chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ligament sprain, Limb injury, Muscle strain, Nausea, Orthosis user
Clinical narrative: January 10th 2021 1st injection of Moderna Vaccine January 11th 2021 arm hurts January 12th 2021 fatigue and pain and burning from perineum to perianal area [with surrounding skin] January 13th 2021 severe tinnitus still pain and burning from perineum TO perianal area January 14th 2021 Severe nausea-still pain and burning from perineum to perianal area. This goes on still and will never be cured - I NOW HAVE - Lichen Sclerosus et Atrophicus! It TOOK 3 months - numerous doctor visits - numerous Treatments - Final DIAGNOSIS from biopsy April 15, 2021 By my Dermatologist This shot has given me a death sentenance and no chance of a happy life - now and until I die. I can never marry again or have sex - THERE IS NO CURE! All I can do is Treat it with a steroid ointment That does not Take away the pain and burning - I live in pain and burning since January 12, 2021 - 2 days after that horrible shot Oh but That's not all on January 29, 2021 I broke out in this strange rash from my knees up to my groin area - went to urgent care - given steroids - would not say it was from The Moderna Shot - but we know Better - Rash took over 2 weeks to go away Oh but it gets even better on January 31, 2021 Right leg went Totally numb - fell - caused TORN Ligament - high ankle sprain and strain - sprain and strain of foot - I Just started walking normaly the end of July 2021 Doctor had know idea what caused it - oh but we do - that Moderna Shot All of these reactions have been documented by other health care providers and told to people Thru health Agency - Thru TO phones Text whatever with the exception of my life altering diagnosis of Lichen Sclerosus et Atrophicus.  I am so angry and MAD and even your spokesman, said That if you have one auto immune disease This shot can throw you into another Autoimmune disease - Lucky Me - This is a Terrible Vaccine - and I should never had gotten it. Treatments Before finally being diagnosed with -> Lichen Sclerosus et Atrophicus There are The meds They Threw at me because They did not know what to do!  Steriods Fluocinolone Acetonide ointment 0.025% Fluconazole Tablets 150mg Tramadol 100mg Triamcinolone Acetonide Cream 0.1% Calmoseptine ointment Premarin Vaginal cream Pelvic floor ultrasound Treatments Gabepentin - different dosages Desitin cream Vaseline Celebrex I am now on betamethasone [augmented] 0.05% ointment Twice A day - only med out There I can use - clobetasol - can't use because of ingredients - That I would react too. Treatment for Rash January 29, 2021 Prednisone and wait it out Treatment for Right foot injury from numb right Leg January 31, 2021 Diclofenac Ankle brace Adverse outcome: Lichen Sclerosus et Atrophicus - will have the Rest of my Life - NO Quality of Life Only one course of Treatment - That will never eradicate disease I will be in misery The rest of my life Right ankle-foot Injury Finally resolving but still hurts at times - can't walk fast at all Rash Resolved in about 2 weeks
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Perineal pain, Proctalgia, Rash, Skin burning sensation
Clinical narrative: January 10th 2021 1st injection of Moderna Vaccine January 11th 2021 arm hurts January 12th 2021 fatigue and pain and burning from perineum to perianal area [with surrounding skin] January 13th 2021 severe tinnitus still pain and burning from perineum TO perianal area January 14th 2021 Severe nausea-still pain and burning from perineum to perianal area. This goes on still and will never be cured - I NOW HAVE - Lichen Sclerosus et Atrophicus! It TOOK 3 months - numerous doctor visits - numerous Treatments - Final DIAGNOSIS from biopsy April 15, 2021 By my Dermatologist This shot has given me a death sentenance and no chance of a happy life - now and until I die. I can never marry again or have sex - THERE IS NO CURE! All I can do is Treat it with a steroid ointment That does not Take away the pain and burning - I live in pain and burning since January 12, 2021 - 2 days after that horrible shot Oh but That's not all on January 29, 2021 I broke out in this strange rash from my knees up to my groin area - went to urgent care - given steroids - would not say it was from The Moderna Shot - but we know Better - Rash took over 2 weeks to go away Oh but it gets even better on January 31, 2021 Right leg went Totally numb - fell - caused TORN Ligament - high ankle sprain and strain - sprain and strain of foot - I Just started walking normaly the end of July 2021 Doctor had know idea what caused it - oh but we do - that Moderna Shot All of these reactions have been documented by other health care providers and told to people Thru health Agency - Thru TO phones Text whatever with the exception of my life altering diagnosis of Lichen Sclerosus et Atrophicus.  I am so angry and MAD and even your spokesman, said That if you have one auto immune disease This shot can throw you into another Autoimmune disease - Lucky Me - This is a Terrible Vaccine - and I should never had gotten it. Treatments Before finally being diagnosed with -> Lichen Sclerosus et Atrophicus There are The meds They Threw at me because They did not know what to do!  Steriods Fluocinolone Acetonide ointment 0.025% Fluconazole Tablets 150mg Tramadol 100mg Triamcinolone Acetonide Cream 0.1% Calmoseptine ointment Premarin Vaginal cream Pelvic floor ultrasound Treatments Gabepentin - different dosages Desitin cream Vaseline Celebrex I am now on betamethasone [augmented] 0.05% ointment Twice A day - only med out There I can use - clobetasol - can't use because of ingredients - That I would react too. Treatment for Rash January 29, 2021 Prednisone and wait it out Treatment for Right foot injury from numb right Leg January 31, 2021 Diclofenac Ankle brace Adverse outcome: Lichen Sclerosus et Atrophicus - will have the Rest of my Life - NO Quality of Life Only one course of Treatment - That will never eradicate disease I will be in misery The rest of my life Right ankle-foot Injury Finally resolving but still hurts at times - can't walk fast at all Rash Resolved in about 2 weeks
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Ultrasound pelvis
Clinical narrative: January 10th 2021 1st injection of Moderna Vaccine January 11th 2021 arm hurts January 12th 2021 fatigue and pain and burning from perineum to perianal area [with surrounding skin] January 13th 2021 severe tinnitus still pain and burning from perineum TO perianal area January 14th 2021 Severe nausea-still pain and burning from perineum to perianal area. This goes on still and will never be cured - I NOW HAVE - Lichen Sclerosus et Atrophicus! It TOOK 3 months - numerous doctor visits - numerous Treatments - Final DIAGNOSIS from biopsy April 15, 2021 By my Dermatologist This shot has given me a death sentenance and no chance of a happy life - now and until I die. I can never marry again or have sex - THERE IS NO CURE! All I can do is Treat it with a steroid ointment That does not Take away the pain and burning - I live in pain and burning since January 12, 2021 - 2 days after that horrible shot Oh but That's not all on January 29, 2021 I broke out in this strange rash from my knees up to my groin area - went to urgent care - given steroids - would not say it was from The Moderna Shot - but we know Better - Rash took over 2 weeks to go away Oh but it gets even better on January 31, 2021 Right leg went Totally numb - fell - caused TORN Ligament - high ankle sprain and strain - sprain and strain of foot - I Just started walking normaly the end of July 2021 Doctor had know idea what caused it - oh but we do - that Moderna Shot All of these reactions have been documented by other health care providers and told to people Thru health Agency - Thru TO phones Text whatever with the exception of my life altering diagnosis of Lichen Sclerosus et Atrophicus.  I am so angry and MAD and even your spokesman, said That if you have one auto immune disease This shot can throw you into another Autoimmune disease - Lucky Me - This is a Terrible Vaccine - and I should never had gotten it. Treatments Before finally being diagnosed with -> Lichen Sclerosus et Atrophicus There are The meds They Threw at me because They did not know what to do!  Steriods Fluocinolone Acetonide ointment 0.025% Fluconazole Tablets 150mg Tramadol 100mg Triamcinolone Acetonide Cream 0.1% Calmoseptine ointment Premarin Vaginal cream Pelvic floor ultrasound Treatments Gabepentin - different dosages Desitin cream Vaseline Celebrex I am now on betamethasone [augmented] 0.05% ointment Twice A day - only med out There I can use - clobetasol - can't use because of ingredients - That I would react too. Treatment for Rash January 29, 2021 Prednisone and wait it out Treatment for Right foot injury from numb right Leg January 31, 2021 Diclofenac Ankle brace Adverse outcome: Lichen Sclerosus et Atrophicus - will have the Rest of my Life - NO Quality of Life Only one course of Treatment - That will never eradicate disease I will be in misery The rest of my life Right ankle-foot Injury Finally resolving but still hurts at times - can't walk fast at all Rash Resolved in about 2 weeks
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: A dose of the Moderna vaccine was given to the client for second dose instead of Moderna. Client showed up at the site to receive his second dose of the Covid Vaccine. During registration he stated to the data entry person that his first dose of the vaccine was the Moderna. Again, when answering the questions from the consent form he states "Yes, my first dose of the Covid Vaccine was the Moderna. A dose of Moderna was given to the client for his second dose of the Covid Vaccine instead of PFIZER, which the client had received previously. Patient requested a Moderna vaccine since he already got his first Dose on the 8/18/21. I confirmed with the patient that he received Moderna. Since my computer wifi was down I proceeded to finish his paperwork and informed the nurse pt would like Moderna. Nurse administered the Moderna. My wifi started working and I was able to pull his information and I saw he was previously given Pfizer. Since the patient left I informed nurse.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immediate post-injection reaction, Lipase increased, Malaise, Nausea
Clinical narrative: I got the Johnson and Johnson vaccine in June and then got pancreatitis in august that required a 5 day stay in the hospital and a month long recovery process. Thought alcohol might be a cause but I'm 19 I've only been drinking for 2 years now and I dink about twice a week so my doctor brought up the possibility the inflammation in my pancreas was a reaction to the vaccine. After getting the vaccine, I was very ill. Right after getting it, I got a rash that spread across my chest that was treated with a Benadryl immediately after. I was sick for 8 days after the vaccine (vomiting, nausea, sore throat, fatigue). Felt fine and was eating healthy and exercising (running) for months leading up to the pancreatitis. Seemed to happen out of nowhere.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pancreatitis, Rash, Vomiting
Clinical narrative: I got the Johnson and Johnson vaccine in June and then got pancreatitis in august that required a 5 day stay in the hospital and a month long recovery process. Thought alcohol might be a cause but I'm 19 I've only been drinking for 2 years now and I dink about twice a week so my doctor brought up the possibility the inflammation in my pancreas was a reaction to the vaccine. After getting the vaccine, I was very ill. Right after getting it, I got a rash that spread across my chest that was treated with a Benadryl immediately after. I was sick for 8 days after the vaccine (vomiting, nausea, sore throat, fatigue). Felt fine and was eating healthy and exercising (running) for months leading up to the pancreatitis. Seemed to happen out of nowhere.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: I received a third dose of the Moderna COVID-19 vaccine per the advice of my physician, as I am immunosuppressed. (My first and second doses were in March and April of this year.) Within 24 hours of receiving my third dose of the vaccine, I was in bed with a 103 fever, fatigue, chills, and body aches that lasted 18-20 hours. After my fever broke, my temperature was 95 and I had fatigue, chills and body aches for the next 12 to 15 hours. All of the symptoms went away after about three days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Muscle twitching, Muscular weakness
Clinical narrative: Tx from hospital for for bilateral leg weakness and twitching of whole body. Received second dose of COVID vaccine (Moderna) 7 weeks PTA. Neurology consulted. Concern for vaccine-associated GBS vs. myelopathy vs AIDP. received IVIG empirically for 5 days and had mild symptomatic improvement. Discharged to rehab facility
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Nausea, Palpitations
Clinical narrative: At 9-10PM on 02/28/2021, I was sitting calmly watching television and I became aware that my heart was just going so fast. It was uncomfortable. I didn't have any chest pain or trouble breathing. At some point, it was clear that it wasn't going to stop. I checked my blood pressure and it was very high. It was 180/120. It stayed up in that range. My pulse was around 120. I think my pulse went over 120. Within about 20 minutes of this starting, we decided that we should call the hospital. I did take my Atenolol  before going to the hospital. That was around a quarter to 10. The paramedics came and took me to the hospital. I had also become nauseated. That was very unusual. My blood pressure had started to come down by the time we got to the hospital. We got there around 10PM. The nausea persisted. They had to give me 3 injections for nausea over the course of the time in the ER. My blood pressure finally came down to around the normal range. They did a lot of blood tests. They decided to admit me. My Troponin level went up. I stayed until around mid-morning. The nausea had finally gone away. I was discharged sometime around noon. I was there a little over 12 hours I believe. They said they were having a lot of people come in like this. He is the only one that I can remember.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Smear test
Clinical narrative: At 9-10PM on 02/28/2021, I was sitting calmly watching television and I became aware that my heart was just going so fast. It was uncomfortable. I didn't have any chest pain or trouble breathing. At some point, it was clear that it wasn't going to stop. I checked my blood pressure and it was very high. It was 180/120. It stayed up in that range. My pulse was around 120. I think my pulse went over 120. Within about 20 minutes of this starting, we decided that we should call the hospital. I did take my Atenolol  before going to the hospital. That was around a quarter to 10. The paramedics came and took me to the hospital. I had also become nauseated. That was very unusual. My blood pressure had started to come down by the time we got to the hospital. We got there around 10PM. The nausea persisted. They had to give me 3 injections for nausea over the course of the time in the ER. My blood pressure finally came down to around the normal range. They did a lot of blood tests. They decided to admit me. My Troponin level went up. I stayed until around mid-morning. The nausea had finally gone away. I was discharged sometime around noon. I was there a little over 12 hours I believe. They said they were having a lot of people come in like this. He is the only one that I can remember.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Discomfort, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: At 9-10PM on 02/28/2021, I was sitting calmly watching television and I became aware that my heart was just going so fast. It was uncomfortable. I didn't have any chest pain or trouble breathing. At some point, it was clear that it wasn't going to stop. I checked my blood pressure and it was very high. It was 180/120. It stayed up in that range. My pulse was around 120. I think my pulse went over 120. Within about 20 minutes of this starting, we decided that we should call the hospital. I did take my Atenolol  before going to the hospital. That was around a quarter to 10. The paramedics came and took me to the hospital. I had also become nauseated. That was very unusual. My blood pressure had started to come down by the time we got to the hospital. We got there around 10PM. The nausea persisted. They had to give me 3 injections for nausea over the course of the time in the ER. My blood pressure finally came down to around the normal range. They did a lot of blood tests. They decided to admit me. My Troponin level went up. I stayed until around mid-morning. The nausea had finally gone away. I was discharged sometime around noon. I was there a little over 12 hours I believe. They said they were having a lot of people come in like this. He is the only one that I can remember.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Nausea, Troponin increased
Clinical narrative: At 9-10PM on 02/28/2021, I was sitting calmly watching television and I became aware that my heart was just going so fast. It was uncomfortable. I didn't have any chest pain or trouble breathing. At some point, it was clear that it wasn't going to stop. I checked my blood pressure and it was very high. It was 180/120. It stayed up in that range. My pulse was around 120. I think my pulse went over 120. Within about 20 minutes of this starting, we decided that we should call the hospital. I did take my Atenolol  before going to the hospital. That was around a quarter to 10. The paramedics came and took me to the hospital. I had also become nauseated. That was very unusual. My blood pressure had started to come down by the time we got to the hospital. We got there around 10PM. The nausea persisted. They had to give me 3 injections for nausea over the course of the time in the ER. My blood pressure finally came down to around the normal range. They did a lot of blood tests. They decided to admit me. My Troponin level went up. I stayed until around mid-morning. The nausea had finally gone away. I was discharged sometime around noon. I was there a little over 12 hours I believe. They said they were having a lot of people come in like this. He is the only one that I can remember.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Dizziness, Dyspnoea, Fatigue, Increased appetite
Clinical narrative: I slept for 2 day; Had months of inflamation after first dose.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced months of inflammation after first dose and eventually slept for 2 days. Patient stated that had a weird situation in regards to the MRNA vaccine. After the first dose, within 30 mins had an adverse reaction. My doctor advised me to not get it as did ER physician. That being said months later with Delta starting to dominate cases and my mother being high risk. I just got my second dose 59 days later. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: I slept for 2 day; Had months of inflamation after first dose.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced months of inflammation after first dose and eventually slept for 2 days. Patient stated that had a weird situation in regards to the MRNA vaccine. After the first dose, within 30 mins had an adverse reaction. My doctor advised me to not get it as did ER physician. That being said months later with Delta starting to dominate cases and my mother being high risk. I just got my second dose 59 days later. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Inflammation
Clinical narrative: I slept for 2 day; Had months of inflamation after first dose.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced months of inflammation after first dose and eventually slept for 2 days. Patient stated that had a weird situation in regards to the MRNA vaccine. After the first dose, within 30 mins had an adverse reaction. My doctor advised me to not get it as did ER physician. That being said months later with Delta starting to dominate cases and my mother being high risk. I just got my second dose 59 days later. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Started itching and breaking out in hives within 10 minutes of the shot. They gave me two doses of liquid benadryl that did not help. They called an ambulance. I was tachycardia. They gave me an iv of benadryl. At the hospital I was given fluids, steriods and more benadryl. The next day I got blisters in my throat and went to minor emergency. They gave me another shot of benadryl. I was sick for 4 days after that. They did a strep test, flu and covid. All came back negative.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test negative, Malaise, Oropharyngeal blistering, Pruritus, SARS-CoV-2 antibody test negative
Clinical narrative: Started itching and breaking out in hives within 10 minutes of the shot. They gave me two doses of liquid benadryl that did not help. They called an ambulance. I was tachycardia. They gave me an iv of benadryl. At the hospital I was given fluids, steriods and more benadryl. The next day I got blisters in my throat and went to minor emergency. They gave me another shot of benadryl. I was sick for 4 days after that. They did a strep test, flu and covid. All came back negative.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test negative, Tachycardia, Urticaria
Clinical narrative: Started itching and breaking out in hives within 10 minutes of the shot. They gave me two doses of liquid benadryl that did not help. They called an ambulance. I was tachycardia. They gave me an iv of benadryl. At the hospital I was given fluids, steriods and more benadryl. The next day I got blisters in my throat and went to minor emergency. They gave me another shot of benadryl. I was sick for 4 days after that. They did a strep test, flu and covid. All came back negative.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: Extreme full-body joint pain that lessened after 1 week but still remains 5 months later
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Extreme full-body joint pain that lessened after 1 week but still remains 5 months later
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Resuscitation, Unresponsive to stimuli
Clinical narrative: Had a massive stoke; Convulsions; Gasping for breath; Lost function of left side of bod; Couldn't take tongue out of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a massive stoke), SEIZURE (Convulsions), DYSPNOEA (Gasping for breath), HEMIPARESIS (Lost function of left side of bod) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Consumer previously had a stoke in his 30's.) and Cardiopulmonary resuscitation. Concurrent medical conditions included Emphysema (little) and Smoker.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a massive stoke) (seriousness criteria death and medically significant), SEIZURE (Convulsions) (seriousness criteria death and medically significant), DYSPNOEA (Gasping for breath) (seriousness criterion death), HEMIPARESIS (Lost function of left side of bod) (seriousness criteria death and medically significant) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. An autopsy was not performed.            No Concomitant medication was reported.  No treatment medications were reported.  Patient had a massive stoke, convulsions, gasping for breath, lost function of left side of body, and couldn't take tongue out of mouth on 13May2021. Wife noticed the symptoms of stoke and called 911 immediately. While on the phone with dispatcher, wife performed CPR and used mouth to mouth technique on her husband for up to 20 minutes.  Wife stated they shocked the patient to bring back but it was unsuccessful and patient passed away on 13May2021 in wife's arms.  Patient was on heavy blood thinners.   Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Seizure
Clinical narrative: Had a massive stoke; Convulsions; Gasping for breath; Lost function of left side of bod; Couldn't take tongue out of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a massive stoke), SEIZURE (Convulsions), DYSPNOEA (Gasping for breath), HEMIPARESIS (Lost function of left side of bod) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Consumer previously had a stoke in his 30's.) and Cardiopulmonary resuscitation. Concurrent medical conditions included Emphysema (little) and Smoker.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a massive stoke) (seriousness criteria death and medically significant), SEIZURE (Convulsions) (seriousness criteria death and medically significant), DYSPNOEA (Gasping for breath) (seriousness criterion death), HEMIPARESIS (Lost function of left side of bod) (seriousness criteria death and medically significant) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. An autopsy was not performed.            No Concomitant medication was reported.  No treatment medications were reported.  Patient had a massive stoke, convulsions, gasping for breath, lost function of left side of body, and couldn't take tongue out of mouth on 13May2021. Wife noticed the symptoms of stoke and called 911 immediately. While on the phone with dispatcher, wife performed CPR and used mouth to mouth technique on her husband for up to 20 minutes.  Wife stated they shocked the patient to bring back but it was unsuccessful and patient passed away on 13May2021 in wife's arms.  Patient was on heavy blood thinners.   Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Dyspnoea, Hemiparesis, Seizure, Tongue movement disturbance
Clinical narrative: Had a massive stoke; Convulsions; Gasping for breath; Lost function of left side of bod; Couldn't take tongue out of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a massive stoke), SEIZURE (Convulsions), DYSPNOEA (Gasping for breath), HEMIPARESIS (Lost function of left side of bod) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Consumer previously had a stoke in his 30's.) and Cardiopulmonary resuscitation. Concurrent medical conditions included Emphysema (little) and Smoker.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a massive stoke) (seriousness criteria death and medically significant), SEIZURE (Convulsions) (seriousness criteria death and medically significant), DYSPNOEA (Gasping for breath) (seriousness criterion death), HEMIPARESIS (Lost function of left side of bod) (seriousness criteria death and medically significant) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. An autopsy was not performed.            No Concomitant medication was reported.  No treatment medications were reported.  Patient had a massive stoke, convulsions, gasping for breath, lost function of left side of body, and couldn't take tongue out of mouth on 13May2021. Wife noticed the symptoms of stoke and called 911 immediately. While on the phone with dispatcher, wife performed CPR and used mouth to mouth technique on her husband for up to 20 minutes.  Wife stated they shocked the patient to bring back but it was unsuccessful and patient passed away on 13May2021 in wife's arms.  Patient was on heavy blood thinners.   Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry skin, Erythema, Pruritus, Skin exfoliation, Tachycardia
Clinical narrative: face is itchy; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date was not reported), via an unspecified route of administration, in right arm on 16Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not get any vaccine in four weeks. The patient reported that, after the first dose she experienced itching on the face where her mask was. After couple of weeks that got a little better. The patient had a visit to physician office. Therapeutic measures were taken as a result of the event. Outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: face is itchy; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date was not reported), via an unspecified route of administration, in right arm on 16Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not get any vaccine in four weeks. The patient reported that, after the first dose she experienced itching on the face where her mask was. After couple of weeks that got a little better. The patient had a visit to physician office. Therapeutic measures were taken as a result of the event. Outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Anuria, Back pain, Bilevel positive airway pressure
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Blood lactic acid increased, Blood pH decreased, Blood urea increased, Chest X-ray abnormal
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumoral swelling, Computerised tomogram abnormal, Dyspnoea, Endotracheal intubation, Hypocomplementaemia
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test increased, Mastication disorder, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myositis, Neck pain, Oropharyngeal pain, Pleural effusion, Renal replacement therapy
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis, Swelling
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. 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).