| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2858596 | 37 | M | SC | 09/14/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8252AA U8252AA |
Asthenia, Bursitis, Inflammation, Injected limb mobility decreased, Joint range ...
Asthenia, Bursitis, Inflammation, Injected limb mobility decreased, Joint range of motion decreased; Magnetic resonance imaging abnormal, Pain, Periarthritis, Shoulder injury related to vaccine administration
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|
Pain, inflammation, loss of range of motion, weakness, immobility of left arm started immediately a...
Pain, inflammation, loss of range of motion, weakness, immobility of left arm started immediately after vaccine administration on 27 May 2025. After two days member noticed symptoms were not going away. Member took ibuprofen 400mg with minimal relief. Member went to ER on 03 June and was told that it was not an urgent issue and was referred to an orthopedic. On 10 June 2025 member went to ortho where member was diagnosed with Shoulder Injury Related to Vaccine Administration and was referred to physical therapy. Member is still doing physical therapy as of 14 September with minimal positive results. Member had follow up with ortho doctor and received an MRI and was diagnosed with adhesive capsulitis and bursitis.
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| 2858597 | 38 | F | CA | 09/14/2025 |
COVID19 |
MODERNA |
3052550 |
Conjunctivitis
Conjunctivitis
|
Pink eye.
Pink eye.
|
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| 2858598 | 63 | F | NM | 09/14/2025 |
COVID19 |
MODERNA |
008B21A |
Eczema
Eczema
|
Eczema on right foot
Eczema on right foot
|
โ | |||||
| 2858599 | 75 | F | VA | 09/14/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Asthenia, Chest discomfort, Chills, Disturbance in attention, Dyspnoea; Fatigue,...
Asthenia, Chest discomfort, Chills, Disturbance in attention, Dyspnoea; Fatigue, Gait disturbance, Headache, Oropharyngeal pain, Pain; Pyrexia, Respiratory tract congestion, Rhinorrhoea
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|
Extreme fatigue and weakness. Fever in low 100s. Chills. Headache. Unable to focus for long. Unable ...
Extreme fatigue and weakness. Fever in low 100s. Chills. Headache. Unable to focus for long. Unable to stand for long. Chest very tight. An effort to breathe. Congestion. Sore throat. Runny nose. Body aches.
More
|
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| 2858600 | 49 | F | CO | 09/14/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FC3184 FC3184 FE3592 FE3592 |
Asthma, Computerised tomogram, Depression, Drug hypersensitivity, Eosinophil cou...
Asthma, Computerised tomogram, Depression, Drug hypersensitivity, Eosinophil count increased; Mast cell activation syndrome, Nasal polyps, Obesity, Sinusitis, Weight increased; Asthma, Computerised tomogram, Depression, Drug hypersensitivity, Eosinophil count increased; Mast cell activation syndrome, Nasal polyps, Obesity, Sinusitis, Weight increased
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Developed asthma, salicylate intolerance, severe aspirin allergy, pansinsitus, nasal polyps, obesi...
Developed asthma, salicylate intolerance, severe aspirin allergy, pansinsitus, nasal polyps, obesity (gained 100 pounds with very little food intake), depression, MAST cell activation syndrome.
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|
โ | |||||
| 2858601 | 21 | F | MA | 09/14/2025 |
COVID19 |
NOVAVAX |
6024MF020 |
Chest pain, Dyspnoea, Fibrin D dimer, Inflammation, Palpitations
Chest pain, Dyspnoea, Fibrin D dimer, Inflammation, Palpitations
|
Inflammation, Chest pain, Shortness of breath, Palpitations
Inflammation, Chest pain, Shortness of breath, Palpitations
|
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| 2858602 | 19 | M | PA | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ca |
Dizziness, Loss of consciousness
Dizziness, Loss of consciousness
|
patient got dizzy and unconscious for few minutes
patient got dizzy and unconscious for few minutes
|
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| 2858603 | 63 | M | OH | 09/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
|
Abdominal discomfort, Arthralgia, Asthenia, Chills, Diarrhoea; Fatigue, Headache...
Abdominal discomfort, Arthralgia, Asthenia, Chills, Diarrhoea; Fatigue, Headache, Myalgia
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headache, muscle and joint pain, feeling tired and weak, upset stomach and diarrhea and chills
headache, muscle and joint pain, feeling tired and weak, upset stomach and diarrhea and chills
|
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| 2858604 | 79 | F | NM | 09/14/2025 |
COVID19 |
MODERNA |
|
Injection site pain, Injection site warmth
Injection site pain, Injection site warmth
|
The patient came in 5 days after vaccination with MNexspike. The patient has red, slightly warm and ...
The patient came in 5 days after vaccination with MNexspike. The patient has red, slightly warm and tender to touch square ish erythema on right upper arm. It starts almost to armpit and extends about 5 inches to middle upper arm. She states, it seems to be getting better.
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|
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| 2858605 | 80 | M | OR | 09/14/2025 |
COVID19 PNC20 TDAP |
MODERNA PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
3051997 LX2498 F9K3L |
Arthralgia; Arthralgia; Arthralgia
Arthralgia; Arthralgia; Arthralgia
|
HAD SEVERE PAIN IN BOTH SHOULDERS AT THE UPPER BONY PART
HAD SEVERE PAIN IN BOTH SHOULDERS AT THE UPPER BONY PART
|
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| 2858606 | 70 | F | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
Rash
Rash
|
Rash on left arm and chest
Rash on left arm and chest
|
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| 2858607 | 82 | F | ME | 09/14/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
F59KR LL8391 |
Extra dose administered, Pain in extremity; Extra dose administered, Pain in ext...
Extra dose administered, Pain in extremity; Extra dose administered, Pain in extremity
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|
Patient received the first RSV vaccination on 10/2/23 as Arexvy. She then received a later RSV vacci...
Patient received the first RSV vaccination on 10/2/23 as Arexvy. She then received a later RSV vaccination on 9/3/25 as Abrysvo. The only adverse event that the patient reported after either instance was a sore arm.
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| 2858608 | 30 | F | PA | 09/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 U8832BA |
Eye pain; Eye pain
Eye pain; Eye pain
|
PT STATES SHE STARTED EXPERIENCING EYE PAIN. SHE STATED IT BEGAN APPROX 9/13/25. SHE IS ON DAY 2 OF ...
PT STATES SHE STARTED EXPERIENCING EYE PAIN. SHE STATED IT BEGAN APPROX 9/13/25. SHE IS ON DAY 2 OF EYE PAIN THAT IS PROGRESSIVELY WORSENING. SHE HAS A CALL INTO HER OPTHAMOLOGIST FOR FURTHER REVIEW.
More
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| 2858609 | 65 | F | TN | 09/14/2025 |
PNC20 |
PFIZER\WYETH |
LG5575 |
Extra dose administered, Fatigue
Extra dose administered, Fatigue
|
Patient was given vaccine twice when she should have received it once. Got it on 11/2024 and was giv...
Patient was given vaccine twice when she should have received it once. Got it on 11/2024 and was given it again on 9/12/2025. Patient reports just tiredness as a symptom
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| 2858610 | 50 | M | MO | 09/14/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Hypoaesthesia oral, Mouth swelling, Paraesthesia oral, Pruritus, Rash; Rash vesi...
Hypoaesthesia oral, Mouth swelling, Paraesthesia oral, Pruritus, Rash; Rash vesicular, Swollen tongue
More
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Mouth and tongue numbness and tingling and swelling. Whole body chickenpox type rash and itching on ...
Mouth and tongue numbness and tingling and swelling. Whole body chickenpox type rash and itching on whole body.
More
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| 2858611 | 67 | F | TX | 09/14/2025 |
COVID19 FLU3 PNC20 RSV |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
MY9547 U8800AA LP4948 5F5XK |
Dizziness, Gait inability, Hallucination, Urinary incontinence; Dizziness, Gait ...
Dizziness, Gait inability, Hallucination, Urinary incontinence; Dizziness, Gait inability, Hallucination, Urinary incontinence; Dizziness, Gait inability, Hallucination, Urinary incontinence; Dizziness, Gait inability, Hallucination, Urinary incontinence
More
|
patient states having hallucinations of bed on fire, extreme dizziness, inability to walk due to diz...
patient states having hallucinations of bed on fire, extreme dizziness, inability to walk due to dizziness, and urinary incontinence due to not being able to walk to bathroom day of vaccination. stated feeling better today, but still experiencing some dizziness.
More
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| 2858612 | 68 | M | FL | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
Extra dose administered
Extra dose administered
|
Duplicate administration
Duplicate administration
|
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| 2858613 | 84 | F | IA | 09/14/2025 |
FLU3 |
SEQIRUS, INC. |
407252 |
Erythema, Skin warm, Tenderness
Erythema, Skin warm, Tenderness
|
Patient exhibits redness, slight warmth, and somewhat painful to the touch
Patient exhibits redness, slight warmth, and somewhat painful to the touch
|
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| 2858614 | 69 | F | TX | 09/14/2025 |
FLU3 RSV |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
407256 24M94 |
Cellulitis, Erythema, Limb discomfort, Peripheral swelling; Cellulitis, Erythema...
Cellulitis, Erythema, Limb discomfort, Peripheral swelling; Cellulitis, Erythema, Limb discomfort, Peripheral swelling
More
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pt had 2 vaccines that day. She had no problems in the arm of the flu vaccine. Pt reported discomfor...
pt had 2 vaccines that day. She had no problems in the arm of the flu vaccine. Pt reported discomfort, erythema and swelling in the Right arm ( where Arexvy was injected). Pt said she followed up with her Doctor and she was told she has cellulitis
More
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| 2858616 | 74 | F | FL | 09/14/2025 |
RSV TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 793PT |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
Pt was given another dose of Arexvy on 9/12/25, after previously getting one on 10/23/2023. To repor...
Pt was given another dose of Arexvy on 9/12/25, after previously getting one on 10/23/2023. To report, pt has had no known side effects from the vaccination. Pt made an appointment for another dose. RPh questioned why pt was getting one before the age of 75 and pt reported having severe lung disease putting her at increased risk. RPh did not go back far enough into her history to see the previous dose.
More
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| 2858617 | 75 | M | TX | 09/14/2025 |
COVID19 PNC21 |
PFIZER\BIONTECH MERCK & CO. INC. |
MY9547 Z006889 |
Erythema, Malaise, Pyrexia, Skin warm; Erythema, Malaise, Pyrexia, Skin warm
Erythema, Malaise, Pyrexia, Skin warm; Erythema, Malaise, Pyrexia, Skin warm
|
PATIENT RECIEVED BOTH VACCINES IN SAME ARM (AND ONE IN THE OTHER ARM) - THE FOLLOWING DAY, FELT ILL ...
PATIENT RECIEVED BOTH VACCINES IN SAME ARM (AND ONE IN THE OTHER ARM) - THE FOLLOWING DAY, FELT ILL WITH FEVER AND MALAISE. TODAY CAME INTO PHARMACY - 3 DAYS POST VACCINATION - WITH REDNESS AND HEAT DOWN THE ARM - UPPER AND FOREARM -BUT IMPROVEMENT IN SYSTEMIC SYMPTOMS . ADVISED COLD PACKS/TYLENOL/IBUPROFEN -WATCH FOR S/S OF INFECTION AND FOLLOW UP WITH MD PRN. RETURN OR CALL PHARMACY IF FURTHER QUESTIONS OR CHANGES THAT DO NOT INDICATE IMPROVEMENT
More
|
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| 2858618 | 0.75 | M | NJ | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8523ba |
Injection site nodule
Injection site nodule
|
A hard elevated nodule developed at the injection site. The size of the nodule was probably the dia...
A hard elevated nodule developed at the injection site. The size of the nodule was probably the diameter of a quarter. This bump began developing within 24 hours of vaccination and took over a month to begin resolving. As of 12/9/25 the nodule had started reducing in size, however it took approximately 2 months for the nodule and to disappear entirely.
More
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| 2858619 | 67 | M | TX | 09/14/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3051998 ut8763ga |
Chills, Muscle tightness, Tremor; Chills, Muscle tightness, Tremor
Chills, Muscle tightness, Tremor; Chills, Muscle tightness, Tremor
|
9/13 pt got the vaccines then went to brunch with his family. once he came home, he had the shakes, ...
9/13 pt got the vaccines then went to brunch with his family. once he came home, he had the shakes, as in extreme shakiness with tight muscles like he was going through withdrawal and cold chills. No other symptoms. He went outside to sit in the heat for about 45mins that helped it a little. pharmacist advised him to take a tylenol. 9/14, pharmacist called to check in. He's feeling much better but still a little tired.
More
|
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| 2858620 | 62 | F | AL | 09/14/2025 |
COVID19 |
MODERNA |
3051997 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
|
Small patch of red and itchy skin at injection site that began day after receiving vaccine. Still oc...
Small patch of red and itchy skin at injection site that began day after receiving vaccine. Still occurring on day reported to pharmacy.
More
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| 2858621 | 70 | F | 09/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
Incorrect gave duplicate dose. Previously received vaccine on 9/21/2024. Patient not indicated to re...
Incorrect gave duplicate dose. Previously received vaccine on 9/21/2024. Patient not indicated to receive vaccine
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| 2858622 | 82 | F | FL | 09/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
H4K3S |
Extra dose administered
Extra dose administered
|
PATIENT WAS GIVEN THIS VACCINE BUT ALREADY HAD ONE LAST YEAR ON 09/14/2024
PATIENT WAS GIVEN THIS VACCINE BUT ALREADY HAD ONE LAST YEAR ON 09/14/2024
|
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| 2858623 | 34 | F | TN | 09/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PD324 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
patient was given dose of tdap when she had received a tdap less than 5 years prior on 4/15/24. This...
patient was given dose of tdap when she had received a tdap less than 5 years prior on 4/15/24. This was not disclosed by patient and was not recognized until after the vaccine had been administered. No symptoms/side effects.
More
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| 2858624 | 64 | M | CO | 09/14/2025 |
COVID19 |
JANSSEN |
202A21A |
Echocardiogram, Heart valve incompetence, Laboratory test, Mitral valve prolapse...
Echocardiogram, Heart valve incompetence, Laboratory test, Mitral valve prolapse, Mitral valve repair
More
|
After the shot I was diagnosed with mitral valve prolapse and had to have surgery to repair the valv...
After the shot I was diagnosed with mitral valve prolapse and had to have surgery to repair the valve as it was leaking.
More
|
โ | |||||
| 2858625 | 67 | F | CO | 09/14/2025 |
COVID19 |
JANSSEN |
202A21A |
Aortic thrombosis, Echocardiogram, International normalised ratio
Aortic thrombosis, Echocardiogram, International normalised ratio
|
After I received my Covid 19 shots and moved I was diagnosed with a clot in my aorta and currently g...
After I received my Covid 19 shots and moved I was diagnosed with a clot in my aorta and currently going through INR testing to see if anything can be done to reduce the size of the clot.
More
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| 2858626 | 46 | F | CA | 09/14/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5EF45 5EF45 |
Brain fog, Chills, Dyspnoea, Headache, Nausea; Photopsia, Presyncope
Brain fog, Chills, Dyspnoea, Headache, Nausea; Photopsia, Presyncope
|
Immediately upon standing, she experienced presyncope, visual disturbances described as "seeing...
Immediately upon standing, she experienced presyncope, visual disturbances described as "seeing stars," and dyspnea. She self-administered Benadryl 25 mg due to severe rigors. Despite this, rigors persisted, and she was advised by the rapid response nurse and on-call physician to take an additional 25 mg of Benadryl, totaling 50 mg. Her symptoms improved, but she was transported to the ED for further evaluation. She was monitored in the ED without further treatment needed. She has had persistent brain fog, headache, and nausea even though it's been more than a week. This plus the idiopathic urticaria which started a few weeks before vaccination suggest possible mast cell activation syndrome.
More
|
โ | |||||
| 2858627 | 79 | F | 09/14/2025 |
FLU3 |
SEQIRUS, INC. |
407242 |
Asthenia
Asthenia
|
patient said right after she go the vaccine she was unable to get out of bed and experienced general...
patient said right after she go the vaccine she was unable to get out of bed and experienced generalized weakness and was in bed from 9/12 -9/14 (9/12 is when she got the vaccine) unknown what she did to feel better but she did say this is the first time she has ever experienced this considering she gets this vaccine yearly and was always fine afterwards.
More
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| 2858628 | 47 | F | GA | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8823AA |
Injection site bruising, Injection site swelling
Injection site bruising, Injection site swelling
|
PATIENT COMPLAINS OF SWELLING AT SITE AND BRUISING
PATIENT COMPLAINS OF SWELLING AT SITE AND BRUISING
|
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| 2858629 | 64 | F | KS | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8800BA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
The patient completed the Vaccine consent paperwork and under the AGE she put 65 years old, Her date...
The patient completed the Vaccine consent paperwork and under the AGE she put 65 years old, Her date of birth is XXXX, so she was 64 years old at the time the vaccine was given.
More
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| 2858630 | 64 | F | MA | 09/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Incorrect route of product administration, Injection site erythema, Injection si...
Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site warmth
More
|
Red Hot very sore large raised tissue/skin from the flu shot given subcutaneous
Red Hot very sore large raised tissue/skin from the flu shot given subcutaneous
|
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| 2858664 | 25 | M | KY | 09/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
H4k3s |
Dizziness, Pallor, Tinnitus
Dizziness, Pallor, Tinnitus
|
Patient received vaccine, left the pharmacy area and went to lawn and garden, and started experienci...
Patient received vaccine, left the pharmacy area and went to lawn and garden, and started experiencing ringing in the ears and dizziness. He returned to the pharmacy and we had him sit down. He said he may have had a panic attack but wasn't sure. He was pale when he came back. After he sat he started to feel better and then symptoms went away. He sat approximately 20 minutes.
More
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| 2858665 | 11 | M | OK | 09/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8779NA |
Asthenia, Dizziness, Hyperhidrosis, Pallor
Asthenia, Dizziness, Hyperhidrosis, Pallor
|
Approximately 4 minutes after receiving a flu shot, the patient became dizzy and weak. Parent broug...
Approximately 4 minutes after receiving a flu shot, the patient became dizzy and weak. Parent brought the patient back to the pharmacy where patient sat on a bench. He seemed pale and was sweating and seemed like he might pass out. No problem with breathing. Applied ice pack to the back of neck and wet paper towels to the forehead. Patient remained able to speak and respond. Patient fully recovered within approximately 10 minutes. Remained at the pharmacy for approximately 15 more minutes after that. Patient was nervous before receiving the flu shot so this may have been a reaction from that.
More
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| 2858666 | 15 | M | WA | 09/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9547 U8823CA |
Head injury, Loss of consciousness, Muscle spasms; Head injury, Loss of consciou...
Head injury, Loss of consciousness, Muscle spasms; Head injury, Loss of consciousness, Muscle spasms
More
|
Patient received Covid shot in the left arm, then after receiving the flu shot patient passed out in...
Patient received Covid shot in the left arm, then after receiving the flu shot patient passed out in chair for 5 seconds then woke up. Patient seemed to have full body spasm upon waking and bumped his head on furniture.
More
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| 2858667 | 48 | F | TX | 09/14/2025 |
COVID19 |
MODERNA |
|
Herpes zoster
Herpes zoster
|
I have had four outbreaks of shingles since the vaccine. I am perfectly healthy other than that.
I have had four outbreaks of shingles since the vaccine. I am perfectly healthy other than that.
|
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| 2858668 | 75 | F | WA | 09/14/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9587 |
Vertigo
Vertigo
|
Severe vertigo for 6 hrs after the 7th booster for COVID
Severe vertigo for 6 hrs after the 7th booster for COVID
|
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| 2858669 | 34 | F | TN | 09/14/2025 |
ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
|
Erythema, Fatigue, Headache, Muscle swelling, Nodule; Pain, Swelling
Erythema, Fatigue, Headache, Muscle swelling, Nodule; Pain, Swelling
|
Redness swelling pain soreness fatigue headache and large knot/bump in muscle
Redness swelling pain soreness fatigue headache and large knot/bump in muscle
|
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| 2858670 | 21 | F | KS | 09/14/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Extra dose administered, No adverse event, Wrong product administered
Extra dose administered, No adverse event, Wrong product administered
|
Patient received the wrong vaccine due to multiple miscommunications. Patient intended to receive th...
Patient received the wrong vaccine due to multiple miscommunications. Patient intended to receive the meningitis B vaccine but recieved the meningitis ACWY vaccine. She had previously received 2 doses of the meningitis ACWY vaccine appropriately, so this error gave her an unnecessary 3rd dose. No adverse effects have since been reported by the patient. The patient?s transplant physician was contacted and will follow up with the patient.
More
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| 2858671 | 0.33 | M | WI | 09/14/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
D252F |
Crying, Injection site induration, Injection site nodule, Injection site pain
Crying, Injection site induration, Injection site nodule, Injection site pain
|
Patient developed a hard 3cm nodule in his right thigh and he would cry if pressure was applied. i...
Patient developed a hard 3cm nodule in his right thigh and he would cry if pressure was applied. it was present until February 2025.
More
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| 2858672 | 14 | F | HI | 09/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9547 U8790BA |
Syncope; Syncope
Syncope; Syncope
|
Patient was given a Comirnaty vaccine. She was able to talk during the administration. Patient was...
Patient was given a Comirnaty vaccine. She was able to talk during the administration. Patient was then given a Flublok vaccine. After administration she experience vasovagal syncope. It happened in less than a minute. The patient drank some water and was observed. She was okay to stand up and walk on her own after about 5-10 minutes.
More
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| 2858513 | 09/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
|
pain; This non-serious case was reported by a consumer via interactive digital media and described t...
pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 02-SEP-2025 This case was reported by a patient via interactive digital media. The patient asked about how he/she can stop the pain.
More
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| 2858514 | 44 | F | 09/13/2025 |
HEPAB HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
|
have not received the third dose so far; Late second dose; This non-serious case was reported by a p...
have not received the third dose so far; Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 44-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Received 1st dose of Twinrix vaccine on 22-MAR-2017). On 05-OCT-2017, the patient received the 2nd dose of Twinrix. The patient did not receive the 3rd dose of Twinrix. On 05-OCT-2017, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: have not received the third dose so far). The outcome of the drug dose administration interval too long and incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-AUG-2025 A patient got first dose of Twinrix on 22-Mar-2017 and second dose on 05-Oct-2017 and did not receive the third dose so far.
More
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| 2858516 | F | CA | 09/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0587 TFAA2504 |
Vaccination site discharge, Vaccination site haemorrhage; Vaccination site disch...
Vaccination site discharge, Vaccination site haemorrhage; Vaccination site discharge, Vaccination site haemorrhage
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her bandage was very moist and not just with blood.; her bandage was very moist and not just with bl...
her bandage was very moist and not just with blood.; her bandage was very moist and not just with blood.; This is a spontaneous report received from a Pharmacist from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Lot number: NA0587, Expiration Date: 16Jun2026) intramuscular, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 07Sep2025 as dose number unknown, single (Lot number: TFAA2504) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), VACCINATION SITE DISCHARGE (non-serious) all with onset 07Sep2025, outcome "unknown" and all described as "her bandage was very moist and not just with blood.". Additional information: Patient was administered a Covid vaccine, 2025-2026 formula, over the weekend. When patient got home about 2 hours later, she noticed that her bandage was very moist and not just with blood. It appeared that the vaccine had possibly leaked out onto the bandage and patient is concerned that she did not get the full dose. The pharmacist looked at the bandage as well and there was blood from vaccine on the bandage, but it was difficult to tell if vaccine had leaked out on the bandage as well. Caller wanted to know if Pfizer had reported of there being a defective lot of Comirnaty which might cause vaccine leakage from the needle or syringe. Patient was immunocompromised. Transferring agent stated, "I have a Pharmacist to transfer to you. She is reporting on the Comirnaty, 2025-2026 formula. She states that a patient received the vaccine and two hours later after arriving home, noticed that their band aid was very moist. Patient felt like some of the vaccine might have leaked out of her arm because the bandage was more moist than it just being blood. The bandage was more moist than they are just being blood. The patient felt that the vaccine leaked out of her arm onto the bandage. Patient has a history of being Immunocompromised." Reporter stated, "I just do not have the height. I can guess the height, but I do not have the height." Reporter stated, "The date was Sunday, the 7th (Clarified as 07Sep2025) around noon, but it is around noon, I do not have time in record, but for sure 07Sep2025." Any vaccination on same date or any four weeks prior vaccination: Reporter stated, "Same day vaccination with the Flu shot." (Further details about Flublok not available on which arm Patient got the vaccine, hence Flublok captured as suspect). Name of Flu shot: Reporter stated, "So, patient also got Flublok for the 25-26 season." Other medical conditions and concomitant medications: Reporter stated, "Not that I know of, no, nothing else." Caller, a pharmacist was calling about the Vaccine Comirnaty 2025-2026 formula that was administered to a patient. Caller mentioned that the patient went back to their office claiming that the vaccine was not fully administered since the injection sight was leaking as the band aid was moist. Causality: Reporter stated, "I do not know. I was not the one who administered so, I would not know how much was their vaccine that leaked out. So, in honest with me, I would not know."
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| 2858517 | M | 09/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypoaesthesia, Mobility decreased, Neuropathy peripheral, Pain in extremity, Ren...
Hypoaesthesia, Mobility decreased, Neuropathy peripheral, Pain in extremity, Renal disorder
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he has some numbness and severe pain in his feet/it can be neuropathy; he has some numbness and seve...
he has some numbness and severe pain in his feet/it can be neuropathy; he has some numbness and severe pain in his feet/it can be neuropathy; he has some numbness and severe pain in his feet/his arm would be sore for about a day/it can be neuropathy; After having his COVID shot he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day; he has a lesion on his kidney; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020715 (BioNTech), 2025SA246640 (Sanofi). A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; sarilumab (KEVZARA), at 200 mg (200 mg, every other week), subcutaneous for polymyalgia rheumatica. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid shots (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid shots (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "he has some numbness and severe pain in his feet/it can be neuropathy"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "he has some numbness and severe pain in his feet/his arm would be sore for about a day/it can be neuropathy"; MOBILITY DECREASED (non-serious), outcome "recovering", described as "After having his COVID shot he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day"; RENAL DISORDER (non-serious), outcome "recovering", described as "he has a lesion on his kidney". On an unknown date, the patient reported he has some numbness (unknown latency) and severe pain in his feet (unknown latency). After he takes his injection, he feels better. He has an appointment with new MD (doctor of medicine) on 26Aug2025 as his previous provider passed away. He believes its neuropathy (unknown latency). He currently has three doses on hand. He advised that he now takes his injection every 3 to 4 weeks to make it stretch (unknown latency). Patient reported after the last three doses are taken will try wing himself off. He was uncertain if Kevzara really works (unknown latency). He believes this started when he started taking the COVID shots. After having his COVID shot, he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day (unknown latency). He also stated that he has a lesion on his kidney (unknown latency) that the doctor told him that it was nothing to lose sleep over. The action taken for sarilumab was unknown. At time of reporting, the outcome was not recovered/not resolved for event hypoaesthesia, recovering/resolving for event pain in extremity and unknown for the remaining events. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.
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| 2858518 | 09/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pain
Pain
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sore; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and ge...
sore; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore". Additional information: It was reported that the patient got the Covid shot. While it was sore after it was the best decision for them as a family. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858519 | F | 09/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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lost 2 aunts; This is a spontaneous report received from a Consumer or other non HCP. A female pati...
lost 2 aunts; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "lost 2 aunts". The date and cause of death for the patient were unknown.The patient was asked what 3 things are that Pfizer could immediately do to become more patient-centric that you would notice right away. Answer: "Never, I lost 2 aunts and 2 sisters now have health related issues thanks to the covid vaccine." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500179939 same reporter/drug/AE, different patient;; Reported Cause(s) of Death: Unknown cause of death
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| 2858541 | 58 | F | CA | 09/13/2025 |
FLU3 |
SEQIRUS, INC. |
406986 |
Pruritus
Pruritus
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Patient received flu shot on 9/8/25 and came back to pharmacy on 9/12/25 to report that she was havi...
Patient received flu shot on 9/8/25 and came back to pharmacy on 9/12/25 to report that she was having itching on her hands after the flu shot. Patient contacted doctor and doctor recommended benadryl.
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