chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: it was reconstituted with sterile water instead of NaCl with no reported adverse event; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (under the reference number- 00766997).  This case involves a patient of (unknown demographics) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was reconstituted with sterile water instead of NACl (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (suspension for injection, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation error (same day).  It was reported "Caller reporting they are in the process of researching to determine if these errors occurred, but if it did occur there is no way to identify which 1-2 patients were involved out of 8 patients. Caller did not have any patient data available as they are researching."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired vaccine/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (GMI) (Reference number- 00768466) and transmitted to Sanofi on 14-Sep-2021.   This case involves a 34-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Sep-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Injection) [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported, "Caller states that 4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: patient was received an expired vaccine/ no AE; patient was administered vaccine during pregnent/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00768515) and transmitted to Sanofi on 14-Sep-2021.   This case involves a 31-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (expired product administered) during her pregnancy (Maternal exposure during pregnancy).  Gestation period at onset was 10 weeks.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was 06-Jul-2021.  The estimated due date is 12-Apr-2022.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Sep-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used and Maternal exposure during pregnancy (latency was on same day).  Relevant prenatal testing after exposure was not reported.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: patient was administered an expired vaccine/ no AE; patient was administered vaccine during pregnent/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Regulatory Authority (Reference number- 00768515) and transmitted to Sanofi on 14-Sep-2021. This case involves a 31-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (expired product administered) during her pregnancy (Maternal exposure during pregnancy).  Gestation period at onset was 45 weeks.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was 12-Oct-2020  The estimated due date is 29-Sep-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 14-Sep-2021 patient received a 0.5 ml (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported,"4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used and Maternal exposure during pregnancy (latency was on same day).  Relevant prenatal testing after exposure was not reported.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: menactra vaccine 0.5ml given through subcutaneous route/ no AE; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer/ non-health professional .  This case involves a 20-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneous route (incorrect route of product administration ).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, strength: 0.5 mL, lot U6745AA, expiry date: 06-Oct-2021] via subcutaneous route at an left tricep for prophylactic vaccination.  This was actual medication error case due to inappropriate route of vaccination (latency: same day).  The Reporter reported "MENACTRA vaccine was given to a patient using the subcutaneous route. patient age less than 1 year enter as 2month, 4month, etc. many pediatric vaccines need month for age 20 years old".  At the time of this report the patient was fine and had no adverse events after the vaccination.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vertigo
Clinical narrative: 5 minutes of vertigo; lightheaded; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case from consumer/non healthcare professional via call center via Agency (Reference number- 00770195). This case involves Elderly female patient who experienced lightheaded (dizziness) and 5 minutes of vertigo (vertigo) when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious lightheaded (dizziness) and 5 minutes of vertigo (vertigo) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller would like to know if the vaccine is available in the area and if the vaccine is 3 or 4 strain. Caller did not want to give any other information besides her name. Caller stated that she will give that information to the person she is being transferred to. The caller wanted to know if she can get a "regular" flu shot that is four strains and not three strains. She would like to know if "quad" is always four. She would like to know if the "senior" flu shot is "double". The caller states that she didn't feel her last flu vaccine when it was administered so she wants to go back to "her" at Rite Aid. She states that she doesn't want to fill out any paperwork but she got the "senior" vaccine once "many, many years ago" and she got a little lightheaded and had 5 minutes of vertigo that was not bad. She states that she is going to try and not get the "senior" flu vaccine even though she is about to be 72. She states that she will try to have the regular one (vaccine) and then wait 4 weeks until the antibodies form and she is safe from the flu and then she will get the booster from Pfizer for COVID 19. She states that in February and March we were told that if you had the Pfizer vaccine you were 94-95% covered for COVID but then a month or two ago we were told we were 80% covered or lower and then yesterday it came out that we don't need the booster so fast and she said it was a little disconcerting with all the backtracking. She states that she doesn't want the flu or COVID."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for dizziness.  On an unknown date, the patient recovered from vertigo.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Swelling face, Throat irritation
Clinical narrative: Facial swelling, numbness, scratchy throat, headache and fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling jittery, Hypertension, Palpitations
Clinical narrative: Plantations x 4 days Jitters x 4 days Chest pain x4 days High blood pressure
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature increased, Breast tenderness, Fatigue, Headache
Clinical narrative: I received my first dose of Pfizer COVID-19 vaccine on 07/21/2021.  The next day, 07/22/2021 I woke up at approx 0600 with tenderness to my injection site on my left deltoid.  I had radiating pain to my left shoulder into my neck.  This pain triggered a migraine with nausea.  The left arm pain persisted for approximately 3 days after injection. At or around 07/27/2021, I developed breast tenderness, increased appetite, irritability, lower abdominal and back cramping.  The breast tenderness, increased appetite, and irritability persisted until 08/27/2021.  I had visited my PCP and was offered testing but declined to see if the symptoms would reside on their own, in which they did.  I received my second dose of Pfizer COVID-19 vaccine on 08/11/2021.  Once again on the following day, I had tenderness along with bruising to the injection site on my left deltoid.  I also awoke with a low grade temperature of 99.9 orally, body aches, headache, sore throat, and fatigue.  I was not able to go to work that day.  Symptoms started to subside throughout the day.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Increased appetite, Injection site bruising, Injection site pain, Irritability, Migraine
Clinical narrative: I received my first dose of Pfizer COVID-19 vaccine on 07/21/2021.  The next day, 07/22/2021 I woke up at approx 0600 with tenderness to my injection site on my left deltoid.  I had radiating pain to my left shoulder into my neck.  This pain triggered a migraine with nausea.  The left arm pain persisted for approximately 3 days after injection. At or around 07/27/2021, I developed breast tenderness, increased appetite, irritability, lower abdominal and back cramping.  The breast tenderness, increased appetite, and irritability persisted until 08/27/2021.  I had visited my PCP and was offered testing but declined to see if the symptoms would reside on their own, in which they did.  I received my second dose of Pfizer COVID-19 vaccine on 08/11/2021.  Once again on the following day, I had tenderness along with bruising to the injection site on my left deltoid.  I also awoke with a low grade temperature of 99.9 orally, body aches, headache, sore throat, and fatigue.  I was not able to go to work that day.  Symptoms started to subside throughout the day.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: I received my first dose of Pfizer COVID-19 vaccine on 07/21/2021.  The next day, 07/22/2021 I woke up at approx 0600 with tenderness to my injection site on my left deltoid.  I had radiating pain to my left shoulder into my neck.  This pain triggered a migraine with nausea.  The left arm pain persisted for approximately 3 days after injection. At or around 07/27/2021, I developed breast tenderness, increased appetite, irritability, lower abdominal and back cramping.  The breast tenderness, increased appetite, and irritability persisted until 08/27/2021.  I had visited my PCP and was offered testing but declined to see if the symptoms would reside on their own, in which they did.  I received my second dose of Pfizer COVID-19 vaccine on 08/11/2021.  Once again on the following day, I had tenderness along with bruising to the injection site on my left deltoid.  I also awoke with a low grade temperature of 99.9 orally, body aches, headache, sore throat, and fatigue.  I was not able to go to work that day.  Symptoms started to subside throughout the day.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Hypertension, Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Extra dose administered, Fatigue
Clinical narrative: Systemic: Weakness-Mild, Additional Details: Patient reported that he was experiencing off and on fatigue nearly three weeks after receiving his third dose of Moderna's mRNA COVID-19 vaccine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Depression, Headache, Mood altered
Clinical narrative: Systemic: Confusion-Mild, Systemic: Headache-Medium, Additional Details: Patient complained of mood changes and depression and headache for 4 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus
Clinical narrative: Itching and dryness to multiple areas of body
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Lung infiltration, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/20/21 for other reasons, SARS-CoV-2 positive prior to admission but CT scan of the chest reveals pulmonary infiltrates not inconsistent with COVID-19 pneumonia this admission.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pallor, Syncope, Vomiting projectile
Clinical narrative: Pale, projectile vomiting, fainting, inability to pick self off of the ground
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Change of bowel habit, Diarrhoea, Injection site pruritus, Lymphadenopathy
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: experienced change in bowel movement, getting diarrhea
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Fear
Clinical narrative: 9/17/21: 13 minutes after I got headache with blurry vision, palpatations and nausea felt weird. at 5:20pm my face, neck tinglied felt swollen, feeling very dizzy and week at this point. 5:23PM took a baby aspirin (scared I might be stroking out).  9/18/21: very weak and tired rest all day baby aspirin morning and bedtime as I am still getting facial tingling and throat tightness, heart rate felt fast. 9/19/21: same as saturday, 9/20/21: facial tingling in morning took baby aspirin went to work at 1:28PM very very dizzing short of breath, nauseated headache and blurry vision co-worker took me to doctor. Negative labs doctor stated "most likely inflammatory reation to J&J vaccine. No arrhythmia"
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Headache, Heart rate increased, Inflammation
Clinical narrative: 9/17/21: 13 minutes after I got headache with blurry vision, palpatations and nausea felt weird. at 5:20pm my face, neck tinglied felt swollen, feeling very dizzy and week at this point. 5:23PM took a baby aspirin (scared I might be stroking out).  9/18/21: very weak and tired rest all day baby aspirin morning and bedtime as I am still getting facial tingling and throat tightness, heart rate felt fast. 9/19/21: same as saturday, 9/20/21: facial tingling in morning took baby aspirin went to work at 1:28PM very very dizzing short of breath, nauseated headache and blurry vision co-worker took me to doctor. Negative labs doctor stated "most likely inflammatory reation to J&J vaccine. No arrhythmia"
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Metabolic function test, Nausea, Palpitations, Paraesthesia
Clinical narrative: 9/17/21: 13 minutes after I got headache with blurry vision, palpatations and nausea felt weird. at 5:20pm my face, neck tinglied felt swollen, feeling very dizzy and week at this point. 5:23PM took a baby aspirin (scared I might be stroking out).  9/18/21: very weak and tired rest all day baby aspirin morning and bedtime as I am still getting facial tingling and throat tightness, heart rate felt fast. 9/19/21: same as saturday, 9/20/21: facial tingling in morning took baby aspirin went to work at 1:28PM very very dizzing short of breath, nauseated headache and blurry vision co-worker took me to doctor. Negative labs doctor stated "most likely inflammatory reation to J&J vaccine. No arrhythmia"
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness, Urine analysis, Vaccination complication, Vision blurred
Clinical narrative: 9/17/21: 13 minutes after I got headache with blurry vision, palpatations and nausea felt weird. at 5:20pm my face, neck tinglied felt swollen, feeling very dizzy and week at this point. 5:23PM took a baby aspirin (scared I might be stroking out).  9/18/21: very weak and tired rest all day baby aspirin morning and bedtime as I am still getting facial tingling and throat tightness, heart rate felt fast. 9/19/21: same as saturday, 9/20/21: facial tingling in morning took baby aspirin went to work at 1:28PM very very dizzing short of breath, nauseated headache and blurry vision co-worker took me to doctor. Negative labs doctor stated "most likely inflammatory reation to J&J vaccine. No arrhythmia"
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Malaise, Nausea, Paraesthesia
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: A few minutes after recieving the Moderna vaccine the patient said that she wasn't feeling well, & she thought she might vomit & faint. I monitored the patient for 50 minutes, she never vomited but was dizzy & had some tingline in her hands. She said she actually experiences the tingling when she has anxiety attacks and she wasn't sure if it was due to the shot. Her vitals were within normal, she never lost consciousness and her temp was 98.6F. Patient was feeling fine declined care at end.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Immunodeficiency, Multiple sclerosis
Clinical narrative: hospitalized 9/17/21 with COVID-19 pneumoniae, immunocompromised with multiple sclerosis on Ocrevus.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Unresponsive to stimuli
Clinical narrative: Hypoxia, patient became unresponsive. Hospitalization.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Fatigue, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient received the vaccine. Within five minutes he asked to go to the bathroom to which he was advised to stay in the area. He did not look well so we asked if he was ok. He said he couldn't see well and he felt very tired and nauseous. He started coughing and saying he had trouble breathing. When I grabbed my emergency response kit he stated that he was breathing ok but just felt nauseous. We called 911 and his blood pressure was 80/60 mmhg. They did not give epipen. Brough to hospital.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: General physical condition abnormal, Hyperhidrosis, Hypotension, Lethargy, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient received the vaccine. Within five minutes he asked to go to the bathroom to which he was advised to stay in the area. He did not look well so we asked if he was ok. He said he couldn't see well and he felt very tired and nauseous. He started coughing and saying he had trouble breathing. When I grabbed my emergency response kit he stated that he was breathing ok but just felt nauseous. We called 911 and his blood pressure was 80/60 mmhg. They did not give epipen. Brough to hospital.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient received the vaccine. Within five minutes he asked to go to the bathroom to which he was advised to stay in the area. He did not look well so we asked if he was ok. He said he couldn't see well and he felt very tired and nauseous. He started coughing and saying he had trouble breathing. When I grabbed my emergency response kit he stated that he was breathing ok but just felt nauseous. We called 911 and his blood pressure was 80/60 mmhg. They did not give epipen. Brough to hospital.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/18/21 with diarrhea, SARS-CoV-2 positive which was found incidentally.  Remains asymptomatic from COVID-19.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Experiencing dizziness that was mild at first and barely noticeable to more serve the 3rd day
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR)-
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospitalized 9/20/21 from skilled nursing facility, SARS-CoV-2 positive 9/20/21,  acute hypoxic respiratory failure due to Covid 19 Pneumonia
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: DEVELOPED HIVES THE NEXT DAY, THROUGHOUT THE ENTIRE BODY TO THE BOTTOMS OF THE FEET
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Cold sweat, Dizziness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: COLD, CLAMMY SKIN
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Hyperventilation, Nasopharyngitis, Tachycardia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: COLD, CLAMMY SKIN
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: COLD, CLAMMY SKIN
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Myalgia
Clinical narrative: hospitalized 9/19/21, SARS-CoV-2 positive prior to admission.  Complaints of generalized weakness, myalgias, mild cough, and subjective fever and chills.  PMH morbid obesity.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/19/21, SARS-CoV-2 positive prior to admission.  Complaints of generalized weakness, myalgias, mild cough, and subjective fever and chills.  PMH morbid obesity.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, International normalised ratio decreased, Petechiae, Rash
Clinical narrative: Petechial rash to right medial thigh region--2cm x 6 cm in size.  Skin is intact.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Petechial rash to right medial thigh region--2cm x 6 cm in size.  Skin is intact.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Additional Details: Pt received prevnar 13 and flulaval quad at our store but received covid at another location. Pt states she felt feverish and ended up fainting later that day. At the hospital, they stated that her getting 3 shots that day may have resulted in her body being overloaded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Dyspnoea, Hypoxia
Clinical narrative: hospitalized 9/20/21, presented with generalized weakness and SOA,  admitted with hypoxia secondary to COVID-19 pneumonia.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Pericardial effusion
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: small fluid pericardial, patient to follow up with cardiologist
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, Gait disturbance, Illness
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: small fluid pericardial, patient to follow up with cardiologist
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pericarditis
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: small fluid pericardial, patient to follow up with cardiologist
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Intensive care, Mechanical ventilation, SARS-CoV-2 test positive
Clinical narrative: patient with severe COVID-19 pna requiring non-invasive mechanical ventilation and ICU level of care
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: 2 days post vaccine sore welt on arm at injection site. 5 days after shot ring shaped rash at site and spread out. 7 days post vaccine hives on left arm. 8 days post vaccine hives on right arm. still has hives 17 days later, and is experincing itching on both arms
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Pruritus, Rash, Urticaria
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: 2 days post vaccine sore welt on arm at injection site. 5 days after shot ring shaped rash at site and spread out. 7 days post vaccine hives on left arm. 8 days post vaccine hives on right arm. still has hives 17 days later, and is experincing itching on both arms
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Endotracheal intubation, Loss of consciousness, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/17/21, tested positive for SARS-CoV-2 on 9/15/21. Found unconscious at home by his caretaker. Severe COVID 19 Pneumonia requiring intubation.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: Fever, racing heart, sweating, dizziness, pain under armpits.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: High Fever, heart racing, uncontrollable shaking, dizziness, excessive sweating, minor headache ache.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: High Fever, heart racing, uncontrollable shaking, dizziness, excessive sweating, minor headache ache.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Late period for the first time, I have never been 5 days late.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder, Vaccination site pain
Clinical narrative: Experiencing pain in my left arm around the area of the vaccine. It hurts when I turn over in bed at nights. My left arm hurts when I put clothes on. My husband has helped me many times getting  dressed. My arm hurts to raise it.  Pain is worse at night and interrupts my sleep.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Contusion, Ear pain, Feeling of body temperature change, Headache
Clinical narrative: 7:00PM (9 hours after shot) -Ringing in Ears -Muffled Hearing -Ear Pain/Ache (Dr. Recommended taking a decongestant) This did not help the situation and this symptom is still occurring as of 9/21/21. 7:00PM (9 hour after shot) -Extreme nausea -Severe Headache (Dr. Recommended taking Tylenol for this during appointment--Tylenol did not greatly help headache) Saturday 9/11 at 9:00AM (All other symptoms persisted along with....) -Blurry Vision -Unable to regulate temperature. Very hot/very cold---did not have a temperature.  Sunday 9/12 (All other symptoms persisted along with...) -Spontaneous unexplained bruises over night. Appeared on thighs, 9 large bruises the size of a quarter or larger. (Did not participate in any activity that would explain bruises) -Dr. Ordered a Complete Blood Panel. Numbers came back "ok". Will be asking for another test in a few weeks to confirm numbers are "ok". Tuesday-Wednesday 9/14-9/15 (All other symptoms with the exception of blurry vision persisted along with...) -More bruises appeared on the back of right upper arm, lower right leg near ankle, calf of left leg -Injection Arm Pain and Weakness (from elbow to shoulder)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Muscular weakness, Nausea, Pain in extremity, Temperature regulation disorder
Clinical narrative: 7:00PM (9 hours after shot) -Ringing in Ears -Muffled Hearing -Ear Pain/Ache (Dr. Recommended taking a decongestant) This did not help the situation and this symptom is still occurring as of 9/21/21. 7:00PM (9 hour after shot) -Extreme nausea -Severe Headache (Dr. Recommended taking Tylenol for this during appointment--Tylenol did not greatly help headache) Saturday 9/11 at 9:00AM (All other symptoms persisted along with....) -Blurry Vision -Unable to regulate temperature. Very hot/very cold---did not have a temperature.  Sunday 9/12 (All other symptoms persisted along with...) -Spontaneous unexplained bruises over night. Appeared on thighs, 9 large bruises the size of a quarter or larger. (Did not participate in any activity that would explain bruises) -Dr. Ordered a Complete Blood Panel. Numbers came back "ok". Will be asking for another test in a few weeks to confirm numbers are "ok". Tuesday-Wednesday 9/14-9/15 (All other symptoms with the exception of blurry vision persisted along with...) -More bruises appeared on the back of right upper arm, lower right leg near ankle, calf of left leg -Injection Arm Pain and Weakness (from elbow to shoulder)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: 7:00PM (9 hours after shot) -Ringing in Ears -Muffled Hearing -Ear Pain/Ache (Dr. Recommended taking a decongestant) This did not help the situation and this symptom is still occurring as of 9/21/21. 7:00PM (9 hour after shot) -Extreme nausea -Severe Headache (Dr. Recommended taking Tylenol for this during appointment--Tylenol did not greatly help headache) Saturday 9/11 at 9:00AM (All other symptoms persisted along with....) -Blurry Vision -Unable to regulate temperature. Very hot/very cold---did not have a temperature.  Sunday 9/12 (All other symptoms persisted along with...) -Spontaneous unexplained bruises over night. Appeared on thighs, 9 large bruises the size of a quarter or larger. (Did not participate in any activity that would explain bruises) -Dr. Ordered a Complete Blood Panel. Numbers came back "ok". Will be asking for another test in a few weeks to confirm numbers are "ok". Tuesday-Wednesday 9/14-9/15 (All other symptoms with the exception of blurry vision persisted along with...) -More bruises appeared on the back of right upper arm, lower right leg near ankle, calf of left leg -Injection Arm Pain and Weakness (from elbow to shoulder)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dyspnoea, Fatigue
Clinical narrative: Symptoms began at 10am  on Sept 18 and lasted until approx 7am on Sept 20. Difficulty breathing - shortness of breath, chest pain, extreme muscle and joint pain all over body, severe headache, fatigue to the point I could not get out of bed, chills, fever, injection site swelling
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Symptoms began at 10am  on Sept 18 and lasted until approx 7am on Sept 20. Difficulty breathing - shortness of breath, chest pain, extreme muscle and joint pain all over body, severe headache, fatigue to the point I could not get out of bed, chills, fever, injection site swelling
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Flushing, Hyperhidrosis, Myalgia
Clinical narrative: Chills, muscle aches, heart rate 110, pounding heart, weakness,  flushed skin hot to touch. Sweating. Chills began in early morning and lasted about 4 hours. Then skin was flushed and hot. Heart racing and pounding, muscle aches lasted until the next day. Then on the second day weak pulse rate over 100 and heart pounding and break into a sweat with any  activity all day. The third day all symptoms had subsided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulse abnormal, Skin warm
Clinical narrative: Chills, muscle aches, heart rate 110, pounding heart, weakness,  flushed skin hot to touch. Sweating. Chills began in early morning and lasted about 4 hours. Then skin was flushed and hot. Heart racing and pounding, muscle aches lasted until the next day. Then on the second day weak pulse rate over 100 and heart pounding and break into a sweat with any  activity all day. The third day all symptoms had subsided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations lasting through the night
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block second degree, Malaise, Pulmonary embolism
Clinical narrative: Had been feeling unwell since March. Patient developed a PE on 8/4/2021 and subsequently second degree heart block on 9/8/2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive covid test results
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Echocardiogram, Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: I was working out months after my second dose and my heart rate spiked above 210 beats per minute and it felt as though my heart was incorrectly beating (palpitations), it took 30 minutes to somewhat stabilize, by the time I got to the hospital my blood pressure was high but all the other tests were inconclusive, so I was referred to a cardiologist for follow-up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypertension, Laboratory test, Palpitations, Urine analysis normal
Clinical narrative: I was working out months after my second dose and my heart rate spiked above 210 beats per minute and it felt as though my heart was incorrectly beating (palpitations), it took 30 minutes to somewhat stabilize, by the time I got to the hospital my blood pressure was high but all the other tests were inconclusive, so I was referred to a cardiologist for follow-up.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Malaise
Clinical narrative: hospitalized 9/19/21 with COVID-19 pneumonia, received dose of vaccine at the same time that he became sick with COVID-19 on 9/6/21
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: hospitalized 9/17/21 with Acute hypoxic respiratory failure due to Covid 19 Pneumonia.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: hospitalized 9/17/21 with Acute hypoxic respiratory failure due to Covid 19 Pneumonia.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: Menstrual cycle was delayed. Once menstruation started, it has been ongoing and not stopped. Today is 14 days, 2 weeks of continued bleeding. I previously had issues with regualrity with menstruation but this has been remedied for a few years with the birth control I take.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest X-ray abnormal, Gastrointestinal tube insertion, Lung opacity, Pneumonia aspiration
Clinical narrative: Continuous vomiting since receiving the vaccine.  Patient is febrile at 101.4 F.   Patient has epithelial ovarian cancer FIGO stage IV B.  She was treated one week prior with injections of pembrolizumab and bevacizumab.  Patient becomes septic, found to have NSTEMI.  Antibiotics started.  Dobhoff placed.  Patient discharged to hospice.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, Pyrexia, Sepsis, Vomiting
Clinical narrative: Continuous vomiting since receiving the vaccine.  Patient is febrile at 101.4 F.   Patient has epithelial ovarian cancer FIGO stage IV B.  She was treated one week prior with injections of pembrolizumab and bevacizumab.  Patient becomes septic, found to have NSTEMI.  Antibiotics started.  Dobhoff placed.  Patient discharged to hospice.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Condition aggravated, Ear infection, Headache, Impaired work ability
Clinical narrative: Sore throat; severe untreatable headache; body aches; ear infection; sinus infection,; lethargy.; heart arrhythmia.   Pain at injection site was also an issue, however, it is understandable that this happens with most injections.  The first symptom experienced was sore throat and headache.  These started 2-3 days following the first vaccine on 9/7/21 and they continue today (9/21/21).  My headache continually got worse to the point where I have had to miss work and despite taking ibuprofen alternated with Tylenol around the clock, I have not been able to get relief.  The heart palpitations had already been an issue for which I was tested by a cardiologist earlier in the summer months of 2021.  These symptoms had improved approx a month or 6 weeks prior to receiving the vaccine, but they reoccured following the first vaccine.  On 9/20/21,  I finally decided to contact my PCP.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Oropharyngeal pain, Pain, Sinusitis
Clinical narrative: Sore throat; severe untreatable headache; body aches; ear infection; sinus infection,; lethargy.; heart arrhythmia.   Pain at injection site was also an issue, however, it is understandable that this happens with most injections.  The first symptom experienced was sore throat and headache.  These started 2-3 days following the first vaccine on 9/7/21 and they continue today (9/21/21).  My headache continually got worse to the point where I have had to miss work and despite taking ibuprofen alternated with Tylenol around the clock, I have not been able to get relief.  The heart palpitations had already been an issue for which I was tested by a cardiologist earlier in the summer months of 2021.  These symptoms had improved approx a month or 6 weeks prior to receiving the vaccine, but they reoccured following the first vaccine.  On 9/20/21,  I finally decided to contact my PCP.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Swelling, Swelling face
Clinical narrative: Swelling on left sid of upper body, including neck and face.  6-7 days: rest, Tylenol and Gatorade
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral amyloid angiopathy, Computerised tomogram, Haemorrhagic stroke, Magnetic resonance imaging
Clinical narrative: Pt. had a sever hemmoragic stroke the week after her 2nd vaccine dose. We did not know it at the time but she was later diagnosed with Cerebral Amyloid Angiopathy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness
Clinical narrative: patient experienced weakness in legs 2 days after vaccine with fatique
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Late onset- Itch/ rash all over body. Hives
Sex: U
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Waste of 60 doses of Pfizer vaccine. 48 doses overdrawn, 12 doses splash back during drawing.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Patient developed breakthrough COVID-19 requiring hospitalization
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arrhythmia, Cardiac discomfort, Cardiac monitoring, Cardiomyopathy
Clinical narrative: Heart palpitations with anxiety/panic attacks, dizziness/feeling like passing out,  arrhythmias/SVTs, depression/stating he felt like he was having a heart attack and going to die x 6-7 weeks. Treated by cardiologist with EKG, ECHO and heart monitor. Diagnosed with Cardiomyopathy, started on Carvedilol.