| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1915676 | U | TN | 12/02/2021 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
Unknown Johnson&Johnson Johnson&Johnson |
Unevaluable event; Electromyogram, Gait disturbance, Headache, Lumbar puncture a...
Unevaluable event; Electromyogram, Gait disturbance, Headache, Lumbar puncture abnormal, Magnetic resonance imaging; Memory impairment, Multiple sclerosis, Muscle tightness
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UNEVALUABLE EVENT; This spontaneous report received from a patient via a company representative conc...
UNEVALUABLE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unevaluable event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unevaluable event was not reported. This report was non-serious.
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| 2868392 | 78 | M | FL | 10/26/2025 |
COVID19 FLU3 |
NOVAVAX SANOFI PASTEUR |
6315mf002c u8764bb |
Abdominal distension, Malaise, Pain; Abdominal distension, Malaise, Pain
Abdominal distension, Malaise, Pain; Abdominal distension, Malaise, Pain
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Significant swelling of 1/2" or greater at injection site without heat or significant pain and ...
Significant swelling of 1/2" or greater at injection site without heat or significant pain and general malaise plus achiness all lasting approximately 3 days.
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| 2868393 | 12 | M | NY | 10/26/2025 |
COVID19 |
MODERNA |
3052835 |
Confusional state, Disorientation, Immediate post-injection reaction
Confusional state, Disorientation, Immediate post-injection reaction
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Immediately after receiving spikevax standard dose, child appeared to momentarily lose consciousnes...
Immediately after receiving spikevax standard dose, child appeared to momentarily lose consciousness. He then appeared confused and disoriented. After several minutes of observation in the immunization room, an icepack was provided to mother and they were escorted to the waiting for further observation for approximately 15 more minutes, with the child using a second chair to keep his legs elevated. At all times child was accompanied by parent.
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| 2868394 | 65 | M | FL | 10/26/2025 |
COVID19 |
MODERNA |
305266 |
Headache
Headache
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patient reports consistent headache after recieving vaccines that has continued for about 2 weeks
patient reports consistent headache after recieving vaccines that has continued for about 2 weeks
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| 2868395 | 65 | F | IL | 10/26/2025 |
RSV RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3M9DS 3M9DS 3M9DS |
Abdominal pain upper, Biliary colic, Fall, Gait disturbance, Gastrointestinal pa...
Abdominal pain upper, Biliary colic, Fall, Gait disturbance, Gastrointestinal pain; Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Laboratory test, Muscular weakness; Walking aid user, Wheelchair user
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After 12 days, some numbness & knee buckled a couple of times. After 13 days, fell at 2 am. G...
After 12 days, some numbness & knee buckled a couple of times. After 13 days, fell at 2 am. Got to emergency room at Hospital at about 4 am. Was diagnosed with GBS (Guillon-Barre Syndrome) that day and was started on IVIG solution for 5 days. Went home that day (needed wheelchair). Started to walk with walker in the first 2 weeks (fell a couple of times). Eventually able to walk without walker after 3 months. Still some issues - hand numb, stomach/gall bladder/intestine area pains.
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โ | |||||
| 2868396 | 44 | F | FL | 10/26/2025 |
FLU3 HEPAB |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8832AA AZ2A3 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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None
None
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| 2868434 | 53 | F | WA | 10/26/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0589 U8790AA |
Dizziness, Hypotension, Loss of consciousness, Malaise, Unresponsive to stimuli;...
Dizziness, Hypotension, Loss of consciousness, Malaise, Unresponsive to stimuli; Dizziness, Hypotension, Loss of consciousness, Malaise, Unresponsive to stimuli
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Patient was feeling a little unwell after receiving two vaccinations. She laid down on the floor for...
Patient was feeling a little unwell after receiving two vaccinations. She laid down on the floor for a couple of mins. Once she thought she was ok, she got up and proceeded towards the counter to pay. She sat down on the bench between the health services room and the counter where she then proceeded to tense up and slump backwards. She was not responsive. The pharmacist and technician moved the patient to the floor safely. Within a minute of being placed on the floor, the patient regained consciousness and was alert and oriented. Upon speaking with her, she noted she felt a sudden lightheadedness and pain when she was ambulating to the counter, prompting her to sit down. She has a history of vasovagal syncope and passing out after vaccinations but it had not happened in a long time. She was further observed for 20 mins in which no other events occurred and patient reported feeling okay. She was accompanied by her husband who will be driving her home.
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| 2868435 | 50 | M | AZ | 10/26/2025 |
FLU3 PNC20 VARZOS |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
U8790AA MA2505 55KB9 |
Chest discomfort, Chest pain; Chest discomfort, Chest pain; Chest discomfort, Ch...
Chest discomfort, Chest pain; Chest discomfort, Chest pain; Chest discomfort, Chest pain
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Patient received Prevnar 20, Shingrix, and Flublok on 9/15/25. He presented to the pharmacy on 10/24...
Patient received Prevnar 20, Shingrix, and Flublok on 9/15/25. He presented to the pharmacy on 10/24/25 wanting to know if any of the vaccines he received could have caused pain on the right side of the chest and a feeling of fluid in the chest. Patient claimed the pain began approximately 2 weeks after he received the vaccine. He stated he was not initially concerned, but when the pain had not subsided by the evening, he worried and decided to call 911. EMS responded and evaluated him outside his residence. EMS advised patient that his vitals were all normal and there was nothing apparently wrong. Patient stated the pain subsided, but was curious if the experience could have been the result of any of the vaccines he received. Pharmacy advised him that it was not a common side effect of any of the vaccines he received and the time onset (2 weeks after administration) cast some suspicion on the likelihood of the vaccines being the cause. Pharmacy advised patient the event would be reported internally and to VAERS. He appreciated the time and consideration.
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| 2868436 | 58 | F | NY | 10/26/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
F4A7R |
Arthralgia, Product administered at inappropriate site
Arthralgia, Product administered at inappropriate site
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Received Flu shot into my right shoulder instead of my arm muscle. The student nurse that gave it t...
Received Flu shot into my right shoulder instead of my arm muscle. The student nurse that gave it to me went higher up my arm and I felt the vaccine go into my right shoulder. I went home, went to bed and woke up with my shoulder aching, not my arm muscle aching like it usually will if it's put in the right place.
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| 2868437 | 69 | F | TX | 10/26/2025 |
UNK |
UNKNOWN MANUFACTURER |
407249 |
Eye pain, Eye pruritus, Ocular hyperaemia
Eye pain, Eye pruritus, Ocular hyperaemia
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My right eye was red with itching and almost closed and pain. I cleaned my eye with water. No treat...
My right eye was red with itching and almost closed and pain. I cleaned my eye with water. No treatment. Now continues in pain.
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| 2868291 | 56 | M | 10/25/2025 |
COVID19 |
MODERNA |
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Feeling cold, Feeling hot, Loss of consciousness, Pyrexia
Feeling cold, Feeling hot, Loss of consciousness, Pyrexia
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hot and cold symptoms; hot and cold symptoms; fever; lost consciousness; This spontaneous case was r...
hot and cold symptoms; hot and cold symptoms; fever; lost consciousness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness), FEELING COLD (hot and cold symptoms), FEELING HOT (hot and cold symptoms) and PYREXIA (fever) in a 56-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (bad case of COVID that had hospitalized him in 2021.) in 2021. On 11-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On 12-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). In October 2025, the patient experienced FEELING COLD (hot and cold symptoms) (seriousness criterion hospitalization), FEELING HOT (hot and cold symptoms) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). The patient was hospitalized from sometime in October 2025 to sometime in October 2025 due to FEELING COLD, FEELING HOT and PYREXIA. On 12-Oct-2025, LOSS OF CONSCIOUSNESS (lost consciousness) had resolved. At the time of the report, FEELING COLD (hot and cold symptoms), FEELING HOT (hot and cold symptoms) and PYREXIA (fever) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown Route) was unknown. Concomitant medications were not reported. It was reported that on 12-Oct-2025, 26 hours after receiving the vaccine, patient lost consciousness for about 3 minutes. The patient had contracted COVID-19 in 2021, had a bad case of COVID that had hospitalized him in 2021. Patient had a very strong reaction to the COVID vaccine because he had COVID. It was confirmed that patient had not received the COVID-19 vaccine in 2021 prior to contracting COVID-19. Patient was hospitalized for 2 days trying to recover from hot and cold symptoms, fever symptoms, it was sated that was patient was expecting it to clear up in 24 hours but unfortunately it did not. The reporter was terrified of the event particularly with the losing consciousness. Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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โ | ||||||
| 2868292 | 10/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, Dyskinesia, Fall, Hypotonia; SARS-CoV-2 test
COVID-19, Drug ineffective, Dyskinesia, Fall, Hypotonia; SARS-CoV-2 test
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tested positive for Covid; tested positive for Covid; had a fall at home; lost all muscle tone from ...
tested positive for Covid; tested positive for Covid; had a fall at home; lost all muscle tone from the waist down/hard to move in bed or stand; lost all muscle tone from the waist down/hard to move in bed or stand; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790323 (Moderna), AE-00234751 (Moderna Call Center Number). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "tested positive for Covid"; FALL (hospitalization), outcome "recovered", described as "had a fall at home"; HYPOTONIA (hospitalization), DYSKINESIA (hospitalization), outcome "recovered" and all described as "lost all muscle tone from the waist down/hard to move in bed or stand". The patient was hospitalized for drug ineffective, covid-19, fall, hypotonia, dyskinesia (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated had tested positive for Covid and then had a fall at home. Patient was hospitalized for a week and was treated for Covid. Patient stated that patient was sent to a redacted after the hospital for a week. Patient also stated lost all muscle tone from the waist down for 2 days after getting Pfizer's vaccine making it hard to move in bed or stand. Patient stated after 2 days, patient was recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2868312 | 31 | F | IL | 10/25/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
203a201a 203a201a 203a201a |
Amenorrhoea, Blood test, Computerised tomogram, Gait inability, Hypoaesthesia; M...
Amenorrhoea, Blood test, Computerised tomogram, Gait inability, Hypoaesthesia; Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Muscular weakness, Neuralgia, Neuropathy peripheral; Restless legs syndrome
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Muscle weakness to the point of not being able to walk. Neuropathy pain 24/7 from knee down and on b...
Muscle weakness to the point of not being able to walk. Neuropathy pain 24/7 from knee down and on both hands from the thumb to the middle finger. Didn?t have my period for 8 months and wasn?t pregnancy. Restless leg syndrome at night. Can?t feel feet. Prescribed duloxotine and gabapentin.
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โ | โ | ||||
| 2868313 | 76 | M | CA | 10/25/2025 |
COVID19 |
MODERNA |
3052733 |
Death, Pyrexia, Vomiting
Death, Pyrexia, Vomiting
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Vomited at 0700 hours on 10/24/2025 - 20 hours after receiving the vaccine, also had a fever at that...
Vomited at 0700 hours on 10/24/2025 - 20 hours after receiving the vaccine, also had a fever at that time, died at 0912 hours on 10/24/2025
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โ | |||||
| 2868315 | 13 | M | MN | 10/25/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052671 ut8792la |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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After giving patient his Covid then his Flu vaccines patient passed out in chair and was caught befo...
After giving patient his Covid then his Flu vaccines patient passed out in chair and was caught before falling to the floor, his father carried him to reclining chair and was reclined. Immediately patient recovered and was alert and asked what happen. RN explained about vasovagal episode and importance of drinking and eating before vaccination. Father stated patient had had no water or food prior to vaccination. After 15 minutes patient was feeling much better and was able to stand and walk without assistance. Father stated he would make sure he was given fluid and breakfast. Father and patient both denied any additional help. Patient was discharged.
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| 2868316 | 71 | F | TX | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
NA590 |
Rash
Rash
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rash on upper torso , front and back--gone by morning of 10-25-2025. I went to pharmacy on 10-24-202...
rash on upper torso , front and back--gone by morning of 10-25-2025. I went to pharmacy on 10-24-2025 and showed Pharmacist the rash. She said to contact CDC.
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| 2868317 | 6 | M | MI | 10/25/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
LT9HP |
Dyspnoea, Malaise, Pallor, Somnolence
Dyspnoea, Malaise, Pallor, Somnolence
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After receiving vaccine, pt began to complain to Mom that he did not feel well. He described difficu...
After receiving vaccine, pt began to complain to Mom that he did not feel well. He described difficulty breathing and wanting to go to sleep. When Mom and pt entered vaccination room, pt looked pale/white in the face sitting on Mom's lap. Mom reported she had given him some sugar to see if that would help. Patient put in exam room with family. after about 3-5 min of laying down, he was able to sit up and eat part of a granola bar. HR at that time was 104. After an additional 5 minutes he was able to stand and walk. His coloring improved, lips more pink as he left with Mom. Mom did report he was more of his shy demeanor as they were leaving.
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| 2868318 | 6 | F | MI | 10/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA0846 NB3X7 |
Dizziness; Dizziness
Dizziness; Dizziness
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Patient felt faint and dizzy. Patient did not lose consciousness.
Patient felt faint and dizzy. Patient did not lose consciousness.
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| 2868319 | 4 | F | NE | 10/25/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
724TF |
Asthenia, Dysstasia, Pallor, Syncope
Asthenia, Dysstasia, Pallor, Syncope
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Vasovagal syncope. Within 2 minutes she lost all color in her face became weak and laid on the floo...
Vasovagal syncope. Within 2 minutes she lost all color in her face became weak and laid on the floor. She had trouble standing up and when we asked her to try she kept asking to be picked up because she "couldn't stand up."
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| 2868321 | 77 | M | FL | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Abdominal pain lower, Asthenia, Flatulence
Abdominal pain lower, Asthenia, Flatulence
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day 3-4: colon pain, gas day #5-6; very weak, slept on/off all day; day #7-9 improving; #10 mu...
day 3-4: colon pain, gas day #5-6; very weak, slept on/off all day; day #7-9 improving; #10 much improved. No respiratory symptoms.
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| 2868323 | 26 | F | FL | 10/25/2025 |
FLU3 |
SANOFI PASTEUR |
U8832AA |
Rash, Urticaria
Rash, Urticaria
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Patient reports hives/bumps on her legs approximately 2 -3 days since having vaccination. Pt denies ...
Patient reports hives/bumps on her legs approximately 2 -3 days since having vaccination. Pt denies any exposure to other allergens but during further discussion did express being outside on the same day of administration. Told pt it is unclear if it was an exposure to an allergen or if the actual vaccine caused the reaction so will report to be safe. Pt has had flucelvax without any issues in the past so informed pt it could be exposure to something else that is causing the reaction or she can be reacting to an inactive ingredient. Advised pt to use benadryl tablets and cream and if no relief consult PCP.
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| 2868324 | 26 | F | IA | 10/25/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052669 u8832ca |
Dizziness, Hyporesponsive to stimuli; Dizziness, Hyporesponsive to stimuli
Dizziness, Hyporesponsive to stimuli; Dizziness, Hyporesponsive to stimuli
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patient experienced beginning stages of Vasovagal syncope type reaction after administration of immu...
patient experienced beginning stages of Vasovagal syncope type reaction after administration of immunizations. Patient started feeling "woozy" , became slow to respond, did not actually lose consciousness. We gave her water and candy and she started responding and felt better. Reaction started about 1 minute after immunizations given. Patient was feeling better after about 5 minutes
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| 2868325 | 81 | F | 10/25/2025 |
FLU3 |
SANOFI PASTEUR |
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Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Patient reports baseball size swelling at injection site with erythema around area of arm, noting th...
Patient reports baseball size swelling at injection site with erythema around area of arm, noting that the site is hot to the touch. Patient reports icing the area for two hours overnight, seeing a little improvement today. Patient will continue to monitor today that swelling goes down and reaction goes away. Patient instructed to seek emergency medical attention if reaction worsens or does not go away.
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| 2868326 | 35 | F | NE | 10/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Blood test, Chest discomfort, Chest pain, Chills, Computerised tomogram thorax; ...
Blood test, Chest discomfort, Chest pain, Chills, Computerised tomogram thorax; Electrocardiogram, Myocarditis, Pain
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Severe chills and body aches on 10/21-10/23. Went to the ER on 10/24 for chest pain and tightness in...
Severe chills and body aches on 10/21-10/23. Went to the ER on 10/24 for chest pain and tightness in chest. Began experiencing chest tightness on 10/23 while sleeping. It was intermittent but worse when laying down or exercising/walking.
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| 2868328 | 48 | F | AR | 10/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Ataxia, CSF test normal, Laboratory test normal, Magnetic resonance imaging norm...
Ataxia, CSF test normal, Laboratory test normal, Magnetic resonance imaging normal, Muscle spasticity; Ataxia, CSF test normal, Laboratory test normal, Magnetic resonance imaging normal, Muscle spasticity
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Moderna 8/17/2021 , Moderna 7/13/2021, patient with spasticity, ataxia symptoms and exam consistent ...
Moderna 8/17/2021 , Moderna 7/13/2021, patient with spasticity, ataxia symptoms and exam consistent with seronegative Stiff person syndrome. Timeline of symptoms not clear as per records but patients reports slow and progressive symptoms after Vaccine COVID were done. Never filed report as was not aware of this.
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โ | |||||
| 2868329 | 26 | F | OR | 10/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
MY9548 407359 |
Chest discomfort, Dizziness, Flushing; Chest discomfort, Dizziness, Flushing
Chest discomfort, Dizziness, Flushing; Chest discomfort, Dizziness, Flushing
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Tight chest, dizziness, flushed face. Checked by RN. Patient had already sat for 5 minutes when ch...
Tight chest, dizziness, flushed face. Checked by RN. Patient had already sat for 5 minutes when checked on and continued to lay for 10 more, given water and monitored. Rechecked by nurse after 10 min and patient felt stable. Walked out to vehicle by MA.
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| 2868331 | 46 | F | NY | 10/25/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
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Product administered at inappropriate site, Wrong technique in product usage pro...
Product administered at inappropriate site, Wrong technique in product usage process; Product administered at inappropriate site, Wrong technique in product usage process
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Provider placed the flu and Covid vaccines 0.25? apart instead of the medical guideline of a minimum...
Provider placed the flu and Covid vaccines 0.25? apart instead of the medical guideline of a minimum of 1? apart. I am uncertain which flu vaccine I received as no paperwork was provided. I was told I should receive an email with the details but have not yet. A single bandaid was provided. Photo of the injection sites with a ruler has been taken.
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| 2868332 | 65 | F | FL | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Extra dose administered
Extra dose administered
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On 10/25/2025 10:49am, patient was recommended to her covid vaccine. After she was administer Comirn...
On 10/25/2025 10:49am, patient was recommended to her covid vaccine. After she was administer Comirnaty by pharmacist. While printing patient's vaccine records, technician alerted pharmacist that patient had received Mnexspike vaccine on 10/4/2025. Pharmacist apologize to patient, and counseled patient regarding receiving an extra dose of covid vaccine. Patient was instructed to call the pharmacy if she experiences any side effects so it can be documented and that her primary doctor will be notified on Monday 10/27/25 when her doctor office opens (closed on weekends).
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| 2868333 | 76 | F | VA | 10/25/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8837CA U8837CA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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PATIENT RECEIVED 2 HD FLU VACCINES AT OUR LOCATION. ONE VACCINE WAS GIVEN 09/18/2025 AND THE OTHER W...
PATIENT RECEIVED 2 HD FLU VACCINES AT OUR LOCATION. ONE VACCINE WAS GIVEN 09/18/2025 AND THE OTHER WAS GIVEN 10/13/2025. PATIENT HAS NO ADVERSE EFFECTS.
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| 2868334 | 66 | F | OH | 10/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
my9547 407272 |
No adverse event, Syringe issue, Underdose; No adverse event, Syringe issue, Und...
No adverse event, Syringe issue, Underdose; No adverse event, Syringe issue, Underdose
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No adverse event noted. Full dose of vaccine was not given to the patient. There was a needle malf...
No adverse event noted. Full dose of vaccine was not given to the patient. There was a needle malfunction and the dose came out of the side of the syringe. Explained to patient that an additional dose was not indicated, however, the patient was adamant that she did not receive the vaccine and wanted a redose. Patient was educated on it being outside of the requirements, and assumed the risk.
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| 2868336 | 62 | F | FL | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Arthralgia, Erythema, Joint swelling, Skin warm
Arthralgia, Erythema, Joint swelling, Skin warm
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On 10/25/25, patient reported that overnight, her left shoulder became red, swollen, painful and hot...
On 10/25/25, patient reported that overnight, her left shoulder became red, swollen, painful and hot to the touch.
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| 2868339 | 41 | M | NE | 10/25/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7cf5m |
Pain, Product administered at inappropriate site
Pain, Product administered at inappropriate site
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Patient thinks that the vaccine was given to high up in the shoulder. Two weeks later still having p...
Patient thinks that the vaccine was given to high up in the shoulder. Two weeks later still having pain. Has no restriction of movement, just intermittent pain. Will be seeing his healthcare provider for physical on 10/27 and ask about treatment plan then.
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| 2868341 | 49 | F | IL | 10/25/2025 |
COVID19 |
NOVAVAX |
6315MF002C |
Oropharyngeal discomfort
Oropharyngeal discomfort
|
PT TOLD TO STICK AROUND AFTER VACCINE. PT STATED THAT AFTER 10 OR SO MINUTES HER THROAT FELT "W...
PT TOLD TO STICK AROUND AFTER VACCINE. PT STATED THAT AFTER 10 OR SO MINUTES HER THROAT FELT "WEIRD" LIKE IT WAS SWELLING. PT SAID SAME RXN HAPPENED AFTER SHE GOT MODERNA VACCINE AND THAT IS WHY MD TOLD HER TO GET NOVAVAX INSTEAD. PT DID NOT MENTION RXN ON CONSENT FORM OR TO IMMUNIZER. INFORMED PT TO SIT INFRONT OF ME SO I COULD CONTINUE TO MONITOR BUT PT REFUSED. SAID IT WAS MILD, SHE WAS NOT CONCERNED, HAS EPIPEN AND WANTED TO GO HOME. HAD PT SIGN REFUSING BEING MONITORED. PT DID AGREE TO TAKE LIQUID BENADRYL (15ML) CHECK OUT AND COME BACK TO LET ME KNOW HOW SHE WAS DOING. PT LIVES 10 MIN AWAY ANDJUST WANTED TO LEAVE. PT DID CHECK BACK BEFORE LEAVING STORE AND CLAIMED SHE WAS FEELING BETTER. PT CALLED ABOUT 20-30MIN AGO AND STATED SHE IS FINE.
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| 2868342 | 72 | F | CT | 10/25/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y013009 |
Injected limb mobility decreased, Muscular weakness, Pain in extremity, Product ...
Injected limb mobility decreased, Muscular weakness, Pain in extremity, Product administered at inappropriate site
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Patient received pneumonia vaccine on 10/23/25 at around 4pm. Vaccine was administered intramuscular...
Patient received pneumonia vaccine on 10/23/25 at around 4pm. Vaccine was administered intramuscularly in left deltoid muscle. Patient reports feeling the vaccine was administered too high in arm. Patient called pharmacy on 10/25/25 and reports pain and weakness in left arm, as well as limited range of motion from left shoulder. Patient denies any other adverse effects such as redness, swelling, or bump at administration location. Patient will continue to self-monitor symptoms for 1 week - she is taking anti-inflammatories and resting. She will follow-up with pharmacy if symptoms do not subside.
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| 2868343 | 7 | F | TX | 10/25/2025 |
FLU3 |
SEQIRUS, INC. |
410515 |
Anxiety, Dyspnoea, Pallor, Panic attack
Anxiety, Dyspnoea, Pallor, Panic attack
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PATIENT APPEARED TO BE UNDER DISTRESS. PARENTS WERE WORRIED SHE WAS HAVING TROUBLE BREATHING, CONCER...
PATIENT APPEARED TO BE UNDER DISTRESS. PARENTS WERE WORRIED SHE WAS HAVING TROUBLE BREATHING, CONCERNED IF LIPS WERE TURNING PALE. EMS WAS CALLED. EMS CHECKED VITALS AND ALL WERE NORMAL. CONCLUDED TO BE ANXIETY OR PANIC ATTACK. CALLED PARENTS LATER AROUND 3PM TO CHECK ON STATUS AND THEY SAID PATIENT IS FEELING A LOT BETTER AFTER EATING SOME FOOD.
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| 2868345 | 8 | M | OR | 10/25/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3053253 948400 |
Asthenia, Dizziness, Pallor; Asthenia, Dizziness, Pallor
Asthenia, Dizziness, Pallor; Asthenia, Dizziness, Pallor
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Given by CMA, Vaccine clinic. Patient waited with family for required 15 min. but was brought back i...
Given by CMA, Vaccine clinic. Patient waited with family for required 15 min. but was brought back in by dad being carried. Patient was pale, weak, dizzy, evaluated by RN given water, laying down, rice crispy treat. declined juice, monitored by RN for additional 10 min. patient looking and feeling better ambulating left w/family.
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| 2868346 | 58 | M | NC | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Injury associated with device
Injury associated with device
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we had a needle stick event whereby the technician administering it ended up poking herself after im...
we had a needle stick event whereby the technician administering it ended up poking herself after immunizing the patient
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| 2868347 | 59 | F | WI | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Induration, Muscle mass, Pain
Induration, Muscle mass, Pain
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Pt has a hard lump in the outer deltoid that is very painful. Pt had it for a year, since she got va...
Pt has a hard lump in the outer deltoid that is very painful. Pt had it for a year, since she got vaccination
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| 2868348 | 68 | F | AZ | 10/25/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8794CA UT8794CA |
Chest X-ray normal, Chest discomfort, Culture, Dizziness, Electrocardiogram norm...
Chest X-ray normal, Chest discomfort, Culture, Dizziness, Electrocardiogram normal; Laboratory test, Pyrexia, Tremor, Troponin increased, Vomiting
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Severe shaking, vomiting, 102.2F fever, upper chest pressure, dizziness
Severe shaking, vomiting, 102.2F fever, upper chest pressure, dizziness
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| 2868349 | 13 | M | WA | 10/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA4457 cy53g |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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Vaccine appointment was at 2:45 pm. Prior to vaccination patient definitely seemed nervous and was v...
Vaccine appointment was at 2:45 pm. Prior to vaccination patient definitely seemed nervous and was very afraid prior to administering per immunizer. Patient received flu vaccine first, and then covid. Right after giving covid vaccine (within 5 to 10 seconds), immunizer was putting on band aid and the patient winced, tensed up, and passed out. Immunizer caught patients head, and immunizer described patient as passed out but also was tensing up straight in the chair for a few seconds. He awoke quickly after, and didn't remember what happened. Mother ran out of room and told us to call 911 in the pharmacy. While waiting for EMTs to arrive, patient was alert and oriented, we asked about history and if he had ate today etc. Per patient didn't eat since breakfast, and also father and brother have history of fainting with vaccines. We provided ice packs and juice. EMTs arrived and cleared the patient as okay. Patient and family hung out for a while until was ready to leave and okay. Per consent form--- patient hasn't had any previous history with vaccines reactions such as dizziness, fainting, seizures etc, no seizure disorders, hasn't been sick in past 24 etc. Advised mom to follow up with PCP and let them know about reaction.
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| 2868351 | 54 | F | NJ | 10/25/2025 |
COVID19 |
MODERNA |
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Postmenopausal haemorrhage
Postmenopausal haemorrhage
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post menopausal bleeding
post menopausal bleeding
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| 2868352 | 43 | M | MN | 10/25/2025 |
COVID19 |
MODERNA |
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Presyncope, Pyrexia
Presyncope, Pyrexia
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High fever causing near fainting that lead to an emergency room visit.
High fever causing near fainting that lead to an emergency room visit.
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| 2868355 | 61 | F | IL | 10/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Nasal congestion, Pain, Pyrexia
Asthenia, Nasal congestion, Pain, Pyrexia
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Woke up feeling weak, feverish, nasal congestion, achey
Woke up feeling weak, feverish, nasal congestion, achey
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| 2868356 | 11 | M | MN | 10/25/2025 |
FLU3 |
SANOFI PASTEUR |
UT8826JA |
Injection site pain, Injection site reaction, Pallor, Rash erythematous
Injection site pain, Injection site reaction, Pallor, Rash erythematous
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2 inch blanching erythematous rash around injection site. Tender when touched.
2 inch blanching erythematous rash around injection site. Tender when touched.
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| 2868360 | 47 | M | OK | 10/25/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Wrong product administered
No adverse event, Wrong product administered
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no adverse effects noted as of now, but was upset that the wrong vacccine was given.
no adverse effects noted as of now, but was upset that the wrong vacccine was given.
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| 2387133 | 69 | M | NY | 10/24/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN6201 EN6208 FH8028 ph8028 |
Biopsy skin, Genital rash, Psoriasis; Biopsy skin, Genital rash, Psoriasis; Biop...
Biopsy skin, Genital rash, Psoriasis; Biopsy skin, Genital rash, Psoriasis; Biopsy skin, Genital rash, Psoriasis; Acne, Biopsy, Psoriasis, Rash, Skin infection
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Severe gential rash-Psoriasis 60 % of body
Severe gential rash-Psoriasis 60 % of body
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| 2868063 | 52 | F | MD | 10/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
55M72 |
Expired product administered
Expired product administered
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accidentally administered an expired dose of Havrix to a patient; This non-serious case was reported...
accidentally administered an expired dose of Havrix to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis. On 07-OCT-2025, the patient received Havrix. On 07-OCT-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired dose of Havrix to a patient). The outcome of the expired vaccine used 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: 08-OCT-2025 Th medical assistant mentioned that on 7th October 2025 they accidentally administered an expired dose of Havrix to a patient.
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| 2868064 | 11 | F | CO | 10/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3RE73 |
Extra dose administered, Product administered to patient of inappropriate age
Extra dose administered, Product administered to patient of inappropriate age
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Boostrix was give along with Infanrix; This non-serious case was reported by a nurse via call center...
Boostrix was give along with Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3RE73, expiry date 16-NOV-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix). On 07-OCT-2025, the patient received Boostrix. On 07-OCT-2025, an unknown time after receiving Boostrix, the patient experienced overdose (Verbatim: Boostrix was give along with Infanrix). The outcome of the overdose 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: 08-OCT-2025 A Nurse Practitioner (NP) reported that a patient received both Boostrix and Infanrix on the same day. The vaccines were administered yesterday to an 11-year-old patient. The nurse practitioner inquired about the safety of administering these two vaccines concurrently.
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| 2868067 | 90 | F | CA | 10/24/2025 |
FLU3 |
SEQIRUS, INC. |
40954 |
Cellulitis
Cellulitis
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Patient came back on 9/30 to pick up doxycycline and report that she developed cellulitis on 9/24/25...
Patient came back on 9/30 to pick up doxycycline and report that she developed cellulitis on 9/24/25.
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| 2868068 | 25 | F | FL | 10/24/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
181286 1855199 |
Autoimmune thyroiditis, Biopsy thyroid gland abnormal, Papillary thyroid cancer,...
Autoimmune thyroiditis, Biopsy thyroid gland abnormal, Papillary thyroid cancer, Pathology test; Autoimmune thyroiditis, Biopsy thyroid gland abnormal, Papillary thyroid cancer, Pathology test
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Following receipt of a COVID-19 vaccination, I was later diagnosed with Hashimoto?s thyroiditis and ...
Following receipt of a COVID-19 vaccination, I was later diagnosed with Hashimoto?s thyroiditis and papillary thyroid carcinoma. My diagnosis was confirmed by biopsy and surgical pathology. I am submitting this report because recent peer-reviewed research (withheld) identified a statistical association between COVID-19 vaccination and increased rates of thyroid-cancer diagnoses (hazard ratio 1.35, 95 % CI 1.21?1.51). I understand that this study does not prove causation but wish to report my experience for continued safety monitoring and investigation.
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