chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, Chest X-ray abnormal, Feeling abnormal, Incontinence, Lethargy
Clinical narrative: Lethargy and mental fog appeared on 2 February 2021. Taken to by paramedics to Hospital where she was admitted.  Diagnosis: Fever, pneumonia, and chest x-ray showed  left lung pleural effusion.  Underwent thoracentesis on 4 February 2021.  About 1000ml fluid removed.  Heart meds were adjusted to 100mg metoprolol succinate twice per day.  IV antibiotics given every 8 hours. Eventually discharged from hospital. Continued need for thoracentesis:  Incontinence began with greater frequency the week of 17 August 2020 Left lung pleural effusion so need a thoracentesis Thoracentesis 4 February 2021 Removed 1 liter fluid normal Thoracentesis 11 March 2021 Removed 1 liter fluid normal Thoracentesis   8 April 2021  Removed 1 liter fluid normal Thoracentesis 7 May 2021  Removed 1 liter fluid normal Thoracentesis 15 June 2021  Removed 750ml fluid normal Thoracentesis 16 July 2021  Removed 550ml fluid normal Thoracentesis 31 August 2021 Removed 500ml fluid Thoracentesis 11 November 2021 Removed 500ml fluid
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumonia, Pyrexia
Clinical narrative: Lethargy and mental fog appeared on 2 February 2021. Taken to by paramedics to Hospital where she was admitted.  Diagnosis: Fever, pneumonia, and chest x-ray showed  left lung pleural effusion.  Underwent thoracentesis on 4 February 2021.  About 1000ml fluid removed.  Heart meds were adjusted to 100mg metoprolol succinate twice per day.  IV antibiotics given every 8 hours. Eventually discharged from hospital. Continued need for thoracentesis:  Incontinence began with greater frequency the week of 17 August 2020 Left lung pleural effusion so need a thoracentesis Thoracentesis 4 February 2021 Removed 1 liter fluid normal Thoracentesis 11 March 2021 Removed 1 liter fluid normal Thoracentesis   8 April 2021  Removed 1 liter fluid normal Thoracentesis 7 May 2021  Removed 1 liter fluid normal Thoracentesis 15 June 2021  Removed 750ml fluid normal Thoracentesis 16 July 2021  Removed 550ml fluid normal Thoracentesis 31 August 2021 Removed 500ml fluid Thoracentesis 11 November 2021 Removed 500ml fluid
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Joint range of motion decreased, Migraine
Clinical narrative: Vaccination dates 03/20/2021, 04/10/202021 an 12/07/2021. After the shot I develop migraines. Muscle aches and increased ringing in both ears.  Pain in both arms, waist area and back. The shot made me extremely tired. My range of motion in arms seems to be limited. I sometimes have to use a long handle spoon or a spatula to help with reaching. My shoulders and upper arm hurt.  Dr. suggest that I take Excedrin Migraine. I do take Advil occasionally for muscle ache.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Tinnitus
Clinical narrative: Vaccination dates 03/20/2021, 04/10/202021 an 12/07/2021. After the shot I develop migraines. Muscle aches and increased ringing in both ears.  Pain in both arms, waist area and back. The shot made me extremely tired. My range of motion in arms seems to be limited. I sometimes have to use a long handle spoon or a spatula to help with reaching. My shoulders and upper arm hurt.  Dr. suggest that I take Excedrin Migraine. I do take Advil occasionally for muscle ache.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Magnetic resonance imaging abnormal, Seizure
Clinical narrative: Seizure
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site swelling, Localised oedema, Lymphadenopathy, Tenderness
Clinical narrative: Swelling of lymph nodes, tenderness/discomfort, edema into right collar bone and neck, pain posterior ribs.  Injection site swelling approx size of a large egg
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Blood test, Blood thyroid stimulating hormone decreased, Blood thyroid stimulating hormone increased, Hyperthyroidism
Clinical narrative: I experienced Hyperthyroidism and then later hypothyroidism.  NO PREVIOUS THYROID ISSUES
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism, Thyroid function test abnormal, Thyroxine free decreased
Clinical narrative: I experienced Hyperthyroidism and then later hypothyroidism.  NO PREVIOUS THYROID ISSUES
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: Weakness, headache, nausea.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Electromyogram normal, Hypoaesthesia, Nerve conduction studies normal, Paraesthesia
Clinical narrative: Numbing and tingling sensation decreased feeling or sensitivity  that is still ongoing. Did EMG Nerve conductionNOV 5th 2021 and it turned out negative. was told its paresthesia .  When I did have Covid19  in Janary 2022 the paresthesia worsened and still having issues with it. I reached out to Jassen and Jassen about the risk of paresthesia and was sent information on it my inquiry number is 03090238 and under the risks is listed the paresthesia and the issues I'm experiening. My pcp is listed that its a common side effect and scanned in the information I was given from Jassen and Jassen. I  can provide notes if need be.   Still monitoring with pcp
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory loss
Clinical narrative: Numbing and tingling sensation decreased feeling or sensitivity  that is still ongoing. Did EMG Nerve conductionNOV 5th 2021 and it turned out negative. was told its paresthesia .  When I did have Covid19  in Janary 2022 the paresthesia worsened and still having issues with it. I reached out to Jassen and Jassen about the risk of paresthesia and was sent information on it my inquiry number is 03090238 and under the risks is listed the paresthesia and the issues I'm experiening. My pcp is listed that its a common side effect and scanned in the information I was given from Jassen and Jassen. I  can provide notes if need be.   Still monitoring with pcp
Age: 12.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Allergy test positive, Cardiac function test abnormal, Dyspnoea exertional, Erythema, Exercise tolerance decreased
Clinical narrative: 10/1/2016 - Quick to run out of breath at volleyball practice.  Her face started turning noticeably red during physical activity.   11/12/2016 - Basketball season she struggled with the physical activity and running.  Before the vaccine she would run forever without getting tired.
Age: 12.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Postural orthostatic tachycardia syndrome, Pulmonary function test, Syncope
Clinical narrative: 10/1/2016 - Quick to run out of breath at volleyball practice.  Her face started turning noticeably red during physical activity.   11/12/2016 - Basketball season she struggled with the physical activity and running.  Before the vaccine she would run forever without getting tired.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: large red rash, raised, warm, slight itch. patient used diphenhydramine ointment with some relief
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Treponema test, Treponema test false positive
Clinical narrative: False and Inconsistent RPR Reactivity following Moderna 2nd dose. Presented with no syphilis symptoms. Has no history of syphilis and no history of receiving syphilis treatment.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient reported experiences a rash on the face and swelling in the arm at injection site that lasted a few days
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache, body aches, sore throat, fatigue.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abnormal behaviour, Aggression, Aphasia, Emotional disorder, Head titubation
Clinical narrative: Increase in touch sensitivity, spinning, swinging of head back and forth while seated at the table for meals, inability to stay seated at the table for meals more than 5 minutes, challenges in emotional regulation, significant squirming while seated, overwhelm in social situations and social anxiety, listening to only one song on repeat, blank staring, use of visual schedule to support daily routines, difficulty with transitions, explosive and aggressive meltdowns, difficulties with word retrieval, increased humming, restless sleep, night terrors, difficulties with motor planning
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hyperaesthesia, Intermittent explosive disorder, Loss of personal independence in daily activities, Motor dysfunction, Poor quality sleep
Clinical narrative: Increase in touch sensitivity, spinning, swinging of head back and forth while seated at the table for meals, inability to stay seated at the table for meals more than 5 minutes, challenges in emotional regulation, significant squirming while seated, overwhelm in social situations and social anxiety, listening to only one song on repeat, blank staring, use of visual schedule to support daily routines, difficulty with transitions, explosive and aggressive meltdowns, difficulties with word retrieval, increased humming, restless sleep, night terrors, difficulties with motor planning
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Psychomotor hyperactivity, Restlessness, Sleep terror, Social anxiety disorder, Staring
Clinical narrative: Increase in touch sensitivity, spinning, swinging of head back and forth while seated at the table for meals, inability to stay seated at the table for meals more than 5 minutes, challenges in emotional regulation, significant squirming while seated, overwhelm in social situations and social anxiety, listening to only one song on repeat, blank staring, use of visual schedule to support daily routines, difficulty with transitions, explosive and aggressive meltdowns, difficulties with word retrieval, increased humming, restless sleep, night terrors, difficulties with motor planning
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vertigo
Clinical narrative: Increase in touch sensitivity, spinning, swinging of head back and forth while seated at the table for meals, inability to stay seated at the table for meals more than 5 minutes, challenges in emotional regulation, significant squirming while seated, overwhelm in social situations and social anxiety, listening to only one song on repeat, blank staring, use of visual schedule to support daily routines, difficulty with transitions, explosive and aggressive meltdowns, difficulties with word retrieval, increased humming, restless sleep, night terrors, difficulties with motor planning
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination abnormal, Photopsia, Vitreous floaters
Clinical narrative: I had about 4 eye floaters about a week after receiving the Pfizer 3rd shot. I had previously also had eye floaters about a week after my second shot in the series. I had never had eye floaters before this time. In late December 2021, I had some flashes of light, especially in somewhat darkened rooms/other areas. When I went to see the doctor of optometry on 12/29/2021, she told me it was because of the floaters in my eye. (I had wanted my eyes checked to make sure it wasn't a problem with my retina.) I have not had additional eye floaters since the ones I had after the 3rd shot. I still can see the eye floaters, but they are becoming less noticeable. For item 21 below, I put disability or permanent damage. I do not know if it is permanent. I can still see, so it is not a major disability. I did not know how to represent that it has not totally resolved for the item. You can decide how to code it.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: PATIENT GOT THE VACCINE ON 02/17/2022. PATIENT CAME BACK ON 04/25/22 COMPLAINING ABOUT LIMITED RANGE OF MOTION ON LEFT ARM. SHE STATED THAT THERE IS NO PAIN, JUST COULD NOT MOVE HER ARM UP. ASKED PATIENT TO POINT OUT THE AREA THAT VACCINE WAS GIVEN AND SHE POINTED TO DELTOID MUSCLE. I RECOMMENDED TO CHECK WITH PRIMARY CARE DOCTOR AND SHE SAID THAT THE DOCTOR DID NOT HELP HER. MD DID SUGGEST HER TO USE HOT COMPRESS, BUT SHE STATED THAT SHE DID NOT TRY IT OUT. SHE ALSO DID NOT TAKE ANY PAIN RELIEF ON THE WHOLE 2 MONTHS PERIOD. I RECOMMENDED ALEVE 1 TABLET BY MOUTH 2 TO 3 TIMES A DAY WITH FOOD.  WE ALSO ASKE D HER TO TRY OUT HOT COMPRESS, NSAID, AND LIGHT EXCERCISE INCASE MUSCLE IS CRAMPED. I EDUCATED PATIENT THAT THERE MAY NOT BE PAIN BUT IF THERE IS INFLAMMATION/SWELLING THEN MOTION CANNOT BE IN FULL RANGE.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Tinnitus
Clinical narrative: I was sitting on my couch resting on New Year?s Eve, 12/31/2021 about 8 pm when suddenly my ears started ringing loudly. It startled me. I thought it would pass, but after a couple of weeks, I went to my doctor and then he sent me to the ear nose and throat doctor to have my hearing tested. I had hearing loss. It was shocking to me because first, the ringing started so suddenly out of nowhere, and second, I?ve always had really good hearing.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: I had taken my my Booster shot in November 2021. In the month of February 2022, I started noticing tat I have been starting to breakout in Hives.  It started off that there  few hives...fast forward to today. I have spent the last two months going back and forth to the doctor and the emergency room due to an increase breakout of hives.  I haven't experienced a constant break out of hives that is covered throughout my entire body. where I have to repeatly go the the Emergency Room to get some relief
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Heart rate increased, Pain, Sensory disturbance
Clinical narrative: My heart was beating too fast and i had chest pain , it was like something was ?? walking??? between my back ,my shoulders , my arms and my chest because i was feeling pain in my chest after a while the pain was kind of moving to go to my back  and after my  shoulder and my arms like i said it was like a ?? walking pain??.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test normal, Cardiac imaging procedure normal, Cardiac stress test normal, Dyspnoea
Clinical narrative: Developed shortness of breath and fatigue.  Discovered that I had pulmonary emboli.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pulmonary embolism, Scan with contrast normal
Clinical narrative: Developed shortness of breath and fatigue.  Discovered that I had pulmonary emboli.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Bronchospasm, Cardiac stress test, Dyspnoea exertional, Echocardiogram
Clinical narrative: approx 11 hrs after vaccine administration pt began to experience some sweating and fatigue; the next day, noted to have shortness of breath with exercise during softball game; pt is a runner and prior to vaccine had no difficulty with running long distances and endurance training; the day prior to her vaccine pt had a 2 hr softball game which included sprinting/running and had no difficulty;  the day after vaccine she was unable to tolerate even 30 min of light/moderate exercise; pt noted considered to be significantly iron deficient and started on iron supplements however, her inability to endure moderate exercise persisted despite correction of iron deficiency; has required a pulmonology consult and use of SABA for exercise induced bronchospasm; pt was also evaluated by cardiology and found to have no cardiac etiology of her shortness of breath
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Full blood count, Haemoglobin, Hyperhidrosis
Clinical narrative: approx 11 hrs after vaccine administration pt began to experience some sweating and fatigue; the next day, noted to have shortness of breath with exercise during softball game; pt is a runner and prior to vaccine had no difficulty with running long distances and endurance training; the day prior to her vaccine pt had a 2 hr softball game which included sprinting/running and had no difficulty;  the day after vaccine she was unable to tolerate even 30 min of light/moderate exercise; pt noted considered to be significantly iron deficient and started on iron supplements however, her inability to endure moderate exercise persisted despite correction of iron deficiency; has required a pulmonology consult and use of SABA for exercise induced bronchospasm; pt was also evaluated by cardiology and found to have no cardiac etiology of her shortness of breath
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: approx 11 hrs after vaccine administration pt began to experience some sweating and fatigue; the next day, noted to have shortness of breath with exercise during softball game; pt is a runner and prior to vaccine had no difficulty with running long distances and endurance training; the day prior to her vaccine pt had a 2 hr softball game which included sprinting/running and had no difficulty;  the day after vaccine she was unable to tolerate even 30 min of light/moderate exercise; pt noted considered to be significantly iron deficient and started on iron supplements however, her inability to endure moderate exercise persisted despite correction of iron deficiency; has required a pulmonology consult and use of SABA for exercise induced bronchospasm; pt was also evaluated by cardiology and found to have no cardiac etiology of her shortness of breath
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash pruritic
Clinical narrative: Full body rash, appeared suddenly. Rash is significant and itchy
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after fully vaccinated and booster
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Dizziness, Hearing aid user
Clinical narrative: Dizziness, Severe Hearing Loss Tinnitus, severe
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Dizziness, Severe Hearing Loss Tinnitus, severe
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: pt presents to ED with SOB, productive cough, diarrhea, weakness; states sx started approximately 10 days ago; positive for COVID; O2  sats 88% on RA; O2 supplementation; chest xray shows pneumonia; AHRF; given Decadron, ABX; pt's condition worsened and she passed away in the hospital
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Chest X-ray abnormal, Death
Clinical narrative: pt presents to ED with SOB, productive cough, diarrhea, weakness; states sx started approximately 10 days ago; positive for COVID; O2  sats 88% on RA; O2 supplementation; chest xray shows pneumonia; AHRF; given Decadron, ABX; pt's condition worsened and she passed away in the hospital
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, General physical health deterioration, Pneumonia, Productive cough
Clinical narrative: pt presents to ED with SOB, productive cough, diarrhea, weakness; states sx started approximately 10 days ago; positive for COVID; O2  sats 88% on RA; O2 supplementation; chest xray shows pneumonia; AHRF; given Decadron, ABX; pt's condition worsened and she passed away in the hospital
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt presents to ED with SOB, productive cough, diarrhea, weakness; states sx started approximately 10 days ago; positive for COVID; O2  sats 88% on RA; O2 supplementation; chest xray shows pneumonia; AHRF; given Decadron, ABX; pt's condition worsened and she passed away in the hospital
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test positive
Clinical narrative: 4/13/22 PMH significant for rheumatoid arthritis admitted due to rigors and body shaking.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Respiratory syncytial virus test positive, SARS-CoV-2 test positive, Tremor
Clinical narrative: 4/13/22 PMH significant for rheumatoid arthritis admitted due to rigors and body shaking.
Age: 79.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 79.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Headache, Nausea, SARS-CoV-2 test positive
Clinical narrative: 4/4/22 PMH: spinal cord injury from GSW, quadriplegia, colostomy, neurogenic bladder with suprapubic catheter, UTIs, kidney stones, decubitus ulcer, DVT s/p IVC on Xarelto, gastroparesis, hypotension on midodrine, chronic pain. Presents with a chief complaint of a worsening headache.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 4/4/22 PMH: spinal cord injury from GSW, quadriplegia, colostomy, neurogenic bladder with suprapubic catheter, UTIs, kidney stones, decubitus ulcer, DVT s/p IVC on Xarelto, gastroparesis, hypotension on midodrine, chronic pain. Presents with a chief complaint of a worsening headache.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: 4/4/22 PMH: spinal cord injury from GSW, quadriplegia, colostomy, neurogenic bladder with suprapubic catheter, UTIs, kidney stones, decubitus ulcer, DVT s/p IVC on Xarelto, gastroparesis, hypotension on midodrine, chronic pain. Presents with a chief complaint of a worsening headache.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 067F21A, 007B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            The patient received 2nd and 1st booster in the left arm shoulder deltoid muscle. Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2022-546661, MOD-2022-546697, MOD-2022-546695 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Rash, Rash pruritic, Skin warm, Swelling
Clinical narrative: rash warm to the touch; had a rash the size of a baseball; arm started to get red/rash was red; arm started to get swollen/rash the size of a baseball/rash was swollen; rash was like a big hive.; fever of 100 degrees Farenheight; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) in a 75-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.     The patient's past medical history included Hives (from Iodine contrast dyes and other sources.). Concurrent medical conditions included Iodine contrast media allergy (hives.) and Allergy NOS (other sources).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue). In January 2021, the patient experienced VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.). On 30-Dec-2020, PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degrees Fahrenheit(fever).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported.  The patient had a fever of 100 degrees Fahrenheit and fatigue. The temperature and Fatigue resolved by 30DEC2020. 4 or 5 days after patient had the vaccine the arm started to get red and swollen. Patient then had a rash the size of a baseball. The rash was red and swollen and was warm to the touch. The rash was like a big hive.  No treatment medication details was reported.   This case was linked to MOD-2022-546924, MOD-2022-546935, MOD-2022-546931, MOD-2022-546503.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: rash warm to the touch; had a rash the size of a baseball; arm started to get red/rash was red; arm started to get swollen/rash the size of a baseball/rash was swollen; rash was like a big hive.; fever of 100 degrees Farenheight; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) in a 75-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.     The patient's past medical history included Hives (from Iodine contrast dyes and other sources.). Concurrent medical conditions included Iodine contrast media allergy (hives.) and Allergy NOS (other sources).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue). In January 2021, the patient experienced VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.). On 30-Dec-2020, PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degrees Fahrenheit(fever).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported.  The patient had a fever of 100 degrees Fahrenheit and fatigue. The temperature and Fatigue resolved by 30DEC2020. 4 or 5 days after patient had the vaccine the arm started to get red and swollen. Patient then had a rash the size of a baseball. The rash was red and swollen and was warm to the touch. The rash was like a big hive.  No treatment medication details was reported.   This case was linked to MOD-2022-546924, MOD-2022-546935, MOD-2022-546931, MOD-2022-546503.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: rash warm to the touch; had a rash the size of a baseball; arm started to get red/rash was red; arm started to get swollen/rash the size of a baseball/rash was swollen; rash was like a big hive.; fever of 100 degrees Farenheight; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) in a 75-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.     The patient's past medical history included Hives (from Iodine contrast dyes and other sources.). Concurrent medical conditions included Iodine contrast media allergy (hives.) and Allergy NOS (other sources).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue). In January 2021, the patient experienced VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.). On 30-Dec-2020, PYREXIA (fever of 100 degrees Farenheight) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash warm to the touch), VACCINATION SITE RASH (had a rash the size of a baseball), VACCINATION SITE ERYTHEMA (arm started to get red/rash was red), VACCINATION SITE SWELLING (arm started to get swollen/rash the size of a baseball/rash was swollen) and VACCINATION SITE URTICARIA (rash was like a big hive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degrees Fahrenheit(fever).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported.  The patient had a fever of 100 degrees Fahrenheit and fatigue. The temperature and Fatigue resolved by 30DEC2020. 4 or 5 days after patient had the vaccine the arm started to get red and swollen. Patient then had a rash the size of a baseball. The rash was red and swollen and was warm to the touch. The rash was like a big hive.  No treatment medication details was reported.   This case was linked to MOD-2022-546924, MOD-2022-546935, MOD-2022-546931, MOD-2022-546503.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Mobility decreased, Pain
Clinical narrative: Patient complains of arm pain that has been there since she received the vaccine on 1/24/22. She stated that her arm feels painful when she lifts her arm. She reported to the doctor and to our pharmacy in April 2022 regarding the incident. Consulted patient to report to V-SAFE.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complains of arm pain that has been there since she received the vaccine on 1/24/22. She stated that her arm feels painful when she lifts her arm. She reported to the doctor and to our pharmacy in April 2022 regarding the incident. Consulted patient to report to V-SAFE.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased
Clinical narrative: Kidney CREAT index jumped from ~1.4 (Feb. 2021) to ~1.7(Aug. 2021). No treatment. It keeps stable since then.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Lip swelling, Pain, Paraesthesia
Clinical narrative: I had a severe allergic reaction. The next morning, I woke up and my tongue, lips and the rest of my face was swollen and puffy. I also had tingling in my left hand and arm. I received the vaccine in my left arm, so I wonder if it's correlated. I went to my doctor and was advised to take Benadryl and Zyrtec for 3 days. Periodically, I still have tingling from my face, arms and hands. My left side has been most effected. And I feel fatigued and achy during these times.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Swelling face, Swollen tongue
Clinical narrative: I had a severe allergic reaction. The next morning, I woke up and my tongue, lips and the rest of my face was swollen and puffy. I also had tingling in my left hand and arm. I received the vaccine in my left arm, so I wonder if it's correlated. I went to my doctor and was advised to take Benadryl and Zyrtec for 3 days. Periodically, I still have tingling from my face, arms and hands. My left side has been most effected. And I feel fatigued and achy during these times.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Carditis, Chest discomfort, Electrocardiogram abnormal, Fatigue, Headache
Clinical narrative: Immediately following the injection I experienced a sensation running through my arm that persisted for about an hour. Then the next day I experienced a pretty strong headache and some fatigue. These initial systems went away within a day or so, then about one week later, I experienced chest tightening and floating black spots in my periphery vision. I went to the doctor and he said it was part of my body's natural immune response. The chest tightening/cardiac inflammation eventually subsided several months after receiving the vaccine but I still have black spots floating in my periphery vision. Additionally, in the weeks that followed the vaccine I experienced a dramatically degraded immune system where I got sick two different times in one week and then a third time a week or so later (since then my immune system has improved back closer to normal). This is VERY abnormal for me because under normal circumstances I almost never get sick. These are new conditions that I did not have prior to getting the vaccine. NOTE: because I work for the DoD, I was required to get the second dose of the COVID-19 Vaccine or face disciplinary action up to termination from employment (a career I have worked in for over 15 years).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Sensory disturbance, Troponin, Visual impairment
Clinical narrative: Immediately following the injection I experienced a sensation running through my arm that persisted for about an hour. Then the next day I experienced a pretty strong headache and some fatigue. These initial systems went away within a day or so, then about one week later, I experienced chest tightening and floating black spots in my periphery vision. I went to the doctor and he said it was part of my body's natural immune response. The chest tightening/cardiac inflammation eventually subsided several months after receiving the vaccine but I still have black spots floating in my periphery vision. Additionally, in the weeks that followed the vaccine I experienced a dramatically degraded immune system where I got sick two different times in one week and then a third time a week or so later (since then my immune system has improved back closer to normal). This is VERY abnormal for me because under normal circumstances I almost never get sick. These are new conditions that I did not have prior to getting the vaccine. NOTE: because I work for the DoD, I was required to get the second dose of the COVID-19 Vaccine or face disciplinary action up to termination from employment (a career I have worked in for over 15 years).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cardiac stress test, Cardioversion, Echocardiogram
Clinical narrative: Atrial Fibrillation problems since vaccine. Three separate Cardioversions over the past year to get heart back in rhythm since vaccine. Recently in hospital for four days getting treatment to put heart back in correct rhythm.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ultrasound scan
Clinical narrative: Atrial Fibrillation problems since vaccine. Three separate Cardioversions over the past year to get heart back in rhythm since vaccine. Recently in hospital for four days getting treatment to put heart back in correct rhythm.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: uncertain how much vaccine was given to patient; Needle and syringe malfunctioned and disconnected from each other while administering PROQUAD.; No adverse event; This spontaneous report was received from a nurse concerning to a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.  On 17-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), by subcutaneous route, lot # U029322 with an expiration date of 19-MAR-2023, for prophylaxis (strength, formulation, anatomical site of injection were not reported).  At the moment of the administration of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), the needle and syringe malfunctioned and disconnected from each other (device connection issue and incorrect dose administered). It was uncertain how much vaccines was given to patient and if should be repeated. No additional adverse events.   The causality assessment between incorrect dose administered and device connection issue regarding measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was reported as not related.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient did not have any symptoms or adverse effects; Product origin unknown; Caller is a medical assistant who reports that GARDASIL 9 was given to a pregnant patient.; extra dose administered; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 26-year-old female patient. the patient's concurrent conditions included gestational diabetes and hypothyroidism. The patient's concomitant therapies included acetylsalicylic acid(ASPIRINE), prenatal vitaminis and metformin. The patient's medical history and historical medications were not reported.       On 15-MAY-2007, 17-JUL-2007 and 03-APR-2008, the patient was vaccinated with the 3 doses of an unknown brand of a HPV vaccine (dose, route of administration, lotnubmer and expiration date not reported) for prophylaxis (product origin unknown), and on 11-APR-2022, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular, lot number U032676, expiration date 26-OCT-2023 for immunisation (exposure during pregnancy). This dose was administered as the patient did not recall to have been given and HPV vaccine before (the dates were looked into the patient's chart) (extra dose administered). No adverse event was reported.  The patient became pregnant with LMP of 19-JUL-2021 and EDD of 25-APR-2022. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 38 week(s). The pregnancy outcome was outcome pending.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.      On 01-FEB-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, at a dose of 0.5 milliliter for prophylaxis (route of administration not reported). The vaccine had expired on 28-JAN-2022 (expired product administered). The vaccine had no prior temperature excursions. No additional adverse events reported.
Age: 32.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; PROQUAD was inadvertently given to a 32-year-old adult on 06April2022.; This spontaneous report was received from a nurse and concerns 32-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 06-APR-2022, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) 0.5 ml once, lot number: U029324, expiration date: 19-MAR-2023 (strength, route and site of administration were not reported) that was reconstituted in a sterile diluent (strength, dose, lot#, expiration date and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age).   No other adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE details; LPN calling to report expired MMR II administered to 2 patients. MMR II experienced temperature excursion in the past but the TE details are not available at this time. Informed nurse stability date cannot be given until we have TE details. Nurse sta; temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.  On 15-FEB-2022, the patient was vaccinated with expired and improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot #T001212, expiration date: 12-JAN-2022) for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered and product storage error). Regarding the temperature excursion details were not available. Informed nurse stability date could not be given until having temperature excursion details.  No additional adverse event details were reported (no adverse event).  This is one of the two cases reported by the same reporter. ; Sender's Comments:  US-009507513-2204USA006151:02148137
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; This spontaneous report was received from a nurse concerning to herself.  The patient's concurrent conditions, medical history was not reported or allergies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and varicella zoster vaccine rge (cho) (SHINGRIX),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, the patient experienced swelling and redness (erythema). The patient stated she experienced de adverse reaction after had received the vaccine zoster vaccine live (ZOSTAVAX) or  zoster vaccine rge (cho) (SHINGRIX). At the time of reporting, the outcome of both events was not known. No more information was reported.   The causal relationship between both adverse events with zoster vaccine live (ZOSTAVAX) and  zoster vaccine rge (cho) (SHINGRIX) was not reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001371:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; Medical Assistant reporting the administration of expired VAQTA and inquiring viability of the administration of expired dose. No additional adverse events reported. No product quality complaints reported. No further details provided.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-APR-2022, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T033304, expiration date 02-APR-2022 (dose number, frequency and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event). The medical assistant inquired viability of the administration of expired dose.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reports a 4th dose of ROTATEQ was administered to a 12 month old.  Dates of administration were 5/28/2021,  7/30/2021, 10/15/2021 and 4/15/2022.  Documented Lot # and Expiration date is from the dose administered on 4/15/2022.  All other lots; Dates of administration were 28-MAY-2021, 30-JUL-2021, 15-OCT-2021; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 28-MAY-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and received additionally doses on 30-JUL-2021, 15-OCT-2021 (inappropriate schedule of product administration) (strength, dose, route of administration, lot number and expiration date were not provided), and on 15-APR-2022, the patient received a forth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (extra dose administered) 2 milliliter, orally, (lot number 1742083 has been determined to be valid for, expiration date reported and established as 22-SEP-2022) all vaccines were administered as prophylaxis.  No adverse event.