chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Skin warm, Swelling
Clinical narrative: CAUSING LOTS PAIN IN INJECTION SITE UP INTO SHOULDER, CANT RAISE ARM OR LIFT ANYTHING, HOT, SWOLLEN, RED. GOTTEN WORSE SINCE DATE OF VACCINE UNTIL TODAY 12/30. TRIED APAP (DID NOTHING), TAKING 1/2 OF HER HYRDOCODONE TO HELP WITH PAIN. TOLD HER TO WATCH AND CALL BACK TOMORROW TO UPDATE ME.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: I received my second Pfizer booster for COVID-19 on 4/11/2022. I'm not entirely sure on which days these events happened, but sometime in July 2022, I was exposed to COVID-19 at a family reunion. I tested myself twice with home antigen tests. I got a negative result the first time and a positive result the second time. I didn't really develop any symptoms other than maybe fatigue. I was prescribed PAXLOVID, which I took. Even though I felt fine, I self-isolated to avoid possibly spreading the virus to others. I'm not sure, but I think the isolation was during the week of 7/10/2022-7/16/2022.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: 4yo patient came in on 12/16/22 to receive 2nd dose of the Moderna primary series (0.25mL of the Moderna monovalent for 6mo-5yo). 1st dose given on 9/26/22 (lot # AS1412B). There was a miscommunication and he was instead given 0.25mL of the Moderna Bivalent for 6yo+ (lot # 024H22A). No adverse affect noted. This is reported as an administration error.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Electrocardiogram normal, Oropharyngeal pain
Clinical narrative: I woke up with a coughing fit and I tested negative for COVID-19. I also had a sore throat, congestion, and diarrhea. I called my doctor, and he told me to go to the urgent care. When I was saw by the doctor, he thought I was having a heart attack. He did an EKG, and it was clear. He did not test me for COVID-19 or anything else and he sent me home. I tested positive for COVID-19 on 12/08/2022. My doctor prescribed me PAXLOVID. My throat is still a little scratchy and I have a little cough.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I woke up with a coughing fit and I tested negative for COVID-19. I also had a sore throat, congestion, and diarrhea. I called my doctor, and he told me to go to the urgent care. When I was saw by the doctor, he thought I was having a heart attack. He did an EKG, and it was clear. He did not test me for COVID-19 or anything else and he sent me home. I tested positive for COVID-19 on 12/08/2022. My doctor prescribed me PAXLOVID. My throat is still a little scratchy and I have a little cough.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: IT WAS DISCOVERED THAT THE DOSE WAS GIVEN OUTSIDE OF THE 12 HOUR ROOM TEMPERATURE RANGE.  MODERNA WAS CALLED AND IT WAS DETERMINED THAT THE VACCINE IS STABLE UNDER CERTAIN CONDITIONS FOR UP TO BUT NO LONGER THAN 24 HOURS.  THE DOSE WAS GIVEN AT ABOUT THE 21ST HOUR.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Ascites, Atelectasis, COVID-19, Hepatic cirrhosis
Clinical narrative: Patient received Pfizer COVID vaccine on 4/2/21 (lot # ER8732), 5/2/21 (lot # EW0171), and 12/30/21 (lot # 33025BD). On 12/26/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 infection and hypervolemia /pleural effusion with atelectasis, prominent ascites, cirrhosis with portal hypertension related to alcohol use, symptomatic ascites, and alcohol use disorder with history of delirium tremens/hospitalization. Patient was discharged home on 12/29/22.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervolaemia, Pleural effusion, Portal hypertension, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 4/2/21 (lot # ER8732), 5/2/21 (lot # EW0171), and 12/30/21 (lot # 33025BD). On 12/26/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 infection and hypervolemia /pleural effusion with atelectasis, prominent ascites, cirrhosis with portal hypertension related to alcohol use, symptomatic ascites, and alcohol use disorder with history of delirium tremens/hospitalization. Patient was discharged home on 12/29/22.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Hypoglycaemia
Clinical narrative: most likely not an adverse to the vaccine however, patient did experience a hypglcyemic event afer a covid vaccine with pfizer bivalant booster.Patient had in implanted glucometer on her left arm that read on the low 50s following a the vaccine. On site RN contacted on call MD and he advised to give a glucose tab.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Alopecia areata, COVID-19, Condition aggravated, Cough, Eczema
Clinical narrative: My COVID-19 symptoms started in the morning around 8:00AM on 12/09/2022. I had cough, sore throat and stuffy nose. I did COVID-19 home test which was positive. On 12/11/2022 I went to the urgent care and they prescribed me with PAXLOVID for 5 days. They advised me to take TYLENOL as per needed. On 12/14/2022 I tested negative for COVID-19 infections. After my 2nd vaccine I developed Eczema which I had when I was very young now after the 2nd dose it came back. I think this is an Autoimmune side effect which should be noted. I also developed Alopecia areata on my beard and top of my hands. I used hydrocortisone and ROGAINE to treat it.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: My COVID-19 symptoms started in the morning around 8:00AM on 12/09/2022. I had cough, sore throat and stuffy nose. I did COVID-19 home test which was positive. On 12/11/2022 I went to the urgent care and they prescribed me with PAXLOVID for 5 days. They advised me to take TYLENOL as per needed. On 12/14/2022 I tested negative for COVID-19 infections. After my 2nd vaccine I developed Eczema which I had when I was very young now after the 2nd dose it came back. I think this is an Autoimmune side effect which should be noted. I also developed Alopecia areata on my beard and top of my hands. I used hydrocortisone and ROGAINE to treat it.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given 0.3mL of undiluted Pfizer Bivalent 5-11 instead of 0.3mL of Pfizer Bivalent 12+. Patient reports no adverse reactions.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: IT WAS DISCOVERED THAT THE DOSE WAS GIVEN OUTSIDE OF THE 12 HOUR ROOM TEMPERATURE RANGE.  MODERNA WAS CALLED AND IT WAS DETERMINED THAT THE VACCINE IS STABLE UNDER CERTAIN CONDITIONS FOR UP TO BUT NO LONGER THAN 24 HOURS.  THE DOSE WAS GIVEN AT ABOUT THE 21ST HOUR.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: patient received the moderna omicron vaccine on 9/26/22 and requested another omicron vaccine on 12/29/22 and this was not caught and a second omicron vaccine was administered
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Chest X-ray normal, Cough, Fatigue, Influenza, Influenza A virus test negative
Clinical narrative: 75 days after COVID vaccination, I had a flu that was bad enough that I saw a doctor and tested positive for Influenza Type B.  I had not tested positive for COVID either with an at-home test nor with a doctor's office test at any time between vaccination and this episode of the flu.  Symptoms were overall fatigue, fever, coughing, and nasal congestion.  Treatment was a 5 day course of Tamiflu, also Flonase, and OTC cough suppressant (Mucinex 12-Hour).  Outcome was that the fever broke by 15-Dec-2022, coughing has been steadily reducing and is nearly effectively gone as of the date of this report.  NOTE: Both COVID19 and Flu vaccines on 28-Sep-2022 were administered at Pharmacy.  They probably have the flu vaccination records that were asked for, here.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Influenza B virus test, Nasal congestion, Pyrexia, Streptococcus test negative
Clinical narrative: 75 days after COVID vaccination, I had a flu that was bad enough that I saw a doctor and tested positive for Influenza Type B.  I had not tested positive for COVID either with an at-home test nor with a doctor's office test at any time between vaccination and this episode of the flu.  Symptoms were overall fatigue, fever, coughing, and nasal congestion.  Treatment was a 5 day course of Tamiflu, also Flonase, and OTC cough suppressant (Mucinex 12-Hour).  Outcome was that the fever broke by 15-Dec-2022, coughing has been steadily reducing and is nearly effectively gone as of the date of this report.  NOTE: Both COVID19 and Flu vaccines on 28-Sep-2022 were administered at Pharmacy.  They probably have the flu vaccination records that were asked for, here.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Gave Pfizer COVID 6m-4yrs instead of Moderna COVID 6m-5yrs
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Headache, Oral herpes zoster, Oral pain, Pain in jaw
Clinical narrative: Developed oral shingles. Approximate onset date of symptoms was 12-15-22. Initial symptoms were jaw/mouth pain, chills, headache. Developed  sores in mouth on 12-21-22. Shingles initially diagnosed by dentist on 12-21-22 and diagnosis confirmed by PCP on same date via televisit. Only treatment received was ibuprofen/ acetaminophen/topical medication for pain.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Stomatitis
Clinical narrative: Developed oral shingles. Approximate onset date of symptoms was 12-15-22. Initial symptoms were jaw/mouth pain, chills, headache. Developed  sores in mouth on 12-21-22. Shingles initially diagnosed by dentist on 12-21-22 and diagnosis confirmed by PCP on same date via televisit. Only treatment received was ibuprofen/ acetaminophen/topical medication for pain.
Age: 56.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 Pfizer bivalent boosters. One on 10/19/22 and a second on 12/29/22.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Pruritus, Vomiting
Clinical narrative: Patient stated that she experienced nausea, vomitting, itching on arms, legs, and back, as well as dizziness after receiving shot.  She reported this 10 days after vaccination.  Additionally, patient said that her arm has hurt for an entire year since she got her last vaccine
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered an expired dose of vaccine. The vial that had been punctured approximately 48 hours prior and maintained in the refrigerator during the interim period. Patient was advised of the situation and Modera drug information specialist was contacted for further guidance in the matter. Pharmacy is awaiting this guidance and will advise the patient
Age: 1.75
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: right thigh swelling, redness, tenderness for 2 days, muscle aches at injection site. nearly the size of half the right thigh
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pyrexia
Clinical narrative: Fever started just after midnight and was around 101.5.  She also complained of headache.  I gave Motrin and the fever and headache subsided.  She continued to have a fever for 24 hours but it resolved with Motrin each time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Emotional distress, Fall, Fatigue
Clinical narrative: At first I got the normal COVID vaccine symptoms, I was tired, weak, and slept the first two days.  My arm got hard where the injection was. It was end of December holiday so I had to push through and try to stay awake as much as I could but I felt sick. I took off the first week of work after the New Year because I didn't feel well.  I went back to work and was dizzy and falling and had brain fog. I managed 12 physical therapy outpatient practices and several hundred employees normally and kept everything straight. When I returned after the New Year, I was very forgetful and not thinking correctly.   My legs were swelling horribly. My body was in pain everywhere. I had horrible headaches. My blood pressure was high. My heart was racing.  I didn't feel well at all. I was upset. I fell several times at work down the stairs.  I fell into the conference table. I was swelling by 10AM where I thought my legs would split open. My head hurt so bad I needed to lay down. My arm had nerve pain that started fingertips to neck that was shooting pain. This happened many times throughout the day.  Finally a manager told me on February 18, 2022 I needed to see a doctor that day. I am dizzy everyday. I have pain in my right arm. I have brain fog. I have swelling in my legs. I have pain everywhere. I have bad headaches. I am unable to work and manage the clinics I did for the past 20 years.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersomnia, Hypertension, Impaired work ability
Clinical narrative: At first I got the normal COVID vaccine symptoms, I was tired, weak, and slept the first two days.  My arm got hard where the injection was. It was end of December holiday so I had to push through and try to stay awake as much as I could but I felt sick. I took off the first week of work after the New Year because I didn't feel well.  I went back to work and was dizzy and falling and had brain fog. I managed 12 physical therapy outpatient practices and several hundred employees normally and kept everything straight. When I returned after the New Year, I was very forgetful and not thinking correctly.   My legs were swelling horribly. My body was in pain everywhere. I had horrible headaches. My blood pressure was high. My heart was racing.  I didn't feel well at all. I was upset. I fell several times at work down the stairs.  I fell into the conference table. I was swelling by 10AM where I thought my legs would split open. My head hurt so bad I needed to lay down. My arm had nerve pain that started fingertips to neck that was shooting pain. This happened many times throughout the day.  Finally a manager told me on February 18, 2022 I needed to see a doctor that day. I am dizzy everyday. I have pain in my right arm. I have brain fog. I have swelling in my legs. I have pain everywhere. I have bad headaches. I am unable to work and manage the clinics I did for the past 20 years.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Malaise, Memory impairment, Neck pain, Neuralgia
Clinical narrative: At first I got the normal COVID vaccine symptoms, I was tired, weak, and slept the first two days.  My arm got hard where the injection was. It was end of December holiday so I had to push through and try to stay awake as much as I could but I felt sick. I took off the first week of work after the New Year because I didn't feel well.  I went back to work and was dizzy and falling and had brain fog. I managed 12 physical therapy outpatient practices and several hundred employees normally and kept everything straight. When I returned after the New Year, I was very forgetful and not thinking correctly.   My legs were swelling horribly. My body was in pain everywhere. I had horrible headaches. My blood pressure was high. My heart was racing.  I didn't feel well at all. I was upset. I fell several times at work down the stairs.  I fell into the conference table. I was swelling by 10AM where I thought my legs would split open. My head hurt so bad I needed to lay down. My arm had nerve pain that started fingertips to neck that was shooting pain. This happened many times throughout the day.  Finally a manager told me on February 18, 2022 I needed to see a doctor that day. I am dizzy everyday. I have pain in my right arm. I have brain fog. I have swelling in my legs. I have pain everywhere. I have bad headaches. I am unable to work and manage the clinics I did for the past 20 years.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Peripheral swelling, Thinking abnormal
Clinical narrative: At first I got the normal COVID vaccine symptoms, I was tired, weak, and slept the first two days.  My arm got hard where the injection was. It was end of December holiday so I had to push through and try to stay awake as much as I could but I felt sick. I took off the first week of work after the New Year because I didn't feel well.  I went back to work and was dizzy and falling and had brain fog. I managed 12 physical therapy outpatient practices and several hundred employees normally and kept everything straight. When I returned after the New Year, I was very forgetful and not thinking correctly.   My legs were swelling horribly. My body was in pain everywhere. I had horrible headaches. My blood pressure was high. My heart was racing.  I didn't feel well at all. I was upset. I fell several times at work down the stairs.  I fell into the conference table. I was swelling by 10AM where I thought my legs would split open. My head hurt so bad I needed to lay down. My arm had nerve pain that started fingertips to neck that was shooting pain. This happened many times throughout the day.  Finally a manager told me on February 18, 2022 I needed to see a doctor that day. I am dizzy everyday. I have pain in my right arm. I have brain fog. I have swelling in my legs. I have pain everywhere. I have bad headaches. I am unable to work and manage the clinics I did for the past 20 years.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Chills, Crying, Feeling abnormal
Clinical narrative: I want to report that the side effects I suffered with the Shringrix vaccine were worse than the drug info provided online led me to believe.  I was incapacitated for 24 hrs with both doses.  Site soreness, though present, doesn't need to be discussed. But a fever of 100F, body wracking shivers, myalgia, joint pain, difficulty walking a straight line, feeling like my skin was tingling and painful, a severe headache, and violent vomiting were horrible with the 1st vaccine.  I was surprised that as bad as it was, the second was worse.  Everytime I took motrin, it was back up in 5 minutes.  I expressed understanding to my husband at how people with chronic pain could be driven to suicide.  Ifelt that bad.. .and paniky, anxious, desperate. Luckily, I understood and believed what I was experiencing would be temporary.  If there were a third dose in the series, I wouldn't take it.   I am writing to say, patients should be better informed and approached with more honesty.  The CDC has a poor reputation for truth telling among the public.  At least advise people not to get the vaccine prior to a workday.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Headache, Injection site pain, Myalgia, Pain of skin
Clinical narrative: I want to report that the side effects I suffered with the Shringrix vaccine were worse than the drug info provided online led me to believe.  I was incapacitated for 24 hrs with both doses.  Site soreness, though present, doesn't need to be discussed. But a fever of 100F, body wracking shivers, myalgia, joint pain, difficulty walking a straight line, feeling like my skin was tingling and painful, a severe headache, and violent vomiting were horrible with the 1st vaccine.  I was surprised that as bad as it was, the second was worse.  Everytime I took motrin, it was back up in 5 minutes.  I expressed understanding to my husband at how people with chronic pain could be driven to suicide.  Ifelt that bad.. .and paniky, anxious, desperate. Luckily, I understood and believed what I was experiencing would be temporary.  If there were a third dose in the series, I wouldn't take it.   I am writing to say, patients should be better informed and approached with more honesty.  The CDC has a poor reputation for truth telling among the public.  At least advise people not to get the vaccine prior to a workday.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Panic reaction, Paraesthesia, Vomiting
Clinical narrative: I want to report that the side effects I suffered with the Shringrix vaccine were worse than the drug info provided online led me to believe.  I was incapacitated for 24 hrs with both doses.  Site soreness, though present, doesn't need to be discussed. But a fever of 100F, body wracking shivers, myalgia, joint pain, difficulty walking a straight line, feeling like my skin was tingling and painful, a severe headache, and violent vomiting were horrible with the 1st vaccine.  I was surprised that as bad as it was, the second was worse.  Everytime I took motrin, it was back up in 5 minutes.  I expressed understanding to my husband at how people with chronic pain could be driven to suicide.  Ifelt that bad.. .and paniky, anxious, desperate. Luckily, I understood and believed what I was experiencing would be temporary.  If there were a third dose in the series, I wouldn't take it.   I am writing to say, patients should be better informed and approached with more honesty.  The CDC has a poor reputation for truth telling among the public.  At least advise people not to get the vaccine prior to a workday.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Illness, SARS-CoV-2 test positive
Clinical narrative: My wife and I were vaccinated on the same day/time. Dec10 she tested positive. Dec10 she took Plaxivid. By Dec14 she tested negative. On Dec23 she experienced rebound from the Plaxivid. We had not distanced for several days. I tested positive on Dec25. Became very ill.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Blood test normal, Chest pain, Computerised tomogram abdomen normal
Clinical narrative: Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Endoscopy upper gastrointestinal tract normal, Fatigue, Heart rate decreased
Clinical narrative: Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Hypotension, Irritable bowel syndrome, Peripheral coldness
Clinical narrative: Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Stool analysis normal, Ultrasound abdomen normal, Urine analysis normal, Vascular test normal
Clinical narrative: Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Endometriosis, Fallopian tube disorder, Hysterectomy, Immediate post-injection reaction
Clinical narrative: May 2,2021 I got my first period after D&C last March 2021.. After the shot,I immediately got a high fever but did not take medication.. Had muscle pains and the following morning felt the pain on my right pelvic,unexplainable pain but were able to tolerate it for 3 days..on May 6-pain was intolerable, and decided to wait until May 7 4:30 am to go to ER.. The ultrasound showed inflammation on my tubes ,ovaries and other organs. Was put on antibiotics and said it was PID but I kept on saying that it started when i got the covid shot. They told me I am fine after 3 days without explanation so I decided to go home since they are not explaining what happened and if the vaccine has something to do with it. I got the vaccine at pharmacy and not sick or ill during the time I got vaccinated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laparoscopy abnormal, Multi-organ disorder, Myalgia, Noninfective oophoritis
Clinical narrative: May 2,2021 I got my first period after D&C last March 2021.. After the shot,I immediately got a high fever but did not take medication.. Had muscle pains and the following morning felt the pain on my right pelvic,unexplainable pain but were able to tolerate it for 3 days..on May 6-pain was intolerable, and decided to wait until May 7 4:30 am to go to ER.. The ultrasound showed inflammation on my tubes ,ovaries and other organs. Was put on antibiotics and said it was PID but I kept on saying that it started when i got the covid shot. They told me I am fine after 3 days without explanation so I decided to go home since they are not explaining what happened and if the vaccine has something to do with it. I got the vaccine at pharmacy and not sick or ill during the time I got vaccinated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pelvic inflammatory disease, Pelvic pain, Pyrexia, Ultrasound scan
Clinical narrative: May 2,2021 I got my first period after D&C last March 2021.. After the shot,I immediately got a high fever but did not take medication.. Had muscle pains and the following morning felt the pain on my right pelvic,unexplainable pain but were able to tolerate it for 3 days..on May 6-pain was intolerable, and decided to wait until May 7 4:30 am to go to ER.. The ultrasound showed inflammation on my tubes ,ovaries and other organs. Was put on antibiotics and said it was PID but I kept on saying that it started when i got the covid shot. They told me I am fine after 3 days without explanation so I decided to go home since they are not explaining what happened and if the vaccine has something to do with it. I got the vaccine at pharmacy and not sick or ill during the time I got vaccinated.
Age: 0.75
Sex: F
Vaccine: HEP, PNC13
Symptoms: Abnormal behaviour, C-reactive protein normal, Decreased appetite, Fatigue, Full blood count normal
Clinical narrative: Fever 102-103 f lethargy alt with irritability Loss of appetite- solid/formula/pedialyte. Emesis 3X. Not moving right leg injection area. No swelling  no redness, mild induration at injection site. Baby very clingy "not herself" Rx: Motrin/tylenol prn 12/23/ infant seened slightly better. Last night, drank formula and pedilyte. Urinating fine, but very tired, somnolent, clingy today. Definitely not her usual self.Rx given for STAT Labs. CBC, c-Reactive protein Amalyse. 12/24 Labs normal. SI increase, CRP . Infant much improved. Eating drinking, more active, less irritable! Systomnsresolving on day 4.  12/26/2022 Infant back to normal.
Age: 0.75
Sex: F
Vaccine: HEP, PNC13
Symptoms: Injected limb mobility decreased, Injection site induration, Irritability, Laboratory test normal, Lethargy
Clinical narrative: Fever 102-103 f lethargy alt with irritability Loss of appetite- solid/formula/pedialyte. Emesis 3X. Not moving right leg injection area. No swelling  no redness, mild induration at injection site. Baby very clingy "not herself" Rx: Motrin/tylenol prn 12/23/ infant seened slightly better. Last night, drank formula and pedilyte. Urinating fine, but very tired, somnolent, clingy today. Definitely not her usual self.Rx given for STAT Labs. CBC, c-Reactive protein Amalyse. 12/24 Labs normal. SI increase, CRP . Infant much improved. Eating drinking, more active, less irritable! Systomnsresolving on day 4.  12/26/2022 Infant back to normal.
Age: 0.75
Sex: F
Vaccine: HEP, PNC13
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever 102-103 f lethargy alt with irritability Loss of appetite- solid/formula/pedialyte. Emesis 3X. Not moving right leg injection area. No swelling  no redness, mild induration at injection site. Baby very clingy "not herself" Rx: Motrin/tylenol prn 12/23/ infant seened slightly better. Last night, drank formula and pedilyte. Urinating fine, but very tired, somnolent, clingy today. Definitely not her usual self.Rx given for STAT Labs. CBC, c-Reactive protein Amalyse. 12/24 Labs normal. SI increase, CRP . Infant much improved. Eating drinking, more active, less irritable! Systomnsresolving on day 4.  12/26/2022 Infant back to normal.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (First dose 0.3ml) on 25-Mar-2021 and Pfizer COVID-19 vaccine (Second dose 0.3ml) on 15-Apr-2021; for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 3 (Booster 1), 0.25ml) on 12-Jan-2022, MODERNA COVID-19 VACCINE (Dose 4 (Booster 2), 0.25ml, 065K21A and Intramuscular) on 28-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient ID was reported as 4357667. No concomitant information was reported. It was reported as patient was COVID19 Eligible. Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A It was reported that patient received this expired dose of Moderna vaccine, since 7 and 6 days after the 30 days Beyond Use Date (Days past 30). No treatment information was reported.   This case was linked to MOD-2022-690987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2022: Live significant follow-up: updated narrative.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Pain
Clinical narrative: ON 8/17/20 PAIN BEGAN ON 2ND TOE, DIFFICULTY WALKING, EXTREME PAIN ON THE LEFT SIDE OF MY BODY FROM SHOULDERS TO FOOT. SAW PODIATRIST, ORTHOPEDIST, PHYSICAL THERAPY. STILL HAVE PAIN AT VACCINE SITE AND LEFT SIDE OF MY BODY, VERY PAINFUL TO SLEEP.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Gait disturbance, Insomnia, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: ON 8/17/20 PAIN BEGAN ON 2ND TOE, DIFFICULTY WALKING, EXTREME PAIN ON THE LEFT SIDE OF MY BODY FROM SHOULDERS TO FOOT. SAW PODIATRIST, ORTHOPEDIST, PHYSICAL THERAPY. STILL HAVE PAIN AT VACCINE SITE AND LEFT SIDE OF MY BODY, VERY PAINFUL TO SLEEP.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Vaccination site pain, X-ray
Clinical narrative: ON 8/17/20 PAIN BEGAN ON 2ND TOE, DIFFICULTY WALKING, EXTREME PAIN ON THE LEFT SIDE OF MY BODY FROM SHOULDERS TO FOOT. SAW PODIATRIST, ORTHOPEDIST, PHYSICAL THERAPY. STILL HAVE PAIN AT VACCINE SITE AND LEFT SIDE OF MY BODY, VERY PAINFUL TO SLEEP.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: mild aches; tired; slight elevation of temperature; injection site pain; Interchange of vaccine products; The initial case was missing the following minimum criteria: [Unspecified AE]. Upon receipt of follow-up information on (27Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020, stop date: Apr2020, notes: She had a mild case of COVID Apr2020.; "MVP", start date: 1990 (ongoing), notes: W/regargitation; "Bradycardia", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: 039KZOA), administration date: 07Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous"; moderna coviD-19 vaccine (DOSE 2, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: OOZAZIA or 002A21A), administration date: 07Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Nov2021, outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "mild aches"; FATIGUE (non-serious), outcome "unknown", described as "tired"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "slight elevation of temperature"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Dose: 3rd (Pfizer 1st booster) on 04Nov2021, Lot/Batch number: FL3527 or HI3527 (Difficult to read lot number), Vaccination facility type: Pharmacy or Drug store. Vaccine was not administered at Military facility. Prior vaccinations: None. Concomitant drugs: None. Injection site pain. Improved with gentle arm movement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Interchange of vaccine products, Pain
Clinical narrative: mild aches; tired; slight elevation of temperature; injection site pain; Interchange of vaccine products; The initial case was missing the following minimum criteria: [Unspecified AE]. Upon receipt of follow-up information on (27Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020, stop date: Apr2020, notes: She had a mild case of COVID Apr2020.; "MVP", start date: 1990 (ongoing), notes: W/regargitation; "Bradycardia", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: 039KZOA), administration date: 07Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous"; moderna coviD-19 vaccine (DOSE 2, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: OOZAZIA or 002A21A), administration date: 07Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Nov2021, outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "mild aches"; FATIGUE (non-serious), outcome "unknown", described as "tired"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "slight elevation of temperature"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Dose: 3rd (Pfizer 1st booster) on 04Nov2021, Lot/Batch number: FL3527 or HI3527 (Difficult to read lot number), Vaccination facility type: Pharmacy or Drug store. Vaccine was not administered at Military facility. Prior vaccinations: None. Concomitant drugs: None. Injection site pain. Improved with gentle arm movement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild aches; tired; slight elevation of temperature; injection site pain; Interchange of vaccine products; The initial case was missing the following minimum criteria: [Unspecified AE]. Upon receipt of follow-up information on (27Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020, stop date: Apr2020, notes: She had a mild case of COVID Apr2020.; "MVP", start date: 1990 (ongoing), notes: W/regargitation; "Bradycardia", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: 039KZOA), administration date: 07Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous"; moderna coviD-19 vaccine (DOSE 2, SINGLE , Anatomical location of injection: left arm, route of administration: Intramuscular, Batch/lot number: OOZAZIA or 002A21A), administration date: 07Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Her reaction seemed to be from that and didn't have anything extraordinary from the previous". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Nov2021, outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "mild aches"; FATIGUE (non-serious), outcome "unknown", described as "tired"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "slight elevation of temperature"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Dose: 3rd (Pfizer 1st booster) on 04Nov2021, Lot/Batch number: FL3527 or HI3527 (Difficult to read lot number), Vaccination facility type: Pharmacy or Drug store. Vaccine was not administered at Military facility. Prior vaccinations: None. Concomitant drugs: None. Injection site pain. Improved with gentle arm movement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: PNC20, PPV
Symptoms: Arthralgia, Arthritis, Injection site induration, Injection site swelling, Joint range of motion decreased
Clinical narrative: injection site pain (rigth bicep); injection site swelling; Injection site hard up to his right shoulder; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; right arms feels weak; it has a fever and sometimes gets really intense; experiencing serious pain his right shoulder; This spontaneous report was received from Consumer and refers to a 70-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 18-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in the right bicep for prophylaxis (dose, route of administration, vaccination scheme frequency, lot number, and expiration date were not reported). The vaccination site was fine on that date.  On 19-OCT-2022 (also reported as next day), he experienced injection site swelling (vaccination site swelling), his right arm felt weak (muscular weakness), and he presented serious pain in his right bicep (vaccination site pain) and right shoulder (arthralgia). On that date, the patient also presented burning pain and a muscle sprain, it felt like it had been hit with a 2x4 (pain, ligament sprain, malaise). By that time, the vaccination site did not turn red, or nothing just turned hard up to his right shoulder (vaccination site induration). On unspecified dates in 2022, the patient's shoulder still was really in pain and the vaccination site seemed to be dissipating but the shoulder had not, he also experienced a fever that sometimes got really intense. As a self-treatment for the events, the patient had been putting lidocaine 4% (ASPERCREME) Patch XL and "Maximum Strength Lidocaine pain relief" patch 4% on his arm (covering around the vaccination site); nevertheless, they did not work. Later, the patient tried using roll-on lidocaine and icy hot therapy since he could not afford to keep buying those lidocaine patches.   At the time of reporting, the patient had not recovered from the events of vaccination site induration, pain, ligament sprain, malaise, weakness of arms, and was recovering from vaccination site pain; the outcome of the events of vaccination site swelling, arthralgia, and fever was not known. The causal relationship between the events and the suspect vaccine was not provided.