| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2871745 | 65 | F | GA | 11/10/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8852MA UT8852MA |
Contusion, Headache, Influenza, Mass, Nausea; Pain, Skin warm
Contusion, Headache, Influenza, Mass, Nausea; Pain, Skin warm
|
*Severe nausea and flu symptoms lasting seven days; severe headache; LARGE (8cm) bruise and hot to ...
*Severe nausea and flu symptoms lasting seven days; severe headache; LARGE (8cm) bruise and hot to touch lump with pain
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| 2871746 | 74 | M | 11/10/2025 |
COVID19 RSV |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
MY9548 7HZ93 |
Asthenia, Pyrexia, Vomiting; Asthenia, Pyrexia, Vomiting
Asthenia, Pyrexia, Vomiting; Asthenia, Pyrexia, Vomiting
|
COVID and RSV vaccination and fever, emesis, weakness prompting hospitalization.
COVID and RSV vaccination and fever, emesis, weakness prompting hospitalization.
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โ | ||||||
| 2871750 | 56 | F | CA | 11/10/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
Unknown Unknown |
Chills, Cough, Dysphagia, Pruritus, Pyrexia; Rhinorrhoea, Throat tightness
Chills, Cough, Dysphagia, Pruritus, Pyrexia; Rhinorrhoea, Throat tightness
|
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch General...
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: Runny nose and coughing for a month and the patient was unsure of the date of immunization but stated it was 3 years ago the first week of October. She used OTC for some symptoms like ibuprofen, Tylenol, NyQuil and [withheld] Medical Center prescribed a cough syrup that had codeine in it.
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| 2871751 | 3 | M | WI | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
409108 |
Circumstance or information capable of leading to medication error, Exposure via...
Circumstance or information capable of leading to medication error, Exposure via skin contact, Extra dose administered, Underdose
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Systemic: Vaccine administration error. Dose needed to be repeated.-Mild, Additional Details: Patien...
Systemic: Vaccine administration error. Dose needed to be repeated.-Mild, Additional Details: Patient jerked their arm away from vaccinator before vaccine was fully administered resulting in vaccine being sprayed onto patient's arm. Vaccine was repeated and successfully given a few minutes after this administration error.
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| 2871752 | 55 | F | MA | 11/10/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
u8864BA |
Arthralgia, Impaired driving ability, Injected limb mobility decreased, Injectio...
Arthralgia, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Joint injury
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Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Se...
Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient experienced more than typical pain at the time of injection which was mentioned to the immunizing pharamcist. the pain progressed 5 days after immunization despite using around the clock NSAIDS and tylenol. Patient is unable to raise left arm above shoulder height and find diffuclt to turn the steering wheel while driving. She has made an appointment with her PCP to follow up
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| 2871753 | F | NY | 11/10/2025 |
TDAP TDAP TDAP |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Arthralgia, Fatigue, Full blood count normal, Injected limb mobility decreased, ...
Arthralgia, Fatigue, Full blood count normal, Injected limb mobility decreased, Lipids normal; Metabolic function test normal, Musculoskeletal discomfort, Pain, Poor quality sleep, Product administered at inappropriate site; Shoulder injury related to vaccine administration, Sleep disorder, Vitamin D decreased
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shoulder injury related to vaccine administration/acute shoulder injury following Tdap vaccination; ...
shoulder injury related to vaccine administration/acute shoulder injury following Tdap vaccination; vaccine injection was administered higher than expected; This serious case was reported in a literature article and described the occurrence of shoulder injury related to vaccine administration in a 51-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis. Literature Reference: Concurrent medical conditions included finger injury (to patient's finger). Additional patient notes included Patient with no significant medical history. Patient had no previous history of musculoskeletal or shoulder pathology and had tolerated previous vaccinations without incident. On 05-APR-2025, the patient received DTPa vaccine (intramuscular, left deltoid) .5 ml. On 05-APR-2025, less than a day after receiving DTPa vaccine, the patient experienced shoulder injury related to vaccine administration (Verbatim: shoulder injury related to vaccine administration/acute shoulder injury following Tdap vaccination) (serious criteria clinically significant/intervention required) and extra dose administered (Verbatim: vaccine injection was administered higher than expected). The patient was treated with ibuprofen and paracetamol (Acetaminophen). The outcome of the shoulder injury related to vaccine administration was resolving and the outcome of the extra dose administered was not applicable. The reporter considered the shoulder injury related to vaccine administration to be related to DTPa vaccine. The company considered the shoulder injury related to vaccine administration to be unrelated to DTPa vaccine. Additional Information: GSK receipt date: 03-NOV-2025 A 51-year-old female health professional with no significant medical history sustained a minor kitchen injury to finger on April 4, 2025. Patient received a Tdap vaccine in left (non-dominant) shoulder at an urgent care facility by a standing nurse while seated. The injection at a dose of 0.5ml was administered into the upper outer portion of deltoid muscle. As a healthcare professional, patient noticed immediately that the vaccine injection was administered higher than expected. Although patient did not initially experience severe discomfort, by evening patient developed progressive shoulder pain, reaching a severity of 8out of 10on the visual analog scale (VAS). The sharp, localized pain was aggravated by arm elevation and activities such as tying hair. There were no systemic symptoms like fever or chills,and patient did not experience numbness, tingling, or weakness. The contralateral arm was unaffected. Patient noted, It hurt so bad that I couldn't move or lie on the left side. Patient also said patient could barely sleep all night and awoke feeling fatigued and drained the next morning. Patient had no previous history of musculoskeletal or shoulder pathology and had tolerated previous vaccinations without incident. Initial self-management included ibuprofen 200 mg and acetaminophen 1000 mg taken three times daily for several days, resulting in partial relief. Patient began light self-guided physical therapy, reporting gradual improvement. No imaging was obtained, citing lack of time, and surgical opinion was not sought. As of May 3, 2025, which was 29 days after the initial injection, patient reported residual pain of 2/10 on the VAS but can perform moderate work duties. Physical Examination At approximately four weeks post-vaccination, a clinical evaluation was performed. The pain persisted at 2/10, but both active and passive range of motion (ROM) were preservedfully. Patient was able to raise both arms to shoulder height and overhead with proper form. Patient demonstrated full external and internal rotation, and a positive Apley Scratch test, indicating preserved shoulder mobility. No muscle atrophy or neurological deficits were identified. Sensation over the deltoid region was intact, and there was no cervical or thoracic spine involvement. Laboratory work, including complete blood count, basic metabolic panel, and lipid profile, was unremarkable. Vitamin D was mildly low but not thought to be contributory. The diagnosis of SIRVA was made based of the temporal relationship between vaccine administration and the onset of symptoms, absence of prior shoulder issues, and clinical findings. Patient was advised to continue conservative treatment, including physical therapy and as-needed NSAIDs. Should symptoms persist, patient might require further evaluation by the orthopaedic surgeons. Adverse events were reported to the Vaccine Adverse Event Reporting System (VAERS), and the patient was counselled on the expected recovery course. In this case, symptoms began within hours of Tdap administration, in the absence of other etiologies, supporting a diagnosis of SIRVA. Patient improved with conservative treatment but continued to experience mild discomfort. This case underscored the importance of proper vaccine administration to prevent SIRVA, a painful and potentially disabling condition. This article is not available for regulatory reporting purpose due to copyright restriction.; Sender's Comments: A case of Shoulder injury related to vaccine administration, less than a day after receiving a dose of DTPa vaccine in a 51-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (vaccine injection was administered higher than expected).
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| 2871755 | 30 | F | MI | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
6315MF002C |
Joint injury
Joint injury
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild
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| 2871756 | 88 | F | CA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052154 |
Asthenia
Asthenia
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Systemic: Weakness-Severe, Other Vaccines: VaccineTypeBrand: ABRYSVO; Manufacturer: PFIZER; LotNumb...
Systemic: Weakness-Severe, Other Vaccines: VaccineTypeBrand: ABRYSVO; Manufacturer: PFIZER; LotNumber: MM9167; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: FLUZONE HIGH DOSE; Manufacturer: SANOFI-PASTEUR; LotNumber: UT8794DA; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
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| 2871757 | 35 | F | CA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
8146670 |
Injection site bruising, Injection site pain, Joint injury
Injection site bruising, Injection site pain, Joint injury
|
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Shoulder Joint I...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Other Vaccines: VaccineTypeBrand: FLUCELVAX; Manufacturer: SEQUIRUS; LotNumber: 407008; Route: IM; BodySite: LA; Dose: ; VaxDate: UNKNOWN
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| 2871758 | 84 | M | CA | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Chest discomfort, Chest pain
Chest discomfort, Chest pain
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Patient reports chest pain at the sit...
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Patient reports chest pain at the site of pacemaker when laying down.-Medium, Other Vaccines: VaccineTypeBrand: Fluad 2025-2026 Syringe; Manufacturer: Seqirus, Inc.; LotNumber: 407241; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 10/21/2025
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| 2871759 | 82 | F | CA | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Insomnia, Restless legs syndrome
Insomnia, Restless legs syndrome
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Systemic: Patient reports restless leg syndrome symptoms.-Medium, Systemic: Unable to Sleep-Medium, ...
Systemic: Patient reports restless leg syndrome symptoms.-Medium, Systemic: Unable to Sleep-Medium, Other Vaccines: VaccineTypeBrand: Fluad 2025-2026 Syringe; Manufacturer: Seqirus, Inc.; LotNumber: 407241; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 10/21/2025
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| 2871760 | 38 | F | PA | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Medium
Site: Pain at Injection Site-Medium
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| 2871761 | 15 | M | IA | 11/10/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8873ka ut8873ka |
Anxiety, Dizziness, Loss of consciousness, Syncope, Unresponsive to stimuli; Vom...
Anxiety, Dizziness, Loss of consciousness, Syncope, Unresponsive to stimuli; Vomiting
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient with a history of fainting with vaccines temporarily lost consciousness. He was brought to the floor until he came to. Patient was given sips of water. He then tensed up which caused him to temporarily pass out again. His vitals were checked and normal. He vomited up water from the anxiety of the situation. An ice pack was placed to the back of his neck. He rested with his parents for 15 minutes until feeling ok to leave.
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| 2871764 | 57 | F | PA | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Asthenia, Injection site erythema, Syringe issue, Underdose
Asthenia, Injection site erythema, Syringe issue, Underdose
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Site: Redness at Injection Site-Mild, Systemic: none-Mild, Systemic: Weakness-Mild, Additional Detai...
Site: Redness at Injection Site-Mild, Systemic: none-Mild, Systemic: Weakness-Mild, Additional Details: Pt stated that prefilled glass broke while vaccine was injected into left arm . Her blood entered into the vial mixed with clear liquid . Pt concerned that the full dose was not administered . Pt was contacted and District leader informed .The store it occurred at was [information withheld]. NO symptoms occurred per pt > Pt will contact MD to consult ., Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: Seqirus; LotNumber: 407010; Route: IM; BodySite: L arm; Dose: ; VaxDate: UNKNOWN
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| 2871765 | 18 | F | PA | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Severe
Systemic: Fainting / Unresponsive-Severe
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| 2871767 | 26 | F | WA | 11/10/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
na0589 na0589 |
Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis; Hypotension, Lethargy, Pa...
Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis; Hypotension, Lethargy, Paraesthesia
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium
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| 2871769 | 11 | F | NC | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
na0590 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Systemic: Adult dose and pediatric dose given-Mild, Additional Details: I was administering 2 vaccin...
Systemic: Adult dose and pediatric dose given-Mild, Additional Details: I was administering 2 vaccines to each member of the family (family of 4). When patient sat down I went too fast and gave her an adult covid shot (info above), then I gave her the pediatric covid shot. I thought that I was giving her the flu shot and the pediatric covid shot. I informed the family and told them to monitor for potential adverse reactions. Will follow up Monday.
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| 2871770 | 69 | F | MA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052734 |
Injection site pain, Injection site rash, Rash
Injection site pain, Injection site rash, Rash
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: mild rash at...
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: mild rash at injection site lasted few days after shot on 10-10-25-Mild, Additional Details: states she has pain and tenderness at the inject site to this day 11-1-25
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| 2871771 | 28 | F | MA | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Injection site bruising, Injection site pain, Injection site swelling, Rash
Injection site bruising, Injection site pain, Injection site swelling, Rash
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: bump at injection site-Mild
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| 2871772 | 27 | F | VA | 11/10/2025 |
FLU4 FLU4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9JC49 9JC49 |
Arthralgia, Injected limb mobility decreased, Injection site pain, Injection sit...
Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Joint injury; Wrong technique in product usage process
More
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint I...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: cannot lift arm over 90 degrees-Medium, Systemic: Joint Pain-Medium, Additional Details: states that immunizer had to poke twice, hass appointment with GP and using laser heat at work, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: ; LotNumber: ; Route: im; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2871773 | 75 | M | IN | 11/10/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3053756 3053756 |
Asthenia, Chills, Confusional state, Dizziness, Injection site pain; Tremor
Asthenia, Chills, Confusional state, Dizziness, Injection site pain; Tremor
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Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizzin...
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Medium, Additional Details: THESE SYMPTOMS BEGAN ABOUT 11 HOURS AFTER VACCINATION AND WAS SO SEVERE HE SAID HE COULDN'T TURN THE DOOR HANDLE. SYMTOMS OF SHAKINESS CONTINUED FOR OVER AN HOUR AND SLOWLY SUBSIDED, Other Vaccines: VaccineTypeBrand: FLUZONE HIGH DOSE; Manufacturer: SANOFI; LotNumber: UT8781CA; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
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| 2871774 | 79 | F | MA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3053669 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
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Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at In...
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: patients arm is red at vaccine site 4 days after vaccine administration-Severe, Additional Details: patient went to urgent care had reaction or infection from vaccine . urgent care gave patient an antibiotic,if it gets larger patient will go to emergency department, Other Vaccines: VaccineTypeBrand: mnexspike 2025-26; Manufacturer: moderna; LotNumber: 3053669; Route: im; BodySite: deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: u8874ba; Route: im; BodySite: deltoid; Dose: ; VaxDate: UNKNOWN
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| 2871775 | 4 | F | NY | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052668 |
Incorrect dose administered, Injection site pain
Incorrect dose administered, Injection site pain
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Site: Pain at Injection Site-Mild, Systemic: tech administered spikevax adult vaccine to tech withou...
Site: Pain at Injection Site-Mild, Systemic: tech administered spikevax adult vaccine to tech without having it veriified or ran thorugh insurance. this was the adult vaccine intead of the childrens one.-Mild, Additional Details: tech administered vaccines to pt whithout having it verified or rant hrough insurance. did not double check to see that it was adult vaccine and gave it without verification. pt recieived adult vaccine without rph conset and verification. , Other Vaccines: VaccineTypeBrand: spikevax 2025 ages 12+; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2871776 | 15 | F | IL | 11/10/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
8146743 8146743 |
Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis; Lethargy, Nausea, Syncope...
Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis; Lethargy, Nausea, Syncope, Tremor, Unresponsive to stimuli
More
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainti...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: A few minutes after the vaccine patient became unresponsive. Breathing regular, eyes open and moving rapidly. Called EMS, provided sternum rubs, elevated feet, monitored blood pressure (90/57). Per mom, gets queasy after vaccinations but no history of fainting. EMS took patient out on a stretcher., Other Vaccines: VaccineTypeBrand: Fluarix; Manufacturer: GSK; LotNumber: 2LY39; Route: Intramuscular; BodySite: Left arm; Dose: N/A; VaxDate: 11/01/2025
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| 2871777 | 6 | F | CO | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
na0846 |
Asthenia, Dizziness
Asthenia, Dizziness
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Mild, Additional Details: recieved bo...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Mild, Additional Details: recieved both covid and flu vaccine in 2024 and after 15 minutes fainted. administered just covid vaccine this year and 10-15 mins after vaccine reported dizziness and weakness
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| 2871778 | 69 | M | HI | 11/10/2025 |
FLU4 |
SANOFI PASTEUR |
u8859aa |
Injection site mass, Injection site swelling
Injection site mass, Injection site swelling
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Site: Swelling at Injection Site-Mild, Additional Details: visible swelling / lump adjacent to injec...
Site: Swelling at Injection Site-Mild, Additional Details: visible swelling / lump adjacent to injection site about 4 inches away from injection site. not painful. patient reported no other issues otherwise. physician following up with patient, Other Vaccines: VaccineTypeBrand: Mnexspike 2025-26; Manufacturer: Moderna; LotNumber: 3052133; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 09/20/2025
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| 2871779 | 6 | F | MA | 11/10/2025 |
FLU4 FLU4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2ly39 2ly39 |
Circumstance or information capable of leading to medication error, Fear, Inject...
Circumstance or information capable of leading to medication error, Fear, Injection site bruising, Injection site erythema, Injection site pain; Injection site swelling
More
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Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injecti...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: paitent was extremely scared and had to try to vaccinate 3 times---so 3 different injection sites
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| 2871780 | 84 | F | FL | 11/10/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8781ba ut8781ba |
Injection site bruising, Injection site pain, Injection site pruritus, Injection...
Injection site bruising, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling; Rash erythematous
More
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injecti...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: redness/ rash started about 2-3 inches below injection site (which had a small bruise) and traveled like a band wrapped around the arm although the 2 ends did not connect.
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| 2871781 | 76 | M | CA | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Injection site pain, No adverse event
Injection site pain, No adverse event
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Site: Pain at Injection Site-Mild, Additional Details: Patient was provided verbal and written conse...
Site: Pain at Injection Site-Mild, Additional Details: Patient was provided verbal and written consent in Spanish for both the influenza and COVID-19 vaccinations for which they had requested at the POS. Prior to administration, verbal/written consent was confirmed. After administration of both vaccines, the patient stated they only wanted the influenza vaccine. No adverse reactions were observed following the COVID-19 vaccine administration. Patient was advised to stay near pharmacy for 15 minutes for observation. , Other Vaccines: VaccineTypeBrand: Fluzone High Dose 2025-2026; Manufacturer: Sanofi-Pasteur; LotNumber: U8859CA; Route: Intramuscular; BodySite: L-arm; Dose: 00; VaxDate: 10/31/2025
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| 2871783 | 13 | F | MA | 11/10/2025 |
COVID19-2 |
MODERNA |
3052834 |
Abdominal discomfort, Anaphylactic reaction, Anaphylaxis treatment, Dyspnoea
Abdominal discomfort, Anaphylactic reaction, Anaphylaxis treatment, Dyspnoea
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional ...
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Flucelvax & Spikevax were administered IM to patient's left arm. She said she felt something in her stomach. Then she got up from chair & told mom, that she could not breathe. Mom told me, patient might be having anaphylaxis b/c of her allergies. Mom helped patient seated. I administered 1 epinephrine 0.3 mg into patient's left thigh. Within a minute, patient was able to breath slowly through her mouth ti gradually to normal breathing after sitting & drinking water, Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 407010; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 11/02/2025
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โ | |||||
| 2871784 | 9 | F | TX | 11/10/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
2LY39 |
Dizziness, Nausea, Vomiting
Dizziness, Nausea, Vomiting
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
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| 2871787 | 27 | F | TX | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
409108 |
Syncope, Unresponsive to stimuli, Urinary incontinence
Syncope, Unresponsive to stimuli, Urinary incontinence
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Systemic: Fainting / Unresponsive-Mild, Additional Details: she urinated , Other Vaccines: VaccineT...
Systemic: Fainting / Unresponsive-Mild, Additional Details: she urinated , Other Vaccines: VaccineTypeBrand: Spikevax; Manufacturer: moderna; LotNumber: 8146670; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: UNKNOWN, VaccineTypeBrand: Boostrix; Manufacturer: Glaxosmithkline; LotNumber: k4979; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: UNKNOWN
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| 2871788 | 81 | F | CA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052733 |
Arthralgia, Hypoaesthesia, Injection site pain, Injection site swelling, Joint i...
Arthralgia, Hypoaesthesia, Injection site pain, Injection site swelling, Joint injury
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint I...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
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| 2871790 | 62 | F | CA | 11/10/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Rash
Rash
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Systemic: Allergic: Rash Generalized-Medium, Other Vaccines: VaccineTypeBrand: Flublok; Manufacture...
Systemic: Allergic: Rash Generalized-Medium, Other Vaccines: VaccineTypeBrand: Flublok; Manufacturer: Sanfo-Paster; LotNumber: U8864AA; Route: Im; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
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| 2871791 | 24 | F | TX | 11/10/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MY9550 MY9550 |
Asthenia, Blood glucose normal, Flushing, Hyperhidrosis, Nausea; Pallor, Syncope...
Asthenia, Blood glucose normal, Flushing, Hyperhidrosis, Nausea; Pallor, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medi...
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: After receiving 3 vaccination, pt was seated for observation. After a few minutes, her caregive asked for help bc pt fained. She recovered but she fainted again. both lasted several minutes each. When paramedics arrived, pt recovered from both faintings, still pale, sweating, and weak. Her blood pressure and sugar level were normal. Pt stated she had an issue less than a week ago of fainting(moment of blackout) out of nowhere. She said she did not fall at that time but her left arm felt numb aft
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| 2871792 | 16 | F | MA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052864 |
Dizziness, Fatigue, Lethargy, Syncope, Unresponsive to stimuli
Dizziness, Fatigue, Lethargy, Syncope, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted after vaccinations; Parents stated it occurs after every time she gets vaccines because she has extreme anxiety. We gave her water and sugar while we waited for her to recover. Her parents were very prepared for this to occur and she recovered. , Other Vaccines: VaccineTypeBrand: Fluarix; Manufacturer: GSK; LotNumber: 2LY39; Route: IM; BodySite: L; Dose: N/A; VaxDate: UNKNOWN
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| 2871795 | 37 | M | CO | 11/10/2025 |
FLU4 FLU4 FLU4 FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8883AA U8883AA U8883AA U8883AA U8883AA |
Arthralgia, Asthenia, Chills, Dizziness, Fatigue; Flushing, Headache, Hyperhidro...
Arthralgia, Asthenia, Chills, Dizziness, Fatigue; Flushing, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site bruising; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Insomnia; Joint injury, Lethargy, Pain, Product administered at inappropriate site, Pyrexia; Rotator cuff syndrome
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Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injecti...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium, Systemic: Sever shoulder and joint pain, almost immobile.-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Severe, Additional Details: Doctor said it was Rotator Cuff Tendinitis, left shoulder was immobilized for over a week. injection was in the wrong area and possibly injected into a tendon, too low and back on the shoulder. Prescribed 50 mg's of Prednisone to help kick. I am on it until tomorrow.
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| 2871798 | 45 | F | VA | 11/10/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
9jc49 |
Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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Site: Pain at Injection Site-Severe, Additional Details: patient receive 2 vaccines in same arm she ...
Site: Pain at Injection Site-Severe, Additional Details: patient receive 2 vaccines in same arm she came back to report she has no movement in that arm since getting both vaccination
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| 2871802 | 83 | F | MA | 11/10/2025 |
FLU4 |
SANOFI PASTEUR |
U8764DB |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Medium
Site: Bruising at Injection Site-Medium
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| 2871803 | 46 | F | NY | 11/10/2025 |
FLUC4 |
SEQIRUS, INC. |
410515 |
Hypoaesthesia, Injection site pain, Injection site swelling, Joint injury
Hypoaesthesia, Injection site pain, Injection site swelling, Joint injury
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Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint I...
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
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| 2871806 | 85 | F | NC | 11/10/2025 |
COVID19-2 |
PFIZER\BIONTECH |
na4459 |
Confusional state, Dizziness
Confusional state, Dizziness
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Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Other Vaccines: VaccineType...
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Other Vaccines: VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: u8862ea; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
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| 2871807 | 53 | F | GA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052864 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2871808 | 87 | F | NY | 11/10/2025 |
FLU4 |
SANOFI PASTEUR |
U8862BA |
Asthenia, Fatigue, Hepatic enzyme increased, Lethargy, Urinary tract infection
Asthenia, Fatigue, Hepatic enzyme increased, Lethargy, Urinary tract infection
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Systemic: Exhaustion / Lethargy-Medium, Additional Details: HUSBAND NOTIFIED (name withheld) THAT H...
Systemic: Exhaustion / Lethargy-Medium, Additional Details: HUSBAND NOTIFIED (name withheld) THAT HAS BEEN HOSPITALISED AS PT FELT NO ENERGY AND HAS BEEN DIAGNOSED WITH URINARY TRACT INFECTION, ELEVATED LIVER ENZYMES AND ALSO CURRENTLY PUT ON OXYGEN FOR BREATHING, Other Vaccines: VaccineTypeBrand: COMINARTY; Manufacturer: PFIZER; LotNumber: MY9547; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 0; VaxDate: 11/01/2025, VaccineTypeBrand: ABRYSVO ACT O VIAL; Manufacturer: PFIZER; LotNumber: MM9151; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: 0; VaxDate: 11/01/2025, VaccineTypeBrand: PREVNAR; Manufacturer: WYETH PFIZER; LotNumber: MG7423; Route: INTRAMUSCULAR; BodySite: RIGHTA RM; Dose: 0; VaxDate: 11/01/2025
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| 2871810 | 24 | F | OR | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052741 |
Injection site pain, Wrong technique in product usage process
Injection site pain, Wrong technique in product usage process
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Site: Pain at Injection Site-Mild, Additional Details: At time of injection, part of the vaccine was...
Site: Pain at Injection Site-Mild, Additional Details: At time of injection, part of the vaccine was still frozen. So the vaccine had to given as a split dose.
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| 2871811 | 40 | F | NV | 11/10/2025 |
COVID19-2 COVID19-2 |
PFIZER\BIONTECH PFIZER\BIONTECH |
na4452 na4452 |
Erythema, Headache, Injection site bruising, Injection site erythema, Injection ...
Erythema, Headache, Injection site bruising, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Pyrexia
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Mild, Systemic: SLEPT TILL 1 PM THE NEXT DAY-Medium, Systemic: Headache-Mild, Additional Details: SHE HAD REDNESS IN HER ARM, AND SHE WENT TO URGENT CARE ON THE 29TH AND WAS TODL SHE HAS CELLULITIS. SHE WAS GIVEN BACRIM DS AND IT HAS GOTTEN BETTER, Other Vaccines: VaccineTypeBrand: Flu; Manufacturer: glaxosmithkline; LotNumber: 5R4CY; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
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| 2871812 | 68 | F | CA | 11/10/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052133 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for 60 seconds but was okay a...
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for 60 seconds but was okay after that. went to er to get checked, Other Vaccines: VaccineTypeBrand: capvaxive; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: fluad; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2871813 | 54 | F | CA | 11/10/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
7CF5M |
Dysphonia, Dyspnoea, Headache, Lymphadenitis, Oropharyngeal pain
Dysphonia, Dyspnoea, Headache, Lymphadenitis, Oropharyngeal pain
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Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: Pt stated that 30 minutes after...
Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: Pt stated that 30 minutes after taking vaccine, started experiencing changes in voice, lymph node inflammation, difficulty breathing, headache, and pain in throat, pt stated this is her 2nd incidence to have same symptoms after vaccine
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| 2871814 | 75 | M | TN | 11/10/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8781ba ut8781ba |
Asthenia, Joint injury, Joint range of motion decreased, Muscular weakness, Para...
Asthenia, Joint injury, Joint range of motion decreased, Muscular weakness, Paraesthesia; Sensory loss
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: Tingling (specify: fa...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: complaining of limited range of motion, losing grip strength, tingling and loss of sensation especially at night, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: TTV; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2871815 | 72 | F | PA | 11/10/2025 |
FLU4 |
SANOFI PASTEUR |
U8862BA |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild, Additional Details: patient reports that she thinks the dose ...
Site: Bruising at Injection Site-Mild, Additional Details: patient reports that she thinks the dose was given too low on her arm by immunizer , Other Vaccines: VaccineTypeBrand: Covid (Comirnaty 25-26); Manufacturer: Pfizer; LotNumber: NA4457; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 10/23/2025
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| 2871816 | 58 | F | MA | 11/10/2025 |
FLUR4 FLUR4 |
PROTEIN SCIENCES CORPORATION PROTEIN SCIENCES CORPORATION |
U8864CA U8864CA |
Chest discomfort, Chest pain, Cough, Fatigue, Lethargy; Respiratory tract conges...
Chest discomfort, Chest pain, Cough, Fatigue, Lethargy; Respiratory tract congestion, Throat clearing
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemi...
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: congestion, cough-Medium, Additional Details: Patient first complained of fatigue. Then was consisting clearing her throat/coughing. She also complained of tightness in her chest.
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