chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Tremor, Urine analysis, Vomiting
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Alopecia, Aphasia, Aphonia, Asthenia, Balance disorder
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Bedridden, COVID-19, Cardiac disorder, Chest pain, Chills
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Dehydration, Diarrhoea, Dizziness, Dysarthria, Dyspnoea
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Fall, Feeling abnormal, Gait disturbance, Gait inability, Headache
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Heart rate increased, Hormone level abnormal, Hyperhidrosis, Hypoaesthesia, Impaired self-care
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Loss of personal independence in daily activities, Lung disorder, Malaise, Memory impairment, Musculoskeletal disorder
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Nervous system disorder, Oxygen saturation decreased, Pain, Peripheral coldness, Photophobia
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: SARS-CoV-2 test positive, Temperature regulation disorder, Thinking abnormal, Tremor, Visual impairment
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Vomiting
Clinical narrative: After 1st Pfizer vaccine, I became violently ill. I tried to sleep on the toilet for 72+ hours with diarrhea & vomiting into wastebasket. When I could crawl a few feet to my bed I did & had uncontrollable tremors, sweats and chills, unable to walk, do basic hygiene, prepare food that required standing, am intolerant to light, have constant severe headache, can't think, speak correctly, remember my date of birth or SSN, make sense, lost my voice, and that's been over a year and I'm still bedridden. When I get up I'm very dizzy, have had multiple falls, and been chronically dehydrated. I've been taken by ambulance to E.R. many times for dehydration, tremors, chest pain, low oxygen levels, excessive heart rate as high as 160 when I wake. I got the 2nd Pfizer vaccine on 11/26/21 which exacerbated all the symptoms and tried to sleep on the toilet again, for 72+ hours with vomiting and diarrhea, worse tremors, weaker, could not use right arm for over two weeks. I can't hold a thought, can't figure out how to use the remote or phone, slurred speech, cannot regulate temperature, tops of lower legs and feet get icy & numb, can't spell, Can't go on like this. I then got Covid-19 1/28/22, again 12/28/22, & 1/13/2023. I live alone with no help & no family. I can't function. I now have to use inhalers to breathe. I have to take Propranolol to slow my heart rate, have groceries that I can keep in my nightstand to eat, delivered. I spray everything with Lysol, or Clorox wipes that are delivered. I only leave home to go to hospital or doctors who have no answers & suggest I see a psychiatrist. THIS WAS AN INJURY CAUSED BY THE PFIZER VACCINE & OFFERED NO PROTECTION AS I'VE TESTED POSITIVE FOR COVID TRHEE TIMES IN ONE YEAR. WHY ARE YOU ALLOWING AND TRYING TO FORCE THE PUBLIC TO TAKE THIS POISON WITH YOUR FEAR PROPAGANDA? IT DID NOTHING TO PROTECT ME IN ISOLATION!!!! THIS IS NOT A LIFE, ONLY EXISTENCE. I DO NOT WNAT TO CONTINUE EXISTING IN THIS STATE OF PERPETUAL NON-EXISTENCE. NO SUPPORT. NO HELP. JUST SLOWLY DYING. PEOPLE SHOULD BE TRIED FOR CRIMES AGAINST HUMANITY. WHY GO ON? YOU DON'T CARE.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: heart fluttering; lack of energy; slight fatigue/ little bit of fatigue /extreme fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart fluttering) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient reported no chronic medical conditions. The patient had never had Covid-19 and the patient was not diagnosed with Myocarditis or Pericarditis.     On 25-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Feb-2023, the patient experienced CARDIAC FLUTTER (heart fluttering) (seriousness criterion medically significant), ASTHENIA (lack of energy), FATIGUE (slight fatigue/ little bit of fatigue /extreme fatigue) and ARTHRALGIA (joint pain). At the time of the report, CARDIAC FLUTTER (heart fluttering), ASTHENIA (lack of energy), FATIGUE (slight fatigue/ little bit of fatigue /extreme fatigue) and ARTHRALGIA (joint pain) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not take any medications.  The patient received first Moderna Covid 19 vaccine on 16-Sep-2021 (lot 02M20A), 2nd dose on Dec-2021. (Lot number 012M20A) and  expiration date was not known.  The patient booster dose on 27-Oct-2021 (lot number AS7146B, expiration date was not known)  All of these reactions lasted for 24 to 48 hours. Patient never had adverse reactions for as long as these reactions have lasted. The patient did not have any vaccines within 4 weeks of her bivalent Moderna Covid-19 bivalent.  No treatment medications were reported.  Company comment:This Spontaneous case concerns 82-year-old female patient with no reported medical history who experienced the unexpected serious (medically significant) AESI event of cardiac flutter, which occurred on same day after the booster dose of the mRNA-1273 bivalent BA.1 vaccination. Symptoms lasted for 24 to 48 hours.  At the time of reporting event was recovered. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccination is not affected by this report.   This case was linked to MOD-2023-713040.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Arthralgia, Asthenia, Cardiac flutter, Fatigue
Clinical narrative: heart fluttering; lack of energy; slight fatigue/ little bit of fatigue /extreme fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart fluttering) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient reported no chronic medical conditions. The patient had never had Covid-19 and the patient was not diagnosed with Myocarditis or Pericarditis.     On 25-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Feb-2023, the patient experienced CARDIAC FLUTTER (heart fluttering) (seriousness criterion medically significant), ASTHENIA (lack of energy), FATIGUE (slight fatigue/ little bit of fatigue /extreme fatigue) and ARTHRALGIA (joint pain). At the time of the report, CARDIAC FLUTTER (heart fluttering), ASTHENIA (lack of energy), FATIGUE (slight fatigue/ little bit of fatigue /extreme fatigue) and ARTHRALGIA (joint pain) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not take any medications.  The patient received first Moderna Covid 19 vaccine on 16-Sep-2021 (lot 02M20A), 2nd dose on Dec-2021. (Lot number 012M20A) and  expiration date was not known.  The patient booster dose on 27-Oct-2021 (lot number AS7146B, expiration date was not known)  All of these reactions lasted for 24 to 48 hours. Patient never had adverse reactions for as long as these reactions have lasted. The patient did not have any vaccines within 4 weeks of her bivalent Moderna Covid-19 bivalent.  No treatment medications were reported.  Company comment:This Spontaneous case concerns 82-year-old female patient with no reported medical history who experienced the unexpected serious (medically significant) AESI event of cardiac flutter, which occurred on same day after the booster dose of the mRNA-1273 bivalent BA.1 vaccination. Symptoms lasted for 24 to 48 hours.  At the time of reporting event was recovered. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccination is not affected by this report.   This case was linked to MOD-2023-713040.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: No reported side effects at this time; Nurse called stating that a patient who is on HUMIRA was accidently given the MMR-II vaccine and should not have been due to the HUMIRA making the patient immunocompromised and MMR-II being a live vaccine. AE filed for MMR-II (live vaccine) that was; This spontaneous report was received from nurse, referring to a unspecified patient of unknown gender and age. The patient's medical history was not reported. The concurrent conditions included  immunocompromised. Concomitant medications included adalimumab (HUMIRA).   On an unknown date, the patient immunocompromised was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous product quantity 1, administered for prophylaxis (strength, dose regimen, lot #, expiration date, and route of administration were not provided) (contraindicated product administered). No reported side effects at this time (no adverse event).  This is non-valid report due the lack of patient's identifiers.  Follow-up information was received from the nurse/vaccine provider on 17-FEB-2023 referring to a 36-year-old female patient. The patient's information was updated. The patient's concurrent conditions included ulcerative proctitis with rectal bleeding and dysthymia. The patient's concomitant medication included mesalazine (MESALAMINE).   On an unknown date, the patient started therapy with adalimumab (HUMIRA) pen pnkt 40 milligram (mg)/0.4 milliliter (mL) (40 mg, route was reported as injection, frequency, lot# and expiration date were unknown) for ulcerative proctitis. The reporter reported adalimumab (HUMIRA) as a suspect therapy.  On 22-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection (lot# W007181, expiration date 01-MAR-2024) subcutaneously (subq) in a medical center. The operator was trained. The patient was on adalimumab (HUMIRA) and should not have received this vaccine. The reporter called the doctor's office to ask what they should do. A certified nurse practitioner (CNP) spoke with the reporter and also called the patient. The CNP asked if the patient became symptomatic to prevent to emergency room (ER) for evaluation. The patient was not symptomatic at the reporting time (reported as to date). The outcome of the event contraindicated product administered was reported as recovered. It was unknown if the experience required prescription drug treatment. This adverse event had also been reported to manufacturer. There was no product quality complaint.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reporting a temperature excursion for GARDASIL9 RECOMBIVAX ROTATEQ VAQTA that occurred on 12/16/2022 states it is unknown at time of call if any products have been administered.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information regarding the patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies provided.  On unspecified date, the patients were vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, route of administration, vaccination scheme were not provided; lot number 1775808 that was verified to be valid, expiration date reported and established as 20-AUG-2023); hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023);hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023) (strengths, doses, routes of administration and vaccination schemes were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration, at a dose of 2 ml (lot number 1837117 that was verified to be valid,  expiration date reported and established as 3/24/2023) (strength and vaccination scheme were not provided)(product storage error). All of the vaccines were administered as prophylaxis.  The administered doses of the vaccine were stored at a temperature of 27.03 degrees Fahrenheit (F) during a time frame of  6 minutes, and it was mentioned that the temperature excursion occured on 16-DEC-2022. There was no previous temperature excursion. No additional adverse events were reported.    Follow-up information has been received on 24-FEB-2023.  Case previously reported as non-valid due to a lack of patient identifiers, has now patient's demographics . Referring a 11-year-old female patient. Suspect vaccine was updated to only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), vaccination anatomical location left deltoid.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Allergies: PNEUMOVAX 23 INJ 25MCG/0.5ML SDV; This spontaneous report has been received from an elderly female patient of unknown age, regarding their self, via Pfizer Inc.   The patient's pertinent medical history and concurrent conditions included cancer or neoplasm, malignant neoplasm of breast, malignant neoplasm of bone, diabetes mellitus, hypothyroidism, hypertension and hyperlipidemia. Their concomitant medications included insulin lispro (HUMALOG) 100 units (U) per milliliter (ml) kwik pen injection, insulin glargine (LANTUS SOLOSTAR) pen injection 3 ml, metoprolol tartrate 10 milligrams (mg) tablet, simvastatin 10 mg tablet, calcium carbonate (+) colecalciferol (CALCIUM 500+D3) tablet, cyanocobalamin (VITAMIN B-12) 250 microgram (mcg) tablet.  Their drugs reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 25mcg per 0.5ml (dose, vaccination scheme, frequency, route of administration, lot number, expiration date and anatomical injection site was not provided) for prophylaxis and experienced an allergy (drug hypersensitivity). The outcome of the event drug hypersensitivity was not provided.   The causality assessment between the event drug hypersensitivity with the suspect pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information  ?    Names of vaccines involved (including lot/exp): VARIVAX  Lot W025273, Exp 10AUG2024        ?    Temperature: 34; This spontaneous report has been received a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml), lot number W025273 verified as valid, expiration date reported and upon internal review established as 10-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion with a temperature of 34.7 degree Fahrenheit for 13 hours and 15 minutes (product storage error). No additional adverse event reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood blister, Body temperature increased, Bronchoalveolar lavage abnormal, Rash pustular, Rash vesicular
Clinical narrative: crusting; hemorragic blisters; pustular rash; Varicella virus test positive; Body temperature abnormal; vesicular rash; This spontaneous report has been received from a physician, concerning a 3-years-old male patient. The patient's pertinent medical history and concurrent conditions included trichothiodystrophy, hypogammaglobulinemia, influenza A, bilateral pneumonia, tracheotomy, "AK s/p CRRT with progressive decline" (information not legible), chronic steroid exposure. His previous drug reactions, allergies included oxycodone (angioedema), and concomitant medications were not provided.  On 23-FEB-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, on left arm, for prophylaxis (valid lot number T017686 [expiration date 21-MAY-2022]) (dose, dose number, vaccination scheme, route of administration, anatomical location, frequency, lot number and expiration date were not provided).   On 17-FEB-2023, a sample was obtained with vesicle lesion, the patient experienced a vesicular rash, pustular rash, crusting (scab), hemorrhagic blisters (blood blister), 710 lesions left chest an upper extremity with a temperature of 38.8 degrees Celsius (body temperature abnormal), the patient was hospitalized and as a treatment, the patient begun acyclovir. The hospital lab determined that a bronchial alveolar lavage (BAL) sample identified VZV (varicella virus test positive). The hospital would like to have strain identification performed on plasma, BAL and lesion samples. The outcome of the events was recovering (ongoing) (conflicting information, also reported as recovered).   The causality assessment between the events rash vesicular, scab, blood blister, rash pustular, varicella virus test positive and body temperature abnormal was not provided.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella virus test positive
Clinical narrative: crusting; hemorragic blisters; pustular rash; Varicella virus test positive; Body temperature abnormal; vesicular rash; This spontaneous report has been received from a physician, concerning a 3-years-old male patient. The patient's pertinent medical history and concurrent conditions included trichothiodystrophy, hypogammaglobulinemia, influenza A, bilateral pneumonia, tracheotomy, "AK s/p CRRT with progressive decline" (information not legible), chronic steroid exposure. His previous drug reactions, allergies included oxycodone (angioedema), and concomitant medications were not provided.  On 23-FEB-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, on left arm, for prophylaxis (valid lot number T017686 [expiration date 21-MAY-2022]) (dose, dose number, vaccination scheme, route of administration, anatomical location, frequency, lot number and expiration date were not provided).   On 17-FEB-2023, a sample was obtained with vesicle lesion, the patient experienced a vesicular rash, pustular rash, crusting (scab), hemorrhagic blisters (blood blister), 710 lesions left chest an upper extremity with a temperature of 38.8 degrees Celsius (body temperature abnormal), the patient was hospitalized and as a treatment, the patient begun acyclovir. The hospital lab determined that a bronchial alveolar lavage (BAL) sample identified VZV (varicella virus test positive). The hospital would like to have strain identification performed on plasma, BAL and lesion samples. The outcome of the events was recovering (ongoing) (conflicting information, also reported as recovered).   The causality assessment between the events rash vesicular, scab, blood blister, rash pustular, varicella virus test positive and body temperature abnormal was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of RECOMBIVAX was administered.; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.    On 03-FEB-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # U019135 with expiration date of 22-NOV-2022 (expired product administered), 0.5 milliliter, intramuscularly for prophylaxis.   No additional event reported.   This is one of several reports received from the same source.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; Healthcare provider reports an administration of an incomplete dose of VAQTA to a 2 year old patient on 16FEB2023. No further information provided. AE 02341822 filed. No additional AE reported. No PQC reported.; This spontaneous report has been received from a medical assistant concerning to a 2-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 16-FEB-2023, the patient was vaccinated with an incomplete dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose number, dose, route of administration and anatomical location was not provided (lot#: W036135, expiration date: 13-MAY-2024) (incomplete dose administered). No additional adverse event (AE) reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE reported.; pregnant patient inadvertently received a dose of GARDASIL 9; This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unknown date in February 2023, the pregnant patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation defaulted as injection, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. Fetal outcome was unknown. No additional adverse events were reported (exposure during pregnancy) (no adverse event).
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administration of expired MMR II vaccine. Caller reports vaccine expired on 2/26/23 and was administered on 2/27/23.; This spontaneous report was received from a Licensed Practical Nurse (also reported as LVN) and refers to a 7-year-old male patient. No pertinent medical history, current conditions, drug reactions or allergies were provided. Concomitant therapy included sterile diluent.   On 27-FEB-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (M-M-R II)  recombinant human albumin (rHA) subcutaneous injection at a dose of 0.5 milliliter once, lot #U006488, expiration date: 26-FEB-2023, administered for prophylaxis (dose number, route and anatomical location were not reported). The reporter indicated no temperature excursion and sterile diluent was not expired. No additional adverse events were reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported.; Customer reported patient got additional dose (4th dose) of GARDASIL 9 today, 28FEB2023.; This spontaneous report has been received from a nurse practitioner concerning to an 18-year-old patient. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On 22-FEB-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; on 18-APR-2022, the second dose and the 3rd dose on 23-AUG-2022 of the aforementioned vaccine (strengths, doses, lot number, expiration dates, routes of administration were not provided).   On 28-FEB-2023, the patient was vaccinated with a dose (4th dose) of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml)(strength and route of administration was not provided; lot number W007760  that was verified to be valid, expiration date reported and established as 04-DEC-2024) (extra dose). All the administration were for prophylaxis.   No additional adverse event (AE) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shot gave my mom shingles / Suspected vaccination failure; The shot gave my mom shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: This case was reported by the Consumer via interactive digital media.  The reporter stated that, the shot gave his/her mom shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: baseball/softball size Rash on arm, 6 inches below injetcion site; Warm to the touch; This case was reported by a consumer and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash and skin warm. On an unknown date, the outcome of the rash and skin warm were recovering/resolving.   It was unknown if the reporter considered the rash and skin warm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's Comments: The patient reported that a baseball to softball size rash developed on his arm approximately 2 to 3 days after the vaccination, and it was about 6 inches below the location where the needle went in and was warm to the touch.  It seems to be dissipating now. The reporter consented to follow-up.