chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Diagnosis with deep vein thrombosis, in August he suffer DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 030l20a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included TAMSULOSIN, MELOXICAM, LEVOCETIRIZINE, MONTELUKAST, ASPIRIN [ACETYLSALICYLIC ACID], LORATADINE and VITAMINS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Other concomitant medication included arthritis medicine. Patient received booster dose on 10 September 2021 with lot number 020f21a.  Company comment: This case concerns an 80-year-old male patient, with no relevant medical history reported in this case, who experienced the serious unexpected AESI of Deep vein thrombosis. The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine and the outcome was reported as Unknown.  The event was assessed with the seriousness criteria of Medically Significant although no further information on clinical course, diagnostic tests performed or required treatment was disclosed. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80-year-old male patient, with no relevant medical history reported in this case, who experienced the serious unexpected AESI of Deep vein thrombosis. The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine and the outcome was reported as Unknown.  The event was assessed with the seriousness criteria of Medically Significant although no further information on clinical course, diagnostic tests performed or required treatment was disclosed. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: sore arm; 1st two doses made her sick for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ILLNESS (1st two doses made her sick for a day) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetic and Cataract (Cataract in one eye).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ILLNESS (1st two doses made her sick for a day). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and ILLNESS (1st two doses made her sick for a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-416207, MOD-2021-416208 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Dementia, Vaccination complication
Clinical narrative: The patient has dementia; trouble communicating; experienced side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of DEMENTIA (The patient has dementia) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (The patient has dementia) (seriousness criterion medically significant), COMMUNICATION DISORDER (trouble communicating) and VACCINATION COMPLICATION (experienced side effects). At the time of the report, DEMENTIA (The patient has dementia), COMMUNICATION DISORDER (trouble communicating) and VACCINATION COMPLICATION (experienced side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Company Comment This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Dementia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.     This case was linked to MOD-2021-415894, MOD-2021-416026 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Dementia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Dementia, Vaccination complication
Clinical narrative: The patient has dementia, trouble communicating; The patient has dementia, trouble communicating; Experienced side effects from the first two shots; This spontaneous case was reported by a pharmacist and describes the occurrence of DEMENTIA (The patient has dementia, trouble communicating) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (The patient has dementia, trouble communicating) (seriousness criterion medically significant), COMMUNICATION DISORDER (The patient has dementia, trouble communicating) and VACCINATION COMPLICATION (Experienced side effects from the first two shots). At the time of the report, DEMENTIA (The patient has dementia, trouble communicating), COMMUNICATION DISORDER (The patient has dementia, trouble communicating) and VACCINATION COMPLICATION (Experienced side effects from the first two shots) 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.   Concomitant products were not provided. The patient experienced dementia, trouble communicating and experienced side effects from the first two shots. Treatment medication were not reported. Company Comment: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of dementia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-415894, MOD-2021-416025 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of dementia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: He has a sore arm after the injection; My husband had a breakthrough COVID-19 infection; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (My husband had a breakthrough COVID-19 infection) and VACCINATION SITE PAIN (He has a sore arm after the injection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure (stage 4 kidney failure). Concomitant products included ATORVASTATIN, GLIPIZIDE, ALLOPURINOL, CHLORTALIDONE (CHLORTHALIDONE), SODIUM BICARBONATE and IXEKIZUMAB (TALTZ) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced COVID-19 (My husband had a breakthrough COVID-19 infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (He has a sore arm after the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (My husband had a breakthrough COVID-19 infection) had resolved and VACCINATION SITE PAIN (He has a sore arm after the injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.  Company comment: This case concerns a 69-year-old male patient, with medical history of kidney failure, who experienced the non-serious, unexpected AESI event of Covid-19, 1 month after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also suffered from injection site pain, on unknown date after the vaccine. The patient's age and history of kidney failure may have increased his risk of getting Covid-19 infection. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Reporter details and second dose date, events and treatment medication were updated; Sender's Comments: This case concerns a 69-year-old male patient, with medical history of kidney failure, who experienced the non-serious, unexpected AESI event of Covid-19, 1 month after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also suffered from injection site pain, on unknown date after the vaccine. The patient's age and history of kidney failure may have increased his risk of getting Covid-19 infection. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Neuropathy peripheral, Pain, Positron emission tomogram
Clinical narrative: severe neuropathy; pain affecting entire low body; feeling pain in the spine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe neuropathy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SPINAL PAIN (feeling pain in the spine). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe neuropathy) (seriousness criterion medically significant) and PAIN (pain affecting entire low body). At the time of the report, NEUROPATHY PERIPHERAL (severe neuropathy) outcome was unknown and SPINAL PAIN (feeling pain in the spine) and PAIN (pain affecting entire low body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported (Inconclusive) Results not reported. On an unknown date, Magnetic resonance imaging: results not reported (Inconclusive) Results not reported. On an unknown date, Positron emission tomogram: results not reported (Inconclusive) Results not reported. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on concomitant medication but she did not give any specifications about them.  No treatment information was provided. Patient stated that went to doctor´s and surgeon´s appointments. Company Comment This case concerns a 53-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of neuropathy peripheral. The events occurred the same day after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416137 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no medical history reported, who experienced the unexpected event of spinal pain on the same day after the first dose of mRNA-1273 vaccine. She also experienced the unexpected serious event of neuropathy peripheral (reported as severe neuropathy) and pain at an unknown date. The event spinal pain was reported after both doses of the vaccine, however, since the outcome had not resolved, the rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Case was assessed as serious due to important medical event and medical judgement.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, X-ray
Clinical narrative: severe neuropathy; pain affecting entire low body; feeling pain in the spine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe neuropathy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SPINAL PAIN (feeling pain in the spine). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe neuropathy) (seriousness criterion medically significant) and PAIN (pain affecting entire low body). At the time of the report, NEUROPATHY PERIPHERAL (severe neuropathy) outcome was unknown and SPINAL PAIN (feeling pain in the spine) and PAIN (pain affecting entire low body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported (Inconclusive) Results not reported. On an unknown date, Magnetic resonance imaging: results not reported (Inconclusive) Results not reported. On an unknown date, Positron emission tomogram: results not reported (Inconclusive) Results not reported. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on concomitant medication but she did not give any specifications about them.  No treatment information was provided. Patient stated that went to doctor´s and surgeon´s appointments. Company Comment This case concerns a 53-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of neuropathy peripheral. The events occurred the same day after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416137 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no medical history reported, who experienced the unexpected event of spinal pain on the same day after the first dose of mRNA-1273 vaccine. She also experienced the unexpected serious event of neuropathy peripheral (reported as severe neuropathy) and pain at an unknown date. The event spinal pain was reported after both doses of the vaccine, however, since the outcome had not resolved, the rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Case was assessed as serious due to important medical event and medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guerre barre syndrome; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) in an elderly male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient was retired schoolteacher. Company Comment This case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Recurring daily fevers for 3 months post vaccine.; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Recurring daily fevers for 3 months post vaccine.) 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 PYREXIA (Recurring daily fevers for 3 months post vaccine.). At the time of the report, PYREXIA (Recurring daily fevers for 3 months post vaccine.) outcome was unknown.        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. No treatments were Reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test, Lower respiratory tract infection, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID after receiving the first dose; Chest cold; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 017B21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold). At the time of the report, COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Influenza virus test: negative (Negative) Patient Tested negative for flu.. In January 2021, SARS-CoV-2 test: positive (Positive) Patient diagnosed with COVID after receiving the first dose..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Company comment: This case concerns a 73-year-old male patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unspecified date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had chest cold a week or two after the first shot and tested negative for flu. The patient's age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416211 (Patient Link).; Sender's Comments: This case concerns a 73-year-old male patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unspecified date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had chest cold a week or two after the first shot and tested negative for flu. The patient's age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: shoulder is not better in this two months after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot). At the time of the report, MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that his shoulder was not better in these two months after getting the shot, and was going to blow his brains out if he had to get another one. No concomitant medications provided. No treatment medications provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: Inflammation of the axilar and near the breast. Big bump.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, New daily persistent headache
Clinical narrative: A few days after the Moderna vaccine, I started having a persistent daily headache.  I have been to the doctor and emergency room.  It has now lasted 2 months with no improvement.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: No menstruation for 83 days post vaccine. Was due for menstruation the next day (11/8/2021). Menstruation began on 12/30/2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Dizziness, Fatigue
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Hypertension, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Lymphadenopathy, Nausea, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tachycardia, Tinnitus, Tremor
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient called later that day and said she was losing her eye sight. Told her to go to nearest hospital
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: After Admenstring Vaccine, noticed patient is fainting. Held patient to ground and called for hlep and pharmacy staff called EMS. Patient gained consciousness before EMS arrive. When EMS arrived, we relayed info to the EMS responders. They took over
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hypotension, Nausea, Syncope
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: bp 90/70; hypotension-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: bp 90/70; hypotension-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: bp 90/70; hypotension-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hypotension, Nausea, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted few   minutes   after getting  her first  dose of the  covid-19   vaccine.Nurse practitioner was  immediately summoned who attended to her untill she was able to get back on her feet to go home
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted few   minutes   after getting  her first  dose of the  covid-19   vaccine.Nurse practitioner was  immediately summoned who attended to her untill she was able to get back on her feet to go home
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted few   minutes   after getting  her first  dose of the  covid-19   vaccine.Nurse practitioner was  immediately summoned who attended to her untill she was able to get back on her feet to go home
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Intermenstrual bleeding, Malaise
Clinical narrative: About 12 hours after my shot I began experiencing chills, severe body pain and aches, headache, nausea and fatigue. My fever rose to 101.5 degrees. I was I?ll with these symptoms for three days and continued feeling fatigued for several more days after.  Over the course of the following month I had heavy break thru spotting on and off for almost four weeks despite having had my period regularly the week before my shot  (my period is usually completely predictable because I am on birth control).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: About 12 hours after my shot I began experiencing chills, severe body pain and aches, headache, nausea and fatigue. My fever rose to 101.5 degrees. I was I?ll with these symptoms for three days and continued feeling fatigued for several more days after.  Over the course of the following month I had heavy break thru spotting on and off for almost four weeks despite having had my period regularly the week before my shot  (my period is usually completely predictable because I am on birth control).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 1.08
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Flushing, Irritability, Swelling face
Clinical narrative: Flushing, facial swelling, difficulty breathing, mast Cell mediator release and irritability
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Flushing, Hyperhidrosis, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: About 2-3 minutes after vaccine went back into vaccine area and pt was diaphoretic and pale and fainted post vaccine. Pt was assisted to a flat postions and she regained consciousness approx 15-30 seconds after she was flat.  She was monitored in the pharmacy area for 30 minutes and given water. Pt reports that she is needle phobic.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: About 2-3 minutes after vaccine went back into vaccine area and pt was diaphoretic and pale and fainted post vaccine. Pt was assisted to a flat postions and she regained consciousness approx 15-30 seconds after she was flat.  She was monitored in the pharmacy area for 30 minutes and given water. Pt reports that she is needle phobic.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt reported with a large bruise and self reported "bubbling" - bruise center was approximately 2-3'' lower than an expected injection site.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient experienced apparent episode of syncope as he fell while standing up from chair and hit his head on the privacy screens surrounding the vaccination area. Patient did not appear to lose consciousness. Patient was very nervous prior to administration&experienced weakness that likely resulted in fall. Patient helped up my pharmacist, helped to chair to recover, and advised to reach out to PCP about potential head injury from fall. Encounter observed by pharmacist.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported hives that did not itch
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: pt experienced lighthead, flushing and mild sweating symptoms, had pt lay down on floor and elevate legs, took blood pressure (was 112/80, osat 99 HR 75). pt started feeling better, had drink water and retook blood pressure ( 126/70, osat 99 HR 71), pt called wife who came to pick him up, pt declined calling 911, had nurse practicioner take blood glucose at pt request was (117)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fear of injection, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted shortly after receiving Pfizer booster today. She was alert after 1-2 minutes. Her mother was with her and stated she faints after every immunization she receives due to needle phobia. Patient stayed longer than 15 mins and was fine. She was advised to drink lots of water today and to take it easy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy uterus normal, Postmenopausal haemorrhage, Ultrasound uterus normal
Clinical narrative: I am 15 years post menopausal. 5 days after 2nd vaccine listed above, I got a light period for 2-3 days, month later another for 2-3 days and July had one for 5 days. Called Dr she sent me for ultrasound then on to gyno who performed a uterine biopsy. Results were no cancer. Since end of July, no period. Had booster shot Dec 3, no issues since
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: pt brought over by pharmacist to clinic- vitals 88/52 HR 80 glucose and fluids given- pt placed in supine position- improved with interventions-
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Moderna COVID?19 Vaccine; significantly swollen lymph node (left arm pit near injection site
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt given flu shot and Moderna booster in L arm. She moved chairs so I could provide same thing to her dad: as I was providing his flu shot she said she felt lightheaded; When i finished his shot dad noticed she looked wobbly and her eyes were rolling around. I held her shoulders and asked if her dad could help me lay her down and keep her legs elevated. She lost consciousness briefly but opened her eyes pretty quickly when her mom asked her if she was ok (she replied YES);ems came & assessedher
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient complains of red, and itchy rashes on his left arm extending above and below is elbow. Patient states that the rashes appeared 2 days after Moderna booster was administered and has not gone away. I counseled patient to take OTC antihistamine and topical steroid (hydrocortisone) and to refer to doctor if symptoms don't improve in the next couple days.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus, Swelling face
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reports his face is flushed with redness, he also has swelling in the face and itching of the face. He took benadryl. He did not have trouble breathing. This began about 24 hours after vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Restlessness, Slow speech
Clinical narrative: Pt was vaccinated by RN @ 12:01 pm.  At 12:06pm, the pt stated she was feeling unwell.  While sitting in the observation area, the patient experienced restlessness, slowed speech, and weakness.  EMT intervened right away for support.  A set of vitals were taken.   BP - 80/52, 02 @ 98%, HR 70.  Mom denied PMH and no current medications.  Mom reported patient being seen by a Cardiologist 2 weeks prior d/t a history of and abnormal EKG:  slight prolonged QT interval.  Pt transported to South Shore Hospital by EMS for further evaluation.  Follow up call to Mom on 12/29/2021:  Mom stated that no intervention needed.  The patient was feeling much better after an hour and was released to home.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: A GRANULE BLISTER AT SITE OF INJECTION WITH REDNESS AND SWELLING IN THE SURROUNDING AREA-Mild, Additional Details: Patient reported a blister with fluid the size of granule at the injection site with redness and swelling at the surrounding area.  Pt will monitor and report if there is any worsening or no improvement after a few days.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Condition aggravated, Dialysis, Diuretic therapy, End stage renal disease
Clinical narrative: Moderna COVID-19 Vaccine EUA: three days after vaccination patient hospitalized for volume overload, pulmonary edema, and worsening CKD progressing to ESRD. Patient diuresed and dialyzed with improvement. Discharged to home medically stable with outpatient dialysis in place.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervolaemia, Pulmonary oedema
Clinical narrative: Moderna COVID-19 Vaccine EUA: three days after vaccination patient hospitalized for volume overload, pulmonary edema, and worsening CKD progressing to ESRD. Patient diuresed and dialyzed with improvement. Discharged to home medically stable with outpatient dialysis in place.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Dizziness, Influenza virus test negative, Mobility decreased, Nausea
Clinical narrative: Woke up and couldn?t get out of bed room was spinning counterclockwise severe dizziness and nausea. Severe dizziness to look up, down and basically any direction but straight ahead. Ringing in ears as well. Went to get a covid and flu rapid test thinking possibility I might have either one. Both were negative. Physicians assistant checked my ears for sign of ear infection and also checked my blood pressure sitting and standing. She couldn?t find anything that might be causing severe dizziness. I continue to have severe dizziness approximately 10 episodes day. Sometimes it?s so extreme, I almost fall over into floor if I don?t move very slow in my activities.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tinnitus, Vertigo
Clinical narrative: Woke up and couldn?t get out of bed room was spinning counterclockwise severe dizziness and nausea. Severe dizziness to look up, down and basically any direction but straight ahead. Ringing in ears as well. Went to get a covid and flu rapid test thinking possibility I might have either one. Both were negative. Physicians assistant checked my ears for sign of ear infection and also checked my blood pressure sitting and standing. She couldn?t find anything that might be causing severe dizziness. I continue to have severe dizziness approximately 10 episodes day. Sometimes it?s so extreme, I almost fall over into floor if I don?t move very slow in my activities.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Laboratory test, Pain
Clinical narrative: Vomits, diarrhea, fever, body ache, shaking chills, lost of appetite for 3 days and counting.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Tremor, Vomiting
Clinical narrative: Vomits, diarrhea, fever, body ache, shaking chills, lost of appetite for 3 days and counting.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, extremely sore arm, chills, nausea, dizziness
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Vomiting
Clinical narrative: Chills started at 0200 on 12/30/21. Left arm pain, headache, and vomiting at 0800 on 12/30/21.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse event noted vaccine given more than 12 hours after vial was punctured
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Angiogram cerebral, Blood glucose, Blood magnesium, Body temperature increased, Cerebral infarction
Clinical narrative: dizziness - spinning sensation - Before going to hospital Nausea vomiting low grade temp Acute Subacute infarcts with Left cerebellar Hemiphere microangiopathic diseas Sm chronic Lacunar infarcts - Bilateral Frontal Coronal
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cerebral microangiopathy, Computerised tomogram head, Dizziness, Echocardiogram, Full blood count
Clinical narrative: dizziness - spinning sensation - Before going to hospital Nausea vomiting low grade temp Acute Subacute infarcts with Left cerebellar Hemiphere microangiopathic diseas Sm chronic Lacunar infarcts - Bilateral Frontal Coronal
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Lacunar infarction, Magnetic resonance imaging, Metabolic function test, Nausea, Procalcitonin
Clinical narrative: dizziness - spinning sensation - Before going to hospital Nausea vomiting low grade temp Acute Subacute infarcts with Left cerebellar Hemiphere microangiopathic diseas Sm chronic Lacunar infarcts - Bilateral Frontal Coronal
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Troponin, Vertigo, Vomiting
Clinical narrative: dizziness - spinning sensation - Before going to hospital Nausea vomiting low grade temp Acute Subacute infarcts with Left cerebellar Hemiphere microangiopathic diseas Sm chronic Lacunar infarcts - Bilateral Frontal Coronal
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient vaccinated by RN @ 3:07pm.  At 3:10pm, the patient called for help.  The patient reported that he briefly passed out.  This event was not observed by any medical staff members.  The patient was provided with water and an ice pack to his neck.  EMS called to our area for further observation.  BP 106/62.  The patient quickly recovered and stated he was 'feeling fine'.  Patient escorted to observation area by EMT for remainder of his observation time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Sensitive skin, Tinnitus
Clinical narrative: Severe Headache  Severe Body Aches Severe Skin Hypersensitivity  Tinnitus  Nausea  Vaccination Completed 12/27- Time Course 72 Hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Ultrasound scan
Clinical narrative: Pericarditis without an effusion presented with chest pain unable to lie down that started 5 hrs post injection.  Presented to PCP on 12/1/21 when they did not resolve and she was not sleeping. Sent to the ER when she presented so bedside sono  could be done to demonstrate no effusion and ruled out PE as cause of symptoms. Echo done confirming no effusion.  ER ECG showed mild S-T changes.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fall, Orthostatic hypotension, SARS-CoV-2 test positive
Clinical narrative: Moderna COVID-19 Vaccine EUA: seven months after vaccination patient admitted to hospital for orthostatic hypotension, diarrhea, and falls with COVID-19 breakthrough infection. Patient hydrated, received PT/OT, remdesivir, and discharged to home medically stable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Moderna COVID-19 Vaccine EUA: seven months after vaccination patient admitted to hospital for orthostatic hypotension, diarrhea, and falls with COVID-19 breakthrough infection. Patient hydrated, received PT/OT, remdesivir, and discharged to home medically stable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial disorder, Bronchitis, Cough, Throat irritation, Wheezing
Clinical narrative: 1 week later developed scratchy throat bad cough wheezing and possible bronchitis or bronchial infection.   Lungs sounded clear except for upper respiratory