chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptoms experienced from the vaccine cannot be transmitted; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted) 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.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted). At the time of the report, VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Sciatic nerve pain; Pain is going down my right leg; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Sciatic nerve pain) and PAIN IN EXTREMITY (Pain is going down my right leg) 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.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Sciatic nerve pain) and PAIN IN EXTREMITY (Pain is going down my right leg). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of Unknown. At the time of the report, NEURALGIA (Sciatic nerve pain) had not resolved and PAIN IN EXTREMITY (Pain is going down my right leg) outcome was unknown.             Concomitant drugs were not reported
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Mammogram
Clinical narrative: Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Arthralgia, Myalgia, Chest discomfort, Cardiac murmur and Sinus bradycardia. Previously administered products included for Immunization: Influenza (series 1) on 03-Oct-2018, Influenza (series 2) on 28-Sep-2020 and Influenza (series 3) on 15-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza, Influenza and Influenza. Concurrent medical conditions included Pedal edema, Weight gain, Hypertension, Benign neoplasm of carotid body (right), Synovitis wrist (tenosynovitis, left wrist), Reactive airways disease, Bronchitis acute, Paroxysmal atrial fibrillation, Cerumen impaction, Hyperlipidemia, Postmenopausal symptoms, Hypothyroidism, Osteopenia and Hypertension (FH). Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR), VITAMIN D3, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B12 NOS, LEVOTHYROXINE, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR), LOSARTAN POTASSIUM, UBIDECARENONE (COQ 10) and MAGNESIUM for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) abnormal, right breast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 11 Nov 2021.  Patient lab data includes screen (ovarian Cancer, lung Cancer, skin cancer, breast cancer, osteoporosis, cervical cancer, colon cancer), preoperative examination, physical examination. The patient had anticoagulant therapy.  Patient other medication included SARS COV 2 SEMI QUANTITATIVE and anti hyperlipidemic use(Long term), centrum silver oral tablet (multiple vitamins- minerals) one by mouth once a day.  Patient services due included Flu vax, Pneumovax, TD Booster.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain about 1 week ago; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain about 1 week ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: ibuprofen. Past adverse reactions to the above products included No adverse event with ibuprofen.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain about 1 week ago). The patient was treated with CELECOXIB (CELEBREX) ongoing since an unknown date for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain about 1 week ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Patient called with concerns of drug interaction and Moderna Covid-19 vaccination. Patient's  second dose is scheduled on 22MAR2021. He is inquiring if there is any contraindication or drug interaction between Celebrex and Moderna Covid-19 vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis B virus test, Pain in extremity
Clinical narrative: I had a sore arm.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B (Patient get tested every 6 months) in 1980.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm.). At the time of the report, PAIN IN EXTREMITY (I had a sore arm.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Hepatitis B virus test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  Patient received her second dose of vaccine on 02FEB2021. Patient tested Negative for Hepatitis B in April 2021 & July 2021.   This case was linked to MOD-2021-425684 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: The potential AE is a fever of 101.2 degrees Fahrenheit.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (The potential AE is a fever of 101.2 degrees Fahrenheit.) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (The potential AE is a fever of 101.2 degrees Fahrenheit.). At the time of the report, PYREXIA (The potential AE is a fever of 101.2 degrees Fahrenheit.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) 101.2 degrees fahrenheit.         No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Dec-2021: F/U received on 24-DEC-2021 and contains no new information. On 26-Dec-2021: F/U received on 26-dec-2021 contains no new information.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Forearm fracture, Vaccination site pain
Clinical narrative: pain at the injection site (similar to the 1st and 2nd doses); she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot) and VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 2001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)). At the time of the report, FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot) outcome was unknown and VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)) had resolved.            no concomitant medication were reported.  no treatment medication were reported.  She had to clean and drain the boy.   She has had boy in her armpit before but never on her forearm   This case was linked to MOD-2021-423448, MOD-2021-422951 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: running a fever of 102.6; achy; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (running a fever of 102.6) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running a fever of 102.6) and MYALGIA (achy). At the time of the report, PYREXIA (running a fever of 102.6) and MYALGIA (achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) fever of 102.6F.         No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2021-404967 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after getting the booster dose and these were worse than the 1st and 2nd doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses). At the time of the report, VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-426873, MOD-2021-404967 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: the next day was a little tired; 5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours; was flailing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was flailing), FATIGUE (the next day was a little tired) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (was flailing) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours). On 05-Mar-2021, the patient experienced FATIGUE (the next day was a little tired). On 04-Mar-2021, FEELING ABNORMAL (was flailing) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours) had resolved. At the time of the report, FATIGUE (the next day was a little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 103 (High) 103 degree celsius.         No concomitant medications were reported.  Treatment information was not provided. Patient has received 3 doses of the Moderna COVID 19 vaccine by intramuscular injection. 5 hours after receiving the second dose of the vaccine, patient experienced fever of 103 and was flailing. Fever broke within 2.5 hours and the next day patient was a little tired, but otherwise patient was fine. The third dose was given on 22 December 2021.   This case was linked to MOD-2021-425601 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026c21a and 007c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.     Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-426170 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pain, Ultrasound scan, Vaccination site pain
Clinical narrative: Brain fog; Body pain; Body achiness; Swelling and pain at the site of the injection; Swelling and pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Pain, at a dose of Sometimes. At the time of the report, FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: normal (normal) Thought it was a blood clot. 3 months ago doctor performed an ultrasound ruling that out..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was stated by patient that within 24-48 hours after receiving dose of the vaccine patient started to experience side effects that have continued up until today. Patient pain at the injection site was sometimes a slow dull pain, but also was sometimes sharper. Patient had thought it was a blood clot, but 3 months ago doctor who performed an ultrasound on her ruled that out. Treatment details stated taking of Tylenol PM sometimes to help her get to sleep with the pain No concomitant medications were mentioned. No other medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Brain fog; Body pain; Body achiness; Swelling and pain at the site of the injection; Swelling and pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Pain, at a dose of Sometimes. At the time of the report, FEELING ABNORMAL (Brain fog), PAIN (Body pain), MYALGIA (Body achiness), VACCINATION SITE SWELLING (Swelling and pain at the site of the injection) and VACCINATION SITE PAIN (Swelling and pain at the site of the injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: normal (normal) Thought it was a blood clot. 3 months ago doctor performed an ultrasound ruling that out..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was stated by patient that within 24-48 hours after receiving dose of the vaccine patient started to experience side effects that have continued up until today. Patient pain at the injection site was sometimes a slow dull pain, but also was sometimes sharper. Patient had thought it was a blood clot, but 3 months ago doctor who performed an ultrasound on her ruled that out. Treatment details stated taking of Tylenol PM sometimes to help her get to sleep with the pain No concomitant medications were mentioned. No other medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Dizziness postural, Pain in extremity, Paraesthesia
Clinical narrative: hands and wrists tingly about two minutes after injection.  30 minutes after injection, hands ice cold.  Hands remained ice cold for two days.  Had to wear gloves indoors.  Arm very hot and sore for two days.   third day just a little sore.  Fourth day I got dizzy and fluttering in chest after light exertion.  Still  slightly dizzy on occasion after standing up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Skin warm
Clinical narrative: hands and wrists tingly about two minutes after injection.  30 minutes after injection, hands ice cold.  Hands remained ice cold for two days.  Had to wear gloves indoors.  Arm very hot and sore for two days.   third day just a little sore.  Fourth day I got dizzy and fluttering in chest after light exertion.  Still  slightly dizzy on occasion after standing up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Platelet count decreased
Clinical narrative: Platelet count fell critically low,  <5. I'm now taking prednisone to try to bring count back up.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus surfaced and has remained a problem since March.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Additional Details: patient had a 20 to 30 second seizure within 5 mins of getting the vaccine, patient reports extreme anxiety all day over vaccine and previous undiagnosed seziures that have been worsening
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Tachycardia, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Additional Details: patient had a 20 to 30 second seizure within 5 mins of getting the vaccine, patient reports extreme anxiety all day over vaccine and previous undiagnosed seziures that have been worsening
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Tachycardia
Clinical narrative: Systemic: palpitations and rapid heart rate/rythm-Medium, Systemic: Tachycardia-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Deafness, Dizziness, Fatigue
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Additional Details: -Dizziness occured 3 minutes after vaccination. At first this was a frequent occurence and now it happens sometimes (rarely). -Ring in my ears - Consistent; stronger as the day goes by. Results in me being very tired. ENT has confirmed slight hearing loss and tinnitus. He has classified this as permanent damage.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Insomnia, Lethargy, Lymphadenopathy
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Additional Details: -Dizziness occured 3 minutes after vaccination. At first this was a frequent occurence and now it happens sometimes (rarely). -Ring in my ears - Consistent; stronger as the day goes by. Results in me being very tired. ENT has confirmed slight hearing loss and tinnitus. He has classified this as permanent damage.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Tinnitus
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Additional Details: -Dizziness occured 3 minutes after vaccination. At first this was a frequent occurence and now it happens sometimes (rarely). -Ring in my ears - Consistent; stronger as the day goes by. Results in me being very tired. ENT has confirmed slight hearing loss and tinnitus. He has classified this as permanent damage.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patinet inidcated feeling a little light headed/dizzy, helped patient lay down and proved OJ, no allergic reaction was observed or reported by patient, per patient has history of feeling dizzy post vaccination, after OJ patient was oberseved for 30min and was without any symptoms or complicatoins, patient said he felt back to normal after OJ.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore arm and mild chills beginning around 7:00pm. Chills increased in severity throughout the night. Did not experience fever, only chills. Nausea began at night around 11:00pm and vomiting at least three times during the night up until after 4:30am. Nausea continues mildly into morning,, 12/28/2021. Able to eat dry toast to stave off nausea and vomiting.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Vomiting
Clinical narrative: Sore arm, chills, nausea, vomiting
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Eye pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: patient started experiencing allerigies around eye area and chap lips about 1 week after administration
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Vomiting-Mild, Additional Details: Patient remained in pharmacy until blood pressure was normal and felt better for about 1 hour
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient stated feeling fuzzy and hand tingling-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotension, Paraesthesia
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient stated feeling fuzzy and hand tingling-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Chills, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Patient had fevers, chills, headache for 3 days after booster that subsided with assistance of acetaminophen. He then woke on the night of presentation (12/24/2021 -12/25/2021) with severe burning midsternal chest pain worst when laying flat.  Chest pain not relieved with antacids, acetaminophen or position change. Patient presented to the emergency department where he was found to have a normal appearing EKG, but elevated troponin lab value raising concern for vaccine/booster related myocarditis. Patient was observed on monitor in ED, given ketorolac IV which resolved symptoms, and admitted 03:33 am 12/25/2021, to the hospital for further studies.  Patient was admitted and had normal echocardiogram, down trending troponin as below, was discharged  14:43 12/25/2021 with plan for outpatient cardiac follow up and outpatient cardiac MRI
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sleep disorder, Troponin increased
Clinical narrative: Patient had fevers, chills, headache for 3 days after booster that subsided with assistance of acetaminophen. He then woke on the night of presentation (12/24/2021 -12/25/2021) with severe burning midsternal chest pain worst when laying flat.  Chest pain not relieved with antacids, acetaminophen or position change. Patient presented to the emergency department where he was found to have a normal appearing EKG, but elevated troponin lab value raising concern for vaccine/booster related myocarditis. Patient was observed on monitor in ED, given ketorolac IV which resolved symptoms, and admitted 03:33 am 12/25/2021, to the hospital for further studies.  Patient was admitted and had normal echocardiogram, down trending troponin as below, was discharged  14:43 12/25/2021 with plan for outpatient cardiac follow up and outpatient cardiac MRI
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Received the Booster on 12/23 injection sight was sore as expected however, work up 12/26 at 6am and injection sight has become swollen, very red, and hot to the touch.  it is now itching.  I've been applying ice and antibiotic cream to the injection sight.  Was taking Benadryl however, caused sinus headaches so, am taking Tylenol instead.   Still have headaches, aches all over, chills come and go, fever, doest go over 99, fatigue, and a cough.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Received the Booster on 12/23 injection sight was sore as expected however, work up 12/26 at 6am and injection sight has become swollen, very red, and hot to the touch.  it is now itching.  I've been applying ice and antibiotic cream to the injection sight.  Was taking Benadryl however, caused sinus headaches so, am taking Tylenol instead.   Still have headaches, aches all over, chills come and go, fever, doest go over 99, fatigue, and a cough.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Sleep disorder
Clinical narrative: Received the Booster on 12/23 injection sight was sore as expected however, work up 12/26 at 6am and injection sight has become swollen, very red, and hot to the touch.  it is now itching.  I've been applying ice and antibiotic cream to the injection sight.  Was taking Benadryl however, caused sinus headaches so, am taking Tylenol instead.   Still have headaches, aches all over, chills come and go, fever, doest go over 99, fatigue, and a cough.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antiplatelet therapy, Breast operation
Clinical narrative: Denies developed rheumatoid arthritis, TIA, and breast cancer folowing vaccine adminstration
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: symptoms after shot: severe muscle aches, headache, nausea
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient presented 6 days later stating he just started having a rash on his arm where the injection took place. It was his 3rd dose but previously had the pfizer vaccine for his first 2 doses
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Seizure
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Systemic: Seizure-Medium.
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Systemic: Seizure-Medium.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 years and 10 months old and was administered a booster dose of Pfizer vaccine.  Not currently approved or indicated in this age.    Description of reported administration error:  "Patient came into office today and her mother wanted patient to get a COVID pfizer booster. Dr approved of the vaccine booster. After the vaccine was given, we realized she is only 15 and 10 months, and not yet 16, which is the approved age for the pfizer booster. Mother was called and a message was left for her to call us back."
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt says she believes the vaccine was administered too low on her arm and it was not administered to the muscle. She also questioned whether the vaccine dose will be viable because of administration technique.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Limb injury, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt says she believes the vaccine was administered too low on her arm and it was not administered to the muscle. She also questioned whether the vaccine dose will be viable because of administration technique.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dysmenorrhoea, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Fainted on 10.25.2021 Fever, Body aches  10.23 + 10.24. Extreme menstrual cramps 10.24 10.25 - present weakness - unable to continue running -(school sport - xc) (Patient never previously  vaccinated)
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Fainted on 10.25.2021 Fever, Body aches  10.23 + 10.24. Extreme menstrual cramps 10.24 10.25 - present weakness - unable to continue running -(school sport - xc) (Patient never previously  vaccinated)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: INTERMITTENT LIGHT HEADEDNESS WITH POSITIONAL CHANGES; This spontaneous report received from a health care professional concerned a 57-year-old adult male, of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have adverse event after any previous vaccination. The patient previously received covid-19 vaccine ad26. cov2. s. (suspension for injection, route was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination (Unspecified manufacturer) (Dose number in series 1). It was not unknown if the patient had any adverse event with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204B21A, expiry: unknown) dose was not reported, 1 total administered on 09-DEC-2021 10:27 at left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. It was reported that patient called clinic and reported that he had been experiencing intermittent light headedness on (16-DEC-2021) with positional changes, only (such as going from laying to sitting or sitting to standing) (dose number in series 2). The Patient denied passing out and denied having sought medical evaluation at the time of reporting. The patient stated symptoms lasted 3 days then subsided. The patient had not experienced recurrence to events till the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent light headedness with positional changes on 19-DEC-2021. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Tachycardia
Clinical narrative: Systemic: Tachycardia-Medium, Additional Details: Patient reported pinching feeling in heart muscle
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea-Medium, Additional Details: Patient felt nauseous ~5mins after vaccine. She laid on the floor which she said helped, she did not feel lightheaded or other symptoms. Pharmacist sat with her for 15 mins and she said she felt better and went home, no ambulance required.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nerve injury, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The individual administering the vaccine jabbed me too close to my shoulder, causing nerve damage.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dizziness, Headache, Injection site pain
Clinical narrative: The shot itself was very painful going in right arm radiating pain thru  my right arm which had not happened on my first 2 vaccine shots of Pfizer. Then I began having a lot of pain moving around my breastbone, sternum, heart and maybe lung area all through the night after getting the booster. The next day I continued having some pain in these same areas intermittently thru the day. I also began having a lot of lower back pain and also very bad and lingering headache and some dizziness. I am still having the headache 5 days later but the other pain has subsided for the most part.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pulmonary pain
Clinical narrative: The shot itself was very painful going in right arm radiating pain thru  my right arm which had not happened on my first 2 vaccine shots of Pfizer. Then I began having a lot of pain moving around my breastbone, sternum, heart and maybe lung area all through the night after getting the booster. The next day I continued having some pain in these same areas intermittently thru the day. I also began having a lot of lower back pain and also very bad and lingering headache and some dizziness. I am still having the headache 5 days later but the other pain has subsided for the most part.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema multiforme, Hypersensitivity, Rash, Rash erythematous, Rash macular
Clinical narrative: Rash on torso (front & back) appeared around 12/11/21.   We did a virtual pediatrician visit on 12/13/21.  We saw doctor at his regular pediatrician.  She believed an allergic rash and advised to give 5ml of zyrtec per day and be seen in person if not better.  The zyrtec did not seem to make any difference.  The rash continued to spread to the face, and arms.   We went to the pediatrician ) and saw Dr.  in person on 12/20/21.  He called in his colleague to confirm and and believed it was likely erythema multiforme.  He explained this is usually an allergic reaction to a medication or a vaccine.  Although no way to know for sure, as we didn't introduce any additional medication other than his regular mutlivitamin before the rash appeared and the rash is not itchy, we believe it is a vaccine reaction.  We were instructed to stop the zyrtec and just do over the counter lotion.  Dr.  thought it might last up to a month.  As of today 12/28/21, it has not gone away yet and continues to spread up his face.  There are no other symptoms except the rash and it doesn't seem to bother him, it looks really red and blotchy.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Rash on torso (front & back) appeared around 12/11/21.   We did a virtual pediatrician visit on 12/13/21.  We saw doctor at his regular pediatrician.  She believed an allergic rash and advised to give 5ml of zyrtec per day and be seen in person if not better.  The zyrtec did not seem to make any difference.  The rash continued to spread to the face, and arms.   We went to the pediatrician ) and saw Dr.  in person on 12/20/21.  He called in his colleague to confirm and and believed it was likely erythema multiforme.  He explained this is usually an allergic reaction to a medication or a vaccine.  Although no way to know for sure, as we didn't introduce any additional medication other than his regular mutlivitamin before the rash appeared and the rash is not itchy, we believe it is a vaccine reaction.  We were instructed to stop the zyrtec and just do over the counter lotion.  Dr.  thought it might last up to a month.  As of today 12/28/21, it has not gone away yet and continues to spread up his face.  There are no other symptoms except the rash and it doesn't seem to bother him, it looks really red and blotchy.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: sharp pain/tingling  at/around injection site 7+ days after injection when arm is moved into a particular position. pain goes away when arm is not in particular position inducing pain. pt still reporting pain 5+ weeks from injection. pt received flu shot in same arm 11 days prior to pfizer injection. pt has not tried any thermal therapy or medication related therapy due to the pain going away quickly when out of the position that causes it.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in the arm where the vaccine (both doses) was administered during night/sleep time.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Laboratory test, Urticaria
Clinical narrative: 2nd pregnancy. Due with boy. 22 weeks pregnant at time of shot. On 12/25, broke out in full body hives starting behind ears and scalp and worked way down body. Still ongoing. Dr prescribed antihistamine, topical steroid and Pepcid. Waiting to start oral steroids given risk to pregnancy.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Head discomfort
Clinical narrative: Painful Ear Ache and Pressure in head
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Right side of upper and lower lip tingling and numb. Resolved an hour or so after onset.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Horrible nerve pain throughout my entire body.  Tylenol did not help.  I have had my elbow relocated without pain medication for two hours, tore my ACL, and naturally delivered a 8.7lb baby and this hurt much worse.  Pain lasted for about 18 hours.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies negative, Cytomegalovirus test negative, Directional Doppler flow tests, Exposure during pregnancy, Foetal biophysical profile score
Clinical narrative: First pregnancy, diagnosed at 32 weeks pregnant with IUGR, previous ultrasounds showed baby as normal size for fetal age. Due date 02/07/2022
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal growth restriction, Foetal non-stress test, Toxoplasma serology negative, Ultrasound antenatal screen
Clinical narrative: First pregnancy, diagnosed at 32 weeks pregnant with IUGR, previous ultrasounds showed baby as normal size for fetal age. Due date 02/07/2022
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus.  This was a Pfizer booster after a Janssen initial vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Injection site pain
Clinical narrative: Woke with chest pain, headache, and soreness at my injection site of my arm.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant self reported that she had just given a Covid Pfizer booster to a 15 year old.  Patient did not have any adverse reactions.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Musculoskeletal stiffness, Pyrexia
Clinical narrative: High fever -102-105 lasting total of 5 days. Stiff neck from day 2-5. Chest pain/ shortness of breath days 3-5. Hyperhidrosis during sleep.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Impaired work ability, Lethargy
Clinical narrative: got a rash on bottom of right arm for a couple hours got very tired and liturgic.  My bones and muscles are aching and weak. I am very weak and it is day 6. I can barely function at work. I was walking down the stairs and my leg gave out. Almost like my muscle atrophy.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy, Muscular weakness, Myalgia, Rash
Clinical narrative: got a rash on bottom of right arm for a couple hours got very tired and liturgic.  My bones and muscles are aching and weak. I am very weak and it is day 6. I can barely function at work. I was walking down the stairs and my leg gave out. Almost like my muscle atrophy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo. Antivert 25 mg every 4-6 hours x 72 hours Minimum relief