 |
Epistaxis
Epistaxis
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Nose Bleed
Nose Bleed
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| 2863463 | 66 | M | IN | 10/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 U8837AA |
Death; Death
Death; Death
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NP, ALERTED THE PHARMACY ON 10/6/25 THAT THE PATIENT PASSED AWAY 09/17/2025, THE SAME DAY HE RECEIV...
NP, ALERTED THE PHARMACY ON 10/6/25 THAT THE PATIENT PASSED AWAY 09/17/2025, THE SAME DAY HE RECEIVED THE TWO VACCINATIONS INDICATED. SHE DOES NOT BELIEVE HIS DEATH IS RELATED TO THE VACCINATIONS BUT WANTED THE PHARMACY TO KNOW, AND WE ARE REPORTING THIS OUT OF AN ABUNDANCE OF PRECATION.
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| 2863464 | 66 | F | WI | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8862AA |
Arthralgia
Arthralgia
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Patient reports moderate-severe shoulder pain 5 days after vaccination.
Patient reports moderate-severe shoulder pain 5 days after vaccination.
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| 2863465 | 48 | F | WI | 10/06/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Headache, Injection site erythema, Injection site swelling, Injection site warmt...
Headache, Injection site erythema, Injection site swelling, Injection site warmth
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swelling, heat, redness at injection site, worsening up to 3 days post injection (likely longer, but...
swelling, heat, redness at injection site, worsening up to 3 days post injection (likely longer, but follow up not completed yet); headaches
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| 2863466 | 4 | M | TN | 10/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JS74H |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received first flu vaccine of lifetime on 10/2/2025. Today, 10/6/2025, received a second dos...
Patient received first flu vaccine of lifetime on 10/2/2025. Today, 10/6/2025, received a second dose. The recommendation is to give the second dose of an influenza vaccine at least 4-weeks following the first dose when patient has not been vaccinated prior.
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| 2863467 | 66 | F | KS | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8859BA |
Injection site pruritus, Injection site swelling
Injection site pruritus, Injection site swelling
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patient said her right arm caused swelling and itching in and around area vaccine was given. She sa...
patient said her right arm caused swelling and itching in and around area vaccine was given. She said she has been applying ice to the area and it and swelling has gone down. i also recommended using over the counter ibuprofen
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| 2863468 | 61 | F | NH | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
AX4605A |
Abdominal pain, Chills, Pain, Vomiting
Abdominal pain, Chills, Pain, Vomiting
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Shaking chills, aching, abdominal pain, vomiting -- started within hours of taking vaccine. Felt be...
Shaking chills, aching, abdominal pain, vomiting -- started within hours of taking vaccine. Felt better after 24 hours with lingering sx for 2 days
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| 2863469 | 73 | F | IL | 10/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NDC:00069-2528- |
Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
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Fever, chills, congestion, cough, malaise
Fever, chills, congestion, cough, malaise
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| 2863470 | 4 | F | MI | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8852KA |
Blister, Erythema, Swelling
Blister, Erythema, Swelling
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arm redness and swelling, blistering on band-aid site
arm redness and swelling, blistering on band-aid site
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| 2863471 | 23 | F | AK | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8836LA |
Erythema, Pain, Pruritus, Swelling
Erythema, Pain, Pruritus, Swelling
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local swelling, redness, pain, itching
local swelling, redness, pain, itching
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| 2863472 | 45 | F | MO | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8858LA |
Rash
Rash
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rash started on arms and chest later spread to neck, stomach and legs
rash started on arms and chest later spread to neck, stomach and legs
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| 2863473 | 80 | F | CA | 10/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 U8837CA |
Injected limb mobility decreased, Musculoskeletal stiffness; Injected limb mobil...
Injected limb mobility decreased, Musculoskeletal stiffness; Injected limb mobility decreased, Musculoskeletal stiffness
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Patient complained of right arm stiffness a few hours after receiving MNEXSPIKE covid vaccine. Patie...
Patient complained of right arm stiffness a few hours after receiving MNEXSPIKE covid vaccine. Patient stated that she was unable to raise her right arm. Pharmacist suggested massage, compresses and take Tylenol or pain meds on hand if she has pain. Patient was advised to seek medical attention if stiffness prolongs and/or if she develops other reactions. Pharmacist followed up again 3 days after and patient stated that she was better and able to raise her right arm.
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| 2863474 | 18 | F | 10/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5P2P7 |
Injection site pruritus, Injection site urticaria
Injection site pruritus, Injection site urticaria
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2 days after the vaccine the patient experience hives and extreme itching in the area of the injecti...
2 days after the vaccine the patient experience hives and extreme itching in the area of the injections that continued to worsen. Pt went to er where they were given an oral steroid and a prescription for 5 days of steroids. The following day the area was clearing up and doing much better.
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| 2863475 | 23 | F | CA | 10/06/2025 |
RSV |
PFIZER\WYETH |
LM1211 |
Exposure during pregnancy, Rash, Rash erythematous, Rash pruritic
Exposure during pregnancy, Rash, Rash erythematous, Rash pruritic
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Patient is pregnant. Erythematous pruritic rash on dorsum of hands and feet.
Patient is pregnant. Erythematous pruritic rash on dorsum of hands and feet.
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| 2863478 | 32 | F | NY | 10/06/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
LL8391 LL8391 |
Bell's palsy, Borrelia test, Exposure during pregnancy, Influenza virus tes...
Bell's palsy, Borrelia test, Exposure during pregnancy, Influenza virus test negative, Respiratory syncytial virus test negative; Road traffic accident, SARS-CoV-2 test negative
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Rec'd Abrysvo on 9/23/25. Became symptomatic for Bells Palsy on 10/5/25. Diagnosed with and sta...
Rec'd Abrysvo on 9/23/25. Became symptomatic for Bells Palsy on 10/5/25. Diagnosed with and started treatment for Bells Palsy on 10/6/25. Was in car accident on 10/3/25.
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