| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862540 | 3 | M | NY | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8854AA |
Blood culture negative, Erythema, Lymphadenopathy, Peripheral swelling, Pyrexia
Blood culture negative, Erythema, Lymphadenopathy, Peripheral swelling, Pyrexia
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Patient presented with fever, erythema, swelling of left arm, lymphadenopathy, that worsened over th...
Patient presented with fever, erythema, swelling of left arm, lymphadenopathy, that worsened over the course of two days (starting the night of the day he received the immunization), prompting an ED visit on 9/27/2025. Due to concerns of possible cellulitis, patient was admitted for IV antibiotics and rule out SBI. Patient improved during inpatient course, blood culture was negative, SBI was ruled out, deeming diagnosis of cellulitis less likely.
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| 2862541 | 20 | F | MA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8790BA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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No adverse event. Patient received High dose Flu (Flublok) instead of Fluarix
No adverse event. Patient received High dose Flu (Flublok) instead of Fluarix
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| 2862543 | M | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Product storage error
Product storage error
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This is the new 2025*2026 formulary. this vaccine was accidently placed in the freezer when it is no...
This is the new 2025*2026 formulary. this vaccine was accidently placed in the freezer when it is now indicated to not freeze this vaccine. Pfizer was called in which they stated the stability of the vaccine has not been tested for temps below 2c as to which it should not be used. This was caught before administering to any patients. These vaccines will be discarded appropriately. This could be a common mistake made for this year as years prior covid 19 has always been frozen.
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| 2862544 | 69 | F | IN | 10/01/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
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Ear pain, Fatigue, Headache, Pain, Pyrexia; Respiratory tract congestion
Ear pain, Fatigue, Headache, Pain, Pyrexia; Respiratory tract congestion
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Fever, congestion, fatigue, earache, headache and body aches
Fever, congestion, fatigue, earache, headache and body aches
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| 2862545 | 48 | F | NJ | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817LA |
Erythema, Pain, Swelling
Erythema, Pain, Swelling
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Erythematous, swollen, and painful from administration to office visit - 2 days
Erythematous, swollen, and painful from administration to office visit - 2 days
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| 2862546 | 59 | F | AR | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
FJ1620 |
COVID-19
COVID-19
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hospitalized with COVID
hospitalized with COVID
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โ | |||||
| 2862547 | 74 | F | MN | 10/01/2025 |
COVID19 |
MODERNA |
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Needle issue, Syringe issue, Underdose
Needle issue, Syringe issue, Underdose
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vaccine leaked between barrel of syringe and needle-insuffiencent dose delivered--- revaccinated 10/...
vaccine leaked between barrel of syringe and needle-insuffiencent dose delivered--- revaccinated 10/01/25 with same vaccine and same lot
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| 2862548 | 62 | F | MO | 10/01/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4JT43 9C75Y |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Vaccine one was administered first by mistake as a Shingrix instead of Arexvy. Administrator noticed...
Vaccine one was administered first by mistake as a Shingrix instead of Arexvy. Administrator noticed shortly after administration that the wrong vaccine was given. There was no adverse events from the Arexvy and patient was notified of the error. The patient then was administered with the Shingrix to complete her two vaccine serious. Patient was counseled both by administrator and staff Pharmacist about the error.
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| 2862549 | 1 | M | WI | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5EF45 |
Needle issue, No adverse event
Needle issue, No adverse event
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BROKEN VIAL FROM NEEDLE AFTER ADMINISTRATION WHEN LOCKING THE NEEDLE TIP- (withheld name), CSA admin...
BROKEN VIAL FROM NEEDLE AFTER ADMINISTRATION WHEN LOCKING THE NEEDLE TIP- (withheld name), CSA administered an influenza vaccine to patient. After injection, she went to lock the needle and the vial snapped off from the attached needle. The break occurred from the tip of the vaccine syringe into the needle. No injury to the patient as vaccine already administered and was away from child. Needle and syringe have been saved in bio bag if needed. Vaccine details: Influenza Flulaval 2025-2026 formula 0.5 ml lot #5EF45 NDC# 19515-904-41 exp- 6/9/26
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| 2862550 | 81 | M | IA | 10/01/2025 |
COVID19 |
MODERNA |
3046734 |
Death
Death
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Resident passed away
Resident passed away
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| 2862551 | 64 | F | MN | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Chills, Decreased appetite, Fatigue, Vomiting
Asthenia, Chills, Decreased appetite, Fatigue, Vomiting
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pt says she multiple systems. She became extremely weak, had vomiting, loss of appetite, very fatigu...
pt says she multiple systems. She became extremely weak, had vomiting, loss of appetite, very fatigued, and had chills. These severe symptoms lasted a couple of days but now she is feeling some better. She is still extremely weak and has no appetite yet. Will contact PCP if symptoms don't improve.
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| 2862552 | 44 | F | WI | 10/01/2025 |
COVID19 |
MODERNA |
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Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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pain at injection site lasting more than 10 days, limited range of motion in arm
pain at injection site lasting more than 10 days, limited range of motion in arm
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| 2862553 | 1 | F | TN | 10/01/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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This vaccine was given 12 days early. No adverse reaction.
This vaccine was given 12 days early. No adverse reaction.
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| 2862554 | 24 | F | NC | 10/01/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2L353 2L353 |
Injected limb mobility decreased, Loss of personal independence in daily activit...
Injected limb mobility decreased, Loss of personal independence in daily activities, Needle issue, Pain, Pain in extremity; Product administered at inappropriate site, Sleep disorder
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Per patient: I received my flu shot at the clinic in the hospital and have been experiencing severe ...
Per patient: I received my flu shot at the clinic in the hospital and have been experiencing severe pain for the past two weeks. During the vaccination, I was injected twice. The first attempt failed due to a crooked needle, and then a second injection was administered to deliver the vaccine. The injection was also placed very high on my shoulder, near the shoulder joint. Within two hours, my arm became very sore and sensitive. For the following four days, I was unable to move my arm, struggling to drive, get dressed, and was working with only one hand. While the soreness has slightly decreased, I have not regained my full range of motion and am still in a lot of pain. I am still waking up in the middle of the night due to the pain, I continue to experience pain getting dressed, reaching to grab items and doing daily talks such as driving. The pain has become more significant in the last day, and it feels as if I have torn something.
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| 2862556 | 39 | F | IA | 10/01/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9JC49 9JC49 |
Anaphylaxis treatment, Chest discomfort, Dyspnoea, Flushing, Hypoaesthesia; Para...
Anaphylaxis treatment, Chest discomfort, Dyspnoea, Flushing, Hypoaesthesia; Paraesthesia
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15 minutes post injection, the patient experienced flushing, numbness/tingling of face, and difficul...
15 minutes post injection, the patient experienced flushing, numbness/tingling of face, and difficulty breathing/chest heaviness. The employee took 25 MG of Benadryl immediately with some minimal improvement. Upon evaluation by RN she reported slight improvement in symptoms but 0.3 MG of Epi was administered IM based on emergency medical protocol for managing anaphylaxis in a community setting. (Mobile Vaccination Clinic at patients workplace). EMS called. Employee declined medical transport to ED.
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| 2862557 | 83 | F | 10/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA0587 NA0587 |
Chest discomfort, Chest pain, Dizziness, Lip swelling, Mouth swelling; Nausea, P...
Chest discomfort, Chest pain, Dizziness, Lip swelling, Mouth swelling; Nausea, Pain in extremity, Peripheral swelling, Vertigo
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arm was swollen and painful; arm was swollen and painful; heaviness in chest; tingling pain shooting...
arm was swollen and painful; arm was swollen and painful; heaviness in chest; tingling pain shooting around the chest; inside her mouth and lips were swollen; inside her mouth and lips were swollen; felt dizzy; room was spinning around; felt like vomiting; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 1, single (Lot number: NA0587) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levofloxacin, reaction(s): "Allergy". The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2025, outcome "recovering" and all described as "arm was swollen and painful"; DIZZINESS (non-serious) with onset 26Sep2025, outcome "recovering", described as "felt dizzy"; NAUSEA (non-serious) with onset 26Sep2025, outcome "recovering", described as "felt like vomiting"; CHEST DISCOMFORT (non-serious) with onset 26Sep2025, outcome "recovering", described as "heaviness in chest"; MOUTH SWELLING (non-serious), LIP SWELLING (non-serious) all with onset 26Sep2025, outcome "recovering" and all described as "inside her mouth and lips were swollen"; VERTIGO (non-serious) with onset 26Sep2025, outcome "recovering", described as "room was spinning around"; CHEST PAIN (non-serious) with onset 26Sep2025, outcome "recovering", described as "tingling pain shooting around the chest". It was unknown if therapeutic measures were taken as a result of peripheral swelling, pain in extremity, chest discomfort, chest pain, mouth swelling, lip swelling, dizziness, vertigo, nausea. Additional information: the patient did not receive any other vaccines on the same date as COMIRNATY (2025-2026 FORMULA). The patient did not receive any other vaccines within 4 weeks prior to the COMIRNATY (2025-2026 FORMULA). The patient reported that she woke up at 3 am on 27Sep2025. Her arm was swollen and painful. She felt like a brick was on her chest, heaviness in chest, tingling pain shooting around the chest, inside her mouth and lips were swollen, felt dizzy as well the room was spinning around and she felt like vomiting. As of 28Sep2025, the patient was feeling better.
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| 2862558 | 64 | F | CO | 10/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MY9547 MY9547 |
Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocard...
Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Headache; Myalgia, Nausea, Troponin abnormal
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myalgias, headache and nausea starting 24 hours after vaccine. Severe chest pain starting 72 hours a...
myalgias, headache and nausea starting 24 hours after vaccine. Severe chest pain starting 72 hours after vaccine, abnormal troponin and EKG, focal wall motion abnormality on echocardiogram, normal coronary arteries by cath. High suspicion of focal myocarditis.
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| 2862559 | 68 | M | IN | 10/01/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
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Injected limb mobility decreased, Pain in extremity, Paraesthesia; Injected limb...
Injected limb mobility decreased, Pain in extremity, Paraesthesia; Injected limb mobility decreased, Pain in extremity, Paraesthesia
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Left arm pain and limited ROM of shoulder starting 2 days after injection. Tingling down left arm.
Left arm pain and limited ROM of shoulder starting 2 days after injection. Tingling down left arm.
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| 2862560 | 49 | F | CA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8823AA |
Condition aggravated, Dizziness, Tremor
Condition aggravated, Dizziness, Tremor
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Acute episode of dizziness w/o additional symptoms - Vaccine administered to L deltoid w/o complicat...
Acute episode of dizziness w/o additional symptoms - Vaccine administered to L deltoid w/o complication. Approximately 15 minutes after pt received flu vaccine, while seated in lobby during recommended waiting period, pt experienced acute onset dizziness. Rapid response was called by front office staff and RN responded immediately alongside many back-office staff. VS taken immediately - BP elevated to 186/95, HR 101, O2 sats 96% on RA, Temp WDL. Pt denied SOB, chest pain, vision changes, headache, N/V. Pupils round, equal (2mm) and reactive to light. Pt A&Ox4. Pt w/ rt sided tremor at baseline which had become more pronounced during incident. No fall occurred. Pt was given sips of water and apple juice. After 3 minutes, VS checked - BP 168/88, HR down to 79. Pt reporting dizziness has passed. Evaluated by PCP at this time - plan to continue monitoring pt for next 15 minutes, ok to leave clinic in absence of any additional changes and VS continue to trend towards pt baseline. VS taken again after 5 minutes - BP 153/85, HR 69. RN and MA sat with pt remainder of time to ensure safety and repeat VS. 15 minute VS check: BP 145/83, HR 75, 20 minute VS check: BP 130/80, HR 64. Pt denying dizziness at this time, able to stand comfortably. Continues to deny chest pain, headache, blurry vision, weakness, SOB. Pt states she feels well and safe to go home. Pt encouraged to wait in lobby as long as needed, but opted to leave at this time. Pt left clinic ambulatory and in NAD.
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| 2862561 | 3 | F | MA | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7F299 |
Injection site erythema, Injection site hypersensitivity, Injection site indurat...
Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth
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Pt received a flu vaccine on 9/29 and after mom noticed an erythematous edematous area at the site t...
Pt received a flu vaccine on 9/29 and after mom noticed an erythematous edematous area at the site that was warm to the touch. The next day that area increased to about a 5 cm circumference that was erythematous and edematous and sensitive and warm to touch. Mom applied ice to area. Today in office the area has decreased edema and erythema with firmness at center 2 cm of area. Sensitive to touch and is warm. No other rashes noted.
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| 2862562 | 33 | M | CO | 10/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
gj952 |
Injection site discharge, Underdose
Injection site discharge, Underdose
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Patient states that when the Medical assistant was preparing the vaccine alot of the liquid was spil...
Patient states that when the Medical assistant was preparing the vaccine alot of the liquid was spilling out of the vial. He also mentioned that once the MA administered the vaccine more liquid was coming out of his arm. He is concerned that he didn't received the full dose.
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| 2862563 | 50 | F | OH | 10/01/2025 |
FLU3 RSV |
SANOFI PASTEUR PFIZER\WYETH |
tfaa2502 md5462 |
Burning sensation, Condition aggravated, Muscular weakness, Pain in extremity; B...
Burning sensation, Condition aggravated, Muscular weakness, Pain in extremity; Burning sensation, Condition aggravated, Muscular weakness, Pain in extremity
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The patient came in on 10/1/26 expressing that her lower extremities were becoming increasingly more...
The patient came in on 10/1/26 expressing that her lower extremities were becoming increasingly more painful and burning. She inquired about Guillian-Barre syndrome and asked if this could be something that she was experiencing. I told her that I would be contacting her pcp and that office directed me to tell the patient to reach out to her neurologist. I communicated this to the patient and she is going to reach out to the neurologist or go to the emergency room if her symptoms continue to worsen.
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| 2862564 | 8 | M | SC | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received incorrect dose based on age
Patient received incorrect dose based on age
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| 2862565 | 10 | F | TN | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Brain fog, Depressed mood, Fatigue, Headache, Laboratory test normal
Brain fog, Depressed mood, Fatigue, Headache, Laboratory test normal
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Patient also received COVID vaccines on 1/23/22, 11/12/22, and 1/7/24. She had COVID illness in 11/2...
Patient also received COVID vaccines on 1/23/22, 11/12/22, and 1/7/24. She had COVID illness in 11/2021. Her mom reports her symptoms developed in early 2022. I saw her first for these symptoms in 2023. She reported feeling excessively tired with a depressed mood. Over time, she has developed recurrent headaches and a "brain fog" feeling. Extensive workup has not revealed the cause of her symptoms. It is unclear if these symptoms represent long-COVID or are related to her COVID vaccines.
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| 2862566 | 25 | M | NM | 10/01/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
NA0589 NA0589 NA0589 |
Chills, Ear pain, Headache, Hyperhidrosis, Hypoacusis; Injection site erythema, ...
Chills, Ear pain, Headache, Hyperhidrosis, Hypoacusis; Injection site erythema, Injection site pruritus, Muscular weakness, Pain, Pain in extremity; Pyrexia, Sleep disorder
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Hearing loss in left ear. Sounds are muffled similar as if there is excessive earwax buildup, howeve...
Hearing loss in left ear. Sounds are muffled similar as if there is excessive earwax buildup, however when observed with a camera there was no significant earwax buildup. No pain present, just pressure. Timeline after vaccination: On day 2 after injection, fever, chills, aching body, sweating, weakness in legs, and inability to sleep were observed. Day 3 after injection same symptoms present with the addition of a soreness on the injection arm as well as injection site redness and headaches with pain behind the eyes. Day 4 same symptoms as before with addition of itching on the injection site arm. Day 5 same symptoms as previous days however it was observed to be decreasing in severity. Day 6 no headaches with minor body aches and soreness. Injection site arm was still red and itchy. Muffled hearing on left ear. Day 7+ No other symptoms except persistent muffled hearing.
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| 2862567 | 70 | M | IL | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
u8837aa |
Immediate post-injection reaction, Injection site haematoma, Injection site mass...
Immediate post-injection reaction, Injection site haematoma, Injection site mass, Injection site pain
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patient received injection in left deltoid by technician. Immediately after injection patient's...
patient received injection in left deltoid by technician. Immediately after injection patient's arm formed a small lump at site of injection and grew to rough the size of a half-dollar by the time the pharmacist made it to vaccination room. Patient reported mild pain at site of injection but no difficulty breathing, dizziness or facial swelling. Patient was encouraged to seek medical attention, ambulance was not called due to patient having a driver and not reporting any life threatening side effects. Patient went to walk in to be seen by doctor who told him that the injection "hit a blood vessel" causing the swelling lump. Patient was prescribed mild pain killers and reported that the lump was gone by the time he left the clinic. Patient did not report any lasting effects to us.
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| 2862568 | 23 | F | CA | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
ES4H5 |
Swollen tongue, Tongue pruritus
Swollen tongue, Tongue pruritus
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tongue swelling, itching
tongue swelling, itching
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| 2862570 | 10 | F | TX | 10/01/2025 |
HPV9 MMR TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR |
Y015560 Y017528 U8564AA |
Fatigue, Headache, Ocular hyperaemia, Pyrexia, Rash; Fatigue, Headache, Ocular h...
Fatigue, Headache, Ocular hyperaemia, Pyrexia, Rash; Fatigue, Headache, Ocular hyperaemia, Pyrexia, Rash; Fatigue, Headache, Ocular hyperaemia, Pyrexia, Rash
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Headache, Fever, Red Eyes, Rash and Fatigue and possible hallucinations for 1-2 weeks.
Headache, Fever, Red Eyes, Rash and Fatigue and possible hallucinations for 1-2 weeks.
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| 2862571 | 24 | F | SC | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8848AA |
Dizziness, Feeling abnormal
Dizziness, Feeling abnormal
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2 minuets after vaccination patient began to feel off. Pt reported feeling lightheaded to clinic 20 ...
2 minuets after vaccination patient began to feel off. Pt reported feeling lightheaded to clinic 20 minuets after vaccination via phone call. Pt was informed to return to clinic for monitoring. When pt arrived to clinic she was still experiencing symptom of lightheadedness. Provider was informed of situation and vitals began being monitored on pt. Provider assessed pt and sent pt home with rest x 24 hours.
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| 2862572 | 34 | F | PA | 10/01/2025 |
TDAP |
SANOFI PASTEUR |
U8670BA |
Arthralgia, Bursitis, Exposure during pregnancy
Arthralgia, Bursitis, Exposure during pregnancy
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EDC 11/16/25, Pregnancy history includes: G2P1001. Patient at routine OB visit and received Tdap vac...
EDC 11/16/25, Pregnancy history includes: G2P1001. Patient at routine OB visit and received Tdap vaccine per guidelines. Patient reported 8 days later to urgent Orthopedic office due to left shoulder pain. Patient was told she likely sustained bursitis from injection by the PA. Radiographs were not obtained. Patient was offered cortisone injection but declined. Patient continued to use ice/Tylenol per PA recommendations. Patient arrived at follow up OB appointment on 9/10/25 questioned if she needed an additional dose of Tdap vaccine since she felt the first dose was given too high on her arm. Patient stated her shoulder pain/discomfort had resolved.
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| 2862573 | 12 | M | WI | 10/01/2025 |
FLU3 HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
7F299 Y018416 |
Injection site bruising; Injection site bruising
Injection site bruising; Injection site bruising
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Patient was compliant during vaccine administration and did not fight MA giving vaccine. On 9/30/20...
Patient was compliant during vaccine administration and did not fight MA giving vaccine. On 9/30/2025, mom sent message with photos of bruising on both arms that appeared when they got home from the physical appointment on 9/29/2025. The bruising was on the outer portion of the arms extending from shoulder to elbow. Patient did not play any contact sports inbetween appointment and message. Patient was brought into clinic on 10/1/2025 for evaluation. Patient did report he was playing street basketball on Sunday night that was a very physical game. Patient had no pain to injection area, no redness at injection site, or swelling.
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| 2862574 | 57 | F | MD | 10/01/2025 |
FLU3 TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8832DA U8620BA |
Headache, Neck pain, Pain, Sleep disorder; Headache, Neck pain, Pain, Sleep diso...
Headache, Neck pain, Pain, Sleep disorder; Headache, Neck pain, Pain, Sleep disorder
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Pt reports sharp throbbing pain going through to her neck and causing headaches since receiving vacc...
Pt reports sharp throbbing pain going through to her neck and causing headaches since receiving vaccines on 9/24/25. She has tried taking aleve/advil pm, which dulls the pain a little but pain reoccurs. She describes worst pain (10/10) - hard to sleep or lay down, worse at night. She sleeps on that right side. Pt was evaluated by physician and given ketorolac 30 mg IM injection on 10/1/25.
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| 2862575 | 77 | F | OR | 10/01/2025 |
FLU3 |
SEQIRUS, INC. |
407245 |
Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
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Patient describes arm pain radiating from the injection site. Patient reports pain lasting longer th...
Patient describes arm pain radiating from the injection site. Patient reports pain lasting longer than normal. Pain is described to be severe enough to cause more limited mobility.
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| 2862578 | 1.25 | M | MA | 10/01/2025 |
DTAPHEPBIP FLU3 PNC20 TDAP |
GLAXOSMITHKLINE BIOLOGICALS SEQIRUS, INC. PFIZER\WYETH SANOFI PASTEUR |
X9EDS 406989 MF0415 3CA304 |
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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NONE Patient had no issues Dcotor called mother and explained in great detail
NONE Patient had no issues Dcotor called mother and explained in great detail
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| 2862579 | 66 | F | VA | 10/01/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4930 LN4930 |
Headache, Injection site pruritus, Injection site rash, Injection site reaction,...
Headache, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling; Pain
More
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had a big ball and swelling very badly/these symptoms occurred at the injection site; Itching/these ...
had a big ball and swelling very badly/these symptoms occurred at the injection site; Itching/these symptoms occurred at the injection site; spread everywhere like a rash/these symptoms occurred at the injection site; sharp shooting pain inside/these symptoms occurred at the injection site; Headache; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Sep2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: Jul2026) for immunisation, Device Lot Number: LN4930, Device Expiration Date: Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2025, outcome "recovered"; VACCINATION SITE PRURITUS (non-serious) with onset 22Sep2025, outcome "recovering", described as "Itching/these symptoms occurred at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 22Sep2025, outcome "recovering", described as "had a big ball and swelling very badly/these symptoms occurred at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2025, outcome "recovering", described as "sharp shooting pain inside/these symptoms occurred at the injection site"; VACCINATION SITE RASH (non-serious) with onset 22Sep2025, outcome "recovering", described as "spread everywhere like a rash/these symptoms occurred at the injection site". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pruritus, vaccination site rash, vaccination site pain. Additional information: The patient reported that she took a shot and had a very bad reaction that has been going on for about a week. Clarified that she had a big ball and swelling very badly and was itching. She stated that it spread everywhere like a rash. The patient clarified that these symptoms occurred at the injection site. The big ball and swelling very badly was worse every single day, but today (29Sep2025) she was feeling a bit better. The patient reported that she had itching, a sharp shooting pain inside, and had swelling and rash the night of the injection. Stated that she took Tylenol. Her symptoms were getting worse and said she put an ice pack on the site. After 2 days, it was a little bit better. The patient also reported that she had a little headache everyday but today she was fine.
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| 2862580 | 0.5 | M | MN | 10/01/2025 |
COVID19 |
MODERNA |
3052663 |
Pyrexia
Pyrexia
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Fever up to 101 degrees
Fever up to 101 degrees
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| 2862581 | 80 | F | SC | 10/01/2025 |
PNC20 |
PFIZER\WYETH |
MA2523 |
Extra dose administered
Extra dose administered
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Patient received an unnecessary dose of Prevnar 20 on 09/30/25 when they had previously received a d...
Patient received an unnecessary dose of Prevnar 20 on 09/30/25 when they had previously received a dose on 04/11/25
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| 2862582 | 42 | F | MN | 10/01/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site swelling, Pruritus, Urticaria
Injection site swelling, Pruritus, Urticaria
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I received a Prevnar20 vaccination in my left arm on 9/30/25 at 9:30 AM; this was administered by a ...
I received a Prevnar20 vaccination in my left arm on 9/30/25 at 9:30 AM; this was administered by a nurse. I also received the 2025-2026 influenza vaccine at the same time in my right arm. My left arm broke out in hives the same evening and has been itchy. The injection site is swollen. This is not typical for me to have a reaction like this. My left arm is fine- no hives, swelling, itching, etc. I'm not having any breathing difficulty and have not required any medical attention as of the time I'm reporting this. I notified my primary care provider of the reaction. My rheumatologist ordered the vaccination.
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| 2862583 | 11 | F | AZ | 10/01/2025 |
MNQ |
SANOFI PASTEUR |
U7949AB |
Fatigue, Injection site erythema, Injection site pruritus, Injection site swelli...
Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
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Vaccine was given at a school clinic for 11 year old vaccines. Parent let school nurse know about t...
Vaccine was given at a school clinic for 11 year old vaccines. Parent let school nurse know about the reaction. School nurse told RN about the adverse. RN called mom and she stated that "child came home and was tired and went to bed did not wake up until dinner time and that this is unusual for child." Mom stated that she "could tell that child's body was trying to fight something." Child was c/o of some pruritus at injection site. Site was red, swollen and warm per mom. Mom stated that they have been putting ice on the site. Mom called doctor today to get child in to doctor office. This was her first Meningococcal vaccine.
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| 2862585 | 22 | F | CO | 10/01/2025 |
FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
u8848aa u8848aa U8848AA U8848AA |
Rash; Feeling hot, Nausea, Rash, Throat irritation; Rash; Feeling hot, Nausea, R...
Rash; Feeling hot, Nausea, Rash, Throat irritation; Rash; Feeling hot, Nausea, Rash, Throat irritation
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Diffused rash on BUE, torso, BLE
Diffused rash on BUE, torso, BLE
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| 2862586 | 50 | F | TN | 10/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pain, Musculoskeletal stiffness
Injection site pain, Musculoskeletal stiffness
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I got the vaccine and it right now hurt and after the last 2.5 months i have been in pain and it sti...
I got the vaccine and it right now hurt and after the last 2.5 months i have been in pain and it stiff.
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| 2862587 | 4 | M | MO | 10/01/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4F2AJ 4F2AJ 4F2AJ |
Body temperature increased, Erythema, Eye pruritus, Injection site pain, Injecti...
Body temperature increased, Erythema, Eye pruritus, Injection site pain, Injection site pruritus; Injection site swelling, Injection site warmth, Nasal pruritus, Oropharyngeal pain, Pain; Pruritus, Streptococcus test negative
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Vaccine given at facility. Mom reports patient received his flu vaccine 9/27 AM. 9/27 PM, he develo...
Vaccine given at facility. Mom reports patient received his flu vaccine 9/27 AM. 9/27 PM, he developed a temperature and sore throat to 102F. 9/28 morning, mom noticed his right upper arm became warm to the touch and he was taken to urgent care where he was swabbed for strep pharyngitis (negative). He developed swelling to his right arm 9/28 afternoon and complained of upper arm pain, especially with movement. 9/28 night he developed itching to his eyes, nose, chest, and right arm. Mom administered zyrtec around 2300. Patient woke mom overnight 9/28 into 9/29 and told her his arm hurt badly and was bigger. Went to ED at which time received NS bolus, benadryl, toradol, morphine, and steroids. Transported to hospital and given ceftriaxone due to concern for overlying cellulitis. Admitted for 3 days 9/29-10/1 while monitoring swelling and erythema, treated with IV ancef and zyrtec with improvement in symptoms.
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| 2862589 | 22 | M | TN | 10/01/2025 |
FLU3 |
SEQIRUS, INC. |
406995 |
Impaired driving ability, Impaired work ability, Loss of personal independence i...
Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities, Pain, Pain in extremity
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Received the flu shot 08/28 at 3:30 and the pain began on 08/29 the following morning. Doing normal ...
Received the flu shot 08/28 at 3:30 and the pain began on 08/29 the following morning. Doing normal everyday motions and actions hurt, raising it and moving it around hurts. I was unable to put on seatbelt and turn the steering wheel. Unable to exercise, and hindered my ability to do something?s at work. Following the pain, we tried ice, heat, anti inflammatory and others, also tried a steroid pack (prednisone) on 09/19, which did not resolve any issues. Our next step is PT on 10/10
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| 2862592 | 1.17 | F | MO | 10/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
90710 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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A combo med was given instead of the separate vaccinations. Provider notified, and they have talked ...
A combo med was given instead of the separate vaccinations. Provider notified, and they have talked to the parent, and he stated understanding. Will get reeducated on further investigation.
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| 2862595 | 4 | M | TX | 10/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
UT8770JA |
Injection site swelling
Injection site swelling
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patient presented with left arm swollen from shoulder to elbow
patient presented with left arm swollen from shoulder to elbow
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| 2862596 | 10/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Axillary mass, Axillary pain
Axillary mass, Axillary pain
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big nodule, hurt and pain for a while underneth arm; This is a spontaneous report received from a Co...
big nodule, hurt and pain for a while underneth arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250923000013 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (BNT162B2 OMICRON (LP.8.1)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious), outcome "unknown", described as "big nodule, hurt and pain for a while underneth arm". Additional information: Caller reporting that the one time took Pfizer, because the pharmacy was out of the Moderna vaccine, had a big nodule, hurt and pain for a while underneath arm. And so, never took it again. That was the only time took it [Pfizer vaccine]. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2862597 | 77 | F | WA | 10/01/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
AX5588A 407256 |
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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Patient presented to clinic requesting a high dose flu shot as well as a COVID-19 shot. This MA admi...
Patient presented to clinic requesting a high dose flu shot as well as a COVID-19 shot. This MA administered a high-dose flu and a standard dose flu (Afluria) instead of a COVID-19 vaccine. Vaccines were administered in bilateral deltoids. Patient monitored in clinic for 15 minutes after administration. Tolerated well. Informed patient of error and discussed possible adverse outcomes. Patient plans to return for COVID shot next week.
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| 2862598 | 42 | M | CA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8830BA |
Incorrect dose administered
Incorrect dose administered
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Accidentally gave the high dose flu shot instead of the regular dose by accident
Accidentally gave the high dose flu shot instead of the regular dose by accident
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| 2862599 | 0.75 | M | MD | 10/01/2025 |
COVID19 |
MODERNA |
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Incorrect dose administered
Incorrect dose administered
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Patient was given 0.5mL dose of vaccine, instead of the recommended 0.25mL per patient's age.
Patient was given 0.5mL dose of vaccine, instead of the recommended 0.25mL per patient's age.
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| 2862600 | 37 | F | PA | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9FG5M |
Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
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She received a seasonal influenza vaccine in the right deltoid approximately 24 hours ago at (withhe...
She received a seasonal influenza vaccine in the right deltoid approximately 24 hours ago at (withheld) Hospital as a part of the annual flu vaccine campaign. I asked her to point to where the vaccine was injected and appears to be in the clinically appropriate deltoid region. Normal during the day, as day went on noticed tingling in her wrist and pain in the arm at the site of injection. She made sure to move the arm a lot. Worked the rest of the day. Around 2pm yesterday ? noted ?superficial numbness." It is only in the anterior aspect of the upper right arm. Describes the sensation as "tingling and dull numbness," with no associated weakness or pain. Only in the anterior region of the upper arm. Avoided sleeping on that arm. Her wrist is tingling. General aching of the whole arm. Minimal to no pain at rest; just with palpation and pressure to area of injection site. Denies fever, redness, swelling, or systemic symptoms. No prior history of similar reactions to vaccines. Allergy to Epinephrine ? rxn fainting. No recent trauma or overuse of the arm. Denies anaphylaxis type symptoms, such as trouble breathing, chest pain, and wheezing.
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