chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Migraine
Clinical narrative: peripheral neuropathy; Still cannot move hands / cannot write anything,cannot type or sign anything; postural orthostatic tachycardia syndrome; Feel dizziness / dizzy all the time; Can't sleep at night; Hands freeze; daily migraines; Still have headache; Fatigue all the time/chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Auto immune disorder .) and Hypotension (low blood pressure).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue). At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome) had not resolved.            Concomitant medications were not provided.  Treatment medications were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains significant information ; event  outcome updated as not recovered not resolved for stiffness, Events migraine, peripheral neuropathy added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuropathy peripheral, Peripheral coldness, Postural orthostatic tachycardia syndrome
Clinical narrative: peripheral neuropathy; Still cannot move hands / cannot write anything,cannot type or sign anything; postural orthostatic tachycardia syndrome; Feel dizziness / dizzy all the time; Can't sleep at night; Hands freeze; daily migraines; Still have headache; Fatigue all the time/chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Auto immune disorder .) and Hypotension (low blood pressure).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue). At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome) had not resolved.            Concomitant medications were not provided.  Treatment medications were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains significant information ; event  outcome updated as not recovered not resolved for stiffness, Events migraine, peripheral neuropathy added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This case was received via FDA VAERS on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included BENDAMUSTINE from 04-Feb-2021 to 05-Feb-2021 and RITUXIMAB from 04-Feb-2021 to 05-Feb-2021 for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). The patient was hospitalized on 12-Jul-2021 due to UNEVALUABLE EVENT. At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient stated that he is positive on 09JUL2021 for unknown lab test reported.  Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Product dose omission issue, Pyrexia, Speech disorder
Clinical narrative: Confusion; Difficulty speaking; Patient has not received the 2nd dose yet; Super high fever 104; This spontaneous case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), SPEECH DISORDER (Difficulty speaking), PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd dose yet) and PYREXIA (Super high fever 104). At the time of the report, CONFUSIONAL STATE (Confusion), SPEECH DISORDER (Difficulty speaking) and PYREXIA (Super high fever 104) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) High fever 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face
Clinical narrative: alergic reaction (  swelling in the right face); pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (alergic reaction (  swelling in the right face)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced SWELLING FACE (alergic reaction (  swelling in the right face)) (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain in the left arm). At the time of the report, SWELLING FACE (alergic reaction (  swelling in the right face)) and PAIN IN EXTREMITY (pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant history was not reported. The treatment history was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Eczema, Myalgia, Pyrexia
Clinical narrative: 1. Fever of up to 100F max.  Onset appx 10 hours after shot.  Duration 12 hours.  No treatment. 2. Sore muscles (both arms, shoulders, neck).  Onset appx 10 hours after shot.  Duration 2 days. Treatment 400 mg ibuprofen in PM both days. 3. Low back arthritis flare up.  Onset appx 10 hours after shot.  Duration 2 days.  Treatment ibuprofen as stated for item 2. 4. Eczema flare up in both arm pits.  Onset appx 24 hours after shot.  Duration 24 hours.  Treatment prescription Protopic cream.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Spondylitis
Clinical narrative: 1. Fever of up to 100F max.  Onset appx 10 hours after shot.  Duration 12 hours.  No treatment. 2. Sore muscles (both arms, shoulders, neck).  Onset appx 10 hours after shot.  Duration 2 days. Treatment 400 mg ibuprofen in PM both days. 3. Low back arthritis flare up.  Onset appx 10 hours after shot.  Duration 2 days.  Treatment ibuprofen as stated for item 2. 4. Eczema flare up in both arm pits.  Onset appx 24 hours after shot.  Duration 24 hours.  Treatment prescription Protopic cream.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: patient called stated arm hurt and having some discomfort of moving the arm-Medium, Systemic: Joint Pain-Medium, Additional Details: Inform patient to seek medical care at urgent care or emergency room
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: patient bled immedately after injection. A small bump formed at injection site. bleeding stopped after compression with a cotton ball.-Mild, Additional Details: patient bled excessively from injection site and a small bump formed at injection site. advised patient to ice arm and monitor it for the next 72 hours. if it worsens contact md. on 8/2/21 at 11 am i conctacted patient, her daughter answered. Daughter stated her monther is fine she is not experiencing pain, site is still a bit swollen but she is okay and was able to return to work today.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest X-ray, Chest pain, Computerised tomogram thorax, Dizziness
Clinical narrative: chest pain, dizziness, shortness in breath.  Has non-ST elevation myocardial infarction
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Full blood count, Metabolic function test, Troponin
Clinical narrative: chest pain, dizziness, shortness in breath.  Has non-ST elevation myocardial infarction
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Discharge, Swelling, Vulval ulceration
Clinical narrative: Lipshultz ulcer to vulva  Pain, discharge, swelling, ulceration and plaques to vaginal area
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: PT FELT DIZZY FEW MINS AFTER INJECTION AND VOMITTING LIGHTLY. 5 TO 10 MINS LATER FELT OK AND WENT HOME WITH HER HUSBAND
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Throat irritation
Clinical narrative: Difficulty breathing, unable to take deep breath without coughing, airway feels constantly irritated
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: 911 called - patient passed out and fell on floor. unknown if patient hit head during fall.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: patient has seizure right after vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID infection post vaccination.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Anxiety, Arthralgia, Condition aggravated, Impaired work ability
Clinical narrative: Extreme joint pain, muscle pain & weakness, causing sleep issues/increased anxiety, inability to work and perform daily functions as previously
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: Extreme joint pain, muscle pain & weakness, causing sleep issues/increased anxiety, inability to work and perform daily functions as previously
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Hyperhidrosis, Injection site bruising, Injection site erythema
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: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient fell about 7 minutes after receiving vaccine, did not lose consciousness, kept for 30 minutes under observation, requested water, left after 30 minutes; said he felt better; had been anxious about receiving vaccine; had no primary care prescriber to follow up with per pt.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Tremor
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: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient fell about 7 minutes after receiving vaccine, did not lose consciousness, kept for 30 minutes under observation, requested water, left after 30 minutes; said he felt better; had been anxious about receiving vaccine; had no primary care prescriber to follow up with per pt.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Noticed tingling and numbness in both my feet first, then it moved into both my hands.   best way to describe it would be if your hands and feet fell asleep then you start to use them for the first time as all the blood starts to flow.   I thought i might of had a pinched nerve so i started chiropractic treatments.  after two weeks with no relief i went to my primary care doctor.  He referred me to a neurologist.  by the time i was able to see a neurologist my strength in my hands has diminished pretty rapidly as well as it was difficult to walk as my legs were weakening as well.   After initial visit with Neurologist the Dr. suspected a neuropathy and called it GBS.  Guillian-Barre Syndrome.  She scheduled a nerve test and after the nerve test she confirmed the GBS and scheduled me for IGIV treatment.  Treatment was about 4hours per day for 5 straight days.   Since treatment i have seen some improvement in strength, but feet and hands are still tingling and numb.  Time Frame.  June 7th noticed symptoms, June 23rd started Chiro Treatments,   Saw Primary Care Doc June June 28th,  Saw Neurologist July 13,  Performed Nerve Test July 14,  Started IGIV July 19 and finished IGIV on July 23.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Muscular weakness, Neuropathy peripheral, Paraesthesia
Clinical narrative: Noticed tingling and numbness in both my feet first, then it moved into both my hands.   best way to describe it would be if your hands and feet fell asleep then you start to use them for the first time as all the blood starts to flow.   I thought i might of had a pinched nerve so i started chiropractic treatments.  after two weeks with no relief i went to my primary care doctor.  He referred me to a neurologist.  by the time i was able to see a neurologist my strength in my hands has diminished pretty rapidly as well as it was difficult to walk as my legs were weakening as well.   After initial visit with Neurologist the Dr. suspected a neuropathy and called it GBS.  Guillian-Barre Syndrome.  She scheduled a nerve test and after the nerve test she confirmed the GBS and scheduled me for IGIV treatment.  Treatment was about 4hours per day for 5 straight days.   Since treatment i have seen some improvement in strength, but feet and hands are still tingling and numb.  Time Frame.  June 7th noticed symptoms, June 23rd started Chiro Treatments,   Saw Primary Care Doc June June 28th,  Saw Neurologist July 13,  Performed Nerve Test July 14,  Started IGIV July 19 and finished IGIV on July 23.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Developed blood clots in right lung
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Dysarthria, Facial paralysis, Mental status changes
Clinical narrative: Altered mental status, slurred speech, facial droop on 6/24/21.  Was admitted to hospital on 6/25/21 and diagnosed with acute stroke - right frontoparietal.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Stevens-Johnson syndrome
Clinical narrative: syndrome allergic reaction
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Chills, Dizziness, Dysphagia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: decreased perfussion to feet,legs, ankles and feet were slighly discolored blue due to decreased perfussion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Fatigue, Lethargy, Mouth swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: decreased perfussion to feet,legs, ankles and feet were slighly discolored blue due to decreased perfussion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sensation of blood flow, Skin discolouration, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: decreased perfussion to feet,legs, ankles and feet were slighly discolored blue due to decreased perfussion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: decreased perfussion to feet,legs, ankles and feet were slighly discolored blue due to decreased perfussion
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Approx. 3 minutes after injection patient had itching and hives on arm of injection and right side down to her waist.  administered 50 mg benadryl orally.  Approx. 3 to 5 minutes later patient started coughing and was having trouble swallowing.  911 was called.  no Epipen was administered on site.  Follow up with patient, she was discharged to home same day within 5 to 6 hours of reaction.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Throat tightness, Urticaria
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Approx. 3 minutes after injection patient had itching and hives on arm of injection and right side down to her waist.  administered 50 mg benadryl orally.  Approx. 3 to 5 minutes later patient started coughing and was having trouble swallowing.  911 was called.  no Epipen was administered on site.  Follow up with patient, she was discharged to home same day within 5 to 6 hours of reaction.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Contusion, Fatigue, Injection site pain, Oral pruritus
Clinical narrative: Patient reports no immediate symptoms other than some mild pain at the site of the injection during the observation period. She noted after the observation period but within the first 24 hours, some mild fatigue and local swelling but no fever, chills or myalgias. The swelling resolved and was without symptoms until 3 days later on 18 June 2021.On that evening she noted hives on her face and itching around her mouth. She heard faint wheezing and noted a bruise on her L wrist. Symptoms were not severe enough to seek care and that evening hives subsided but the following day on 19 June 2021, the hives returned/persisted. She took Benadryl with some transient relief every 6 hours. The hives persisted off/on through the following day through 20 Jun 2021. Because the hives persisted and noted some mild wheezing, she went to a civilian urgent care on 21 June 2021. She was prescribed prednisone and an albuterol inhaler. The lesions and dyspnea resolved within a few hours and was discharged. Labs were drawn. of note PT/PTT and platelet count normal. She reports that the bruise on her wrist persisted for 2 weeks. She reports no other symptoms currently but a day or so ago noted a bruise on her R ankle.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Swelling, Urticaria, Wheezing
Clinical narrative: Patient reports no immediate symptoms other than some mild pain at the site of the injection during the observation period. She noted after the observation period but within the first 24 hours, some mild fatigue and local swelling but no fever, chills or myalgias. The swelling resolved and was without symptoms until 3 days later on 18 June 2021.On that evening she noted hives on her face and itching around her mouth. She heard faint wheezing and noted a bruise on her L wrist. Symptoms were not severe enough to seek care and that evening hives subsided but the following day on 19 June 2021, the hives returned/persisted. She took Benadryl with some transient relief every 6 hours. The hives persisted off/on through the following day through 20 Jun 2021. Because the hives persisted and noted some mild wheezing, she went to a civilian urgent care on 21 June 2021. She was prescribed prednisone and an albuterol inhaler. The lesions and dyspnea resolved within a few hours and was discharged. Labs were drawn. of note PT/PTT and platelet count normal. She reports that the bruise on her wrist persisted for 2 weeks. She reports no other symptoms currently but a day or so ago noted a bruise on her R ankle.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Vision blurred
Clinical narrative: Systemic: pt got blurry vision-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated she was having severe anxiety she got blurry vision and she thought she will pass out so called 911 and upon evaluation by 911 everything vitals were normal she drank water and was just fine she developed anxiety to needles and vaccines and she might be dehydrated but not sure . she left pharmacy with no diffuclties and 911 said she is just fine and can go home
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Identified after vaccine administration that patient was not 12 years old, thus falling outside the current emergency use authorization age for administration of Pfizer vaccine. Pt tolerated vaccine well, no known adverse events. I attempted to outreach to the family to notify them but was unsuccessful.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Infection
Clinical narrative: Error: Infection / Cellulitis (diagnosed by MD)-
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash on right arm from injection site down about 6 inches on arm, slightly swollen, red, itchy and sore. This started on Monday, 2 August. When I woke up on Tuesday, 3 August, the right side of my tongue feels swollen as does the area beneath the right side of my tongue and down the right side of my neck. That whole area feels like I've been given a Novacaine injection. Not really any difficulty swallowing, my mouth and neck area just feel weird.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Swollen tongue
Clinical narrative: Rash on right arm from injection site down about 6 inches on arm, slightly swollen, red, itchy and sore. This started on Monday, 2 August. When I woke up on Tuesday, 3 August, the right side of my tongue feels swollen as does the area beneath the right side of my tongue and down the right side of my neck. That whole area feels like I've been given a Novacaine injection. Not really any difficulty swallowing, my mouth and neck area just feel weird.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia oral, Peripheral swelling
Clinical narrative: Rash on right arm from injection site down about 6 inches on arm, slightly swollen, red, itchy and sore. This started on Monday, 2 August. When I woke up on Tuesday, 3 August, the right side of my tongue feels swollen as does the area beneath the right side of my tongue and down the right side of my neck. That whole area feels like I've been given a Novacaine injection. Not really any difficulty swallowing, my mouth and neck area just feel weird.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Rash on right arm from injection site down about 6 inches on arm, slightly swollen, red, itchy and sore. This started on Monday, 2 August. When I woke up on Tuesday, 3 August, the right side of my tongue feels swollen as does the area beneath the right side of my tongue and down the right side of my neck. That whole area feels like I've been given a Novacaine injection. Not really any difficulty swallowing, my mouth and neck area just feel weird.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy uterus normal, Postmenopausal haemorrhage, Ultrasound scan vagina normal
Clinical narrative: Was in menopause for two years and had a six day heavy period after taking first does of Pfizer vaccine.  A vaginal sonogram was performed and a biopsy occurred both results were negative.    Sonogram technician stated several women were coming in for the same reason. I have not had another period since.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue, Throat irritation
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient did not experience adverse event at the pharmacy but called back ~ 1 hour or so later to report tongue swelling and throat itching. Instructed to take liquid benadryl and if it worsened or her breathing became labored to report to an ER
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Deep vein thrombosis, Diarrhoea, Nausea
Clinical narrative: Diarrhea, vomiting, nausea, abdominal pain that goes to back and to legs, deep vein thrombosis (DVT)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Diarrhea, vomiting, nausea, abdominal pain that goes to back and to legs, deep vein thrombosis (DVT)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Hepatic cirrhosis, SARS-CoV-2 test positive, Vomiting
Clinical narrative: I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Electrocardiogram normal, Syncope, Tachycardia
Clinical narrative: 35-year-old female with past medical history of uterine fibroids, hypertension, syncopal episodes.  She presents the emergency department after a witnessed syncopal episode at a vaccine clinic. She states she has had a syncopal episodes in the past which involved her being on her menstrual cycle and experiencing very painful menstrual cramps. She states this was no different in the past and she states she is currently on her cycle and was having extreme pain which she describes menstrual cramps before her syncopal episode. Her mother witnessed the syncopal episode and states she did not fall there is no signs of trauma on the patient. Patient states she would not come to emergency room other than staff at the vaccine site urging her to come. After using the Wells criteria on the patient it exhibits a very low risk approximately 2% that the patient has a pulmonary embolism. She had tachycardia upon arrival with a rate of 105, But she is currently having multiple pulse checks that have all been under 100 bpm.Patient was given fluids and lab work was ordered.  Patient to be discharged, on physical exam and evaluation of lab work there is no concern for pulmonary embolism or any emergent condition.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: The patient called the pharmacy to report that shortly after receiving the COVID 19 vaccine, she began to feel severe chest pain and shortness of breath.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Seizure, Syncope
Clinical narrative: Patient fainted, assisting patient to the floor, he seized or twitched
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Tinnitus
Clinical narrative: Tettinitis both ears Right ear two fluid filled bubbles
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever, chills, muscle aches, runny nose, sore throat, headache, fatigue, cough, nausea, and diarrhea
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills, muscle aches, runny nose, sore throat, headache, fatigue, cough, nausea, and diarrhea
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Fever, chills, muscle aches, runny nose, sore throat, headache, fatigue, cough, nausea, and diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Inflammation of the injection site on the 8th day after vaccination. (The injection is swollen, reddened and itchy).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Painful injection site that is firm and warm to touch.  No treatment.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Outreach vaccination clinic at the jail.  Client signed up for COVID vaccines, and verified that he had not been vaccinated against COVID.   Due to offsite clinic, unable to verify history so we took patient at his word.  Janssen vaccine given.  Once arriving back to clinic to put vaccines in, noticed client has received a Janssen vaccine on 05/07/2021.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: TACHYCARDIA. DYSPENEA
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Fever, chills, and congestion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products, Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: Patient administered Janssen , unable to take pfizer #2 due to allergic reaction. Evaluated by Allergist and cleared to receive Janssen vaccine. 10 mins following injection, reported throat tightness, headache, tingling sensation mouth and tongue, lips felt puffy, denied sob.  Given benadryl 50 mg IM x1, reports in 10 minutes symptoms improving ., however persisted x 1 hour, milder, still reported lip tingling and mild throat tightness, headache improving.  EMS activated and patient transported to Emergency Room for further monitroing.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Peripheral swelling
Clinical narrative: 8:00- Left arm became numb up to upper deltoid. 12:00- progressed to left shoulder. 14:00- face numb. . Nose, mouth and lips numb. 15:00- Tongue tingling. 21:00- Eye lids, lips, and left side of face swelled. Fingers puffy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Scan normal, Skin swelling, Swelling face, Swelling of eyelid
Clinical narrative: 8:00- Left arm became numb up to upper deltoid. 12:00- progressed to left shoulder. 14:00- face numb. . Nose, mouth and lips numb. 15:00- Tongue tingling. 21:00- Eye lids, lips, and left side of face swelled. Fingers puffy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Pain in extremity, Urine analysis
Clinical narrative: Day after shot: Redness and bumps around injections site (went away after a few days). Pain on arm (went away after a few days). Persistent strong headache (still present). UTI symptoms (pending lab work).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Patient developed L sided numbness, bells palsy on 8/1 - current. no other sx
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness, Seizure, Sinus operation
Clinical narrative: Within 8-10 minutes he started to feel dizzy then passed out; lost consciousness; had seizures (no prior seizure history); eventually came two and was driven home; after had continuous sneezing and nasal drainage for two days and felt awful for four months with cold like symptoms
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Within 8-10 minutes he started to feel dizzy then passed out; lost consciousness; had seizures (no prior seizure history); eventually came two and was driven home; after had continuous sneezing and nasal drainage for two days and felt awful for four months with cold like symptoms
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Feeling cold, Headache, Nausea
Clinical narrative: Per employee:  "Got the second COVID vaccine (Moderna), and a few hours shortly after I felt cold and temp was 103.2 with body aches, nausea, headaches, swelling in the left arm and light headedness. still have some symptoms the next following "
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Per employee:  "Got the second COVID vaccine (Moderna), and a few hours shortly after I felt cold and temp was 103.2 with body aches, nausea, headaches, swelling in the left arm and light headedness. still have some symptoms the next following "
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Injection site pain. Headache two hours after shot. Ibuprofen helped greatly at 600mg dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Catheterisation cardiac abnormal, Chest pain, Echocardiogram abnormal, Electrocardiogram normal
Clinical narrative: July 27. 2021 @1640: unusual chest/back/bilateral arm pain; admitted to ED, EKG normal, troponins elevated, echocardiogram abnormal; showed enlarged left ventricle, troponins reached 0.44 then declined on next two lab draws. transported to another city for heart cath; results showed Takotsubo Cardiomyopathy; will follow up with cardiologist in my home state.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Left ventricular enlargement, Pain in extremity, SARS-CoV-2 test, Stress cardiomyopathy
Clinical narrative: July 27. 2021 @1640: unusual chest/back/bilateral arm pain; admitted to ED, EKG normal, troponins elevated, echocardiogram abnormal; showed enlarged left ventricle, troponins reached 0.44 then declined on next two lab draws. transported to another city for heart cath; results showed Takotsubo Cardiomyopathy; will follow up with cardiologist in my home state.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: July 27. 2021 @1640: unusual chest/back/bilateral arm pain; admitted to ED, EKG normal, troponins elevated, echocardiogram abnormal; showed enlarged left ventricle, troponins reached 0.44 then declined on next two lab draws. transported to another city for heart cath; results showed Takotsubo Cardiomyopathy; will follow up with cardiologist in my home state.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Covid positive, sore throat, headache, cough
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Impaired work ability, Loss of personal independence in daily activities, Migraine
Clinical narrative: Symptoms 1. onset of frequent and severe migraines, include numbness on the left side of my face 2. chest pain in the left and center of my chest  Symptoms have not resolved in over 3 months and prevent me from regular exercise, daily 8 hours of work, and other parts of my general lifestyle. Treatments and investigation ongoing. Due to symptoms, I have not gotten the second dose of the vaccine yet.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding
Clinical narrative: Breakthrough menstrual spotting at end of  May between 5/26/2021 and 5/29/2021. No menstrual cycle since despite ceasing use of oral birth control at end of May.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test normal, Bone pain, Disturbance in attention
Clinical narrative: 06/24/2021 Dizzy, light headed, muscle aches, bone aches, headaches (not migraine stage headache), loss of taste, loss of smell, concentration off bad,  felt like I was having a seizure inside,  my personality changed from being  a fun loving  happy person to just living (not having fun or making people laugh like I normally do).  06/29/2021 Went for a Covid test at Pharmacy. Work sent me do to still not filling well at all. Still had all those symptoms. Called My doctor office, Nurse told me that it was normal to feel this way after vaccine to give it a week.  Covid test was negative. 07/19/2021 Called Medical Center again because my symptoms never went away. Ordered blood work had done at Medical center. 07/22/2021 Seen for results everything looked good. She ordered more blood work and told me to start 12 day therapy step of Prednisone 10mg after bloodwork. Prednisone has helped with muscle and bone aches except for on 7/30/21 i hurt all over that day. Was a really bad day. 08/02/2021 CDC called me told me to fill out this form. 08/03/2021 as of now I still have everything going on but not aches or pains.  Last day of prednisone.  I had to leave work a couple of times to do these symptoms. Which I loss pay on.  I may be missing somethings because of my concentration being way off.  Sorry about that.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Impaired work ability, Malaise
Clinical narrative: 06/24/2021 Dizzy, light headed, muscle aches, bone aches, headaches (not migraine stage headache), loss of taste, loss of smell, concentration off bad,  felt like I was having a seizure inside,  my personality changed from being  a fun loving  happy person to just living (not having fun or making people laugh like I normally do).  06/29/2021 Went for a Covid test at Pharmacy. Work sent me do to still not filling well at all. Still had all those symptoms. Called My doctor office, Nurse told me that it was normal to feel this way after vaccine to give it a week.  Covid test was negative. 07/19/2021 Called Medical Center again because my symptoms never went away. Ordered blood work had done at Medical center. 07/22/2021 Seen for results everything looked good. She ordered more blood work and told me to start 12 day therapy step of Prednisone 10mg after bloodwork. Prednisone has helped with muscle and bone aches except for on 7/30/21 i hurt all over that day. Was a really bad day. 08/02/2021 CDC called me told me to fill out this form. 08/03/2021 as of now I still have everything going on but not aches or pains.  Last day of prednisone.  I had to leave work a couple of times to do these symptoms. Which I loss pay on.  I may be missing somethings because of my concentration being way off.  Sorry about that.