| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2871969 | 60 | TX | 11/10/2025 |
FLU3 |
SANOFI PASTEUR |
U8855CA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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fluzone hd was given to a patient whose age is not approved for the vaccine with no adverse event; I...
fluzone hd was given to a patient whose age is not approved for the vaccine with no adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 60 years old received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with standard strength (expiry date- 30-JUN-2026 and lot U8855CA) once via intramuscular route in the left deltoid for Influenza (Influenza immunization) with no adverse event (product administered to patient of inappropriate age) (same day latency). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2871972 | PA | 11/10/2025 |
FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
Deafness neurosensory, Hypoacusis, Loss of consciousness, Malaise, Tinnitus; Vir...
Deafness neurosensory, Hypoacusis, Loss of consciousness, Malaise, Tinnitus; Viral infection
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Became ill; Felt sick; Real bad virus; Came hard to hearing within two weeks of the flu vaccine/Lost...
Became ill; Felt sick; Real bad virus; Came hard to hearing within two weeks of the flu vaccine/Lost 65 percent of hearing in left ear; This spontaneous case, initially received on 21-Oct-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 09-Oct-2025, the patient received INN Flu Vaccine Seasonal for Active immunization for prevention of Influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: Adverse reactions/events and outcomes: On an unknown date of 2025, the patient Came hard to hearing within two weeks of the flu vaccine/Lost 65 percent of hearing in left ear (outcome: Not Reported). On an unknown date, the patient Became ill (outcome: Not Reported), Felt sick (outcome: Not Reported), Real bad virus (outcome: Not Reported). Non-health professional reported that 14 days later patient had tinnitus, and never ever had tinnitus and reporter said got to be kidding with patient she said no, for real. The nurse friend who was also nurse confirmed that he's hard of hearing and found vaccine he had she would tell but he also became hard to hearing within two weeks of the flu vaccine, did not know what happened and why this vaccine and its ingredients were somehow attacked the cochlear nerve in the ear and it could be bet any amount of money that many people in this country who received that vaccine had problems with their hearing. The patient confirmed that they had lost 65% of the hearing in their left ear and then became ill, feeling sick, as if they had a bad virus. They passed out on the kitchen floor and later explained what had happened. They had received a vaccine one week earlier and said that within that week, they lost their hearing. After visiting an audiologist and then an ENT specialist for multiple tests, the providers had no idea what had caused it and referred the patient on, as they were uncertain about the reason. Something had happened to the cochlear nerve, but it was unknown what it was. The patient mentioned that they had received Flucelvax on 09-Oct-2025, and within seven days, they lost hearing in the left ear with an abrupt, acute onset. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter (non-health professional) did not provide causality assessment and seriousness reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, events considered related for reporting purposes
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| 2871974 | 27 | F | NY | 11/10/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
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Wrong patient received product, Wrong product administered; Wrong patient receiv...
Wrong patient received product, Wrong product administered; Wrong patient received product, Wrong product administered
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I went to pharmacy to get a flu shot. I e-signed and filled out information before getting there. Wh...
I went to pharmacy to get a flu shot. I e-signed and filled out information before getting there. When I got there the lady at the desk said I was due for my tetanus shot. I said I get that shot at my primary so no thank you to getting it today (i was not due for it today, my last tetanus shot was in 2019). The women giving the shot called my name. Sat me down and said what arm. Did not verify my name, DOB, or what shot I was getting. Once she gave me the shot, she gave me a receipt with another persons name. When I walked away I saw it was not my name, turned around and said this was the wrong receipt. It had another name on it or something like that. She said ?that?s not you? Not your last name?? I said no, my name is XX. She said that paper is what they gave her to give me. She said hold on, walked back to the pharmacy area, came out a few minutes later and asked what shot I was supposed to get. I said the flu shot. She said she gave me the tetanus shot. I told her I said no to the tetanus shot and that was not my name on the receipt. She then had me wait, she grabbed the flu shot, and administered that shot. I called a friend who is a nurse who said I should be fine even though I was not due for a tetanus shot, but not only did this women administering the shot not verify who I was, but she game me someone else?s vaccine.
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| 2871975 | 32 | F | CA | 11/10/2025 |
FLU3 |
SEQIRUS, INC. |
948402 |
Hypoaesthesia, Injection site pain, Paraesthesia
Hypoaesthesia, Injection site pain, Paraesthesia
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Per employee, stated that she felt symptoms approximately 1 to 1/2 hours after receiving the vaccina...
Per employee, stated that she felt symptoms approximately 1 to 1/2 hours after receiving the vaccination. Felt burning to the injection site initially and then numbness and tingling in the arm that extended to the finger. Per employee, all symptoms had resolved within a day and half. Reporting event as this is an unexpected side effect of the vaccine.
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| 2871976 | 65 | M | OH | 11/10/2025 |
COVID19 FLU3 PNC21 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
3052035 U8874BA Z007870 |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
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PATIENT'S ARM BELOW VACCINE SITES IS RED AND WARM
PATIENT'S ARM BELOW VACCINE SITES IS RED AND WARM
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| 2871977 | 42 | F | NY | 11/10/2025 |
FLU3 |
SEQIRUS, INC. |
410515 |
Deafness, Headache, Inner ear inflammation, Nausea, Pain
Deafness, Headache, Inner ear inflammation, Nausea, Pain
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Patient felt nauseous and had headaches, aches and pains that then escalated to hearing lose.
Patient felt nauseous and had headaches, aches and pains that then escalated to hearing lose.
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| 2871978 | 4 | F | SC | 11/10/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4K5X2 |
Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decre...
Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
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My daughter developed a severe case of Immune Thrombocytopenic Purpura. On November 3rd, 2025, we no...
My daughter developed a severe case of Immune Thrombocytopenic Purpura. On November 3rd, 2025, we noticed a spot which we initially thought was a freckle. The following morning, November 4th, 2025, she woke up covered in these spots along with a lot of new bruising all over her body. These symptoms worsened through the day and we took her to the pediatrician that day where they did a blood panel (CBC). On November 5th at 11:30am, the doctor called with her results. Her platelet levels came back at a 1, critically low. She was then rushed to the emergency room less than an hour later. Her symptoms worsened and her levels stayed critically low during her visit. She received two doses of IVIG, one on November 6th and one on November 7th. It is now November 10th and we are awaiting results from her blood draw to see if she is responding to treatment.
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| 2871979 | 45 | M | CA | 11/10/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9JC49 |
Diarrhoea, Feeling hot, Pain in extremity, Pyrexia
Diarrhoea, Feeling hot, Pain in extremity, Pyrexia
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45 year old Male presents today w c/o left arm pain, diarrhea, and fever. Pt reports after he got t...
45 year old Male presents today w c/o left arm pain, diarrhea, and fever. Pt reports after he got the flu vaccine to left arm he experienced sore left arm, feeling hot, and diarrhea. Pt states fever lasted until next day and last diarrhea occured this morning. Pt states he no longer has pain to left arm. Pt denies any fever. Pt denies any mor diarrhea. Pt reports having regular bowel movement prior to this visit.
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| 2871991 | 66 | F | IN | 11/10/2025 |
FLU3 |
SANOFI PASTEUR |
U8800CA |
Pruritus, Urticaria
Pruritus, Urticaria
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Itchy hives - all over body per patient report. Treated with oral over-the-counter Benadryl
Itchy hives - all over body per patient report. Treated with oral over-the-counter Benadryl
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| 2871992 | 70 | F | VA | 11/10/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0590 u8875ba |
Pain, Paraesthesia oral, Toothache; Pain, Paraesthesia oral, Toothache
Pain, Paraesthesia oral, Toothache; Pain, Paraesthesia oral, Toothache
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pt reported severe tooth pain on the same side of her body as her vaccines starting the day after h...
pt reported severe tooth pain on the same side of her body as her vaccines starting the day after her vaccination. she got them in the same arm. the tooth pain was one tooth and then the pain radiated to the gums with pain and tingling. she went to the dentist and a specialist and they could not see anything wrong. the only new thing was the vaccinations. it has been about 3 weeks and the tooth pain has improved, but the gum tingling is still present, but getting better.
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| 2871994 | 64 | M | CA | 11/10/2025 |
FLU3 PNC21 VARZOS |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
u8790aa z003579 55kn9 |
Rash; Rash; Rash
Rash; Rash; Rash
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patient came to pharmacy today to get an oral antibiotic as well as a steroid cream, he stated he h...
patient came to pharmacy today to get an oral antibiotic as well as a steroid cream, he stated he had an adverse reaction to the shingles vaccine. He stated he has had this rash for a long time and final went to seek medical attention for it. He stated that when he got the first dose of shingrix(2021) he got a rash on his back and this time after the second dose of shingrix 3 days later presented with a rash on the back top part of his leg that still has not gone away. He had 2 other vaccines the same day but presumes since he had the reaction from the initial dose that the shingrix may be the cause
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| 2871998 | 66 | F | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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PATIENT REPORTED REDNESS AND ITCHING AFTER COVID VACCINE on deltoid around injection site
PATIENT REPORTED REDNESS AND ITCHING AFTER COVID VACCINE on deltoid around injection site
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| 2871999 | 7 | M | OR | 11/10/2025 |
COVID19 |
MODERNA |
3052663 |
Incorrect dose administered
Incorrect dose administered
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Pt received COVID19 Moderna Spikevax 12 years and up dose instead of pediatric dose for 11 and under...
Pt received COVID19 Moderna Spikevax 12 years and up dose instead of pediatric dose for 11 and under.
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| 2872000 | 43 | F | MA | 11/10/2025 |
FLU3 |
SANOFI PASTEUR |
406985 |
Injected limb mobility decreased, Pain, Pain in extremity, Rotator cuff syndrome...
Injected limb mobility decreased, Pain, Pain in extremity, Rotator cuff syndrome, X-ray limb normal
More
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While receiving my flu shot the nurse asked me if I was tensing. I answered, no but I can feel that...
While receiving my flu shot the nurse asked me if I was tensing. I answered, no but I can feel that you can't push that all the way in. She then just pushed harder. As I ran the flu clinic (work) I was around for most of the day. She even asked me if it hurt that afternoon. Next day it felt like a normal flu shot pain. The day after that I started having pain that ran down my arm into my fingers. I had/have trouble lifting my arm above my shoulder. I saw my primary on 10/8/25 as it seemed way too long to be experiencing pain. She gave me steroids (Prednisone 10 mg for 5 days) which made the pain dull. Shortly after the pain became worse. Tylenol and Ibuprofen wouldn't touch the pain. I couldn't even type at desk level with my left hand due to pain and weakness. I went back to my doctor for my annual on November 3rd. I complained again of the pain. She referred me to orthopedics. I was seen on November 6th by ortho. I had x-rays done, which showed nothing. The doctor used the physical push and pull tests several ways with my arm. He then stated he believes it is a torn rotator cuff. I am going tomorrow, November 11th for an MRI. I have a follow up with ortho on November 19th. Pain comes and goes but it's always there, just duller sometimes.
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| 2872001 | 37 | M | WA | 11/10/2025 |
COVID19 |
NOVAVAX |
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Dizziness, Dyspnoea, Tunnel vision
Dizziness, Dyspnoea, Tunnel vision
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Lightheadedness, tunnel vision, shortness of breath
Lightheadedness, tunnel vision, shortness of breath
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| 2872198 | 0.33 | M | CA | 11/10/2025 |
DTAPHEPBIP DTAPHEPBIP HIBV HIBV PNC20 PNC20 RV1 RV1 UNK UNK |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Z9349 Z9349 Y020467 Y020467 MA2488 MA2488 5DH4A 5DH4A UK393AA UK393AA |
Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-cloni...
Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging; Status epilepticus; Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging; Status epilepticus; Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging; Status epilepticus; Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging; Status epilepticus; Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging; Status epilepticus
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Siezure tonic clonic every 2 hrs. - seen in ED - got Ativan x5 doses - had status Epilepticus x 12 h...
Siezure tonic clonic every 2 hrs. - seen in ED - got Ativan x5 doses - had status Epilepticus x 12 hrs - D/C'd home on Keppra
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| 2871537 | 45 | F | OH | 11/09/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Injected limb mobility decreased, Pain, Pain in extremity
Injected limb mobility decreased, Pain, Pain in extremity
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Left arm pain with difficulty moving arm that has not subsided in over 8 days. Arm began throbbing ...
Left arm pain with difficulty moving arm that has not subsided in over 8 days. Arm began throbbing within an hour after injection and continued to worsen through the evening and into the next day. Even with ibuprofen, rest and time, this pain is still present and makes it difficult to move my arm forward or backwards.
More
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| 2871539 | 21 | F | 11/09/2025 |
FLU3 |
SEQIRUS, INC. |
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Exposure during pregnancy, Guillain-Barre syndrome
Exposure during pregnancy, Guillain-Barre syndrome
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Flu vaccine 2 weeks ago, patient admitted for AIDP. Currently pregnant.
Flu vaccine 2 weeks ago, patient admitted for AIDP. Currently pregnant.
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| 2871540 | 67 | F | 11/09/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8873JA UT8873JA |
Injection site pain, Neuralgia, Pain, Puncture site bruise, Puncture site reacti...
Injection site pain, Neuralgia, Pain, Puncture site bruise, Puncture site reaction; Wound
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This Flu vaccination was given to employees of [withheld], including me. No discomfort at the time o...
This Flu vaccination was given to employees of [withheld], including me. No discomfort at the time of the vaccination or for the week following. By the end of the 2nd week, muscle pain had developed in the upper arm, and tenderness at the site. During the 3rd week, the puncture site opened up with very sore to the touch raw wet flesh about 1/4" around the puncture site, bruising around the puncture site. By the end of that 3rd week, nerve pain developed in the upper arm, sometimes radiating down the arm. Reported to [withheld], [withheld] Employee Health Nurse, on the morning of 11/4/25, who strongly suggested being seen by a physician at the [withheld] where I worked. I was seen by Dr [withheld] in the afternoon of 11/4/25 who believes it to be a deep hematoma. [withheld], Employee Health Nurse followed up with a call, suggesting heat compresses, inflammation and pain medications to relieve the symptoms while it heals. As of today 11/9/25, the puncture site has closed, bruising is gone, muscle pain and nerve pain are reduced but not gone yet.
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| 2871541 | 74 | F | ME | 11/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA4452 UT8781CA |
Mobility decreased, Muscle spasms, Neck pain; Mobility decreased, Muscle spasms,...
Mobility decreased, Muscle spasms, Neck pain; Mobility decreased, Muscle spasms, Neck pain
More
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A few hours after vaccination, the patient began to experience neck pain that increased in severity ...
A few hours after vaccination, the patient began to experience neck pain that increased in severity over the next few hours. It got to the point that she could not turn her neck to either the left or right and had difficulty looking up or down. She called the pharmacy and was directed to the emergency room to rule out serious complications. At the ER it was determined that the patient was having muscle spasm in the deltoid that was causing neck pain.
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| 2871543 | 68 | F | ME | 11/09/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Rash pruritic
Rash pruritic
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Mild itchy rash on stomach
Mild itchy rash on stomach
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| 2871544 | 54 | F | CA | 11/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
3606917-06127 3606918-06127 |
Bell's palsy, Eyelid function disorder, Hypoaesthesia; Bell's palsy, E...
Bell's palsy, Eyelid function disorder, Hypoaesthesia; Bell's palsy, Eyelid function disorder, Hypoaesthesia
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2nd day I felt there was some changes to my face. I had more feelings in my left face . I was havin...
2nd day I felt there was some changes to my face. I had more feelings in my left face . I was having problems gargling while brushing my teeth. I was unable to gargle in my right side and water kept dripping off. Third day, i couldn?t hold a straw between my lips and closing my right eye was a struggle.
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| 2871545 | 29 | F | MT | 11/09/2025 |
FLU3 FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9FG5M 9FG5M 9FG5M 9FG5M |
Rash, Urticaria; Rash, Urticaria; Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria; Rash, Urticaria; Rash, Urticaria
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Full body rash/hives. Had to take Decadron for 2 days (8mg then 4mg) and Benadryl (25-50mg q 4 hours...
Full body rash/hives. Had to take Decadron for 2 days (8mg then 4mg) and Benadryl (25-50mg q 4 hours for 7 days).
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| 2871546 | 34 | F | ID | 11/09/2025 |
COVID19 |
MODERNA |
3052734 |
Dizziness, Feeling hot, Head injury, Hyperhidrosis, Syncope
Dizziness, Feeling hot, Head injury, Hyperhidrosis, Syncope
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PATIENT HAS HISTORY OF VASOVAGAL RESPONSE, OCCURED WITHIN 5 MINTUES OF VACCINE. HASN'T HAPPENED...
PATIENT HAS HISTORY OF VASOVAGAL RESPONSE, OCCURED WITHIN 5 MINTUES OF VACCINE. HASN'T HAPPENED TO PATIENT IN OVER 12 YEARS. PATIENT COLLAPSED AND HIT HER HEAD, WENT TO THE ER TO HAVE HEAD EVALUATED AND EVERYTHING CAME BACK NORMAL. PATIENT REPORTS FEELING NORMAL TODAY. AT TIME OF RESPONSE SHE FELT LIGHTHEADED AND HOT. REPORTED SWEATING.
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| 2871547 | 50 | M | NC | 11/09/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Catatonia, Cognitive disorder, Hyperacusis, Motor dysfunction, Photophobia; Post...
Catatonia, Cognitive disorder, Hyperacusis, Motor dysfunction, Photophobia; Postural orthostatic tachycardia syndrome, Reversible cerebral vasoconstriction syndrome, Sensory processing disorder, Temperature intolerance, Tilt table test positive; Transient ischaemic attack
More
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2nd shot gave me pots ,Had a TIA in August 2021, In October 2021 was misdiagnosed by a Cardiologist...
2nd shot gave me pots ,Had a TIA in August 2021, In October 2021 was misdiagnosed by a Cardiologist saying the problem was my beta blockers which is the one thing you need for pots. Being off my beta blockers for 5 days triggered a RCVS. Went to local ER where they said I needed brain surgery. Went to local doctor who told me I should get the booster since I was going to health clinic to have my brain checked out. Health clinic decided that I did not need brain surgery and that it was an RCVS. 10 days after shot I went catatonic, lost motor function, as well as my mind. Had an insane sensory issues. Had to be in a darkened room with no lights or sound for 3 weeks. Can't function well with temperature over 75 degrees. Brain does not work like it used to.
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| 2871548 | 40 | F | IA | 11/09/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3052733 3052733 P394K P394K |
Fatigue, Hypoaesthesia oral, Influenza like illness, Injection site pain, Pain; ...
Fatigue, Hypoaesthesia oral, Influenza like illness, Injection site pain, Pain; Paraesthesia; Fatigue, Hypoaesthesia oral, Influenza like illness, Injection site pain, Pain; Paraesthesia
More
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I had normal flu-like symptoms that you get after a vaccine. Fatigue, body aches, soreness at the in...
I had normal flu-like symptoms that you get after a vaccine. Fatigue, body aches, soreness at the injection site. Then a few days later I started to get really intense pins and needles on my arms, legs, and numbness in my lips and tongue. It didn?t last very long and continued to come and go. I currently still have symptoms today, they are still intermittent.
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| 2871550 | 71 | F | AZ | 11/09/2025 |
FLU3 |
SEQIRUS, INC. |
406996 |
Immediate post-injection reaction, Injection site bruising, Injection site pain
Immediate post-injection reaction, Injection site bruising, Injection site pain
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Immediately after injection, patient reported pain in surrounding area of injection site (above and ...
Immediately after injection, patient reported pain in surrounding area of injection site (above and to the left and at injection site). The injection site was bruised immediately. I gave patient water and an ice pack to place on injection site. Patient remained at pharmacy for 15 minutes. I gave her acetaminophen 500mg tablet10 minutes after injection.
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| 2871551 | 51 | F | OH | 11/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Complex regional pain syndrome; Complex regional pain syndrome
Complex regional pain syndrome; Complex regional pain syndrome
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Pfizer Biontech vaccine 4/9/2021 done and then 4/30/2021 and then three week alter complex regional...
Pfizer Biontech vaccine 4/9/2021 done and then 4/30/2021 and then three week alter complex regional pain syndrome of right upper extremity ( both vaccine were done on the left arm , _
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| 2871553 | 54 | M | TX | 11/09/2025 |
COVID19 COVID19 FLU3 FLU3 PNC21 PNC21 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
NA0590 NA0590 U8864CA U8864CA Z007870 Z007870 |
Chills, Fatigue, Feeding disorder, Headache, Mobility decreased; Nausea; Chills,...
Chills, Fatigue, Feeding disorder, Headache, Mobility decreased; Nausea; Chills, Fatigue, Feeding disorder, Headache, Mobility decreased; Nausea; Chills, Fatigue, Feeding disorder, Headache, Mobility decreased; Nausea
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CHILLS TIREDNESS HEADACHE NAUSEA COULD NOT EAT OR GET OUT OF THE BED
CHILLS TIREDNESS HEADACHE NAUSEA COULD NOT EAT OR GET OUT OF THE BED
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| 2871555 | 67 | F | GA | 11/09/2025 |
FLU3 |
SANOFI PASTEUR |
u8855da |
Injection site erythema, Injection site reaction
Injection site erythema, Injection site reaction
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redness at site and allergy square
redness at site and allergy square
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| 2871558 | 65 | F | MO | 11/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3e27g |
Pharyngeal swelling
Pharyngeal swelling
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throat swelling
throat swelling
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| 2871559 | 9 | M | MI | 11/09/2025 |
COVID19 |
MODERNA |
3053669 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The pharmacy inadvertently administered an Mnexspike to a child aged 9 years old. The vaccine was pr...
The pharmacy inadvertently administered an Mnexspike to a child aged 9 years old. The vaccine was processed through pharmacy software and sold out to the patient as the pediatric moderna but the wrong vaccine was given as his whole family was present and getting vaccinated.
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| 2871560 | 75 | F | FL | 11/09/2025 |
FLU3 FLU3 PNC21 PNC21 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8859BA U8859BA Z007870 Z007870 |
Abdominal discomfort, Headache, Injected limb mobility decreased, Nausea, Pain; ...
Abdominal discomfort, Headache, Injected limb mobility decreased, Nausea, Pain; Pain in extremity, Tremor; Abdominal discomfort, Headache, Injected limb mobility decreased, Nausea, Pain; Pain in extremity, Tremor
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patient states 1st times she's ever experienced this. headache, aches, shakes, bad upset stomac...
patient states 1st times she's ever experienced this. headache, aches, shakes, bad upset stomach, nausea, very sore arms with the right arm (pneumonia vaccine) not being able to lift.
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| 2871561 | 34 | M | NY | 11/09/2025 |
COVID19 |
MODERNA |
8146545 |
Mouth ulceration, Oral pain
Mouth ulceration, Oral pain
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mouth sensitivity 3 days after vaccine and then mouth ulcers 5 days out
mouth sensitivity 3 days after vaccine and then mouth ulcers 5 days out
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| 2871562 | 19 | F | FL | 11/09/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
TFAA2534 TFAA2534 |
Back pain, Blood culture, Blood pressure decreased, Computerised tomogram kidney...
Back pain, Blood culture, Blood pressure decreased, Computerised tomogram kidney abnormal, Heart rate increased; Nephritis, Pyrexia, Vomiting, White blood cell count increased
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Daughter started having left side back pain 11/7/25 and got progressively worse then next day extrem...
Daughter started having left side back pain 11/7/25 and got progressively worse then next day extreme pain with 2 episodes of vomiting and was running fever 100.5 ; went to stand alone ER and found to have an elevated wbc of 31 with nephritis on left kidney : was then admitted to hospital where she is currently ; heart rate has been elevated 120 ish and bp low 90/50 and so they are working her up septically : blood cultures pending
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| 2871566 | 70 | M | FL | 11/09/2025 |
FLU3 |
SANOFI PASTEUR |
Ut8781DA |
Injection site pain
Injection site pain
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Pain at injection site continues
Pain at injection site continues
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| 2871653 | 8 | M | TX | 11/09/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2ly39 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Patient reported to the ER on 11/09 with pronounced redness, swelling, and pain around the injection...
Patient reported to the ER on 11/09 with pronounced redness, swelling, and pain around the injection site. The prescriber there ordered an oral steroid and an oral antibiotic which we provided at our pharmacy. Further Details should be available from the Medical Center Hospital Emergency Department.
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| 2871654 | 71 | M | CA | 11/09/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Arthralgia, Back pain, Blood test, Computerised tomogram abnormal, Computerised ...
Arthralgia, Back pain, Blood test, Computerised tomogram abnormal, Computerised tomogram neck; Computerised tomogram thorax, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain in extremity
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Within 24 hours after receiving an influenza vaccination in the right arm, the patient developed sud...
Within 24 hours after receiving an influenza vaccination in the right arm, the patient developed sudden severe shoulder pain in that arm. Over the next several days the pain spread across the upper back and into the left shoulder. The right-arm pain later improved somewhat, but the left arm developed progressive weakness and pain. At present (2 months post-vaccination) the patient cannot lift the left arm above shoulder height because of marked weakness in the deltoid and surrounding muscles. No fever, rash, or systemic illness occurred. Evaluation for possible post-vaccination brachial neuritis (Parsonage Turner syndrome) versus cervical radiculopathy is in progress. The event has caused major limitation of daily activities and concern for neurologic injury.
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| 2871656 | 1 | F | NJ | 11/09/2025 |
COVID19 FLU3 HEPA MMR |
MODERNA SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
3053238 U8919AA Z003748 Z008441 |
Cough, Stridor; Cough, Stridor; Cough, Stridor; Cough, Stridor
Cough, Stridor; Cough, Stridor; Cough, Stridor; Cough, Stridor
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stridor and croupy cough started within 12-24 hours of vaccine administration, child remained afebri...
stridor and croupy cough started within 12-24 hours of vaccine administration, child remained afebrile,she was evaluated in the emergency room where she recieved racepinephrine and then in our office where she recieved a single dose of Decadron. Of note she attends daycare was asymtpomatic for croup prior to vaccine adminstration.
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| 2871469 | F | FL | 11/08/2025 |
COVID19 |
MODERNA |
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Aortitis, Laboratory test
Aortitis, Laboratory test
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aortitis; This spontaneous case was reported by a pharmacist and describes the occurrence of AORTITI...
aortitis; This spontaneous case was reported by a pharmacist and describes the occurrence of AORTITIS (aortitis) in a female 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 fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced AORTITIS (aortitis) (seriousness criterion medically significant). At the time of the report, AORTITIS (aortitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. The patient had received 5th dose of moderna vaccine on 27-Nov-2023 (batch number:3030372) intramuscularly. The patient had received Flu shot (unspecified) on 14-OCT-2025. It was reported that the patient had been experiencing a persistent side effect and was uncertain of its origin. She believed it might have been caused by the Moderna COVID-19 vaccines she had received, although she was not entirely sure. She explained that all diagnostic tests had returned negative, and the vaccine was the only plausible explanation she could identify. She reported that symptoms had begun approximately three to four months prior to June 2023, and she had undergone testing around that time which eventually led to a diagnosis of aortitis (inflammation of the aorta). She mentioned relocating to [withheld state] in Aug-2023 and noted that it had taken five to six months to consult various healthcare providers. The diagnosis was likely confirmed in January or Feb-2024. She stated that she continued to experience symptoms and had been under the care of a rheumatologist who had conducted extensive testing. She added that her internist was less familiar with the condition. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2871490 | 28 | F | MA | 11/08/2025 |
COVID19 |
MODERNA |
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Arthralgia, Limb discomfort, Mobility decreased, Muscular weakness
Arthralgia, Limb discomfort, Mobility decreased, Muscular weakness
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Shoulder pain, heaviness, weakness, can't move arm much
Shoulder pain, heaviness, weakness, can't move arm much
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| 2871491 | 42 | F | WI | 11/08/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UT8792LA UT8792LA UT8792LA |
Arthralgia, Balance disorder, Brain fog, Dizziness, Fatigue; Head injury, Headac...
Arthralgia, Balance disorder, Brain fog, Dizziness, Fatigue; Head injury, Headache, Impaired work ability, Movement disorder, Paraesthesia; SARS-CoV-2 test negative
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Headache for 3 days. Left upper trapezius pain and soreness. Brain fog and woozy feeling for almost...
Headache for 3 days. Left upper trapezius pain and soreness. Brain fog and woozy feeling for almost 2 weeks. Second morning after injection I hit my forehead bending down on the counter due to not feeling like myself and less control of my movements. Overall body tingling started and made me feel off balance and "ungrounded" / "unsteady" on my feet. Extreme fatigue for almost 2 weeks. Took naps when that is completely abnormal. Had to take days off of working out due to the fatigue and tingling. Notified my PCP and consulted with the NP's that I work with. Was taking cold and flu medication during this time. Finally on 11/3/2025 the tingling and fatigue started to subside.
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| 2871492 | 42 | F | NJ | 11/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Abdominal pain, Paraesthesia, Pruritus; Abdominal pain, Paraesthesia, Pruritus
Abdominal pain, Paraesthesia, Pruritus; Abdominal pain, Paraesthesia, Pruritus
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Patient developed generalized intense pruritus (itching) on the hands, as well as abdominal cramping...
Patient developed generalized intense pruritus (itching) on the hands, as well as abdominal cramping, three days after co-administration of the COVID Vaccine and Flu Vaccine. Symptoms were successfully treated with one dose of Zyrtec (cetirizine). Still experiencing intermittent palm tingling.
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| 2871493 | 68 | F | NY | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8855DA |
Headache, Pain in extremity, Wheezing
Headache, Pain in extremity, Wheezing
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Developed severe arm pain, headache, and wheezing hours after vaccine. Short lived response to use o...
Developed severe arm pain, headache, and wheezing hours after vaccine. Short lived response to use of antihistamines and albuterol.
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| 2871494 | 66 | F | MI | 11/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA4457 U8875BA |
Lip swelling, Swelling face, Swollen tongue; Lip swelling, Swelling face, Swolle...
Lip swelling, Swelling face, Swollen tongue; Lip swelling, Swelling face, Swollen tongue
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Patient called this morning informing us of allegic reaction characterized by swollen lips and tongu...
Patient called this morning informing us of allegic reaction characterized by swollen lips and tongue and face. She was going to urgent care and asked which manufacturer's shots she got. She did not seem in respiratory distress on phone.
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| 2871495 | 34 | M | MO | 11/08/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
8146670 407004 |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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The patient received both vaccines he passed out for 15 seconds
The patient received both vaccines he passed out for 15 seconds
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| 2871498 | 54 | M | 11/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Deafness unilateral, Lymphadenopathy, Tinnitus, Tympanometry abnormal
Deafness unilateral, Lymphadenopathy, Tinnitus, Tympanometry abnormal
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pulsatile tinnitus, hear loss in L temporal, L ear, swollen L anterior cervical lymph node
pulsatile tinnitus, hear loss in L temporal, L ear, swollen L anterior cervical lymph node
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| 2871499 | 81 | M | CA | 11/08/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052784 3052784 |
Asthenia, Balance disorder, Decreased appetite, Hypersomnia, Lethargy; Muscular ...
Asthenia, Balance disorder, Decreased appetite, Hypersomnia, Lethargy; Muscular weakness
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High tempoerature (Max temperature of 100F). feeling very weak and lethargic, legs very weak so felt...
High tempoerature (Max temperature of 100F). feeling very weak and lethargic, legs very weak so felt unsteady, slept a lot, not hungry
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| 2871501 | 74 | F | 11/08/2025 |
COVID19 |
MODERNA |
3052668 |
Chills, Pain, Pain of skin, Pyrexia
Chills, Pain, Pain of skin, Pyrexia
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Fever/Aches/Chills/Sore skin all over for 3 days
Fever/Aches/Chills/Sore skin all over for 3 days
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| 2871502 | 20 | F | MI | 11/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA4459 KL47G |
Dizziness; Dizziness
Dizziness; Dizziness
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Pt started to feel lightheaded within a couple of minutes of getting both flu and covid vaccines. Si...
Pt started to feel lightheaded within a couple of minutes of getting both flu and covid vaccines. Similar reaction had happened in the past when she got multiple shots at the same time. Pt drank some juice and lied down on the exam table. BP several minutes later was 102/62 (pulse 91). BP 5 min after that was 107/58 (pulse 83). Pt felt much better and was able to ambulate without assistance. No sob, chest pain, itchiness, rash, vomiting, etc.
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