| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2867391 | M | CT | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Arthralgia, Headache, Myalgia, Pyrexia
Arthralgia, Headache, Myalgia, Pyrexia
|
fever (similar); joint pain; headache; muscle ache; This is a spontaneous report received from a Con...
fever (similar); joint pain; headache; muscle ache; This is a spontaneous report received from a Consumer or other non HCP. A 47-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever (similar)"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle ache". Additional information: the patient received COMIRNATY yearly. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500185284 same patient, different vaccine dose/event;
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| 2867392 | 77 | M | OH | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
U8862DA |
Gingival pain, Oral pain
Gingival pain, Oral pain
|
Soreness around upper and lower gums and inside the cheeks
Soreness around upper and lower gums and inside the cheeks
|
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| 2867394 | 2 | M | PA | 10/21/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
948401 948401 |
Cough, Mouth ulceration, Pruritus, Rash, Rash macular; Urticaria, Vomiting
Cough, Mouth ulceration, Pruritus, Rash, Rash macular; Urticaria, Vomiting
|
After receiving patients first influenza vaccine today, the patient developed a rash. His mom contac...
After receiving patients first influenza vaccine today, the patient developed a rash. His mom contacted the family doctor's office, and the nurse advised them to go to UC. Mom bathed him, but he was covered with hives from head to toe. Mom took him out of the bath and let him air out with just a diaper on to help with the cool air, but it was getting worse. She gave him Zyrtec around 5:00 PM, but he ended up coughing and spitting it up. She waited 15 minutes, and after he had dinner, she gave him an actual dose. He was doing fine, but then he started itching again, and his stomach was covered with hives again. He has not had the influenza vaccine before. He has eczema, so his skin has been like this for a while. He has a combination of both flat and raised splotches. He has some ulcers in his mouth.
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| 2867395 | 14 | F | TX | 10/21/2025 |
FLU3 MENB |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS |
4F2AJ K7JY3 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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MENB (BEXSERO) VACCINE WAS ADMINISTERED OUTSIDE OF AGE RANGE
MENB (BEXSERO) VACCINE WAS ADMINISTERED OUTSIDE OF AGE RANGE
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| 2867396 | 68 | M | OH | 10/21/2025 |
COVID19 FLU3 |
NOVAVAX SANOFI PASTEUR |
|
Mobility decreased, Muscular weakness, Pain in extremity; Mobility decreased, Mu...
Mobility decreased, Muscular weakness, Pain in extremity; Mobility decreased, Muscular weakness, Pain in extremity
More
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SInce receiving both vaccines, patient has had persistent arm pain, loss of mobility and weakness. H...
SInce receiving both vaccines, patient has had persistent arm pain, loss of mobility and weakness. He is following up today and will be prescribed anti0inflammatory medication and PT.
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| 2867398 | 11 | M | ME | 10/21/2025 |
FLU3 MENB TDAP |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
UT8779KA MA2480 9JT4S |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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Patient was due for Meningococcal A, C, Y, W but received meningococcal B vaccine instead.
Patient was due for Meningococcal A, C, Y, W but received meningococcal B vaccine instead.
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| 2867399 | 57 | F | TN | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Lymphadenopathy, Pruritus
Lymphadenopathy, Pruritus
|
supraclavicular lymphadenopathy - painful and pruritic
supraclavicular lymphadenopathy - painful and pruritic
|
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| 2867401 | 29 | M | NH | 10/21/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052586 ut8770ma |
Arthralgia; Arthralgia
Arthralgia; Arthralgia
|
right shoulder pain post injection
right shoulder pain post injection
|
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| 2867402 | 68 | M | WI | 10/21/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052581 U8837BA |
Blood glucose increased, Condition aggravated, Diabetes mellitus, Type 2 diabete...
Blood glucose increased, Condition aggravated, Diabetes mellitus, Type 2 diabetes mellitus; Blood glucose increased, Condition aggravated, Diabetes mellitus, Type 2 diabetes mellitus
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Patient has type 2 diabetes mellitus and reported an increase in his blood sugar after receiving the...
Patient has type 2 diabetes mellitus and reported an increase in his blood sugar after receiving the flu and COVID vaccines. He received them around 0900 and ate and drank per usual that day. Around 11pm his blood sugar increased from his baseline of 120-130 to approximately 200 despite having not eaten for about 3 hours prior. This elevation lasted less than 1 hour and slowly decreased over the next several hours back to his baseline. He never had any symptoms of hyperglycemia with this increase.
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| 2867404 | 81 | M | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
407256 |
Extra dose administered
Extra dose administered
|
Patient received Fluad from the office yesterday and then when returned home daughter called to let ...
Patient received Fluad from the office yesterday and then when returned home daughter called to let us know he had gotten his Flu shot at (withheld location) on 9/12/25. Patient did not recall getting the flu shot on 9/12/25 when patient was in and office. Flu shot was not reported by (withheld) on Database.
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| 2867405 | 50 | M | MI | 10/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
my9547 my9547 |
Abdominal pain upper, Chills, Headache, Hyperhidrosis, Malaise; Vomiting
Abdominal pain upper, Chills, Headache, Hyperhidrosis, Malaise; Vomiting
|
Started with uncontrollable body shivers. Then also I got a severe stomach ache and severe headache....
Started with uncontrollable body shivers. Then also I got a severe stomach ache and severe headache. Then I started sweating an incredible amount. I had to get up every hour to towel dry my entire body off from sweat. The negative side effects continued from 4 AM Saturday until about 4 AM Sunday. It culminated with me throwing up multiple times. After I threw up, I felt like that was the breaking point and it turned out to be. I started feeling better after that and was able to sleep from 4 AM Sunday until 10 AM Sunday. Then I awoke and even though I felt like I had been very sick, I no longer felt the negative side effects. It was extremely difficult experience to go through and makes me hesitant to get another Covid vaccine. shot.
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| 2867406 | 41 | F | OK | 10/21/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
|
Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria
|
I developed hives and a rash over my entire body. It started on my hands and the crease of my forarm...
I developed hives and a rash over my entire body. It started on my hands and the crease of my forarms and then it spread to my neck chest head fast scalp. The next day the rash moved to my arm pits, arms chest breast and creases where ever. Then the rash lead to my hips back private areas legs and knees and feet. I now have a rash over my entire body that has been consistent since 10/17/25.
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| 2867407 | 60 | F | IN | 10/21/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4928 LN4928 |
Bronchitis, Chest X-ray abnormal, Chills, Cough, Dyspnoea; Headache, Malaise, Pa...
Bronchitis, Chest X-ray abnormal, Chills, Cough, Dyspnoea; Headache, Malaise, Pain, Pyrexia, Respiratory tract congestion
More
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The entire top of my arm area was red with a delineated line separating red from non red. I was not ...
The entire top of my arm area was red with a delineated line separating red from non red. I was not feeling well the next day with fever, chills, aches, pains, headaches. I became sicker as the days progressed with a severe cough and chest congestion and some shortness of breath. I eventually went to urgent care where they did a chest X-ray and said I had inflammatory bronchitis. I received an inhaler and tesalon perles. I was severely sick for over a week.
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| 2867408 | 59 | F | GA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
U8823CA-CP |
Headache, Muscle tightness, Pain, Paraesthesia, Throat tightness
Headache, Muscle tightness, Pain, Paraesthesia, Throat tightness
|
Had tightness in neck/throat with original symptoms at 11:15 am. Around 1:30 pm experienced tingling...
Had tightness in neck/throat with original symptoms at 11:15 am. Around 1:30 pm experienced tingling in face, compared to numbness like dentist visits. Went to urgent care around 2:00, received a shot (Decadron) and started Prednisone on 10/16/2025. The face tingling continued the entire evening of 10/15/2025. Had mild body aches on night of 10/16/2025. Had headache every day since 10/15/2025. (Possibly due to steroids and elevated blood sugars or flu shot.)
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| 2867409 | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Lichen planus
Lichen planus
|
Lichens Planus; This is a spontaneous report received from a Pharmacist from medical information tea...
Lichens Planus; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "Lichens Planus". Additional information: One prescriber felt there could be a relation between the Covid vaccine and Lichens Planus. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2867410 | 75 | F | AR | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Fatigue
Fatigue
|
Extreme and incapacitating fatigue
Extreme and incapacitating fatigue
|
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| 2867411 | 57 | F | MA | 10/21/2025 |
FLU3 FLU3 PNC20 PNC20 |
SEQIRUS, INC. SEQIRUS, INC. PFIZER\WYETH PFIZER\WYETH |
|
Balance disorder, Blood test, Eye pain, Headache, Middle ear effusion; Nasophary...
Balance disorder, Blood test, Eye pain, Headache, Middle ear effusion; Nasopharyngitis, Sleep disorder, Visual impairment, Vomiting; Balance disorder, Blood test, Eye pain, Headache, Middle ear effusion; Nasopharyngitis, Sleep disorder, Visual impairment, Vomiting
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|
having history of head twinges. Fifteen minutes after vaccination her head started twinging. She dev...
having history of head twinges. Fifteen minutes after vaccination her head started twinging. She developed a severe headache and and pain in her eye then had trouble with vision in her right eye. She then developed fluid in her right ear. She is now off balance and feeling like she will fall. Sleeping only a couple of hours at a time due to waking up with severe head pain. Takes Tylenol for the pain that helps very little. The pain from her headache is causing her vomit. She saw a healthcare provider and has been ordered to have a CT that she will have in a few days from now. She went ER. to be seen. She was discharged without a CT and wasctold she probably had a head cold. She continues to have these symptoms and they are getting worse.
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| 2867412 | 24 | F | TN | 10/21/2025 |
COVID19 |
MODERNA |
|
Lymphadenopathy
Lymphadenopathy
|
Axillary adenopathy
Axillary adenopathy
|
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| 2867413 | 75 | M | MI | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
na4457 |
Dyspnoea, Myalgia, Peripheral swelling, Sleep disorder, Tenderness
Dyspnoea, Myalgia, Peripheral swelling, Sleep disorder, Tenderness
|
Pt called and stated he was having side effects from covid vaccine. He stated he had a swollen arm a...
Pt called and stated he was having side effects from covid vaccine. He stated he had a swollen arm and tender to the touch. He state he was up all night didn't get much sleep and also muscle aches. He also stated he had a little troubles breathing but is better today. I stated if it worsens he should go to the emergency room
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| 2867414 | 74 | M | VA | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
346353 |
Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extrem...
Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extremity
More
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Patient reported to clinic after receiving his vaccine with complaints of left arm stiffness, dimini...
Patient reported to clinic after receiving his vaccine with complaints of left arm stiffness, diminished range of motion and radiating pain down his arm.
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| 2867416 | 73 | M | FL | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
407261 |
Erythema
Erythema
|
patient presented to the pharmacy on 10/17/2025 with redness all over his right arm. He claimed he r...
patient presented to the pharmacy on 10/17/2025 with redness all over his right arm. He claimed he received a vaccine on 10/15/2025 which caused the red spots to appear all over his arm. He said everything was ok after receiving the vaccine but he mentioned after receiving the flu-shot he noticed two red spots appeared on his arm. He mentioned within 48 hours he had way more red spots on his arm. He came to the conclusion that the only thing that could've caused this was the vaccine that he received on the same arm on 10/15/2025. He did show his doctor his arm with the red spots and the doctor advised him to come to the pharmacy for further evaluation. Pharmacist noticed patient arms has multiple red spots. The patient requested the NDC number for the vaccine he received and the pharmacist provided it to him. He mentioned that he purchased hydrocortisone over the counter at pharmacy for his arm and he will keep using that to help with the red spots. He was not upset but wanted to report what he thought was the cause of his reaction which is the flu shot.
More
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| 2867417 | 37 | F | AZ | 10/21/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Pain
Arthralgia, Pain
|
Prolonged pain in left shoulder, onset within 48 hours of vaccine. Now lasting 2,5 weeks. Full range...
Prolonged pain in left shoulder, onset within 48 hours of vaccine. Now lasting 2,5 weeks. Full range of motion possible, but some movements are painful. Worse in morning. Sudden shooting pain on some movements, feels like nerve pain.
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| 2867419 | 90 | M | MN | 10/21/2025 |
COVID19 |
MODERNA |
3052553 |
No adverse event, Underdose
No adverse event, Underdose
|
No adverse reaction, just was given the pediatric dose instead of the adult dose. Called the CDC for...
No adverse reaction, just was given the pediatric dose instead of the adult dose. Called the CDC for guidance and gave the patient a second pediatric dose as recommended for the full volume of 0.5 mL.
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| 2867420 | 14 | M | CA | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Headache, Tachycardia
Headache, Tachycardia
|
Mother state roughly 8-12 hours post vaccination, patient was having elevated heart rate for few hou...
Mother state roughly 8-12 hours post vaccination, patient was having elevated heart rate for few hours and experiencing tachycardia and headaches. Patient was admitted to the emergency room and was monitored for signs of myocarditis. Per mother, patient was back to normal ~24 hours later.
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| 2867421 | 73 | F | MS | 10/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MD3414 MD3414 |
Asthenia, Computerised tomogram, Fatigue, Full blood count abnormal, Joint swell...
Asthenia, Computerised tomogram, Fatigue, Full blood count abnormal, Joint swelling; Pyrexia, Rash
More
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Fever, weakness, migrating rashes, migrating swollen joints, (Hands, wrist, knees, ankles, overwhelm...
Fever, weakness, migrating rashes, migrating swollen joints, (Hands, wrist, knees, ankles, overwhelming fatigue
More
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| 2867422 | 66 | F | OH | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Arthralgia, Back pain, Injected limb mobility decreased, Pain, Pain in extremity
Arthralgia, Back pain, Injected limb mobility decreased, Pain, Pain in extremity
|
Vaccine was administered in my right arm. Approximately 1 hour after receiving vaccine, I was unabl...
Vaccine was administered in my right arm. Approximately 1 hour after receiving vaccine, I was unable to left might arm without assistance from my left arm. Pain in my arm has continued daily and sometime radiates into my shoulder and upper back.
More
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| 2867424 | 10 | M | AL | 10/21/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
sef45 |
Anaphylactic reaction, Flushing, Throat tightness, Urticaria
Anaphylactic reaction, Flushing, Throat tightness, Urticaria
|
Pt had an Anaphylactic episode. Complained of closing air way, hives on limbs, flushing in face.
Pt had an Anaphylactic episode. Complained of closing air way, hives on limbs, flushing in face.
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| 2867426 | 47 | M | MA | 10/21/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Arthralgia, Injected limb mobility decreased, Injection site pain, Injection sit...
Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
More
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Within 24 hours developed left upper arm/shoulder pain and tenderness at site of injection/upper del...
Within 24 hours developed left upper arm/shoulder pain and tenderness at site of injection/upper deltoid region. Progressed to include swelling at site and decreased range of motion due to pain (forward elevation, abduction of arm) within few days-1 week. Symptoms slightly improved but have continued to persist now 3 weeks post vaccination.
More
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| 2867428 | 73 | M | MN | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
Unknown |
Condition aggravated, Insomnia
Condition aggravated, Insomnia
|
Severely worsened sleep issues (insomnia)
Severely worsened sleep issues (insomnia)
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| 2867429 | 30 | F | PA | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
5RE93 |
Urticaria
Urticaria
|
Hives about 45 minutes post vaccine. I took benadryl. Symptoms resolved by the next day
Hives about 45 minutes post vaccine. I took benadryl. Symptoms resolved by the next day
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| 2867430 | 36 | M | 10/21/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
AX6342A AX6342A |
Arthralgia, Asthenia, Chills, Myalgia, Night sweats; Sleep disorder
Arthralgia, Asthenia, Chills, Myalgia, Night sweats; Sleep disorder
|
Appx 12 hours following administration was woken from sleep with severe, debilitating, diffuse joint...
Appx 12 hours following administration was woken from sleep with severe, debilitating, diffuse joint pain as well as muscle aches, night sweat, and chills
More
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| 2867431 | 85 | M | CA | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Asthenia, Dysstasia, Pyrexia, Tremor
Asthenia, Dysstasia, Pyrexia, Tremor
|
Per patients wife -- Patient woke up at 3AM with 101.4 F fever, patient took 2 Advils and after 40 m...
Per patients wife -- Patient woke up at 3AM with 101.4 F fever, patient took 2 Advils and after 40 min his fever went up to 102.4 with shakes. Patient went to the restroom around 3:30AM but he had no strength to get off the toilet. His wife called 911 and he was hospitalized. The hospital gave the patient IV fluids and told the patient to alternate between ADvil and Tylenol every 3 hours. Patient did this for about a day and his fever went down to 98.5 F.
More
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| 2867432 | 58 | F | MO | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Injection site pruritus, Injection site swelling
Injection site pruritus, Injection site swelling
|
4 days after injection, injection site was still itching. Patient states injection site was greatly ...
4 days after injection, injection site was still itching. Patient states injection site was greatly swollen the day after injection. Patient did not seek medical attention. Patient states the injection site on 10/18/25 was reduced by half from what it was on the day of the injection.
More
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| 2867435 | 7 | M | CT | 10/21/2025 |
COVID19 |
MODERNA |
3052668 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Vaccine given was not age appropriate for the patient. Patient was accidentally given the Moderna Sp...
Vaccine given was not age appropriate for the patient. Patient was accidentally given the Moderna Spikevax 12yr+ instead of the 6m-11yr. No current reactions report, pt mother made aware and will report any adverse reaction. Call the CDC for clinical guidance, due to government shutdown, was told response may take longer than 24hrs.
More
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| 2867438 | 49 | F | CA | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
406994 |
Cough, Fatigue, Pain, Wheezing
Cough, Fatigue, Pain, Wheezing
|
Fatigue followed by cough and wheezing the evening of 10/16 which lasted about an hour. On 10/17 fat...
Fatigue followed by cough and wheezing the evening of 10/16 which lasted about an hour. On 10/17 fatigue continues followed by body aches the remainder of the day. .No fever. On 10/18, fatigue continued but achiness resolved.
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| 2867439 | 69 | F | TN | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8804AA |
Injection site mass, Injection site swelling, Injection site warmth
Injection site mass, Injection site swelling, Injection site warmth
|
As of today, Oct 21, 2025, patient still have a raised lump from where shot was given. It also has a...
As of today, Oct 21, 2025, patient still have a raised lump from where shot was given. It also has a little heat to it. There is no pain or redness.
More
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| 2867440 | 88 | F | MN | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Cough, Diarrhoea, SARS-CoV-2 test negative
Cough, Diarrhoea, SARS-CoV-2 test negative
|
Cough, diarrhea
Cough, diarrhea
|
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| 2867443 | 30 | F | AL | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802LA |
Periorbital swelling, Pruritus, Urticaria
Periorbital swelling, Pruritus, Urticaria
|
Patient supervisor reported that patient broke in hives, puffy eyes, and severe itching about 30 min...
Patient supervisor reported that patient broke in hives, puffy eyes, and severe itching about 30 minutes after receiving the flu vaccine. They administered Benadryl, Zyrtec, and Pepcid. They placed patient in cool area for observation.
More
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| 2867444 | 27 | F | OR | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Chills, Injection site haemorrhage, Injection site pain, Injection site warmth, ...
Chills, Injection site haemorrhage, Injection site pain, Injection site warmth, Nausea
More
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Describes more than usual bleeding from injection, like a capillary was hit. 5 days after injection ...
Describes more than usual bleeding from injection, like a capillary was hit. 5 days after injection became more painful than expected for being that long post-immunization, wondering if delayed reaction, reported chills, nausea, warmth at injection site. Presented for same day appt to have evaluated. -Unsure which manufacturer / brand flu shot was given. Given by employee health at Medical Center
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| 2867445 | 44 | F | AL | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802LA |
Erythema, Pruritus
Erythema, Pruritus
|
Patient supervisor reports that patient got really itchy and turned red about 30 minutes after recei...
Patient supervisor reports that patient got really itchy and turned red about 30 minutes after receiving her vaccine. Her supervisor gave her Pepcid.
More
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| 2867446 | 45 | F | ME | 10/21/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
T9DX2 T9DX2 |
Immediate post-injection reaction, Injected limb mobility decreased, Injection s...
Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder; X-ray limb normal
More
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Injection into right deltoid on 10/1/25 was immediately painful and has continued to be painful. (3 ...
Injection into right deltoid on 10/1/25 was immediately painful and has continued to be painful. (3 weeks to date) Vaccinated has had trouble raising arm above the shoulder level without severe pain and cannot sleep on her right side. X-ray of right shoulder on 10/20/25 was normal. Vaccinated is currently being treated with PT/OT for two weeks with a follow up scheduled after therapy is completed.
More
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| 2867448 | 53 | M | FL | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
948407 |
Arthralgia
Arthralgia
|
Patient reports lingering shoulder pain from 10/7/25 (vaccine date) until 10/16/25 (reported date) a...
Patient reports lingering shoulder pain from 10/7/25 (vaccine date) until 10/16/25 (reported date) and states it started since the vaccine was administered. Patient states he will follow up with urgent care to obtain imaging to rule out shoulder injury.
More
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| 2867449 | 9 | F | WA | 10/21/2025 |
COVID19 |
MODERNA |
3052741 |
Fatigue, Incorrect dose administered, Malaise, Pain in extremity
Fatigue, Incorrect dose administered, Malaise, Pain in extremity
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An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for th...
An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for the patient. The patient received Moderna Spikevax 12+ years (0.5mL) instead of the intended Moderna Spikevax 6 months?11 years (0.25mL) formulation. Following discovery of the error, I contacted both the vaccine manufacturer (Moderna) and the CDC for guidance. Per their recommendation, the administered dose is considered valid, and no repeat vaccination is required. The patient may, however, experience increased side effects such as fever, fatigue, headache, or localized injection site reactions. ? Will notify patient?s parent of the incident and advised on possible side effects, symptom monitoring, and when to seek medical attention if needed. ? -Called and spoke to patient's mother who reported that patient felt tired and "crummy" for approximately 24 hours after receiving the vaccine. Mom asked patient how she was feeling while on the phone with me and patient told mom her arm was still a little sore but otherwise felt fine.
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| 2867451 | 44 | F | ND | 10/21/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
N9CS2 N9CS2 |
Arthralgia, Blood pressure increased, Headache, Heart rate increased, Swollen to...
Arthralgia, Blood pressure increased, Headache, Heart rate increased, Swollen tongue; Vomiting
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swelling of the tongue within a few minutes (sent to ER), received epi and prednisone. Blood pressur...
swelling of the tongue within a few minutes (sent to ER), received epi and prednisone. Blood pressure and heart rate were high in the ER. She has been having headaches, emesis, joint pain since.
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| 2867452 | 76 | F | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
407981 |
Inflammation, Pain
Inflammation, Pain
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15-20 minutes after receiving vaccine, patient says she felt a burning pain and feeling of inflammat...
15-20 minutes after receiving vaccine, patient says she felt a burning pain and feeling of inflammation through her left axilla and into the front and back of her ribs. Over the next few days, the feeling of pain and inflammation spread to her neck muscles, jaw muscles, and hip muscles all on her left side.
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| 2867453 | 5 | F | WA | 10/21/2025 |
COVID19 |
MODERNA |
3052741 |
Incorrect dose administered, Malaise
Incorrect dose administered, Malaise
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An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for th...
An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for the patient. The patient received Moderna Spikevax 12+ years (0.5mL) instead of the intended Moderna Spikevax 6 months?11 years (0.25mL) formulation. ? Following discovery of the error, I contacted both the vaccine manufacturer (Moderna) and the CDC for guidance. Per their recommendation, the administered dose is considered valid, and no repeat vaccination is required. The patient may, however, experience increased side effects such as fever, fatigue, headache, or localized injection site reactions. ? Will notify patient?s parent of the incident and advised on possible side effects, symptom monitoring, and when to seek medical attention if needed. ? - Called and spoke to patient?s father who reported that patient felt ?crummy? for approximately 24 hours after receiving the vaccine, which he noted was unusual as she did not experience any side effects after her previous dose. He stated that she is otherwise doing well at this time.
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| 2867455 | 10 | M | WA | 10/21/2025 |
COVID19 |
MODERNA |
3052741 |
Incorrect dose administered
Incorrect dose administered
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An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for th...
An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for the patient. The patient received Moderna Spikevax 12+ years (0.5mL) instead of the intended Moderna Spikevax 6 months?11 years (0.25mL) formulation. Following discovery of the error, I contacted both the vaccine manufacturer (Moderna) and the CDC for guidance. Per their recommendation, the administered dose is considered valid, and no repeat vaccination is required. The patient may, however, experience increased side effects such as fever, fatigue, headache, or localized injection site reactions. ? Will notify patient?s parent of the incident and advised on possible side effects, symptom monitoring, and when to seek medical attention if needed.
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| 2867457 | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pruritus, Rash
Pruritus, Rash
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rash; itchy; This is a spontaneous report received from a Consumer or other non HCP. Other Case iden...
rash; itchy; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790242 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 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: PRURITUS (non-serious) with onset 2025, outcome "unknown", described as "itchy"; RASH (non-serious) with onset 2025, outcome "unknown". Additional information: Reporter stated, "I was looking for the mNEXSPIKE myself and I was having trouble finding it. I went to something our town had and they did not have it. They didn't have Moderna. They only had Pfizer and I couldn't do Pfizer. I mean, I just have a bad reaction. My arm didn't like it. Alright, so I was actually. And so I've only gotten Moderna of late." Reporter added, "No, it's not with Moderna though it's a Pfizer. I just didn't take Pfizer anymore." Reporter provided "just a rash" and "itchy." Caller did not want to provide additional information and stated, "it's my private medical information and it had to do with Pfizer. It had nothing to do with Moderna, so it's really not any of Moderna's business. "When further asked about rash, Reporter stated, "Right, it just was really itchy. That's all. It's not anything life threatening or dangerous. It's just uncomfortable. It was unknown if the patient experienced any additional symptoms/events. Relatedness: Non-Health care professional did not provide any causality assessment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2867458 | 7 | F | WA | 10/21/2025 |
COVID19 |
MODERNA |
3052741 |
Incorrect dose administered, Malaise
Incorrect dose administered, Malaise
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An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for th...
An incorrect vaccine formulation was administered, resulting in a higher-than-authorized dose for the patient. The patient received Moderna Spikevax 12+ years (0.5mL) instead of the intended Moderna Spikevax 6 months?11 years (0.25mL) formulation. ? Following discovery of the error, I contacted both the vaccine manufacturer (Moderna) and the CDC for guidance. Per their recommendation, the administered dose is considered valid, and no repeat vaccination is required. The patient may, however, experience increased side effects such as fever, fatigue, headache, or localized injection site reactions. ? Will notify patient?s parent of the incident and advised on possible side effects, symptom monitoring, and when to seek medical attention if needed. ? - Called and spoke to patient?s father who reported that patient felt ?crummy? for approximately 24 hours after receiving the vaccine, which he noted was unusual as she did not experience any side effects after her previous dose. He stated that she is otherwise doing well at this time.
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| 2867459 | 46 | F | PR | 10/21/2025 |
COVID19 HEPAB |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3052549 f95hb |
Diarrhoea, Nausea, Pyrexia, Vomiting; Diarrhoea, Nausea, Pyrexia, Vomiting
Diarrhoea, Nausea, Pyrexia, Vomiting; Diarrhoea, Nausea, Pyrexia, Vomiting
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A call was received from (name withheld) at (name withheld) Hospital stating that patient arrived at...
A call was received from (name withheld) at (name withheld) Hospital stating that patient arrived at the hospital complaining of vomiting, diarrhea, nausea, and fever. After treatment, it was determined that these were adverse reactions to the vaccines she had received.
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