chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual period started 13 days early. Significantly heavy flow and twice the normal cycle length at time of reporting (still ongoing bleeding).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood test abnormal, Condition aggravated, Dizziness
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Emotional distress, Fatigue, Feeling abnormal, Hallucination, olfactory
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Hypersomnia, Hypoacusis, Hypogeusia, Hyposmia
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Malaise, Nausea, Parosmia, SARS-CoV-2 antibody test
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence, Synaesthesia, Taste disorder, Tooth extraction
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Cough, Dyspnoea, Pallor, Pneumonia
Clinical narrative: Fever, coughing, paleness of skin, difficulty breathing. Went to the ER and was diagnosed with Pneumonia.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, coughing, paleness of skin, difficulty breathing. Went to the ER and was diagnosed with Pneumonia.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Cyst, Cyst removal, Endometriosis
Clinical narrative: I had a partial hysterectomy because of endometriosis in June of 2020. I was pain free without any major complications until May 16th when I had crippling abdominal pain on both sides requiring an ambulance ride to the emergency room. Pain started around noon that day and was extremely intense. Scans were done, labs were run and meds were given. Nothing major to report except for endometriomas on each ovary. The only explanation is that my endo had come back and to follow up with my GYN. I did follow up with him and it was confirmed they indeed it was back and we needed to do another surgery to alleviate the pain. Once he got inside he found more endo growing in the areas that he had already excised during my hysterectomy. He removed the endometriomas, a cyst and burned what he could see of the endo. I am now approx 8 weeks post op and my pain is still extremely bad. I am going to a specialist for an additional surgery consult in 3 weeks. The only thing that had changed is the COVID injection.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Endometriosis ablation, Laboratory test, Laparoscopic surgery, Ultrasound scan
Clinical narrative: I had a partial hysterectomy because of endometriosis in June of 2020. I was pain free without any major complications until May 16th when I had crippling abdominal pain on both sides requiring an ambulance ride to the emergency room. Pain started around noon that day and was extremely intense. Scans were done, labs were run and meds were given. Nothing major to report except for endometriomas on each ovary. The only explanation is that my endo had come back and to follow up with my GYN. I did follow up with him and it was confirmed they indeed it was back and we needed to do another surgery to alleviate the pain. Once he got inside he found more endo growing in the areas that he had already excised during my hysterectomy. He removed the endometriomas, a cyst and burned what he could see of the endo. I am now approx 8 weeks post op and my pain is still extremely bad. I am going to a specialist for an additional surgery consult in 3 weeks. The only thing that had changed is the COVID injection.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Intermenstrual bleeding, Morning sickness, Nausea
Clinical narrative: I missed my period entirely.  I?m not sure why but I was very worried and I took several pregnancy tests all negative. I also had very tender breasts and other symptoms of pregnancy such as nausea and early morning sickness.  I document my period religiously and I?m always regular.  I did have some spotting on the 12 of April 2021 but I also had that same symptom during actual pregnancy.    I hope this side effect is studied.  I talked to my PA about it and she suggested I complete this form.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Delayed reaction. Injection site turned red and warm, painful.  8 days after injection
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Disorientation, Disturbance in attention
Clinical narrative: About 2-3 minutes after receiving the shot in my left arm, I began to get extremely disoriented. I lost my vision in in both eyes and completely lost my sense of direction. So much so that I walked into several walls in the isles. After regaining vision about a minute after, I began to search for my father who had came with me. As I walked, I felt very heavy like a huge weight was pulling me down. I began to feel flush like a change in temperature but not almost like a tingling but over my whole body. During that time I began to sweat and my walking was heavy like I was carrying extra weight. A few times I had to stop walking and catch my breath but I was not overwhelmed by movement but more so something had come over me as if my body didn?t like what was going on. Once I located my father, I let him know I wasn?t feeling well after receiving the shot. I became thirsty and needed some hydration so I purchased a soda while feeling very fatigued and sweating profusely. I also purchased a candy bar as I had not eaten and hoped it would help. After my purchase I went back to the pharmacy and explained what I had went through. I ate the candy bar and drank the soda and after about 5 minutes I realized what I needed from the store. I advised the doctor that it seemed to go away and that I was no longer feeling the same symptoms. No  explanation was given but was told I could go. Snce then I have had this weird feeling in my head like I am about to get a headach but it never comes just there like it wants to start or something but I just wanted to share my experience because I have not heard anything about what I went theough.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Paraesthesia
Clinical narrative: Shortly after receiving my first covid 19 Pfizer vaccine the right side of my face began feeling pins and needles like coming out of the numbing from the dentist. The numb tingling feeling spread to the top of eye lid and head all staying on the right side of my body.  It then spread down to my right arm and hand then my right leg and foot felt numb and tingling.  When the nurse came in to tell me it had been 15 minutes and said I could go I asked her if it was normal for my face to feel numb and tingling.  She had the doctor come in and he spoke with me. There was no sign of swelling or facial drooping. The tingling and numb feeling continued, but there was no sign of respiratory distress or swelling they watched me for another 30 minutes or so and sent me home with instructions to use benadryl or seek medical help if anything else seemed to come about. The numbness and tingling in the entire right side if my body continued until mid day the day after the first immunization.  The doctor  who spoke with me after my first immunization mentioned I could complete this.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Disturbance in attention, Electrocardiogram, Fatigue
Clinical narrative: Late in the evening of my second dose, a Tuesday, I started to develop a variety of expected side effects (aches, fever, fatigue). At that time, my chest started to ache too. The next day, Wednesday, the chest pain grew worse.  By Thursday, all side effects had subsided but the burning and aching in my chest. I went to the ER, underwent a variety of tests (EKG, X-ray, bloodwork), with no results. Over the following week, my chest pain grew significantly worse: aches, burning, and sharp, debilitating shooting pains across my chest. I couldn?t move. I couldn?t focus. I couldn?t  sleep. I missed work. I returned to the ER, underwent the same tests, and was diagnosed with costochondritis. I was prescribed higher dose of the anti inflammatory, valeron, which helped tremendously for two weeks. More than two months later, the pain is more subtle and less frequent, but persists and impacts daily activities, including sleeping and lifting.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain, Pyrexia
Clinical narrative: Late in the evening of my second dose, a Tuesday, I started to develop a variety of expected side effects (aches, fever, fatigue). At that time, my chest started to ache too. The next day, Wednesday, the chest pain grew worse.  By Thursday, all side effects had subsided but the burning and aching in my chest. I went to the ER, underwent a variety of tests (EKG, X-ray, bloodwork), with no results. Over the following week, my chest pain grew significantly worse: aches, burning, and sharp, debilitating shooting pains across my chest. I couldn?t move. I couldn?t focus. I couldn?t  sleep. I missed work. I returned to the ER, underwent the same tests, and was diagnosed with costochondritis. I was prescribed higher dose of the anti inflammatory, valeron, which helped tremendously for two weeks. More than two months later, the pain is more subtle and less frequent, but persists and impacts daily activities, including sleeping and lifting.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Late in the evening of my second dose, a Tuesday, I started to develop a variety of expected side effects (aches, fever, fatigue). At that time, my chest started to ache too. The next day, Wednesday, the chest pain grew worse.  By Thursday, all side effects had subsided but the burning and aching in my chest. I went to the ER, underwent a variety of tests (EKG, X-ray, bloodwork), with no results. Over the following week, my chest pain grew significantly worse: aches, burning, and sharp, debilitating shooting pains across my chest. I couldn?t move. I couldn?t focus. I couldn?t  sleep. I missed work. I returned to the ER, underwent the same tests, and was diagnosed with costochondritis. I was prescribed higher dose of the anti inflammatory, valeron, which helped tremendously for two weeks. More than two months later, the pain is more subtle and less frequent, but persists and impacts daily activities, including sleeping and lifting.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dizziness, Heart rate increased, Panic reaction, Vertigo
Clinical narrative: Severe vertigo and lightheadedness Lot of panic and anxiety, sharp increase of heart rate. Extreme case triggered once while driving Neurologist diagnosed with vestibular neuritis
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: Severe vertigo and lightheadedness Lot of panic and anxiety, sharp increase of heart rate. Extreme case triggered once while driving Neurologist diagnosed with vestibular neuritis
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Palpitations, SARS-CoV-2 RNA, Vertigo
Clinical narrative: Severe vertigo and lightheadedness Lot of panic and anxiety, sharp increase of heart rate. Extreme case triggered once while driving Neurologist diagnosed with vestibular neuritis
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Patient had no mensuration (has Nexplanon). After getting J&J began to have new and increased menstrual bleeding 1 month after that has persisted monthly to date.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate irregular
Clinical narrative: Sharp chest pain, light headed, irregular heart beat
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: 64 yo female patient came in for a flu shot. We processed her paperwork for regular dose Fluzone. The immunizer accidentally grabbed Fluzone HD from the refrigerator and administered it to the patient. The patient was informed of the error approximately 5 minutes after administration. She was informed to contact both us (the administering pharmacy) and her physician if she experiences any side effects.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Mild headache at first,  sore arm but day after (like 30 hours after shot) Chills, fever, body aches
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness
Clinical narrative: Severe flue like symptoms. Unable to work the next day. Severe muscle pain, headache, chills.  I was given no vaccine pamphlet or discussion of the severe effects.  CVS gives ample information on all prescription drugs. I got ample manufacturer information on the Pfizer Covid Vaccine (the symptoms were mild in comparison), and explained the side effects multiple times. I always get a vaccine disclosure and pamphlet with the flue shot. I never had such a sever reaction to a vaccine.
Age: 87.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: RESPIRATORY ARREST
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Bruxism, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: A few minutes after administration of Covid 19 Vaccine made by Pfizer, patient went into a seizure like adverse event.  Patient fell out of chair onto the floor and was unresponsive.  Pt had labored breathing, clenched, shaking  arms, and pale skin color.  Pt's eyes were open and emergency services were called.  Pharmacy team made sure pt was still breathing and in a safe position until help could arrive.  Pt remained unsresponsive for a few minutes with his eyes open and then suddenly came to as if nothing happened.  Pt was experiencing some dizziness, nausea, light headed ness and fatigue.  Was given water and allowed to remaining sitting on the floor.  EMT arrived and started to evalaute vitals.  BP, HR was elevated.  ECG was performed and vitals continued to be monitored.  EMTs described the event as a vagal response which may have been due to the process of vaccination rather than the vaccine itself.  EMT reccomended Pt to go to  the hospital but pt was feeling better and refused and after feeling better was able to leave on his accord with family.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Heart rate increased, Nausea, Pallor
Clinical narrative: A few minutes after administration of Covid 19 Vaccine made by Pfizer, patient went into a seizure like adverse event.  Patient fell out of chair onto the floor and was unresponsive.  Pt had labored breathing, clenched, shaking  arms, and pale skin color.  Pt's eyes were open and emergency services were called.  Pharmacy team made sure pt was still breathing and in a safe position until help could arrive.  Pt remained unsresponsive for a few minutes with his eyes open and then suddenly came to as if nothing happened.  Pt was experiencing some dizziness, nausea, light headed ness and fatigue.  Was given water and allowed to remaining sitting on the floor.  EMT arrived and started to evalaute vitals.  BP, HR was elevated.  ECG was performed and vitals continued to be monitored.  EMTs described the event as a vagal response which may have been due to the process of vaccination rather than the vaccine itself.  EMT reccomended Pt to go to  the hospital but pt was feeling better and refused and after feeling better was able to leave on his accord with family.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: A few minutes after administration of Covid 19 Vaccine made by Pfizer, patient went into a seizure like adverse event.  Patient fell out of chair onto the floor and was unresponsive.  Pt had labored breathing, clenched, shaking  arms, and pale skin color.  Pt's eyes were open and emergency services were called.  Pharmacy team made sure pt was still breathing and in a safe position until help could arrive.  Pt remained unsresponsive for a few minutes with his eyes open and then suddenly came to as if nothing happened.  Pt was experiencing some dizziness, nausea, light headed ness and fatigue.  Was given water and allowed to remaining sitting on the floor.  EMT arrived and started to evalaute vitals.  BP, HR was elevated.  ECG was performed and vitals continued to be monitored.  EMTs described the event as a vagal response which may have been due to the process of vaccination rather than the vaccine itself.  EMT reccomended Pt to go to  the hospital but pt was feeling better and refused and after feeling better was able to leave on his accord with family.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Brain oedema, Cerebrovascular accident
Clinical narrative: CVA WITH SEVERE CEREBRAL EDEMA
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: SEQUENTIAL USE WITH MODERNA COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 04-AUG-2021, the patient experienced sequential use with moderna covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use with moderna covid-19 vaccine was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Drowning
Clinical narrative: DROWNING
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Axillary mass, Biopsy lymph gland abnormal, Cell marker, Computerised tomogram, Condition aggravated
Clinical narrative: Vaccine #1 4/22/21  #2  5/13/21  On 5/30/21 she noted a golfballl-size lump in her L axillathe same arm in which she had a previous melanoma excised in 2016 (T1b NX) and cancer-free for 5 years. 6/15/21 One biopsy L axilary lymph node reveals metastic melanoma. SOX10 POS, Melana POS. CKAE1-3 NEG.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metastatic malignant melanoma, Pathology test, Positron emission tomogram
Clinical narrative: Vaccine #1 4/22/21  #2  5/13/21  On 5/30/21 she noted a golfballl-size lump in her L axillathe same arm in which she had a previous melanoma excised in 2016 (T1b NX) and cancer-free for 5 years. 6/15/21 One biopsy L axilary lymph node reveals metastic melanoma. SOX10 POS, Melana POS. CKAE1-3 NEG.
Age: 38.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac death
Clinical narrative: PRESSUMED CARDIAC DEATH
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac monitoring, Condition aggravated, Fall, Fatigue
Clinical narrative: Witnessed seizure about 9-10 minutes after administration of second covid shot. I work in the ER, so my treatment was immediate. I woke up to the doctor taking care of me saying "it looks like you had a reaction to the vaccine, you had a seizure after it was administered" I was observed and discharged home with supervision after about 2 hours, but the events directly after the seizure are unclear. I do know due to second account, i was placed on a cardiac monitor, seizure pads needed to be placed on stretcher, my vital signs were monitored, routine labs were drawn, i was treated with ativan for the seizure, and i came out of my post ictal period wa shorter than previous seizures, as well as my seizure length. My previous average seizure length was 5-7 minutes, this seizure was described to me as between 2-3 minutes.  When I did start to remember things, I said I felt like I had a small fever, and i did have a very low grade fever of about 99.3. The following day, it was hard to distinguish the symptoms felt by many of my coworkers (achy joints, fever, headache) because I was fatigued from the seizure the night before, but I did feel "feverish", and opted to take anti pyretics on the event my seizure threshold was lowered from fever and recent seizure. I also had joint pain, but it's hard to say if this was related to the vaccine as i (reportedly) fell to the floor suddenly and struck my head along with a good slam to the rest of my body. 2 moths later, I again had a seizure in the presence of ER healthcare providers. I did test positive for the antibodies after donating blood before my first dose, which was 12/18/20.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Laboratory test normal, Memory impairment, Postictal state, Pyrexia
Clinical narrative: Witnessed seizure about 9-10 minutes after administration of second covid shot. I work in the ER, so my treatment was immediate. I woke up to the doctor taking care of me saying "it looks like you had a reaction to the vaccine, you had a seizure after it was administered" I was observed and discharged home with supervision after about 2 hours, but the events directly after the seizure are unclear. I do know due to second account, i was placed on a cardiac monitor, seizure pads needed to be placed on stretcher, my vital signs were monitored, routine labs were drawn, i was treated with ativan for the seizure, and i came out of my post ictal period wa shorter than previous seizures, as well as my seizure length. My previous average seizure length was 5-7 minutes, this seizure was described to me as between 2-3 minutes.  When I did start to remember things, I said I felt like I had a small fever, and i did have a very low grade fever of about 99.3. The following day, it was hard to distinguish the symptoms felt by many of my coworkers (achy joints, fever, headache) because I was fatigued from the seizure the night before, but I did feel "feverish", and opted to take anti pyretics on the event my seizure threshold was lowered from fever and recent seizure. I also had joint pain, but it's hard to say if this was related to the vaccine as i (reportedly) fell to the floor suddenly and struck my head along with a good slam to the rest of my body. 2 moths later, I again had a seizure in the presence of ER healthcare providers. I did test positive for the antibodies after donating blood before my first dose, which was 12/18/20.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vaccination complication
Clinical narrative: Witnessed seizure about 9-10 minutes after administration of second covid shot. I work in the ER, so my treatment was immediate. I woke up to the doctor taking care of me saying "it looks like you had a reaction to the vaccine, you had a seizure after it was administered" I was observed and discharged home with supervision after about 2 hours, but the events directly after the seizure are unclear. I do know due to second account, i was placed on a cardiac monitor, seizure pads needed to be placed on stretcher, my vital signs were monitored, routine labs were drawn, i was treated with ativan for the seizure, and i came out of my post ictal period wa shorter than previous seizures, as well as my seizure length. My previous average seizure length was 5-7 minutes, this seizure was described to me as between 2-3 minutes.  When I did start to remember things, I said I felt like I had a small fever, and i did have a very low grade fever of about 99.3. The following day, it was hard to distinguish the symptoms felt by many of my coworkers (achy joints, fever, headache) because I was fatigued from the seizure the night before, but I did feel "feverish", and opted to take anti pyretics on the event my seizure threshold was lowered from fever and recent seizure. I also had joint pain, but it's hard to say if this was related to the vaccine as i (reportedly) fell to the floor suddenly and struck my head along with a good slam to the rest of my body. 2 moths later, I again had a seizure in the presence of ER healthcare providers. I did test positive for the antibodies after donating blood before my first dose, which was 12/18/20.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Sudden cardiac death
Clinical narrative: SUDDEN CARDIAC DEATH
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY
Age: 64.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Sudden cardiac death
Clinical narrative: SUDDEN CARDIAC DEATH
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: T821286, expiry: unknown) dose was not reported, 1 total administered on 12-JUL-2021 for prophylactic vaccination on left arm. Concomitant medications included metformin.  On 23-JUL-2021, the patient first experienced seizure where patient was shaking in the driveway and past out. Patient reported that on 25-JUL-2021, the patient's wife found him on his bed in a daze. Patient's wife called the ambulance to hospital where patient was admitted for 8 days. Patient was discharged on 01-AUG-2021. Patient was only on the medications that they gave in the hospital (list was unavailable to him at the movement). Patient reports that this morning (07-AUG-2021) that patient was on bathroom floor and not sure for how long.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210815132-covid-19 vaccine ad26.cov2.s -Seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest
Clinical narrative: CARDIOPULMONARY ARREST
Age: 56.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial Infarction
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: SUDDEN CARDIAC ARREST
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. On 26-MAY-2021, the nurse had made a home visit. The patient was checked by physician on 10-JUN-2021 and blood sample was taken. The patient's labs showed that he had very low levels of haemoglobulin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  At 11:00 PM on 10-JUN-2021, the patient started throwing up, grabbed his chest, and fell over. He received immediate medical attention and time of death was announced at 12:10 AM on 11-JUN-2021. The physicians said cause of death was due to acute myocardial infarction. After the patient's death, reporter had received a phone call from doctor asking to take patient right away to the hospital as his labs showed that he had very low levels of hemoglobulin. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from acute myocardial infarction on 11-JUN-2021. This report was serious (Death).; Sender's Comments: V0:20210815166-COVID-19 VACCINE AD26.COV2.S-Acute myocardial infaraction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Swelling face
Clinical narrative: SWOLLEN  FACE; BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was 140 pounds, and height was 62 inches. The patient's pre-existing medical conditions included: Patient had no known allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced swollen face. On 05-AUG-2021, the patient experienced body ache. On 05-AUG-2021, the patient experienced headache. On 05-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-AUG-2021, and had not recovered from swollen face, headache, and body ache. This report was non-serious.; Sender's Comments: Vo: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; LEG CRAMPS; This spontaneous report received from a patient concerned a patient of unspecified gender, age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-AUG-2021, the patient tested positive for Coronavirus disease (COVID-19), (suspected clinical vaccination failure, suspected covid-19 infection). At the time of the report the patient still had been feeling very sick for the last 5 days. The symptoms include leg cramps, chills, chest tightness, coughing and extremely tired, the breathing felt okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and leg cramps, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210815211-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; BRAIN FOG; CAN BARELY WALK; SEVERE FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the patient experienced shortness of breath. On JUL-2021, the patient experienced brain fog. On JUL-2021, the patient experienced can barely walk. On JUL-2021, the patient experienced severe fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe fatigue, shortness of breath, brain fog and can barely walk was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815104.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: A LITTLE  BIT TIREDNESS; NAUSEA FOR 5 SECONDS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: double mastectomy, and concurrent conditions included: penicillin allergy, and occasional leg swelling, and other pre-existing medical conditions included: The patient was taking water pills everyday. The patient had allergies to pain medications and vitamin D. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, the patient experienced a little bit tiredness. On 23-JUL-2021, the patient experienced nausea for 5 seconds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea for 5 seconds on 23-JUL-2021, and the outcome of a little bit tiredness was not reported. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LIGHT FATIGUE; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's weight was 188 pounds, and height was 69 inches. The patient's past medical history included: covid-19, and concurrent conditions included: alcohol use, non-smoker, and plant allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced light fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light fatigue on 06-AUG-2021. This report was non-serious. This case, from the same reporter is linked to 20210815214.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SORENESS AT THE VACCINATION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: alcohol use (consumes occasionally), non-smoker, shellfish allergy, attention deficit hyperactivity disorder, and hypothyroidism for which patient takes T3 T4 compounded thyroid medication, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included Vyvanse (lisdexamfetamine mesilate) for attention deficit hyperactivity disorder. On 05-MAR-2021, the patient experienced soreness at the vaccination site. On 05-AUG-2021, the patient experienced confirmed covid-19 infection and aching all over the body, malaise which worsened on 06-AUG-2021, sinus pressure, runny nose, sneezing, dry cough where she started coughing up something mucous (assumingly), watery eyes, feverish feeling (patient had not measure temperature but felt like she usually does whenever she has a fever) and that feeling worsened on 06-AUG-2021. The patient experienced terrible headache when woke up on 06-AUG-2021 and she felt like someone was stabbing her eyebrows. Whenever patient tried to move around, like petting her dog, she had a pounding headache and cannot do very much. The patient experienced sore throat which worsened on 07-AUG-2021, the patient experienced burning in the lungs, shortness of breath and raspy voice (which was getting worse), on the same day patient underwent SARS-CoV-2 RT-PCR test (NR: not provided) and results came out positive on 08-AUG-2021.The patient confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at the vaccination site on 07-MAR-2021, recovered with sequelae from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188862.; Sender's Comments: V0 - 20210815593-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: RETURN OF CLEAR TRANSPARENT QUARTER SIZE GEL LIKE SPUTUM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: viral infection, fever, and dry persistent cough, and concurrent conditions included: clear transparent quarter size gel like sputum, and other pre-existing medical conditions included: The patient have several controlled comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced return of clear transparent quarter size gel like sputum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of return of clear transparent quarter size gel like sputum was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Laryngoscopy, Off label use
Clinical narrative: HUSKY VOICE; FEELING A BIT TIRED; SALINE, HISTAMINE AND LITTLE AMOUNT OF VACCINE ADMINISTERED WITH A PLASTIC PRESSOR; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anesthetics allergy, perfume allergy, and smoke allergy, and other pre-existing medical conditions included: Patient has multiple allergies that causes laryngitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205AZIA expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced saline, histamine and little amount of vaccine administered with a plastic pressor. On 06-AUG-2021, the patient experienced husky voice. On 06-AUG-2021, the patient experienced feeling a bit tired. Laboratory data (dates unspecified) included: Laryngoscopy (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling a bit tired, husky voice and saline, histamine and little amount of vaccine administered with a plastic pressor was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: PERSISTENT DRY COUGH AFTER VACCINATION; SEVERE PAIN UPON COUGH IN AREA OF LOWER LEFT LOBE (OF LUNG); FEVER; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the patient experienced persistent dry cough after vaccination, severe pain upon cough in area of lower left lobe (of lung), and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent dry cough after vaccination, fever, and severe pain upon cough in area of lower left lobe (of lung). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dry throat, Emotional disorder, Feeling hot
Clinical narrative: EXTREMELY THIRSTY; THROAT FEELS DRY; SOMETHING WRONG WITH STOMACH; FEELS LIKE A HANGOVER; EYES LIKE CRIED ENDLESSLY; SWEAT; FEELING EMOTIONAL; NOT FEELING GOOD AND SICK; CHILLS; HEADACHES; FELT GIGGLY LIKE DOPAMINE RUSH; UNABLE TO SLEEP; SLEEPY; FEELING WARM (HOT); SLEPT ALL DAY AND NIGHT; HEAVY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-AUG-2021, the patient experienced felt giggly like dopamine rush. On 05-AUG-2021, the patient experienced unable to sleep. On 05-AUG-2021, the patient experienced sleepy. On 05-AUG-2021, the patient experienced feeling warm (hot). On 05-AUG-2021, the patient experienced slept all day and night. On 05-AUG-2021, the patient experienced heavy arm. On 06-AUG-2021, the patient experienced extremely thirsty. On 06-AUG-2021, the patient experienced throat feels dry. On 06-AUG-2021, the patient experienced something wrong with stomach. On 06-AUG-2021, the patient experienced feels like a hangover. On 06-AUG-2021, the patient experienced eyes like cried endlessly. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced feeling emotional. On 06-AUG-2021, the patient experienced not feeling good and sick. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt giggly like dopamine rush, unable to sleep, sleepy, feeling warm (hot), extremely thirsty, throat feels dry, something wrong with stomach, feels like a hangover, eyes like cried endlessly, sweat, feeling emotional, slept all day and night, heavy arm, not feeling good and sick, chills, and headaches on 07-AUG-2021. This report was non-serious.