| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2716204 | 19 | F | NY | 11/21/2023 |
HPV9 HPV9 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Cardiac monitoring, Echocardiogram, Fatigue, Headache, Postural orthostatic tach...
Cardiac monitoring, Echocardiogram, Fatigue, Headache, Postural orthostatic tachycardia syndrome; Presyncope, Syncope, Tilt table test positive; Autoimmune disorder, Blood pressure decreased, Disturbance in attention, Dizziness, Fatigue; Headache, Loss of consciousness, Loss of personal independence in daily activities, Memory impairment, Pain; Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive; Autoimmune disorder, Blood pressure decreased, Disturbance in attention, Dizziness, Fatigue; Headache, Loss of consciousness, Loss of personal independence in daily activities, Memory impairment, Pain; Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive; Autoimmune disorder, Blood pressure decreased, Disturbance in attention, Dizziness, Fatigue; Headache, Loss of consciousness, Loss of personal independence in daily activities, Memory impairment, Pain; Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive
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After recieving the injection within the next couple of months; experienced fatigue, presyncope, syn...
After recieving the injection within the next couple of months; experienced fatigue, presyncope, syncope and headaches. Visited cardiologist to address concerns and symptoms. Later diagnosed with POTS on 12/27/2023 after enduring a tilt table test, and echo and wearing a heart monitor.
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| 2869383 | 74 | M | NC | 10/29/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Laryngospasm, Muscle spasms
Laryngospasm, Muscle spasms
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Extreme muscle spasms in left leg, especially calf. Laryngospasms. Laryngospasm had not been experie...
Extreme muscle spasms in left leg, especially calf. Laryngospasms. Laryngospasm had not been experienced before. Symptoms subsided after a few minutes.
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| 2869385 | 28 | F | CO | 10/29/2025 |
FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
Not listed on r Not listed on r Not listed on r Not listed on r |
Arthralgia, Axillary pain, Flushing, Hypoaesthesia, Immediate post-injection rea...
Arthralgia, Axillary pain, Flushing, Hypoaesthesia, Immediate post-injection reaction; Inflammation, Injection site pain, Localised oedema, Magnetic resonance imaging normal, Muscle spasms; Musculoskeletal stiffness, Neck pain, Neuralgia, Oedema peripheral, Pain; Paraesthesia, Skin warm
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10/10/2025 Recieved flu shot adminitered by nursing student at flu clinic. Pain was felt with insert...
10/10/2025 Recieved flu shot adminitered by nursing student at flu clinic. Pain was felt with insertion and adminsitration of the flu vaccine. Immediatey following the vaccine administration my arm became warm and my body flushed. My neck became sore and stiff on the left side only. This was the administration side. Pain then radiated from my left neck, to the shoulder. I reported the symptoms to health clinic following these symptoms on 10/10/2025. I was instructed to take ibuprofen and ice. If symtoms worsened to come to be evaluated. on 10/12/2025 with the same symotms as lsited above, I experienced muscle spasm throughtout the shoulder neck and left jaw. In my left shoulder blade and arm felt numbness and tingling. I called the nurse line and reported to the urgent care. I was instructed to contune ibuprofen, heat and ice. I presented back to health clinic on 10/13/2025 with worsening sympstoms of neck pain, stifness and shoulder pain with muscle spasms. I had an MRI of the left sholder on 10/13/2025. The MRI was negative but imflammation and edema was noted. I continued the recommended treatment above with no relief. I was started in physical therapy and medical massage therapy on 10/15/2025. I was prescribed a muscle relaxant. Left hand feels stiff I have reported an increase in the numbess and tingling from the left side of my neck, shoulder and radiating nerve pain down into the arm and hand. I followed up in health clinic on 10/28/2025 and requested further testing due to no relief in my symtoms. I had labs ordered CBC, C-Reactive protein and ESR. I was prescribed oral prenisone. Today, 10/29/2025 I have an EMG nerve test ordered for further evaluation. As of today 10/29/2025 I have numbness, tingling and burning nerve pain in my left neck, shoulder and arm. Swelling and pain noted in the axillary area. Health department contacted for vaccine record. Vaccine brand, lot number and manufactureer not provided on record. Vaccine type selcted was NOT the brand given. Brand unknown.
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| 2869387 | 79 | F | WI | 10/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8847AA |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Patient received a vaccine at around 12:30 at the pharmacy and started to see pain that evening arou...
Patient received a vaccine at around 12:30 at the pharmacy and started to see pain that evening around bedtime. She called the pharmacy 2 days later stating she was in extreme pain and had a lot of swelling at the site. She denied redness or warmness at the site. Pharmacist discussed the patient adding ibuprofen to decrease swelling and to contact primary care. Pharmacist called to check back in later to see how the patient was doing and if she talked to the doctor. She went to see her doctor that day for an appointment and was instructed to take ibuprofen and acetaminophen for pain and inflammation and to follow up with additional issues.
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| 2869388 | 66 | F | PA | 10/29/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3053115 407264 |
Acoustic stimulation tests, Audiogram, Deafness neurosensory, Deafness unilatera...
Acoustic stimulation tests, Audiogram, Deafness neurosensory, Deafness unilateral; Acoustic stimulation tests, Audiogram, Deafness neurosensory, Deafness unilateral
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Woke up the next day with profound hearing loss in right ear. It is sensiorneural hearing loss, diag...
Woke up the next day with profound hearing loss in right ear. It is sensiorneural hearing loss, diagnosed by Dr. on 10/29/25
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| 2869389 | 33 | F | 10/29/2025 |
FLU3 |
SANOFI PASTEUR |
u8823da |
Dysgeusia
Dysgeusia
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Pt reported metallic taste in mouth shortly after getting the vaccine.
Pt reported metallic taste in mouth shortly after getting the vaccine.
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| 2869391 | 24 | F | IN | 10/29/2025 |
FLU3 |
SEQIRUS, INC. |
948409 |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
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Started out as sore with small swollen area night of vaccine, by next morning area had gotten bigger...
Started out as sore with small swollen area night of vaccine, by next morning area had gotten bigger was red and warm also then day 2 after vaccine entire arm from shoulder to elbow was swollen red warm to touch
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| 2869393 | 5 | F | 10/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8881CA |
Aggression, Anxiety, Condition aggravated
Aggression, Anxiety, Condition aggravated
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Behavior change with increased anxiety, outbursts at home and school, aggression (hitting).
Behavior change with increased anxiety, outbursts at home and school, aggression (hitting).
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| 2869394 | 86 | F | FL | 10/29/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
Z009681 |
Injection site erythema, Injection site pruritus, Injection site warmth; Injecti...
Injection site erythema, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site warmth
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Pt came to pharmacy to report an adverse reaction of redness, warm to touch, and itchiness on her le...
Pt came to pharmacy to report an adverse reaction of redness, warm to touch, and itchiness on her left upper arm. The reaction with around the injection area. She said it was like that for a few days. I recommended an antihistamine (she preferred loratadine twice daily), ibuprofen/aleve, and icing. Followed up with customer at 430pm by phone. She said itchiness and warmth has subsided. She will continue to ice, take loratadine, and add aleve.
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| 2869395 | 0.5 | F | OH | 10/29/2025 |
DTPPVHBHPB PNC20 RV5 UNK |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. UNKNOWN MANUFACTURER |
U8265AA LX2498 Z007664 UT8802MA |
Urticaria; Urticaria; Urticaria; Urticaria
Urticaria; Urticaria; Urticaria; Urticaria
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Hives developed shortly (minutes) after vaccine administration. No other allergic symtoms. Resolved ...
Hives developed shortly (minutes) after vaccine administration. No other allergic symtoms. Resolved within 10 minutes. Note: RSV preventative antibody was administered with vaccines. 10/29/2025 -- Left lower vastus lateralis Intramuscular, Sanofi Pasteur, lot UK267AA 3/31/2026
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| 2869397 | 47 | F | CA | 10/29/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
LD9Y5 |
Ophthalmic migraine
Ophthalmic migraine
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ocular migraine starting about 4 hours after administration
ocular migraine starting about 4 hours after administration
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| 2869398 | 11 | F | CO | 10/29/2025 |
FLU3 HEPA HPV9 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
2NG23 MB599 Y018416 Y011017 |
Hypotonia, Pallor; Hypotonia, Pallor; Hypotonia, Pallor; Hypotonia, Pallor
Hypotonia, Pallor; Hypotonia, Pallor; Hypotonia, Pallor; Hypotonia, Pallor
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Patient recieved vaccines at a vaccine clinic event that was hels at her school. After recieving im...
Patient recieved vaccines at a vaccine clinic event that was hels at her school. After recieving immunizations the patient lost color in her face ane eyes closed as she slumped down in the chair. She was caught by her mother, sister and the nurse doing the vaccination. (This writer was not the vaccinator) Patient was placed in the tredelenburg position until her color returned and was feeling more like herself. MOC stated that this same thing happened the last time that she recieved vaccines. Once recovered MOC was given 'After the Shots' hand out with instructions to follow incase the patint were to have other problems once at home.
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| 2869401 | 50 | F | AL | 10/29/2025 |
FLU3 |
SEQIRUS, INC. |
AX5589A |
Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling
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itching, redness, swelling
itching, redness, swelling
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| 2869402 | 67 | M | OH | 10/29/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3053253 4D255 |
Underdose; Underdose
Underdose; Underdose
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Patient given pediatric dosage of Covid-19 immunization, 0.25 mL, instead of adult dosage, 0.5 mL
Patient given pediatric dosage of Covid-19 immunization, 0.25 mL, instead of adult dosage, 0.5 mL
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| 2869403 | 79 | M | MI | 10/29/2025 |
FLU3 |
SEQIRUS, INC. |
407263 |
Immediate post-injection reaction, Renal pain
Immediate post-injection reaction, Renal pain
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Patient complained of kidney pain immediately after vaccine was administered. Patient was observed ...
Patient complained of kidney pain immediately after vaccine was administered. Patient was observed for 30 minutes and seen by NP. blood pressure and pulse were taken. 142/72 hr 76. No shortness of breath or difficulty breathing. Cool wash cloth was applies and patient drink glass of water.
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| 2869404 | 78 | F | OH | 10/29/2025 |
FLU3 VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P327D G2HA7 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Adult patient given Nirsevimab
Adult patient given Nirsevimab
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| 2869406 | 1.5 | F | IL | 10/29/2025 |
COVID19 HEPA |
MODERNA MERCK & CO. INC. |
3053238 Z010429 |
Urticaria; Urticaria
Urticaria; Urticaria
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Urticaria every day, multiple times a day, starting 10/19/25 and ongoing (today is 10/29/25). Site o...
Urticaria every day, multiple times a day, starting 10/19/25 and ongoing (today is 10/29/25). Site of hives varies; face, hands, arms, legs, buttocks, belly, back. Subsides without antihistamines within 20-45 minutes. No respiratory distress detected. No fever at any point following the 2 vaccinations given 10/17/25. Appetite and play normal and unaffected. Just hives several times a day, every day since 10/29/25. Unrelated to dog allergy.
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| 2869407 | 5 | M | NY | 10/29/2025 |
FLU3 |
SEQIRUS, INC. |
409413 |
Cold sweat, Fatigue, Hyperhidrosis, Tremor, Vomiting
Cold sweat, Fatigue, Hyperhidrosis, Tremor, Vomiting
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I gave a flu shot to a 5 year old. He was in the lobby getting his coat on 5 minutes after vaccine a...
I gave a flu shot to a 5 year old. He was in the lobby getting his coat on 5 minutes after vaccine and got really clammy and threw up on the floor. As he was sitting I noticed shaky hands. Asked about what he had to eat/drink. Said he didn't eat a lot of lunch or snack and hadn't had a lot to drink. He ate some animal crackers and drank a small water bottle. He stopped sweating, shaking subsided, and felt better after about 5 minutes. Maintained consciousness the entire time. Within a minute of standing he started sweating and threw up again. I called 911 due to his age. Sat with him until paramedics came. Upon sitting his body temp came back down to normal and he declined anything more to eat/drink. Paramedics came and monitored vitals - all within normal limits. Pt went home without further monitoring. Called patient after an hour and patient was feeling fine, just worn out.
More
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| 2869420 | 59 | F | CA | 10/29/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0176 EW0176 EW0187 EW0187 |
Amnesia, Blindness, Blood pressure increased, Haemorrhagic stroke, Impaired work...
Amnesia, Blindness, Blood pressure increased, Haemorrhagic stroke, Impaired work ability; Migraine; Amnesia, Blindness, Blood pressure increased, Haemorrhagic stroke, Impaired work ability; Migraine
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2 months after jab, migrain headaches, slightly elevated blood pressure, progressively getting worse...
2 months after jab, migrain headaches, slightly elevated blood pressure, progressively getting worse, then unable to do her job as an Oncology Nurse. 5 months after the second jab, decided to retire in December due to migrain headaches and not being able to continue her day to day as an Oncology Nurse. Symptoms seem to worsen and June 6 months into retirement she had the 1st of 4 intracranial hemorrhagic strokes. June 2022 lost all memory, April 2024 lost memory, two weeks later April 2024 lost vision, August 2025 lost most of all her vision.
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โ | โ | โ | |||
| 2869423 | 17 | F | ID | 10/29/2025 |
COVID19 FLU3 MNQ |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
my9548 4NT7F U8574AA |
Feeling abnormal, Immediate post-injection reaction, Nausea, Pallor, Syncope; Fe...
Feeling abnormal, Immediate post-injection reaction, Nausea, Pallor, Syncope; Feeling abnormal, Immediate post-injection reaction, Nausea, Pallor, Syncope; Feeling abnormal, Immediate post-injection reaction, Nausea, Pallor, Syncope
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Syncope immediately after all 3 immunizations completed. Reported feeling funny just before faintin...
Syncope immediately after all 3 immunizations completed. Reported feeling funny just before fainting. Pale. Placed supine feet elevated. Nauseated. Pt reports not eating much that day. Able to ambulate out of clinic after approx 1 hour of monitoring.
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| 2869424 | 79 | F | CA | 10/29/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
NA4452 NA4452 NA4452 |
Aldolase, Blood creatine phosphokinase, Blood thyroid stimulating hormone normal...
Aldolase, Blood creatine phosphokinase, Blood thyroid stimulating hormone normal, C-reactive protein normal, Fatigue; Full blood count normal, Headache, Metabolic function test normal, Myalgia, Nausea; Red blood cell sedimentation rate normal
More
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headache, nausea, fatigue, diffuse myalgia x 15 days
headache, nausea, fatigue, diffuse myalgia x 15 days
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| 2869425 | 38 | F | MI | 10/29/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
409109 409109 409109 409109 409109 409109 |
Hypoaesthesia, Injected limb mobility decreased, Injection site paraesthesia, Mu...
Hypoaesthesia, Injected limb mobility decreased, Injection site paraesthesia, Muscular weakness, Nerve injury; Pain, Pain in extremity, Paraesthesia; Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Skin warm; Hypoaesthesia, Injected limb mobility decreased, Injection site paraesthesia, Muscular weakness, Nerve injury; Pain, Pain in extremity, Paraesthesia; Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Skin warm
More
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Per the Doctor, axillary nerve injury in the left shoulder. Left arm pain, limited range of motion, ...
Per the Doctor, axillary nerve injury in the left shoulder. Left arm pain, limited range of motion, weakness, paresthesia extending from the deltoid region to the lateral forearm and into the thumb. Numbness and shooting pain in the left arm post-vaccine.
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| 2869430 | 69 | F | SC | 10/29/2025 |
FLU3 HEPAB |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
u8874ca f95hb |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient was given the Fluzone HD vaccine on 10/28/25 when she had previously received the Fluzone HD...
Patient was given the Fluzone HD vaccine on 10/28/25 when she had previously received the Fluzone HD vaccine at a different facility on 10/3/2025.
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| 2869432 | 83 | F | AR | 10/29/2025 |
HEPAB VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
AZ2A3 3EG9B |
Dizziness, Feeling abnormal, Headache, Pain in extremity; Dizziness, Feeling abn...
Dizziness, Feeling abnormal, Headache, Pain in extremity; Dizziness, Feeling abnormal, Headache, Pain in extremity
More
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Patient was given her 2nd shingles immunization and 2nd hepatitis A/B immunization this afternoon. [...
Patient was given her 2nd shingles immunization and 2nd hepatitis A/B immunization this afternoon. [Withheld name], certified immunizing technician/lead technician, gave Patient both vaccinations. The Twinrix was given in the patients right arm, and the Shingrix was given in the patients left arm. After Administration, the patient began to complain and dizziness and feeling faint and pain in her left arm. [Withheld] notified me as the only pharmacist on duty. We gave the patient as ice pack, which [withheld] first laid on the back of the patient's neck, which seemed to give instant reilef. However, the patient still complained of arm pain and faintness. I moved the icepack to the patients left arm to help with the pain. After 10 minutes the patient was not feeling any different and began to complain of a headache. I offered water and two regular strength tylenol (as I usually recommend for shingles immunization patients). The patient did take two regualr strength (500mg) capsules of acetaminophen and drank half a bottle of water. After 10 minutes, the patient said she felt better but physically did not look well. I took patients blood pressure, which was normal with a normal pulse. I offered to call an ambulance multiple times throughout the encounter, which the patient did not want to do. Her friend that was with her was concerned and asked me what he should do for her. I did recommend going to the ER since the patient had tried to stand to walk multiple times and had to be assisted to stand and sit. I then went to the front of the store and got a wheelchair for the patient. I assisted her in standing and walking the the wheelchair. Patient continued to say she felt better, but I was still concerned and recommended going to the ER.
More
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| 2869433 | 45 | F | CA | 10/29/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Arthralgia
Arthralgia
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Patient complains of left shoulder pain post vaccination persisting for over 3.5 weeks.
Patient complains of left shoulder pain post vaccination persisting for over 3.5 weeks.
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| 2869435 | 34 | M | VA | 10/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Injection site erythema, Injection site mass, Injection site rash, Injection sit...
Injection site erythema, Injection site mass, Injection site rash, Injection site swelling
More
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Rash, Redness on site of injection, Swelling / Lump after 1 day at site of injection.
Rash, Redness on site of injection, Swelling / Lump after 1 day at site of injection.
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| 2869436 | 75 | F | CA | 10/29/2025 |
COVID19 |
MODERNA |
3052731 |
Electrocardiogram ambulatory abnormal, Tachycardia
Electrocardiogram ambulatory abnormal, Tachycardia
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Tachycardia around midnight the night after vaccination, lasting 8 hours. Side effect discovered by...
Tachycardia around midnight the night after vaccination, lasting 8 hours. Side effect discovered by patient's smart watch.
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| 2868305 | 67 | F | CA | 10/28/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Expired product administered, Injection site pain
Expired product administered, Injection site pain
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the vaccine stung a little bit; a patient was administered an expired dose of CAPVAXIVE; This sponta...
the vaccine stung a little bit; a patient was administered an expired dose of CAPVAXIVE; This spontaneous report has been received from a pharmacist referring to a 67-year-old female patient. The patient's historical drug included sulfa drugs. Concurrent condition included drug reaction/allergies to sulfa drugs. The patient's other pertinent medical history was unknown. Concomitant therapies included atorvastatin calcium (LIPITOR) and estradiol (ESTRACE) cream. On 24-Oct-2025 (reported as today), the patient was administered an expired dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # Y011819, expiration date 01-Oct-2025), 0.5 ml once administered via intramuscular route by a health professional as pneumonia vaccination for prophylaxis (strength and anatomical site were not reported) (Expired product administered). On the same day (24-Oct-2025) after being administered the dose, the patient stated the vaccine "stung a little bit" (Vaccination site pain). No additional adverse event (AE) or product quality complaint (PQC) reported. At the reporting time, the outcome of vaccination site pain was unknown. The action taken with suspect vaccine was not applicable. The causal relationship between the event of vaccination site pain and suspect vaccine was not reported.
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| 2868896 | 57 | F | OR | 10/28/2025 |
COVID19 FLUX RVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Asthma; Asthma; Asthma
Asthma; Asthma; Asthma
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worsening of asthma; Initial information received on 09-Oct-2025 regarding an unsolicited valid non...
worsening of asthma; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involved a 58 years old female patient who had worsening of asthma while receiving DUPILUMAB [DUPIXENT] via unknown medical device, INFLUENZA VACCINE, COVID-19 VACCINE, RSV vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing drug allergies to hydrochlorothiazide. Concomitant medications included Levofloxacin; LOSARTAN; Prednisone; ATORVASTATIN; CITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]; Gabapentin; Azithromycin; Naproxen; Montelukast sodium (Singulair); MULTIVITAMIN [VITAMINS NOS]; Meloxicam; Mycophenolate (International nonproprietary name unspecified) and MEPOLIZUMAB (NUCALA). On 17-Sep-2024, the patient started taking DUPILUMAB Solution for injection (strength: 300mg/ 2ml) at a dose of 300 mg subcutaneously for Unspecified asthma, uncomplicated. On 07-Oct-2025, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, on the same day, the she received a dose of suspect RSV vaccine and COVID-19 VACCINE not produced by Sanofi Pasteur (lot number, strength, expiry date, formulation not reported for all suspects) via unknown route in unknown administration site. On 08-OCT-2025 the patient developed a non-serious event "worsening of asthma" (asthma) (latency: 1 year 22 days) following the first dose intake (batch number: FW1313 and expiry date on 30-Sep-2027) of DUPILUMAB, (latency: same day) following the administration of INFLUENZA VACCINE, COVID-19 VACCINE, RSV vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "Patient got a series of vaccines (flu/ covid/rsv) on 07-Oct and noticed worsening of asthma on 08-Oct but it started to improve on 08-Oct and has improved further today so patient is not worried about it. Pharmacist advised that it could have been from all the vaccines received on the same day. Patient had no further questions or comments". Action taken: Unknown for dupilumab and therapy was ongoing and Action taken with INFLUENZA VACCINE, RSV vaccine, COVID-19 VACCINE was not applicable. Corrective Treatment: Not reported. Outcome: Recovering / Resolving for the event worsening of asthma.
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| 2868897 | 28 | M | CA | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
U8847CA |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered
More
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gave the wrong fluzone hd, with no reported adverse event; Initial information received on 18-Oct-20...
gave the wrong fluzone hd, with no reported adverse event; Initial information received on 18-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 28 years old male patient who was given the wrong Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received 0.5ml (dose 1) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8847CA, expiry date 30-Jun-2026, Strength Fluzone High Dose and frequency once) via intramuscular route in the left arm for Immunization and gave the wrong fluzone hd, with no reported adverse event (incorrect dose administered) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868898 | 0.42 | M | CT | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
U8863DA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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pediatric patient was given FLUZONE too early. Patient is 5 months old and received the FLUZONE vacc...
pediatric patient was given FLUZONE too early. Patient is 5 months old and received the FLUZONE vaccine with no AE; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case (along with live follow-up processed together with csd dated: 21-Oct-2025) received from a other health professional. This case involves a 5 months old pediatric male patient who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Oct-2025, the pediatric patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8863DA, expiry date:30-Jun-2026, strength not reported via unknown route in unknown administration site for influenza too early no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868902 | 78 | OH | 10/28/2025 |
TD |
SANOFI PASTEUR |
U7927AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient was vaccinated on 20Oct2025 using the product that had expired on 13Oct2025 with no adverse ...
patient was vaccinated on 20Oct2025 using the product that had expired on 13Oct2025 with no adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 78 years old patient of unknown gender who was vaccinated on 20-Oct-2025 using the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that had expired on 13-Oct-2025 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine inact split 3v (Fluzone high dose) for Immunisation. On 20-Oct-2025, the patient received a dose 1 of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Suspension for injection) (lot: U7927AA; strength: standard; frequency: once) that had expired on 13-Oct-2025 with no adverse event (expired product administered) (latency: same day) via intramuscular route in the right arm for Immunisation. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868906 | TX | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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received two doses of a flu vaccine within a 40 minute time period with no reported adverse event; I...
received two doses of a flu vaccine within a 40 minute time period with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received two doses of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] within a 40-minutes time period with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown 2 doses of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Influenza (Influenza immunisation) within a 40-minutes time period with no reported adverse event (extra dose administered) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868907 | 59 | M | WA | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
UT8434KA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of an expired fluzone np with no reported adverse event; Initial information received...
administration of an expired fluzone np with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 59 years old male patient who received an expired dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Oct-2025, the patient received an expired 0.5ml (dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Strength Standard, Suspension for injection, lot UT8434KA and expiry date 30-Jun-2025 via intramuscular route in the deltoid NOS (not otherwise specified) for immunisation, with no reported adverse event (expired product administered) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868911 | TX | 10/28/2025 |
TD |
SANOFI PASTEUR |
U7927AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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stated that a patient was administered an expired Tenivac vaccine with no adverse event; Initial inf...
stated that a patient was administered an expired Tenivac vaccine with no adverse event; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered an expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Oct-2025, the patient received an expired 0.5ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection, (once) lot U7927AA and expiry date 13-Oct-2025, via unknown route in unknown administration site for immunisation, with no reported adverse event (expired product administered) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868914 | DE | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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pre-assessed as a medication error (unintentional) due to receiving 2 shots of Flublok within a mont...
pre-assessed as a medication error (unintentional) due to receiving 2 shots of Flublok within a month with no reported adverse event; Initial information received on 23-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who experienced a medication error (unintentional) due to receiving 2 shots of Influenza Trivalent Recombinant Vaccine [Flublok] within a month with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) On an unknown date, the patient also received second dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation), within a month with no reported adverse event (extra dose administered) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2868941 | 28 | F | 10/28/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Chest pain; Chest pain
Chest pain; Chest pain
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Chest pains on and off for several hours.
Chest pains on and off for several hours.
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| 2868953 | 88 | M | NC | 10/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
H4K3S |
Wrong product administered
Wrong product administered
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Accidentally administered with Boostrix instead of Fluad; This non-serious case was reported by a ph...
Accidentally administered with Boostrix instead of Fluad; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 89-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4K3S, expiry date 30-OCT-2027) for prophylaxis. Co-suspect products included Influenza vaccine inact sAg 3v (Fluad) for prophylaxis. Previously administered products included Boostrix (received 1st dose of vaccine on 10th June 2022). Concomitant products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20). On 02-SEP-2025, the patient received Boostrix. The patient did not receive Fluad. On 02-SEP-2025, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Accidentally administered with Boostrix instead of Fluad). The outcome of the wrong vaccine administered 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: 29-SEP-2025 On 2nd September 2025, Patient had come in to receive pneumonia and flu vaccines. However, they appeared to have been mistakenly given Boostrix instead of Fluad. Patient also received Prevnar 20 on the same day. Patient had previously received their first dose of Boostrix on 10th June 2022.; Sender's Comments: US-GSK-US2025124892:deleted/duplicate case
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| 2868954 | 30 | F | SC | 10/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
72742 |
Exposure during pregnancy, Product administered to patient of inappropriate age,...
Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
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PREGNANT; Drug Exposure During Pregnancy; Inappropriate age at vaccine administration; WRONG VACCINE...
PREGNANT; Drug Exposure During Pregnancy; Inappropriate age at vaccine administration; WRONG VACCINE; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV VACCINE PROT. SUBUNIT PREF 2V (ABRYSVO) for prophylaxis. On 01-OCT-2025, the patient received Arexvy. The patient did not receive ABRYSVO. On 01-OCT-2025, an unknown time after receiving Arexvy the patient experienced wrong vaccine administered (Verbatim: WRONG VACCINE), product use in unapproved population (Verbatim: Drug Exposure During Pregnancy) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: PREGNANT). The outcome of the wrong vaccine administered, vaccine exposure during pregnancy, product use in unapproved population and inappropriate age at vaccine administration were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (ABRYSVO): Trimester unknown Estimated Delivery/Due date: 20-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 22-OCT-2025 The license practice nurse reported pregnant patient received Arexvy instead of Abrysvo. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments: US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER
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| 2868955 | F | 10/28/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Co...
Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Sep-2025, the patient experienced COVID-19 (Covid). In 2025, COVID-19 (Covid) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. It was inquired if she could be vaccinated due to having Covid on 19-Sep-2025. It was also mentioned that her pharmacist told her she would have to wait 6 months until she could get vaccinated. The patient had her last shot in 2021. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. The reporter causality was not reported.
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| 2868966 | 61 | M | AZ | 10/28/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
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Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
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Patient has developed a pruritic rash on his chest, arms and torso after receiving this vaccine. Ras...
Patient has developed a pruritic rash on his chest, arms and torso after receiving this vaccine. Rash is red and bumpy.
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| 2868976 | 46 | M | TX | 10/28/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Arthralgia, Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin...
Arthralgia, Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M; Blood pressure increased, Blood uric acid, C-reactive protein, Full blood count, Gait inability; Joint swelling, Metabolic function test, Myalgia, Pain in extremity, X-ray
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Heel/ankle pain with swollen ankle, inability to walk, along with muscle aches, sore arm, and increa...
Heel/ankle pain with swollen ankle, inability to walk, along with muscle aches, sore arm, and increased blood pressure
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| 2868978 | 36 | F | NC | 10/28/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
H4K3S H4K3S |
Arthralgia, Feeling hot, Injected limb mobility decreased, Musculoskeletal stiff...
Arthralgia, Feeling hot, Injected limb mobility decreased, Musculoskeletal stiffness, Pain; Pain in extremity, Swelling, X-ray limb normal
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36-year-old female here today for f/u of right arm/shoulder pain, stiffness and difficulty with move...
36-year-old female here today for f/u of right arm/shoulder pain, stiffness and difficulty with movement after receiving Tdap vaccination on October 20. She had gone to the ER on 10/24/2025 and had negative workup including shoulder xray. Was placed in a sling and given Oxycodone which she has taken very sparingly, last dose was a few days ago. She has tried to massage the area, has a tried applying cold and warm compresses and taking Ibuprofen and Tylenol without much benefit. reports warmth and some of the swelling has improved. pain is persistent, rated mainly at 7/10 but increases to 10/10 with any motion at the right arm.
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| 2868980 | 86 | M | DE | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
U8862AA |
Extra dose administered
Extra dose administered
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Patient received two doses of the Flu HD. 8/29/2025 and 10/7/025.
Patient received two doses of the Flu HD. 8/29/2025 and 10/7/025.
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| 2868981 | 10 | F | KY | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
U8832BA |
Eye contusion, Fall, Head injury, Pallor, Syncope
Eye contusion, Fall, Head injury, Pallor, Syncope
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After vaccination was given, patient got up to leave with mother and had a syncopal episode: fell do...
After vaccination was given, patient got up to leave with mother and had a syncopal episode: fell down, hit her right temple on this provider's swivel chair and fell back onto the floor. Didn't hit her head on the floor. Minor, 3mm in length (<0.5mm width) bruise noted beside of right eye. Gave patient lollipop and water, sat in a chair. Alert and oriented. Pallor of skin. Reports her head hurts where she hit the chair. No acute distress. PERRLA. Rendered first aid to patient. See incident report. Made patient wait for 20 minutes and she exhibited no acute distress. Discussed with mother to notify health professional before daughter receives vaccination of syncopal episode. Go to the ER if episode of syncope after visit, seizure activity. Mother agreeable and has no further questions or concerns.
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| 2868982 | 74 | F | IL | 10/28/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
u8855aa u8855aa |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient was given 2 Fluzone injections, did not receive the Covid 19 injection.
Patient was given 2 Fluzone injections, did not receive the Covid 19 injection.
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| 2868988 | 63 | M | MN | 10/28/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052579 948406 |
Underdose; Underdose
Underdose; Underdose
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Gave 63-year-old client the wrong age covid vaccine - moderna 6m-11y instead of moderna 12+.
Gave 63-year-old client the wrong age covid vaccine - moderna 6m-11y instead of moderna 12+.
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| 2868989 | 33 | F | VA | 10/28/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2CA5M |
Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling
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BASEBALL SIZED REDNESS, SWELLING, WARMTH, PAIN X 3 DAYS
BASEBALL SIZED REDNESS, SWELLING, WARMTH, PAIN X 3 DAYS
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| 2868990 | 78 | F | GA | 10/28/2025 |
COVID19 |
MODERNA |
NABP 1155236 N |
Body temperature increased, Computerised tomogram, Laboratory test
Body temperature increased, Computerised tomogram, Laboratory test
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Temperature everyday since of 99.9 to 101
Temperature everyday since of 99.9 to 101
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| 2868992 | 39 | F | 10/28/2025 |
FLU3 |
SANOFI PASTEUR |
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Myalgia
Myalgia
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Continuous deltoid pain >7 weeks
Continuous deltoid pain >7 weeks
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