chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Syncope, Tachycardia, Throat tightness, Tinnitus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: patient has experience knee pain since receiving the covid vaccine. Pain that goes up to 9/10.-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: Patient received a covid vaccine on 10/09/2023. Felt knee pain the day after. Until now, patient still has pain and has reached out to her provider for help reducing pain
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: patient has experience knee pain since receiving the covid vaccine. Pain that goes up to 9/10.-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: Patient received a covid vaccine on 10/09/2023. Felt knee pain the day after. Until now, patient still has pain and has reached out to her provider for help reducing pain
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Neuralgia, Spinal pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: pain in nerves and spine-Medium, Other Vaccines:  VaccineTypeBrand: moderna 2023-24 12yr+ syr; Manufacturer: moderna; LotNumber: 3031894; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 10/29/2023
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Systemic: Right medication for both Fluzone and Moderna was given to right pt in correct time and dose and route.   When looking up the pt in chart I accidentally clicked on select on the wrong PT with same name and charting error has occurred.  The vaccines have be-Mild, Additional Details: Right medication for both Fluzone and Moderna was given to right pt in correct time and dose and route.   When looking up the pt in chart I accidentally clicked on select on the wrong PT with same name and charting error has occurred.  The vaccines have been charted in wrong pts chart but given correctly to correct pt., Other Vaccines:  VaccineTypeBrand: Fluzone Quadrivalent; Manufacturer: Sanofi; LotNumber: u8201ea; Route: IM; BodySite: left Deltoid; Dose: 1; VaxDate: 10/27/2023
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: Fluad; Manufacturer: ; LotNumber: 371594; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site abscess, Injection site pain, Injection site swelling, Pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: tendon pain-Severe, Additional Details: patient is a retired physician, believes vaccinator injected too high and it resulted in his pain
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: tendon pain-Severe, Additional Details: patient is a retired physician, believes vaccinator injected too high and it resulted in his pain
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Asthenia, Autoimmune disorder
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Blood disorder, Cardiac disorder, Cerebrovascular accident, Chest discomfort
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Fatigue, Flushing
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Hypertension, Hyperventilation, Hypotension
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Lethargy, Lymphadenopathy, Mouth swelling, Multisystem inflammatory syndrome in adults
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myocardial infarction, Nausea, Nervous system disorder, Pain, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia, Pruritus, Pyrexia, Rash, Seizure
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face, Swollen tongue, Syncope, Tachycardia, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus, Tremor, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Severe, Systemic: Pneumonia rapid onset-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Gait inability, Joint swelling, Peripheral swelling
Clinical narrative: Systemic: swelling of knees and feets-Severe, Additional Details: Patient call us on 10/31/2023 to inform the adverse reaction of swelling of knees and feets, started on 10/272023, he call clinic that day and they prescribe him diclofenac gel he said that it works but feets still swelling on feets and he cant even walk. I explain him that a doctor needs to evaluate him, the best course of action is go to ER.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Nausea, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Moderna and Flucelvax given in same arm, same time.  Patient briefly fainted.-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient revived quickly, gave water, felt nauseous for a moment.  Layed her down, legs propped up, cold compress on neck and head.  Felt better within 15 minutes.  , Other Vaccines:  VaccineTypeBrand: Flucelvax Quad; Manufacturer: Sequirus; LotNumber: 944460; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 10/31/2023
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Moderna and Flucelvax given in same arm, same time.  Patient briefly fainted.-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient revived quickly, gave water, felt nauseous for a moment.  Layed her down, legs propped up, cold compress on neck and head.  Felt better within 15 minutes.  , Other Vaccines:  VaccineTypeBrand: Flucelvax Quad; Manufacturer: Sequirus; LotNumber: 944460; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 10/31/2023
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt reports pain/numbness throughout arm/shoulder joint of injection. Pt believes injection was given too high into the shoulder, however when the pt indicated the location of the vaccine, it was given in the appropriate location (middle of deltoid)
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash, Urticaria
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Patient stated she had hives inside and outside of her body-Severe, Other Vaccines:  VaccineTypeBrand: fluad Quad; Manufacturer: Seqirus; LotNumber: 371623; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient states limited range of motion
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXOSMITHKLINE; LotNumber: YG4SK; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Per Patient - Extreme upper arm pain, cannot move arm behind her and is getting up in middle of night due to the extreme pain. The pain is still persisting as of 11/01/23. Will be following up with primary or ortho to see if due to vaccine administration error and next steps.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood glucose decreased, Burning sensation, Chills, Flushing
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Additional Details: pt stated that night in bed she could feel every bone in her body with a burning feeling, she also was cold all night and her sugar dropped, she treated low blood sugar but for the next 24-48 hours was unable to get out of bed
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Mobility decreased, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Additional Details: pt stated that night in bed she could feel every bone in her body with a burning feeling, she also was cold all night and her sugar dropped, she treated low blood sugar but for the next 24-48 hours was unable to get out of bed
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: patient received only the liquid component of Menveo/Only CYW component administered.; patient received only the liquid component of Menveo/Only CYW component administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid component of Menveo/Only CYW component administered.) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid component of Menveo/Only CYW component administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 11-JUN-2024 A pharmacist reported to asked they had a situation in the clinic that led to the question if the Men CYW135 was administered but the Men A lyophilized was not administered, basically, like when we readminister the entire dose again. The reporter confirmed that a patient received only the liquid component of Menveo which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Other Vaccines:  VaccineTypeBrand: pfizer covid 12yr+; Manufacturer: Pfizer; LotNumber: HF9300; Route: Intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: PATIENT FELL BUT REMAINED CONSCIOUS. REMAINED SEATED AFTERWARDS WHILE DRINKING WATER. RECOVERED WITHIN 15 MINUTES.-Mild, Other Vaccines:  VaccineTypeBrand: AFLURIA; Manufacturer: SEQIRUS; LotNumber: AU1060D; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fatigue, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Lump on the arm-Medium, Systemic: Nausea-Medium, Other Vaccines:  VaccineTypeBrand: Spikevax; Manufacturer: Moderna Inc; LotNumber: 8058492; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 10/06/2023, VaccineTypeBrand: Fluad; Manufacturer: Seqirus; LotNumber: 371594; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 09/24/2023
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Lethargy, Limb mass, Nausea
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Lump on the arm-Medium, Systemic: Nausea-Medium, Other Vaccines:  VaccineTypeBrand: Spikevax; Manufacturer: Moderna Inc; LotNumber: 8058492; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 10/06/2023, VaccineTypeBrand: Fluad; Manufacturer: Seqirus; LotNumber: 371594; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 09/24/2023
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site muscle weakness, Injection site pain, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient reported they have been having weakness/ limited range in motion of their left shoulder beginning 24 hours after vaccination.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient reports extreme pain while receiving vaccine.  Post vaccine, she experienced a frozen shoulder.  She saw her primary care doctor, who said that the vaccine was administered in the wrong part of her arm.  (Also on the documentation, it says she received her vaccine in the left arm, but she received it in the right.)  She reported that she is going to go to physical therapy for her arm.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Systemic: patient states her vision ibecame cloudy 3 days after vaccination-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient states she has ongoing cloudiness of vision that began about 3 days after vaccination and  is continuing to get worse.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt stated she got infected on the injection site after vaccination so she went to urgent care and then got referred to ER. Pt reported this when she pickup her abx on 10/29/2023. (cefdinir)
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Mild, Other Vaccines:  VaccineTypeBrand: Spikevax COVID-19; Manufacturer: Moderna; LotNumber: au3916d; Route: IM; BodySite: Left arm; Dose: 4; VaxDate: 10/23/2023
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: 24-36 hrs post administration, patient experienced redness, swelling, painful area around injection site.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient got her first dose of Twinrix on 07 Oct 2023 and the second dose on 11 Mar 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 39-year-old female patient who received HAB (Twinrix) (batch number 797F9) for prophylaxis.   Previously administered products included Twinrix (on 7th October 2023 received 1st dose).   On 11-MAR-2024, the patient received the 2nd dose of Twinrix. On 11-MAR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: A patient got her first dose of Twinrix on 07 Oct 2023 and the second dose on 11 Mar 2024). The outcome of the drug dose administration interval too long was unknown.   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: 13-JUN-2024 An HCP reported that a patient got her first dose of Twinrix on 07 October 2023 and the second dose on 11 March 2024 now HCP asked when can they give the third dose. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Fatigue, Seizure
Clinical narrative: Systemic: Seizure-Medium, Additional Details: Patient received her flu vaccine at our Store without any issues at the pharmacy. She called a while after to inform us that she had an episode of seizure. She has a history of seizures but has not had any in a while.  She called her neurologist who advised her on what to do. I made a follow call few hours after the vaccine was administered and she said she is doing ok but feeling tired. She will be seeing her neurologist on Monday 11/06/2023 for follow up.; Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 944445; Route: IM; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: After the booster, pt has constant pain in the right arm after vacinne. Pt is unable to reach back.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Lethargy, Nausea, Vomiting
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: After the booster, pt has constant pain in the right arm after vacinne. Pt is unable to reach back.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt rash is 2.54 cm by width and 7.62 cm length. pt noticed rash (itching) on monday. pt states the itchness started on sunday evening, Other Vaccines:  VaccineTypeBrand: moderna spikevax; Manufacturer: moderna; LotNumber: 8058081; Route: intramuscular; BodySite: right arm; Dose: 1; VaxDate: 10/27/2023
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphonia
Clinical narrative: Systemic: voice lost-Severe, Additional Details: voice lost
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site joint pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: painful shoulder joint pain; pt states injection site not painful but shoulder joint
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: covid 19; Manufacturer: moderna; LotNumber: 8058856; Route: IM; BodySite: deltoid; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: covid 19; Manufacturer: moderna; LotNumber: 8058856; Route: IM; BodySite: deltoid; Dose: ; VaxDate: UNKNOWN
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: vasovagal-Mild, Systemic: Nausea-Mild, Additional Details: child was anxious prior to vaccination and started to vasovagal after vaccine was administered. Child did not lose consciousness. Was place in supine position with legs elevated and monitored for 15 minutes before placed into sitting position. Child recovered from vasovagal response without any other complications. Child was monitored in clinic for total of 30 minutes before leaving clinic. , Other Vaccines:  VaccineTypeBrand: COVID vaccine 2023-2024; Manufacturer: Moderna; LotNumber: au5554b; Route: intramuscular; BodySite: right deltoid; Dose: 1; VaxDate: 11/02/2023
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: dizziness and fainted and hit head according to survey-Medium, Additional Details: pt received 2 shots pfizer covid shot as well as afluria...according to immunizer ....pt felt faint afterwards and fell....on the report pt complained that he fell and hit his head....pt was given some water and seemed to be fine after a couple minutes according to pharmicist .....no primary provider was given on the form nor can we find any info on rxconnect, Other Vaccines:  VaccineTypeBrand: afluria; Manufacturer: sequirus; LotNumber: au1073a; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 10/31/2023