chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Peripheral swelling, Pruritus, Rash, Scratch
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Temporomandibular joint syndrome
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune system disorder, Pruritus
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Depression, Feeling abnormal, Herpes zoster
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypotension, Immune system disorder, Insomnia, Pruritus
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Visual impairment, Vitamin B12, Vitamin B12 deficiency, Weight decreased
Clinical narrative: LOW VITAMIN B12; CAN'T SLEEP/SLEEPING ISSUES; SKY HIGH BLOOD PRESSURE; LOW BLOOD PRESSURE; VISION PROBLEMS; WEIGHT LOSS; BRAIN FOG; DEPRESSION; LOW/WEAKENED IMMUNE SYSTEM; RECURRENT SHINGLES; RASH; SEVERE ITCHING; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, multiple allergies, and shingles, and other pre-existing medical conditions included: The patient had cardiac medical history were under control until vaccination. The patient had an effect of her lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 9 decade old. No concomitant medications were reported. On MAY-2021, the patient experienced severe itching. On an unspecified date, the patient experienced low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system, recurrent shingles, and rash. Laboratory data (dates unspecified) included: Blood pressure Low, High, Blood test Not reported, and Vitamin B12 Low. Treatment medications (dates unspecified) included: cyanocobalamin, magnesium sulfate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching, and rash, and the outcome of low vitamin b12, can't sleep/sleeping issues, sky high blood pressure, low blood pressure, vision problems, weight loss, brain fog, depression, low/weakened immune system and recurrent shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162364.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Prior to August 1st, pt. was a healthy and active 14 year old girl who loved playing soccer and hockey and no had medical conditions.  Pt developed sudden onset, severe POTS (postural orthostatic tachycardia syndrome)-like symptoms 10/15 minutes after receiving the Pfizer COVID vaccine on 8/1/22. Her symptoms include notable orthostatic hypotension, fatigue, and postural headache and dizziness that worsens when going from sitting to standing and persists when standing or walking. Orthostatic measurements showed that her heart rate increased by 22 bpm when going from the time to be seated position, going from 65 to 87 bpm, then increased by another 28 bpm when going from the seated to the standing position with a heart rate of 115?120 when standing. Overall her heart rate increased by 50 bpm when going from the supine to the standing position and her systolic blood pressure decreased by 22 points, with a blood pressure of 94/58 while supine and 72/55 while standing. Based on the timing of pt.'s symptoms, she has had an unusual adverse reaction from the COVID-vaccine, triggering POTS-like symptoms. At this point, it is difficult to determine whether these symptoms will subside in a timely manner, or whether the vaccine is possibly triggered in autoimmune reaction, that could potentially linger for a longer period of time. Patient had a stress test at a local Hospital where they showered a "blunted Blood pressure" (her BP was not reacting to running)  and her BP suddenly tanked after a few minutes for no reason. This caused patient to feel ill and severe headache.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure systolic decreased, Cardiac stress test abnormal, Dizziness, Fatigue, Headache
Clinical narrative: Prior to August 1st, pt. was a healthy and active 14 year old girl who loved playing soccer and hockey and no had medical conditions.  Pt developed sudden onset, severe POTS (postural orthostatic tachycardia syndrome)-like symptoms 10/15 minutes after receiving the Pfizer COVID vaccine on 8/1/22. Her symptoms include notable orthostatic hypotension, fatigue, and postural headache and dizziness that worsens when going from sitting to standing and persists when standing or walking. Orthostatic measurements showed that her heart rate increased by 22 bpm when going from the time to be seated position, going from 65 to 87 bpm, then increased by another 28 bpm when going from the seated to the standing position with a heart rate of 115?120 when standing. Overall her heart rate increased by 50 bpm when going from the supine to the standing position and her systolic blood pressure decreased by 22 points, with a blood pressure of 94/58 while supine and 72/55 while standing. Based on the timing of pt.'s symptoms, she has had an unusual adverse reaction from the COVID-vaccine, triggering POTS-like symptoms. At this point, it is difficult to determine whether these symptoms will subside in a timely manner, or whether the vaccine is possibly triggered in autoimmune reaction, that could potentially linger for a longer period of time. Patient had a stress test at a local Hospital where they showered a "blunted Blood pressure" (her BP was not reacting to running)  and her BP suddenly tanked after a few minutes for no reason. This caused patient to feel ill and severe headache.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise, Orthostatic hypotension, Postural orthostatic tachycardia syndrome
Clinical narrative: Prior to August 1st, pt. was a healthy and active 14 year old girl who loved playing soccer and hockey and no had medical conditions.  Pt developed sudden onset, severe POTS (postural orthostatic tachycardia syndrome)-like symptoms 10/15 minutes after receiving the Pfizer COVID vaccine on 8/1/22. Her symptoms include notable orthostatic hypotension, fatigue, and postural headache and dizziness that worsens when going from sitting to standing and persists when standing or walking. Orthostatic measurements showed that her heart rate increased by 22 bpm when going from the time to be seated position, going from 65 to 87 bpm, then increased by another 28 bpm when going from the seated to the standing position with a heart rate of 115?120 when standing. Overall her heart rate increased by 50 bpm when going from the supine to the standing position and her systolic blood pressure decreased by 22 points, with a blood pressure of 94/58 while supine and 72/55 while standing. Based on the timing of pt.'s symptoms, she has had an unusual adverse reaction from the COVID-vaccine, triggering POTS-like symptoms. At this point, it is difficult to determine whether these symptoms will subside in a timely manner, or whether the vaccine is possibly triggered in autoimmune reaction, that could potentially linger for a longer period of time. Patient had a stress test at a local Hospital where they showered a "blunted Blood pressure" (her BP was not reacting to running)  and her BP suddenly tanked after a few minutes for no reason. This caused patient to feel ill and severe headache.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: He got his vaccine, he could not complete a sentence and could not remember dates, times, names.  Had to look up the information on either cards or phone #'s.  He could not remember how many concussions he had or basically could not remember anything. He could remember his great nieces last name, like he had advanced Alzheimer's, which is not in his family.   This lasted severely for 5 days, and then has tapered off.  He still continues to have some problems with some words.  He can picture the words but they do not come out of his mouth.   His speech center got really impaired.   He is a retired medic and EMT, and has had several concussions in the past.    He went to his doctor and she put him on Penicillin.  The heavy snow triggers the infection behind his ear so he is on that.  He is also on vitamin D, red yeast, ginkgko Biloba.  He could still do his design work, but shut down his speech center, cognitive function.    He did not have any problems with the J&J vaccines..  Those were a miracle drug to him, it took away all the pain in his joints and muscles.  He first got COVID in December of 2019 there was no treatment, and he had to go alone.  His doctor was helping him and put him Penicillin as he got double pneumonia and is 45 miles to the nearest grocery store so he was not able to get out and get food.  He lost 50# during this time.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Aphasia, Arthralgia, Cognitive disorder, Memory impairment, Myalgia
Clinical narrative: He got his vaccine, he could not complete a sentence and could not remember dates, times, names.  Had to look up the information on either cards or phone #'s.  He could not remember how many concussions he had or basically could not remember anything. He could remember his great nieces last name, like he had advanced Alzheimer's, which is not in his family.   This lasted severely for 5 days, and then has tapered off.  He still continues to have some problems with some words.  He can picture the words but they do not come out of his mouth.   His speech center got really impaired.   He is a retired medic and EMT, and has had several concussions in the past.    He went to his doctor and she put him on Penicillin.  The heavy snow triggers the infection behind his ear so he is on that.  He is also on vitamin D, red yeast, ginkgko Biloba.  He could still do his design work, but shut down his speech center, cognitive function.    He did not have any problems with the J&J vaccines..  Those were a miracle drug to him, it took away all the pain in his joints and muscles.  He first got COVID in December of 2019 there was no treatment, and he had to go alone.  His doctor was helping him and put him Penicillin as he got double pneumonia and is 45 miles to the nearest grocery store so he was not able to get out and get food.  He lost 50# during this time.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Pneumonia, Speech disorder, Weight decreased
Clinical narrative: He got his vaccine, he could not complete a sentence and could not remember dates, times, names.  Had to look up the information on either cards or phone #'s.  He could not remember how many concussions he had or basically could not remember anything. He could remember his great nieces last name, like he had advanced Alzheimer's, which is not in his family.   This lasted severely for 5 days, and then has tapered off.  He still continues to have some problems with some words.  He can picture the words but they do not come out of his mouth.   His speech center got really impaired.   He is a retired medic and EMT, and has had several concussions in the past.    He went to his doctor and she put him on Penicillin.  The heavy snow triggers the infection behind his ear so he is on that.  He is also on vitamin D, red yeast, ginkgko Biloba.  He could still do his design work, but shut down his speech center, cognitive function.    He did not have any problems with the J&J vaccines..  Those were a miracle drug to him, it took away all the pain in his joints and muscles.  He first got COVID in December of 2019 there was no treatment, and he had to go alone.  His doctor was helping him and put him Penicillin as he got double pneumonia and is 45 miles to the nearest grocery store so he was not able to get out and get food.  He lost 50# during this time.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: She got her vaccine, it seemed to upset the microbiome.  The balance of bacteria and fungus and whatever in her small intestine.  She seemed to develop a digestive problem.  She developed a pain in her upper right quadrant of her abdomen, which finally sent her to the doctor . She had a lot of tests done.  She thinks it was a small intestine bacterial overgrowth.  One doctor called it IBS, and she has see her PCP for it, a GI doctor, and she finally went to a naturopath, who put her on a diet for that.  It has been used for intestinal conditions for a long time.  She was having symptoms of constipation, pain in her upper right quadrant of her abdomen that went all the way across her mid-drift over to where she guesses her pancreas would be.  Then when she got stressed she would get diarrhea, but not very often.   She went to the ER time who diagnosed her with IBS.    The naturopathic doctor is the one who actually got this condition under control.  The GI doctor told her to take Miralax daily and Fenofiber daily which helps somewhat.   She started taking digestive enzymes, which helped quite a bit.   She is on a specific carbohydrate diet.  Digestive issues are in the family, and everbody in her family has had problems since the vaccine.  This condition developed slowly after the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Constipation, Diarrhoea, Dyspepsia
Clinical narrative: She got her vaccine, it seemed to upset the microbiome.  The balance of bacteria and fungus and whatever in her small intestine.  She seemed to develop a digestive problem.  She developed a pain in her upper right quadrant of her abdomen, which finally sent her to the doctor . She had a lot of tests done.  She thinks it was a small intestine bacterial overgrowth.  One doctor called it IBS, and she has see her PCP for it, a GI doctor, and she finally went to a naturopath, who put her on a diet for that.  It has been used for intestinal conditions for a long time.  She was having symptoms of constipation, pain in her upper right quadrant of her abdomen that went all the way across her mid-drift over to where she guesses her pancreas would be.  Then when she got stressed she would get diarrhea, but not very often.   She went to the ER time who diagnosed her with IBS.    The naturopathic doctor is the one who actually got this condition under control.  The GI doctor told her to take Miralax daily and Fenofiber daily which helps somewhat.   She started taking digestive enzymes, which helped quite a bit.   She is on a specific carbohydrate diet.  Digestive issues are in the family, and everbody in her family has had problems since the vaccine.  This condition developed slowly after the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Laboratory test, Stress, X-ray
Clinical narrative: She got her vaccine, it seemed to upset the microbiome.  The balance of bacteria and fungus and whatever in her small intestine.  She seemed to develop a digestive problem.  She developed a pain in her upper right quadrant of her abdomen, which finally sent her to the doctor . She had a lot of tests done.  She thinks it was a small intestine bacterial overgrowth.  One doctor called it IBS, and she has see her PCP for it, a GI doctor, and she finally went to a naturopath, who put her on a diet for that.  It has been used for intestinal conditions for a long time.  She was having symptoms of constipation, pain in her upper right quadrant of her abdomen that went all the way across her mid-drift over to where she guesses her pancreas would be.  Then when she got stressed she would get diarrhea, but not very often.   She went to the ER time who diagnosed her with IBS.    The naturopathic doctor is the one who actually got this condition under control.  The GI doctor told her to take Miralax daily and Fenofiber daily which helps somewhat.   She started taking digestive enzymes, which helped quite a bit.   She is on a specific carbohydrate diet.  Digestive issues are in the family, and everbody in her family has had problems since the vaccine.  This condition developed slowly after the vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF test, Coma, Magnetic resonance imaging head, Neurodegenerative disorder
Clinical narrative: CREUTZFELDT-JAKOB DISEASE; This spontaneous report received from a consumer concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had always been healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: unknown) dose was not reported, 1 in total was administered on 05-MAY-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in MAY-2022, the patient developed diplopia and neurological degenerative disorder. On 14-JUL-2022, the patient was hospitalized for 22 days by a neurologist. MRIs (Magnetic resonance imaging) and CSF (Cerebrospinal fluid) tests were done. The patient's condition got progressively deteriorated and went into a comatose state and remained so, till to the day of reporting. The patient was diagnosed with Creutzfeldt-Jakob disease. On 05-AUG-2022, the patient was discharged home with a gastric tube and has been taken care of at home 24 hours a day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Creutzfeldt-Jakob disease. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20221153762.; Sender's Comments: V0:20221153229-Creutzfeldt-Jakob disease. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF test, Creutzfeldt-Jakob disease, Magnetic resonance imaging
Clinical narrative: CREUTZFELDT-JAKOB DISEASE; This spontaneous report received from a consumer concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had always been healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: unknown) dose was not reported, 1 in total was administered on 05-MAY-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in MAY-2022, the patient developed diplopia and neurological degenerative disorder. On 14-JUL-2022, the patient was hospitalized for 22 days by a neurologist. MRIs (Magnetic resonance imaging) and CSF (Cerebrospinal fluid) tests were done. The patient's condition got progressively deteriorated and went into a comatose state and remained so, till to the day of reporting. The patient was diagnosed with Creutzfeldt-Jakob disease. On 05-AUG-2022, the patient was discharged home with a gastric tube and has been taken care of at home 24 hours a day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Creutzfeldt-Jakob disease. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20221153762.; Sender's Comments: V0:20221153229-Creutzfeldt-Jakob disease. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 40.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE details were provided and no additional AE's were reported; male patient came in to receive a dose of MMR-II and VARIVAX because he had low titers and received PROQUAD; This spontaneous report has been received from a licensed practical nurse, referring to a 40 years old male patient.  Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter stated that the patient came in to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot number and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) because he had low titers, but he received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (dose: 0.5ml, lot # U039260 with expiration date: 03-APR-2023) subcutaneously instead on 19-AUG-2022 (wrong product administered). The strength was unknown for all suspect vaccines. The indication for suspect vaccines was prophylaxis. No additional adverse event (AE) details were provided and no additional AE's were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; Nurse reporting a temperature excursion for PROQUAD that occurred on 10/10/2022 states a dose has been administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 27-OCT-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, lot # U039955 with expiration date 14-JUN-2023, one dose of 0.5 ml (route of administration and anatomical location were not provided) for prophylaxis (product storage error). On 10-OCT-2022, the vaccine has been improperly stored for 30 minutes in the temperature of 6.8 degrees Fahrenheit (F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 34 year old female patient received 1st dose in 2019 and is now requesting to complete series; No additional AEs; This spontaneous report was received from a medical assistant and refers to a 34-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or medical history provided.  On an unknown date in 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, once (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that the vaccination series have been interrupted, and the patient wanted to complete the series "now" (inappropriate schedule of product administration). No additional adverse events have been reported (no adverse event).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 5-year-old (reported as 6 years old) male patient. His concurrent conditions included allergy to chemicals. The patient's medical history included iron deficiency anaemia and sleep apnoea syndrome. The patient had 2 siblings. His concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 20-OCT-2022 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot number W024548, expiration date: 31-JAN-2024, administered subcutaneously in the right vastus lateralis for prophylaxis. Before the administration, the vaccine underwent temperature excursion of 10.8 degrees Fahrenheit for 18 hours 30 minutes (product storage error). There was no previous temperature excursion. There was no adverse event reported (no adverse event).  This is one of several reports from the same reporter.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received a dose of MMRII on 10/12/2022 with a labeled expiry of 10/5/2022; This spontaneous report was received from a nurse and refers to a male of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-OCT-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, quantity 1, lot #T033814, expiration date: 05-OCT-2022, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered).  No additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: profound sensorineural hearing loss in left ear; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 18-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) in her left arm for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than 1 (one) month after receiving the vaccine, pt suffered profound sudden hearing loss and was later diagnosed with profound sensorineural hearing loss in left ear. As a direct and proximate result of the defective vaccine, pt's symptoms had resulted in physical limitations not present prior to using Merck's product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of pt's conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event profound sensorineural hearing loss to be disability. Upon internal review, profound sensorineural hearing loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, pt suffered herpes zoster. As a result of these symptoms, pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the defective vaccine, pt's symptoms had resulted in physical limitations not present prior to using Merck's product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of pt's conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event herpes zoster to be disability.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information provided. No PQC.; HCP states that a 19-year-old patient received a pediatric dose of VAQTA today, instead of the adult dose; Dose administered: 0.5 mL; This spontaneous report was received from a registered medical assistant referring to a 19-years-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 28-NOV-2022 (also reported as today), the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, dose of 0.5 mL, lot number: W007375, expiration date: 16-JAN-2023 (dose number, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age, incorrect dose administered). No additional adverse event (AE) information was provided (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A Healthcare Worker called to report that expired RECOMBIVAX HB was administered to a patient on 11/23/2022. No additional AE reported. No PQC reported.  No further information was provided.; This spontaneous report was received from other health care professional referring to a 7-week-old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 23-NOV-2022, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # T032918, expiration date 12-NOV-2022; dose, strength and route of administration were not reported) for prophylaxis (expired product administered). No further information was available (no adverse event). No product quality complaint (PQC) was reported.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper
Clinical narrative: Upper Left Quadrant Pain; Initial Report Received on 22-SEP-2022  This is a spontaneous report, received from a pharmacist regarding a male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), route and site not specified, was administered for hepatitis B immunisation.    On an unknown date, after having been vaccinated with HEPLISAV B, the patient experienced upper left quadrant pain.  The patient did not reportedly finish the vaccine series.    No further information was available at the time of the report.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Needle issue
Clinical narrative: Causing The Vaccine Landing On My Arm Instead of It Going Into The Patient's Deltoid; Initial Report Received on 28-Sep-2022, 03-Oct-2022, 04-Oct-2022 and 18-Nov-2022  This is a spontaneous report, received via a MedWatch 3500A from the FDA MedWatch Program.  The report was reported by a patient safety specialist regarding a patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 09-Sep-2022, a dose of HEPLISAV B (Lot #937783, expiration date Dec 2025, NDC #43528-003-01), route not specified, was administered in the left deltoid for hepatitis B immunization by the medical assistant.  During administration, when attempting to administer HEPLISAV-B into a patient's left deltoid, the liquid of the vaccine shot out of where the syringe's plain tip and the needle's hub meet, causing the vaccine to land on the medical assistant's arm instead of going into the patient's deltoid. The needle was inserted into the arm, and when medical assistant pressed the plunger to administer the vaccine, a large amount of clear fluid squirted out the side between the hub of the needle and pre-filled syringe. It was reported that it appeared to be the full 0.5 ml as it was dripping from the medical assistant's arm and on her scrubs. This was immediately reported to provider, who advised new vaccine be administered and this was done with no issues.  The outcome of the adverse event was not reported.  The lot was investigated in CN-000018. No lot impact was found.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: 16 Year Old Patient Was Given Heplisav-B; Initial Report Received on 06- Oct-2022   This is a spontaneous report, received from a pharmacist in the regarding a female patient, aged 16 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot # unknown, expiration date 24-Sep-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunization at an "off site clinic". No concomitant medications at the time of vaccination were reported.   The pharmacists reported that the 16-year-old patient had provided an incorrect date of birth. Reporter states that the vaccine was given at an "Off site Clinic." No adverse reactions were reported by the patient.  The reported stated that she had no other information about the event.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient Received An Expired Dose of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a certified medical assistant in the regarding a female patient, aged 56 years, who received HEPLISAV-B for hepatitis B immunisation.   Medical history at the time of vaccination was reported as allergic to fluoxetine, paroxetine, and Wellbutrin (buproprion).  Concomitant medications were not reported.  On 06-Oct-2022, an unspecified dose # of HEPLISAV-B (Lot #934974, expiration date 29-Apr-2022, NDC #43528-003-05), route not specified, was administered in the left deltoid for hepatitis B immunisation. No concomitant vaccinations at the time of vaccination were reported.   The patient has not reported any adverse reactions.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antigen negative, Vaccine induced antibody absent
Clinical narrative: "Titer 6" After 2 Doses 1 Month Apart; Patient Received 3rd Dose of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient that had received 2 doses of HEPLISAV B a month apart did not convert and their titer was 6 so a 3rd dose was given.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antigen, Therapy non-responder
Clinical narrative: "Titer 5" After 2 Doses 1 Month Apart; Patient Received 3 Doses of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient that had received 2 doses of HEPLISAV B a month apart did not convert and their titer was 5 so a 3rd dose was given.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.