chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 59-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date Feb2021 (also reported as 02Feb2021) 13:00 (Lot number: EN5318) at the age of 59 years as dose 2, single for COVID-19 immunization at the nursing Home/Senior Living Facility. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication included: LOSARTAN. Vaccination history included: Bnt162b2 (dose 1 (lot number=EN5318) at 01:15PM administered on the right arm), administration date: Feb2021 (also reported as 23Feb2021-pending clarification), when the patient was 59 years old for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 10Mar2021 12:00, outcome "not recovered", described as "Skin rash on arms legs and buttocks. Buttocks has faded a bit". The event "skin rash on arms legs and buttocks. buttocks has faded a bit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The patient had no other vaccine received in four weeks and no known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "1st and 2nd dose did not result in any adverse reactions"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "1st and 2nd dose did not result in any adverse reactions". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "full body ache"; CHILLS (non-serious), outcome "unknown", described as "chills". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Immunisation, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "1st and 2nd dose did not result in any adverse reactions"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "1st and 2nd dose did not result in any adverse reactions". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "full body ache"; CHILLS (non-serious), outcome "unknown", described as "chills". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Loss of smell and taste; Loss of smell and taste; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 23Nov2021 (Lot number: EW0217) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "known allergies: Bactrum". Vaccination history included: Bnt162b2 (prev dose lot number=ER8729, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 15Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "29Nov2021 covid test result=Positive", "29Nov2021 covid test result=Positive"; Bnt162b2 (prev dose lot number=ER8736, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 07May2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "29Nov2021 covid test result=Positive", "29Nov2021 covid test result=Positive". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "dose number=3"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 29Nov2021, outcome "recovering" and all described as "Loss of smell and taste". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anosmia, ageusia.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Immunisation, SARS-CoV-2 test
Clinical narrative: Loss of smell and taste; Loss of smell and taste; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 23Nov2021 (Lot number: EW0217) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "known allergies: Bactrum". Vaccination history included: Bnt162b2 (prev dose lot number=ER8729, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 15Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "29Nov2021 covid test result=Positive", "29Nov2021 covid test result=Positive"; Bnt162b2 (prev dose lot number=ER8736, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 07May2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "29Nov2021 covid test result=Positive", "29Nov2021 covid test result=Positive". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "dose number=3"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 29Nov2021, outcome "recovering" and all described as "Loss of smell and taste". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anosmia, ageusia.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Dehydration, Diarrhoea, Feeling abnormal, Illness
Clinical narrative: severe diarrhea; weakness; headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 29Nov2021 17:00 (Lot number: FJ8762) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pituitary tumor surgery back in Sept. 2010", start date: Sep2010 (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. The following information was reported: DIARRHOEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "severe diarrhea"; ASTHENIA (medically significant) with onset 30Nov2021, outcome "recovering", described as "weakness"; HEADACHE (medically significant) with onset 30Nov2021, outcome "recovering", described as "headache"; NAUSEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "nausea"; VOMITING (medically significant) with onset 30Nov2021, outcome "recovering", described as "vomiting". The events "severe diarrhea", "weakness", "headache", "nausea" and "vomiting" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative. Therapeutic measures were taken as a result of diarrhoea, asthenia, headache, nausea, vomiting including IV fluid hydration treatment. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test negative
Clinical narrative: severe diarrhea; weakness; headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 29Nov2021 17:00 (Lot number: FJ8762) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pituitary tumor surgery back in Sept. 2010", start date: Sep2010 (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. The following information was reported: DIARRHOEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "severe diarrhea"; ASTHENIA (medically significant) with onset 30Nov2021, outcome "recovering", described as "weakness"; HEADACHE (medically significant) with onset 30Nov2021, outcome "recovering", described as "headache"; NAUSEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "nausea"; VOMITING (medically significant) with onset 30Nov2021, outcome "recovering", described as "vomiting". The events "severe diarrhea", "weakness", "headache", "nausea" and "vomiting" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative. Therapeutic measures were taken as a result of diarrhoea, asthenia, headache, nausea, vomiting including IV fluid hydration treatment. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: severe diarrhea; weakness; headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 29Nov2021 17:00 (Lot number: FJ8762) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pituitary tumor surgery back in Sept. 2010", start date: Sep2010 (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. The following information was reported: DIARRHOEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "severe diarrhea"; ASTHENIA (medically significant) with onset 30Nov2021, outcome "recovering", described as "weakness"; HEADACHE (medically significant) with onset 30Nov2021, outcome "recovering", described as "headache"; NAUSEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "nausea"; VOMITING (medically significant) with onset 30Nov2021, outcome "recovering", described as "vomiting". The events "severe diarrhea", "weakness", "headache", "nausea" and "vomiting" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative. Therapeutic measures were taken as a result of diarrhoea, asthenia, headache, nausea, vomiting including IV fluid hydration treatment. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: severe diarrhea; weakness; headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 29Nov2021 17:00 (Lot number: FJ8762) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pituitary tumor surgery back in Sept. 2010", start date: Sep2010 (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. The following information was reported: DIARRHOEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "severe diarrhea"; ASTHENIA (medically significant) with onset 30Nov2021, outcome "recovering", described as "weakness"; HEADACHE (medically significant) with onset 30Nov2021, outcome "recovering", described as "headache"; NAUSEA (medically significant) with onset 30Nov2021, outcome "recovering", described as "nausea"; VOMITING (medically significant) with onset 30Nov2021, outcome "recovering", described as "vomiting". The events "severe diarrhea", "weakness", "headache", "nausea" and "vomiting" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative. Therapeutic measures were taken as a result of diarrhoea, asthenia, headache, nausea, vomiting including IV fluid hydration treatment. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Intensive care, Peripheral swelling, Supraventricular tachycardia
Clinical narrative: Patient tested (+) for COVID-19 on 12/7/21 by both rapid and PCR tests, requiring hospitalization for cardiogenic shock and transfer to higher level of care at Medical Center for ECMO 12/9/21.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiogenic shock, SARS-CoV-2 test positive
Clinical narrative: Patient tested (+) for COVID-19 on 12/7/21 by both rapid and PCR tests, requiring hospitalization for cardiogenic shock and transfer to higher level of care at Medical Center for ECMO 12/9/21.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: spasms in neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose., after 1st Pfizer covid vaccine she had a urinary track, infection and had to take an antibiotic.), for Covid-19 Immunization, reaction(s): "Urinary tract infection". The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "spasms in neck". Therapeutic measures were taken as a result of muscle spasms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Had both doses of Pfizer covid vaccine. Would like to get booster shot. The Drs she asks they don't know anything.Relayed PMI number and transferred. Placed into call flow. Will fax for AEs.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101593835 Same patient, same drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: spasms in neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose., after 1st Pfizer covid vaccine she had a urinary track, infection and had to take an antibiotic.), for Covid-19 Immunization, reaction(s): "Urinary tract infection". The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "spasms in neck". Therapeutic measures were taken as a result of muscle spasms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Had both doses of Pfizer covid vaccine. Would like to get booster shot. The Drs she asks they don't know anything.Relayed PMI number and transferred. Placed into call flow. Will fax for AEs.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101593835 Same patient, same drug, different dose
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Magnetic resonance imaging abnormal, Magnetic resonance imaging neck, Muscle spasms, Muscular weakness
Clinical narrative: Muscles spasms; Burning sensation; Pins and needles in feet; Weakness in legs and arms; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: EW0175) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Muscles spasms"; BURNING SENSATION (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Burning sensation"; PARAESTHESIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pins and needles in feet"; MUSCULAR WEAKNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Weakness in legs and arms". The events "Muscles spasms", "Burning sensation", "Pins and needles in feet" and "Weakness in legs and arms" were evaluated at the physician office and the emergency room visit. Therapeutic measures were taken as a result of muscle spasms, burning sensation, paraesthesia and muscular weakness.  Additional information: Therapeutic measures included treatment with BACLOFEN and GABAPENTIN (neurology). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Syringomyelia
Clinical narrative: Muscles spasms; Burning sensation; Pins and needles in feet; Weakness in legs and arms; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: EW0175) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Muscles spasms"; BURNING SENSATION (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Burning sensation"; PARAESTHESIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pins and needles in feet"; MUSCULAR WEAKNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Weakness in legs and arms". The events "Muscles spasms", "Burning sensation", "Pins and needles in feet" and "Weakness in legs and arms" were evaluated at the physician office and the emergency room visit. Therapeutic measures were taken as a result of muscle spasms, burning sensation, paraesthesia and muscular weakness.  Additional information: Therapeutic measures included treatment with BACLOFEN and GABAPENTIN (neurology). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: Muscles spasms; Burning sensation; Pins and needles in feet; Weakness in legs and arms; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: EW0175) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Muscles spasms"; BURNING SENSATION (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Burning sensation"; PARAESTHESIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pins and needles in feet"; MUSCULAR WEAKNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Weakness in legs and arms". The events "Muscles spasms", "Burning sensation", "Pins and needles in feet" and "Weakness in legs and arms" were evaluated at the physician office and the emergency room visit. Therapeutic measures were taken as a result of muscle spasms, burning sensation, paraesthesia and muscular weakness.  Additional information: Therapeutic measures included treatment with BACLOFEN and GABAPENTIN (neurology). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Previously submitted  E # 747322  updating with pt death 12/21/2021  Principal Problem:   Acute And Chronic Respiratory Failure With Hypoxia (HCC) Active Problems:  COVID-19 infection  Chronic Diastolic (Congestive) Heart Failure (HCC)  Fibrosis Pulmonary (HCC)  Failure Renal Acute (Acute Kidney Injury) (HCC)  Multiple Subsegmental Pulmonary Embolism Without Acute Cor Pulmonale (HCC)
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Cardiac failure congestive, Chronic left ventricular failure
Clinical narrative: Previously submitted  E # 747322  updating with pt death 12/21/2021  Principal Problem:   Acute And Chronic Respiratory Failure With Hypoxia (HCC) Active Problems:  COVID-19 infection  Chronic Diastolic (Congestive) Heart Failure (HCC)  Fibrosis Pulmonary (HCC)  Failure Renal Acute (Acute Kidney Injury) (HCC)  Multiple Subsegmental Pulmonary Embolism Without Acute Cor Pulmonale (HCC)
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Hypoxia, Pulmonary embolism, Pulmonary fibrosis
Clinical narrative: Previously submitted  E # 747322  updating with pt death 12/21/2021  Principal Problem:   Acute And Chronic Respiratory Failure With Hypoxia (HCC) Active Problems:  COVID-19 infection  Chronic Diastolic (Congestive) Heart Failure (HCC)  Fibrosis Pulmonary (HCC)  Failure Renal Acute (Acute Kidney Injury) (HCC)  Multiple Subsegmental Pulmonary Embolism Without Acute Cor Pulmonale (HCC)
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Headache, Influenza like illness, Product preparation issue
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test normal, Blepharospasm, Blood test normal, Chest pain, Chills
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Dyspnoea, Electrocardiogram normal, Eructation, Fatigue
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Head discomfort, Headache, Incorrect dose administered
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscle disorder, Pain in extremity, Product preparation issue, Pyrexia
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: My symptoms started as a pressure in the head, that by afternoon on 12/14 progressed to headache, low grade fever, inability to sleep whole night, shaking chills, severe arm pain, and weird feeling of not being able to have a full control of my muscles. I felt that afternoon 12/14 like I need to do more effort to breathe (involve my muscles in my chest). I had involuntary left eye twitching of the left eyelid. I took Tylenol for headache during the night ad that helped with fever and headache. Next day I was tired, a little warm, headache continued, and strong arm pain. I started having heartburn going form middle of my stomach up, and some pain towards left side of my chest but it felt like heartburn and followed with burping. In the evening of 12/15 at 7.08pm I received a voice mail from that I call her back regarding my Pfizer covid shot. She left her hospital number and her cell number. I called her back to her cell number and she informed me over the phone that I  was accidentally given too high dose of the vaccine, that the Pfizer vaccine that I received was not diluted properly. I asked how much of mrna I received said that I received 70mcg of mrna, when normal dose is 30mcg. She apologized and offered a free EKG and blood work by Dr. on Friday 12/17, which I accepted. I showed up at the appointment and Dr. examined me. By Friday, my symptoms improved except the headache, heartburn, and arm. I had covid arm which Dr.  noticed. They drew blood and did EKG. I was not able to get official blood lab reports from either Dr.  nor Dr., except email from stating that my EKG was normal. The nurse called me yesterday 12/21 to inform me that my blood work is normal, but when I asked for the exact numbers and what tests were done, she said that she was not given that information from Dr.. I emailed Dr, but she has not emailed me my results.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: presents to the local emergency Department with complaints of chest pain, shortness of breath, productive cough but has recently become grossly bloody for the past 2 days.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Haemoptysis, Productive cough
Clinical narrative: presents to the local emergency Department with complaints of chest pain, shortness of breath, productive cough but has recently become grossly bloody for the past 2 days.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase increased, Basophil count normal
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood chloride decreased, Blood creatinine normal, Blood ethanol normal, Blood glucose normal, Blood lactic acid
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium normal, Blood phosphorus decreased, Blood potassium decreased, Blood sodium normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, Carbon dioxide normal, Chest X-ray normal, Computerised tomogram head normal, Confusional state
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Drug screen positive, Electroencephalogram, Eosinophil count normal, Eosinophil percentage decreased
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye movement disorder, Feeling of body temperature change, Full blood count, Glomerular filtration rate normal, Haematocrit increased
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin increased, Headache, Hyperacusis, Immature granulocyte count, Impaired driving ability
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, International normalised ratio increased, Laboratory test, Lip injury
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphocyte count decreased, Lymphocyte percentage decreased, Magnetic resonance imaging head, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell volume normal, Mean platelet volume normal, Memory impairment, Metabolic function test, Monocyte count increased
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monocyte percentage, Musculoskeletal stiffness, Nausea, Neurological examination, Neutrophil count increased
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neutrophil percentage increased, Photophobia, Platelet count normal, Postictal state, Procalcitonin
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Protein total increased, Prothrombin time prolonged, Red blood cell count increased, Red cell distribution width normal, Respiratory syncytial virus test negative
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Seizure, Social alcohol drinker, Substance use, Tongue biting
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Urine analysis abnormal, Urine cannabinoids increased, Vomiting, White blood cell count increased
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Posterior reversible encephalopathy syndrome, Seizure
Clinical narrative: patient had PRES (posterior reversible encephalopathy syndrome)  2-3 weeks after the vaccine, seizures and confusion
Sex: U
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: symptoms / w/ symptoms; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL SYMPTOM (symptoms / w/ symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL SYMPTOM (symptoms / w/ symptoms). At the time of the report, GENERAL SYMPTOM (symptoms / w/ symptoms) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Son who was vaccinated, contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Son who was vaccinated, contracted COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Son who was vaccinated, contracted COVID). At the time of the report, COVID-19 (Son who was vaccinated, contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment was provided.  Company comment: This spontaneous case report concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur on an unknow date after the administration of an unknown dose of the mRNA-1273 vaccine.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown.  The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur on an unknow date after the administration of an unknown dose of the mRNA-1273 vaccine.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown.  The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; an adult patient was administered a pediatric dose of RECOMBIV AX HB (0.5ml)/patient returned within 4 hours for additional dose (0.5ml); This spontaneous report was received from a physician and an unspecified reporter from the physician's office and refers to a 28-year-old (discrepant information, the patients date of birth also reported as 09-SEP-2021) female patient. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided.  On 22-NOV-2021, the patient was vaccinated by a healthcare professional at a private doctor's office with a pediatric dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml intramuscularly, first dose, expiration date reported as 12-NOV-2022 (serial number (SN) and TTIN # reported as 102895422330, 00300004981001, respectively) (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (incorrect dose administered). On the same date, she was recalled to the facility and returned within 4 hours for additional 0.5 ml dose of the vaccine (expiration date reported as 12-NOV-2022, serial number (SN) and TTIN # reported as 102895422330, 00300004981001; route of administration, anatomical location, lot # and expiration date were not provided). The patient tolerated the vaccinations well without compliant, no adverse event (AE) was reported. No prescription drug treatment was required for the experience.