chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Oxygen saturation, Pruritus, Pyrexia, Wheezing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma) and DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heavy smoker in 2020.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 03-May-2021, the patient experienced PRURITUS (Feeling scratchy). On 04-May-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) (seriousness criterion medically significant) and WHEEZING (Wheezing sounds). On 02-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 03-May-2021, PRURITUS (Feeling scratchy) had resolved. On 06-May-2021, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) and WHEEZING (Wheezing sounds) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Oxygen saturation: 91 Low.         On 03-May-2021, the patient was feeling scratchy and mentioned it could be due to pollen. On 04-May-2021, he was experiencing difficulty breathing, which began in the morning and exacerbated by the evening. He had wheezing sound and by 6 PM he could barely catch his breath. He got breathing treatment using nebulizer and his oxygen level was 91. By 8 PM he went to the ER  and underwent tests. He was diagnosed to have Asthma and COPD.  Treatment: Inhaler, nebulizer and steroid.  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.
Sex: F
Vaccine: COVID19
Symptoms: Plasma cell myeloma
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, 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 PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Weight decreased
Clinical narrative: Severe diarrhoea; Weight loss 80 lbs; Nausea; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Severe diarrhoea), WEIGHT DECREASED (Weight loss 80 lbs) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myocardial infarction, Congestive heart failure and Lung cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe diarrhoea) (seriousness criterion hospitalization), WEIGHT DECREASED (Weight loss 80 lbs) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). At the time of the report, DIARRHOEA (Severe diarrhoea), WEIGHT DECREASED (Weight loss 80 lbs) and NAUSEA (Nausea) had not resolved.        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.   No concomitant medications were reported.  It was reported that the patient had recently undergone successful treatment for lung cancer and was doing well until shortly after receiving the vaccine.   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.  The patient had to be hospitalized in the ICU following the onset of the adverse events and was being fed with a feeding tube. It was reported that multiple tests were conducted to diagnose the underlying cause for the events.  No treatment medications were reported.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Chills, Cough, Dysuria
Clinical narrative: Urinary infection; burning sensation when urinating; The cough is still there; headach; Joint pain; muscle aches; Fatigue; Chills; Flu-like symptoms that lasted seven days; something came out between the axilla and chest; feel like powder in my throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, TOPIRAMATE (TOPAMAX) and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days), AXILLARY MASS (something came out between the axilla and chest), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), COUGH (The cough is still there), HEADACHE (headach), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). On 03-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection) (seriousness criterion hospitalization) and DYSURIA (burning sensation when urinating). On 09-Apr-2021, HEADACHE (headach) had resolved. On 14-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary infection), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), DYSURIA (burning sensation when urinating), COUGH (The cough is still there), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown, AXILLARY MASS (something came out between the axilla and chest) had not resolved and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treated with Tylenol every 6 hours and Ibuprofen 200mg 2 tablets PO every 6 hours.  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 US-MODERNATX, INC.-MOD-2021-114993 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114993:Original Case : MOD-2021-114900
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Oropharyngeal discomfort
Clinical narrative: Urinary infection; burning sensation when urinating; The cough is still there; headach; Joint pain; muscle aches; Fatigue; Chills; Flu-like symptoms that lasted seven days; something came out between the axilla and chest; feel like powder in my throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, TOPIRAMATE (TOPAMAX) and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days), AXILLARY MASS (something came out between the axilla and chest), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), COUGH (The cough is still there), HEADACHE (headach), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). On 03-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection) (seriousness criterion hospitalization) and DYSURIA (burning sensation when urinating). On 09-Apr-2021, HEADACHE (headach) had resolved. On 14-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary infection), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), DYSURIA (burning sensation when urinating), COUGH (The cough is still there), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown, AXILLARY MASS (something came out between the axilla and chest) had not resolved and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treated with Tylenol every 6 hours and Ibuprofen 200mg 2 tablets PO every 6 hours.  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 US-MODERNATX, INC.-MOD-2021-114993 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114993:Original Case : MOD-2021-114900
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary infection; burning sensation when urinating; The cough is still there; headach; Joint pain; muscle aches; Fatigue; Chills; Flu-like symptoms that lasted seven days; something came out between the axilla and chest; feel like powder in my throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, TOPIRAMATE (TOPAMAX) and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days), AXILLARY MASS (something came out between the axilla and chest), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), COUGH (The cough is still there), HEADACHE (headach), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). On 03-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection) (seriousness criterion hospitalization) and DYSURIA (burning sensation when urinating). On 09-Apr-2021, HEADACHE (headach) had resolved. On 14-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary infection), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), DYSURIA (burning sensation when urinating), COUGH (The cough is still there), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown, AXILLARY MASS (something came out between the axilla and chest) had not resolved and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treated with Tylenol every 6 hours and Ibuprofen 200mg 2 tablets PO every 6 hours.  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 US-MODERNATX, INC.-MOD-2021-114993 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114993:Original Case : MOD-2021-114900
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aldolase, Biopsy muscle, Blood creatinine, Electromyogram, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Photopheresis (monthly) since an unknown date. Concurrent medical conditions included Graft versus host disease since 04-Oct-2019 and Weakness (frequently since 2018) since 2010. Concomitant products included RUXOLITINIB from 13-Jan-2021 to an unknown date for Graft versus host disease, PREDNISONE, BUDESONIDE and TACROLIMUS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 23-Mar-2021 due to RHABDOMYOLYSIS. On 23-Mar-2021, RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Aldolase: elevated (High) elevated levels consistent with myositis. In March 2021, Biopsy muscle: abnormal (abnormal) demonstrated mild myopathy, mitochondrial dysfunction, mild reinnervation and severe type 2 fiber atrophy. Microscopic analysis also demonstrated lymphocytic infiltration, along with apoptotic bodies, providing overall gestalt most consistent with a mixed nonspecific liver injury, along with some findings to support graft-versus-host-disease of the liver. In March 2021, Blood creatinine: elevated (High) elevated levels consistent with myositis. In March 2021, Electromyogram: abnormal (abnormal) consistent with myositis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) to be possibly related.    Extensive serologic workup was done in March 2021 which were grossly negative for new autoimmune processes. No specific treatments were reported.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Neck pain, Visual impairment
Clinical narrative: grand maul seizure; vision changes; Feelings of pressure at the back of his neck radiating to right side of his head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On 14-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) had resolved and VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a seizure three days after his first Moderna Covid vaccine and was hospitalized.  CT scan was negative.  The reporter's causality for co-suspect drug, adalimumab, was not provided.  Concomitant product use was not provided. No treatment information was provided.  This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on 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: This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Palpitations
Clinical narrative: I was having palpitations; the feeling was in upper part of stomach; I had difficulty breathing; The initial case was missing the following minimum criteria: No Adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Consumer (patient)  A 84-years-old female patient (weight reported as '140' only) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (at the age of 84) as single dose for covid-19 immunisation; denosumab (PROLIA), via an unspecified route of administration from 2019 and ongoing, cyclic, twice a year for osteoporosis. Medical history included osteoporosis. The patient's concomitant medications were not reported. The patient experienced palpitations, the feeling was in upper part of stomach (not in heart), difficulty breathing, all on 07Feb2021 at 20:00. No treatment received or hospital admission required. By bedtime she was able to fall asleep and awoke in the morning on 08Feb2021 and was fine. The events outcome was recovered on 08Feb2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oral herpes, Pustule
Clinical narrative: 1) Pain/soreness at injection site - Ongoing 2) Fever Blisters around mouth and lips - Ongoing 3) Large pustule under nose - now healed
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%. THIS WAS DISCOVERED ON 5.12.21
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pulmonary congestion, Pyrexia
Clinical narrative: Fever, chills, fatigue. Lung congestion for over 2 weeks (and it?s not breaking up)
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received COVID vaccine mixed with bacteriostatic 0.9% normal saline instead of plain normal saline 0.9%. This was discovered on 5.12.2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid irritation, Eyelid pain, Swelling of eyelid
Clinical narrative: This is my 2nd dose and I woke up in the night with my eye lid on fire it was burning stinging pain and eye lid was very swollen almost transparent looking from the swelling.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%. THIS WAS DISCOVERED ON 5.12.21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain, Pyrexia
Clinical narrative: I had a chills and fever all night and the next morning, Sore body and armpits is majorly sore.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Diagnosed with COVID arm by my doctor?s office. Red, itchy rash surrounding the injection site on my left arm, and is about 3 inches long and 3.5 inches wide. The rash does not have any bumps I can see, but is itchy, red, and warmer to the touch than the rest of my arm.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Cough
Clinical narrative: Symptoms started approximately 14 hours post-vaccination.  Day 1 symptoms:   - Fever (<= 101.0 degrees F)   - Chills   - Headache   - Fatigue/tiredness   - Vomiting (one time exactly 24 hours post onset of symptoms)  Days 2 - 5 symptoms:   - Severe pain/tightness and fatigue feeling in both arms, shoulder blades, and chest.  This has slowly improved over days 2 through 5.   - Nausea associated with the pain/tightness noted above   - Coughing (no phlegm)   - Vomiting (one more time on day 2 exactly 24 hours after the first vomiting episode)   - Fever and chills (both resolved by days 2-3)  Treatments:   - 500 mg Tylenol was used to treat fever and pain during the first several days.  Fever was well controlled, but pain was only partially controlled   - On days 3+ Advil was used for pain relief and it was effective   - Alka Seltzer Gold was used to treat nausea as necessary.  It was not particularly effective as the nausea seemed linked to the severity of the pain.  When the pain eased, the nausea did as well.   Outcomes:   - Symptoms have slowly improved over the 5 days post 2nd dose vaccination.  Advil has been discontinued since the afternoon of day 4.  No fever is present and the pain is now only mild.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle tightness, Pain, Pain in extremity
Clinical narrative: Symptoms started approximately 14 hours post-vaccination.  Day 1 symptoms:   - Fever (<= 101.0 degrees F)   - Chills   - Headache   - Fatigue/tiredness   - Vomiting (one time exactly 24 hours post onset of symptoms)  Days 2 - 5 symptoms:   - Severe pain/tightness and fatigue feeling in both arms, shoulder blades, and chest.  This has slowly improved over days 2 through 5.   - Nausea associated with the pain/tightness noted above   - Coughing (no phlegm)   - Vomiting (one more time on day 2 exactly 24 hours after the first vomiting episode)   - Fever and chills (both resolved by days 2-3)  Treatments:   - 500 mg Tylenol was used to treat fever and pain during the first several days.  Fever was well controlled, but pain was only partially controlled   - On days 3+ Advil was used for pain relief and it was effective   - Alka Seltzer Gold was used to treat nausea as necessary.  It was not particularly effective as the nausea seemed linked to the severity of the pain.  When the pain eased, the nausea did as well.   Outcomes:   - Symptoms have slowly improved over the 5 days post 2nd dose vaccination.  Advil has been discontinued since the afternoon of day 4.  No fever is present and the pain is now only mild.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Symptoms started approximately 14 hours post-vaccination.  Day 1 symptoms:   - Fever (<= 101.0 degrees F)   - Chills   - Headache   - Fatigue/tiredness   - Vomiting (one time exactly 24 hours post onset of symptoms)  Days 2 - 5 symptoms:   - Severe pain/tightness and fatigue feeling in both arms, shoulder blades, and chest.  This has slowly improved over days 2 through 5.   - Nausea associated with the pain/tightness noted above   - Coughing (no phlegm)   - Vomiting (one more time on day 2 exactly 24 hours after the first vomiting episode)   - Fever and chills (both resolved by days 2-3)  Treatments:   - 500 mg Tylenol was used to treat fever and pain during the first several days.  Fever was well controlled, but pain was only partially controlled   - On days 3+ Advil was used for pain relief and it was effective   - Alka Seltzer Gold was used to treat nausea as necessary.  It was not particularly effective as the nausea seemed linked to the severity of the pain.  When the pain eased, the nausea did as well.   Outcomes:   - Symptoms have slowly improved over the 5 days post 2nd dose vaccination.  Advil has been discontinued since the afternoon of day 4.  No fever is present and the pain is now only mild.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Pain
Clinical narrative: Symptomatic  covid 19: low grade fever , congestion, cough and SOB. Body aches and headaches.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Symptomatic  covid 19: low grade fever , congestion, cough and SOB. Body aches and headaches.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen, red, hard, hot arm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: temperature excursion with vaccine administration
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Headache
Clinical narrative: 15 hours -ringing in ears began after first dose. Headache, chills, bodyaches- very bad in back, hips and stomach, fever of 101. Body rash. Ringing in ears became worse  Drank lots of water prior to 2nd vaccine and following  yet very dry mouth probably due to fever. Ate plenty of meals and fluids herbal teas and water.  Fever broke at 48 hours. Headache stopped at 60 hours. Currently 78  hrs  following second vaccine and still have  body rash on back, chest, neck, stomach and ringing in ears.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Tinnitus
Clinical narrative: 15 hours -ringing in ears began after first dose. Headache, chills, bodyaches- very bad in back, hips and stomach, fever of 101. Body rash. Ringing in ears became worse  Drank lots of water prior to 2nd vaccine and following  yet very dry mouth probably due to fever. Ate plenty of meals and fluids herbal teas and water.  Fever broke at 48 hours. Headache stopped at 60 hours. Currently 78  hrs  following second vaccine and still have  body rash on back, chest, neck, stomach and ringing in ears.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Lump between left collar bone and shoulder.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Fever (lasted 4 days), Nausea & diarrhea ( lasted 7 days) extreme fatigue (lasted 10 days), muscle and joint aches (9 days), drowsiness (lasted 8 days)   This was much worse then the first injection. I could not complete ADLs such as work or household chores. The fatigue lasted the longest and was the worst symptom.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Fever (lasted 4 days), Nausea & diarrhea ( lasted 7 days) extreme fatigue (lasted 10 days), muscle and joint aches (9 days), drowsiness (lasted 8 days)   This was much worse then the first injection. I could not complete ADLs such as work or household chores. The fatigue lasted the longest and was the worst symptom.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion with vaccine administered
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Total loss of appetite for more than a week.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was accidentally given Modern vaccine, which is not approved for age 16. Pharmacist thought patient was going to be given Pfizer.  Unknown symptoms at this time and parents are aware of what happened and monitoring.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle ache, and headache began at 3:30 am the next day (17 hours after). Muscle ache persists as of May 13, 8:30 pm (58 hours after). Fever, chills, and muscle ache mostly resolved as of 6:00 am on May 13.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Patient reports experiencing swelling of the left arm ( arm where the vaccine was given) from elbow down the following day after receiving the vaccine she also reports whole body hives starting 05/13/21. per pt took Tylenol but saw no relief
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash erythematous, Swelling, Vaccination complication
Clinical narrative: After 7 days I noticed a red mark / rash around the area the shot was given.  It itches on and off.  The area also feels swollen, like a lump.  Was just reading about COVID-Arm, and it sounds like the same thing.  While it's only been 7 days since my first shot, I'm going to continue to monitor, apply ice, and use Benadryl as needed, and if it doesn't go away in another week, will schedule a doctors appointment to be safe.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Decreased appetite, Headache, Nasal congestion
Clinical narrative: Congestion, cough, whizzing, headaches, joint and body  pain, loss of appetite, fever.  Saw PCP and he prescribed the Butalbital Acctaminoplen,.  Saw him a second time on 5/13/21 due to continued headaches and body aches.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Congestion, cough, whizzing, headaches, joint and body  pain, loss of appetite, fever.  Saw PCP and he prescribed the Butalbital Acctaminoplen,.  Saw him a second time on 5/13/21 due to continued headaches and body aches.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: temperature excursion with vaccine administered
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyskinesia, Eye movement disorder, Foaming at mouth, Generalised tonic-clonic seizure
Clinical narrative: My husband was sleeping the night of getting his 2nd Moderna Vaccination...  He, during his sleep, had a SEVERE Grand Mal Seizure with NOTHING leading up to it and NO PREVIOUS HISTORY WHATSOEVER of having ANY Seizures in his lifetime, nor ANY Epilepsy...  EVER! It was TERRIFYING, to me - I ran to his bedside (I happened to be in the livingroom watching television) after hearing loud grunts and a crash and came to find him convulsing, severely spewing blood and frothing at the mouth.  Grunting, convulsing, and thrashing.  Stiffening, arms and hands (both in a fist) tight and stiff in front of his chest, legs straight, rigid as a board and thrashing about spitting blood, eyes rolled back in his head.  As things began to becoming a little less severe, while waiting for the Fire Dept & EMTs to arrive I felt his legs which were hit to the touch and his face was drenched in sweat! With NEVER EXPERIENCING Anything like this before, and after 30 years of marriage, I thought my husband was dying ???????? He did NOT go with the EMTs, since once he was awake and somewhat cognitive we realized he was over it for the moment and we're in a wait and see basis. He saw our GP first thing the next morning.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Grunting, Haemoptysis, Hyperhidrosis, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: My husband was sleeping the night of getting his 2nd Moderna Vaccination...  He, during his sleep, had a SEVERE Grand Mal Seizure with NOTHING leading up to it and NO PREVIOUS HISTORY WHATSOEVER of having ANY Seizures in his lifetime, nor ANY Epilepsy...  EVER! It was TERRIFYING, to me - I ran to his bedside (I happened to be in the livingroom watching television) after hearing loud grunts and a crash and came to find him convulsing, severely spewing blood and frothing at the mouth.  Grunting, convulsing, and thrashing.  Stiffening, arms and hands (both in a fist) tight and stiff in front of his chest, legs straight, rigid as a board and thrashing about spitting blood, eyes rolled back in his head.  As things began to becoming a little less severe, while waiting for the Fire Dept & EMTs to arrive I felt his legs which were hit to the touch and his face was drenched in sweat! With NEVER EXPERIENCING Anything like this before, and after 30 years of marriage, I thought my husband was dying ???????? He did NOT go with the EMTs, since once he was awake and somewhat cognitive we realized he was over it for the moment and we're in a wait and see basis. He saw our GP first thing the next morning.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: My husband was sleeping the night of getting his 2nd Moderna Vaccination...  He, during his sleep, had a SEVERE Grand Mal Seizure with NOTHING leading up to it and NO PREVIOUS HISTORY WHATSOEVER of having ANY Seizures in his lifetime, nor ANY Epilepsy...  EVER! It was TERRIFYING, to me - I ran to his bedside (I happened to be in the livingroom watching television) after hearing loud grunts and a crash and came to find him convulsing, severely spewing blood and frothing at the mouth.  Grunting, convulsing, and thrashing.  Stiffening, arms and hands (both in a fist) tight and stiff in front of his chest, legs straight, rigid as a board and thrashing about spitting blood, eyes rolled back in his head.  As things began to becoming a little less severe, while waiting for the Fire Dept & EMTs to arrive I felt his legs which were hit to the touch and his face was drenched in sweat! With NEVER EXPERIENCING Anything like this before, and after 30 years of marriage, I thought my husband was dying ???????? He did NOT go with the EMTs, since once he was awake and somewhat cognitive we realized he was over it for the moment and we're in a wait and see basis. He saw our GP first thing the next morning.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in the ears
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Computerised tomogram, Neck pain
Clinical narrative: Pain in back, legs, shoulder and neck with ascending neurological symptoms, hypothesized as Guillain-Barre Syndrome. Still undergoing tests and physical therapy.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, Pain in extremity, Urine analysis, X-ray
Clinical narrative: Pain in back, legs, shoulder and neck with ascending neurological symptoms, hypothesized as Guillain-Barre Syndrome. Still undergoing tests and physical therapy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain
Clinical narrative: First Symptom: Wierd fast heart beating feeling but heart doesn't seem to be beating fast when I check my pulse. This started happening few days after first shot. Usually doesn't last too long but comes back randomly. Seems to be when I lay down or at night..... Second Symptom: Left ear pain. Started 6 days after first shot. Feel it most when I squat down. Feels like it is clogged. Left side of neck below ear also had pain. Came out of nowhere and all of a sudden. Family and friends have had similar issues. Some even loosing their hearing .
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I have not had a period in over a year and I had one on the  03/05/2021 after my shot on the 1st. My doctor told me to report it.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Temperature excursion with vaccine administered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hypotension, Myalgia
Clinical narrative: I was ok after receiving the vaccine. Just a bit nausea and then everything was ok. I received the vaccine on 5th of may and i had a severe headache and fatigue on 11th may (evening) i couldnt figure out the reason. I had a Tylenol and rested for sometime. At night the headache started again severely on the right side of my head and right leg also had muscle aches and i had zero energy. On the 12th it was the sane and blood pressure was on a lower side. On the 13th it was ok in the morning but after noon i had no energy and pain in both legs. I had a blood pressure of 90/48 which was quite low, i never had such an episode of low or a high blood pressure. I had a few boiled eggs with salt and 4-6 dates and i was able to get rid of aches in my body but not fully. At night of 13th may i was able to maintain a blood pressure of 104/55.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: I was ok after receiving the vaccine. Just a bit nausea and then everything was ok. I received the vaccine on 5th of may and i had a severe headache and fatigue on 11th may (evening) i couldnt figure out the reason. I had a Tylenol and rested for sometime. At night the headache started again severely on the right side of my head and right leg also had muscle aches and i had zero energy. On the 12th it was the sane and blood pressure was on a lower side. On the 13th it was ok in the morning but after noon i had no energy and pain in both legs. I had a blood pressure of 90/48 which was quite low, i never had such an episode of low or a high blood pressure. I had a few boiled eggs with salt and 4-6 dates and i was able to get rid of aches in my body but not fully. At night of 13th may i was able to maintain a blood pressure of 104/55.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Multiple sclerosis relapse, Neurological symptom
Clinical narrative: Caused neurological issue related MS to flare. Numb arms and hands no previous issue in 9 years.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Long lasting  Rashes all over the body , some are peeling  by now or obscured,  but since 2 days ago I got new rashes,  smaller in shape than the other ones but  now in areas that I didn't  have the first time (abdomen, inner tights , and glutes), and more in some areas , arms , back,  chest  and legs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Began having nose bleeds, progressively more frequently appx 1 month after  COVID VACCINE #2.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Echocardiogram, Pulmonary embolism, Sternotomy, Surgery
Clinical narrative: Presented with sylucel - CTA chest showed massive suddle pulmonary embolis, with massive bilateral clot burden. Underwent major surgery requiring sternotomy for embolectomy Hospitalized 7 days, now recovered
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Thromboembolectomy
Clinical narrative: Presented with sylucel - CTA chest showed massive suddle pulmonary embolis, with massive bilateral clot burden. Underwent major surgery requiring sternotomy for embolectomy Hospitalized 7 days, now recovered
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appetite disorder, Arthralgia, Back pain, Chest pain
Clinical narrative: Chest pain, ankle swelling, nausea,  vomiting, abdominal pain, change in appetite, muscle aches, joint pain, joint swelling, back pain, dizziness, headache, DVT
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dizziness, Electrocardiogram normal, Full blood count normal, Headache
Clinical narrative: Chest pain, ankle swelling, nausea,  vomiting, abdominal pain, change in appetite, muscle aches, joint pain, joint swelling, back pain, dizziness, headache, DVT
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Metabolic function test normal, Myalgia, Nausea, Troponin normal
Clinical narrative: Chest pain, ankle swelling, nausea,  vomiting, abdominal pain, change in appetite, muscle aches, joint pain, joint swelling, back pain, dizziness, headache, DVT
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal, Vomiting
Clinical narrative: Chest pain, ankle swelling, nausea,  vomiting, abdominal pain, change in appetite, muscle aches, joint pain, joint swelling, back pain, dizziness, headache, DVT
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling occurred 2 days ago after immunizations. Patient starled with swelling to her arm the evening after receiving her shots. it is warm , but not painful and she is using her arm without difficulty The client has redness erythema in the right arm . The swelling is  aggrevated by local pressure but not aggrevated by movement. The client had a poor response to cold compress. The client denies any associated  symptoms. Arm feels warm to the touch. no other complaint unless pressure is applied.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Double stranded DNA antibody, Fatigue, Histone antibody positive
Clinical narrative: Patient seen in the office with persistent fatigue, joint pain.  ANA +; Further workup shows Anti-DsNA antibody equivocal, histone Antibody positive, all other work up negative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal
Clinical narrative: Patient seen in the office with persistent fatigue, joint pain.  ANA +; Further workup shows Anti-DsNA antibody equivocal, histone Antibody positive, all other work up negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Flank pain, Laboratory test, Neuralgia, Ultrasound abdomen
Clinical narrative: Severe neuropathic left flank pain gradually improving after 6 weeks.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Computerised tomogram, Deep vein thrombosis
Clinical narrative: After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Magnetic resonance imaging, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tendon rupture, Ultrasound Doppler, X-ray
Clinical narrative: After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Several minutes after receiving  vaccine patient vomited.  Monitored patient  and he was fine after 15 minutes
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Throat irritation
Clinical narrative: Pt felt scratchy throat, said it felt like a lump was forming in throat. Benadryl 50mg PO x1 given as precaution, Pt kept for 15 extra Min for observation
Age: 56.0
Sex: U
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was given second dose too soon ? impact on vac coverage
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Asthenia, Gait inability, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Seconds after the first vaccine was administered, I felt weak and was unable to walk or stand unsupported. After 30 minutes of observation, I existed the clinic in a wheelchair and received a ride to my home. This weakness lasted a total of 1 hour, after which I was able to stand and walk normally.  The same sequence of events followed my second vaccine, but the weakness was worse and lasted for 3 hours. During the second hour, there was a 15 minute period when I was unable to speak (except to whisper) and unable to lift my arms to reach for a glass of water.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Seconds after the first vaccine was administered, I felt weak and was unable to walk or stand unsupported. After 30 minutes of observation, I existed the clinic in a wheelchair and received a ride to my home. This weakness lasted a total of 1 hour, after which I was able to stand and walk normally.  The same sequence of events followed my second vaccine, but the weakness was worse and lasted for 3 hours. During the second hour, there was a 15 minute period when I was unable to speak (except to whisper) and unable to lift my arms to reach for a glass of water.