chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Overdose, Pain, Product administered to patient of inappropriate age
Clinical narrative: feeling chills; low grade fever; significant swelling; painful realm of reported adverse events; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer program (159558), other case identifier(s) US-PFIZER INC-202101548778 (PFIZER).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:40 (Lot number: 30155BA, Expiration Date: 31Dec2021) at the age of 7 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included FLU VACCINE taken for immunisation, start date: 08Nov2021, stop date: 08Nov2021. The following information was reported OVERDOSE (non-serious), PRODUCT USE ISSUE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 08Nov2021, outcome unknown; CHILLS (non-serious) with onset 09Nov2021, outcome unknown; PYREXIA (non-serious) with onset 09Nov2021, outcome unknown; SWELLING (non-serious) with onset 09Nov2021, outcome unknown; PAIN (non-serious) with onset 09Nov2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section.  No History of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect flu vaccine yesterday in right arm. No AE required a visit to Emergency Room or Physician Office. HCP indicated adult was administered to 7-year-old female yesterday at 17:40. First dose, flu shot in one arm. Mother was present and due to receive dose, HCP administered to patient. Patient was at home today feeling chills, low grade fever, significant swelling, painful realm of reported adverse events. School nurse indicated to for mother to ask about cardiac, cardiomyopathy occurrences in those receiving purple cap dose in pediatric population.  Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product use issue, Pyrexia, Swelling
Clinical narrative: feeling chills; low grade fever; significant swelling; painful realm of reported adverse events; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer program (159558), other case identifier(s) US-PFIZER INC-202101548778 (PFIZER).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:40 (Lot number: 30155BA, Expiration Date: 31Dec2021) at the age of 7 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included FLU VACCINE taken for immunisation, start date: 08Nov2021, stop date: 08Nov2021. The following information was reported OVERDOSE (non-serious), PRODUCT USE ISSUE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 08Nov2021, outcome unknown; CHILLS (non-serious) with onset 09Nov2021, outcome unknown; PYREXIA (non-serious) with onset 09Nov2021, outcome unknown; SWELLING (non-serious) with onset 09Nov2021, outcome unknown; PAIN (non-serious) with onset 09Nov2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section.  No History of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect flu vaccine yesterday in right arm. No AE required a visit to Emergency Room or Physician Office. HCP indicated adult was administered to 7-year-old female yesterday at 17:40. First dose, flu shot in one arm. Mother was present and due to receive dose, HCP administered to patient. Patient was at home today feeling chills, low grade fever, significant swelling, painful realm of reported adverse events. School nurse indicated to for mother to ask about cardiac, cardiomyopathy occurrences in those receiving purple cap dose in pediatric population.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Dysstasia, Fatigue
Clinical narrative: patient reported stabbing pains in knees and legs, fatigue, was bedridden for 2 1/2 months due to pain, got bloodwork done. patient states that she was completely healthy before vaccine. Visited doctors and is currently waiting on test results. patient was unable to stand, walk and move around.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Pain in extremity, Rheumatoid arthritis, Sleep disorder
Clinical narrative: patient reported stabbing pains in knees and legs, fatigue, was bedridden for 2 1/2 months due to pain, got bloodwork done. patient states that she was completely healthy before vaccine. Visited doctors and is currently waiting on test results. patient was unable to stand, walk and move around.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dysstasia, Fatigue, Gait inability
Clinical narrative: patient reported stabbing pains in knees and legs, fatigue, was bedridden for 2 1/2 months due to pain, got bloodwork done. patient states that she was completely healthy before vaccine. Visited doctors and is currently waiting on test results. patient was unable to stand, walk and move around.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient reported stabbing pains in knees and legs, fatigue, was bedridden for 2 1/2 months due to pain, got bloodwork done. patient states that she was completely healthy before vaccine. Visited doctors and is currently waiting on test results. patient was unable to stand, walk and move around.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal
Clinical narrative: patient found Covid + on 11-4-2021, vaccine dates 1-20-2021, 2-10-2021 and 9-23-2021
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient found Covid + on 11-4-2021, vaccine dates 1-20-2021, 2-10-2021 and 9-23-2021
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: +COVID 19 test Cough Shortness of breath
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: +COVID 19 test Cough Shortness of breath
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Papule, Pruritus, Rash
Clinical narrative: Developed rash on left clavicle, left side of throat; two papules on cheek; itchiness on the clavicle and on her face; Other vaccine same date vaccine date 18Nov2021; Other vaccine same date vaccine date 18Nov2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). A 9-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 18Nov2021 13:15 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA) Sanofi, administered in arm right, administration date 18Nov2021 (Lot number: UJ778aa) as dose 1, single.  The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "allergies:Cephalexin". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 18Nov2021";  RASH (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "Developed rash on left clavicle, left side of throat"; PAPULE (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "two papules on cheek"; PRURITUS (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "itchiness on the clavicle and on her face". Therapeutic measures were taken as a result of rash, papule, pruritus.  Treatment included diphenhydramine (Benadryl and hydrocortisone cream. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Off label use, Papule, Product use issue, Pruritus, Rash
Clinical narrative: Developed rash on left clavicle, left side of throat; two papules on cheek; itchiness on the clavicle and on her face; Other vaccine same date vaccine date 18Nov2021; Other vaccine same date vaccine date 18Nov2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). A 9-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 18Nov2021 13:15 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA) Sanofi, administered in arm right, administration date 18Nov2021 (Lot number: UJ778aa) as dose 1, single.  The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "allergies:Cephalexin". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 18Nov2021";  RASH (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "Developed rash on left clavicle, left side of throat"; PAPULE (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "two papules on cheek"; PRURITUS (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "itchiness on the clavicle and on her face". Therapeutic measures were taken as a result of rash, papule, pruritus.  Treatment included diphenhydramine (Benadryl and hydrocortisone cream. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 2019 novel Coronavirus RNA detected 11/08/2021. Diagnosed with pneumonia and ARDS.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, COVID-19, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: 2019 novel Coronavirus RNA detected 11/08/2021. Diagnosed with pneumonia and ARDS.
Age: 26.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report received from contactable Pharmacist from medical information team.  A 26 year-old male patient received full first dose of bnt162b2 (COMIRNATY) adult formulation (purple cap), administered in arm left, administration date 24Nov2021 at about noon (Lot number: FJ1620, Expiration Date: Feb2022, NDC number of Purple Cap: 59267100001) at the age of 26 years as dose 1, 0.3ml single for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), administered in arm right, administration date 24Nov2021 (Lot number: 308451, Expiration Date: Jun2022, NDC number: 7046132104) as 0.5 ml, single for immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 24Nov2021, outcome "recovered" (24Nov2021), described as "passed out". The patient received first dose of Pfizer BioNTech COVID19 Vaccine Purple Cap along with the flu shot. The Pharmacist was not 100% sure when the patient passed out, but it was about 10 minutes after. Relevant tests was none. The event did not require a visit to Emergency Room or Physician Office. His parents picked him up and he did not go to the hospital and seemed fine.; Sender's Comments: As there is limited information in the case provided, the causal association between the event - loss of consciousness and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had an appointment to receive a flu shot; instead I received a 4th (FOURTH) dose of the Pfizer COVID-19 vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: I had an appointment to receive a flu shot; instead I received a 4th (FOURTH) dose of the Pfizer COVID-19 vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Dizziness at 3:30am 12/2; Redness/Pain at injection site 12/2; Redness/Pain at injection site 12/2; This is a spontaneous report from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 12-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 09:00 (Lot number: FJ1611) at the age of 12 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: 32030BD, Route of administration: unknown, Anatomical site: Left arm, Administration time: 09:45), administration date: 10Nov2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 02Dec2021 at 03:30, outcome "recovering", described as "Dizziness at 3:30am 12/2"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 02Dec2021, outcome "recovering", and all described as "Redness/Pain at injection site 12/2". Therapeutic measures were not taken as a result of dizziness, vaccination site erythema and vaccination site pain.  Additional Information: The patient's known allergies were reported as not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site pain
Clinical narrative: Dizziness at 3:30am 12/2; Redness/Pain at injection site 12/2; Redness/Pain at injection site 12/2; This is a spontaneous report from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 12-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 09:00 (Lot number: FJ1611) at the age of 12 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: 32030BD, Route of administration: unknown, Anatomical site: Left arm, Administration time: 09:45), administration date: 10Nov2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 02Dec2021 at 03:30, outcome "recovering", described as "Dizziness at 3:30am 12/2"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 02Dec2021, outcome "recovering", and all described as "Redness/Pain at injection site 12/2". Therapeutic measures were not taken as a result of dizziness, vaccination site erythema and vaccination site pain.  Additional Information: The patient's known allergies were reported as not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Influenza like illness, Laboratory test
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute left ventricular failure, Arteriogram coronary normal, Brain natriuretic peptide increased, Cardiac imaging procedure abnormal, Catheterisation cardiac normal
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Left ventricular dysfunction
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial oedema, Myocarditis, Nausea, Right ventricular dysfunction, Troponin T increased
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular hypokinesia, Vomiting
Clinical narrative: Chest pain, shortness of breath, nausea, vomiting starting the day following the vaccination.  Found to have new onset acute systolic heart failure with ejection fraction of 22%. A cardiac catheterization was pursued revealing normal coronary arteries. Cardiac MRI confirmed the suspected diagnosis of myocarditis.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain in extremity, Somnolence
Clinical narrative: Arm was a little sore; Arm was a little sore/Arm was a little sore was reported as worsened; numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb; Woozy; A Little Sleepy/she slept a little more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Arm was a little sore"; CONDITION AGGRAVATED (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Arm was a little sore/Arm was a little sore was reported as worsened"; HYPOAESTHESIA (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb"; DIZZINESS (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "Woozy"; SOMNOLENCE (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "A Little Sleepy/she slept a little more". Additional information: Patient states that she got the first dose yesterday, 01Mar2021 and within an hour her right arm was a little sore and then she felt numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb. It was reported that it went away maybe after 2-3 hours. Today (02Mar2021), her right arm is a little sore, which is to be expected. And she want to know if that is normal? She states that she doesn't want to get any neurological problems if she gets the second vaccine. Also states that she was a little sleepy and woozy after the vaccine but is better. She states that she slept a little more yesterday. And also clarifies that the only thing she is still experiencing is a sore arm. PCP Information: Declines to Provide. Caller clarifies that the numbness in her jaw felt like a numbing sensation that you would get at the dentist after anaesthesia. She clarifies that the numbness lasted 4-5 hours and went away. Caller states that she is a Restaurant Worker and that is why she got the vaccine; she doesn't even get the flu shot. Caller declines further questions at this time and requests to be transferred to Medical Information to have her question answered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Hypoaesthesia, Pain in extremity, Somnolence
Clinical narrative: Arm was a little sore; Arm was a little sore/Arm was a little sore was reported as worsened; numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb; Woozy; A Little Sleepy/she slept a little more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Arm was a little sore"; CONDITION AGGRAVATED (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Arm was a little sore/Arm was a little sore was reported as worsened"; HYPOAESTHESIA (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb"; DIZZINESS (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "Woozy"; SOMNOLENCE (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "A Little Sleepy/she slept a little more". Additional information: Patient states that she got the first dose yesterday, 01Mar2021 and within an hour her right arm was a little sore and then she felt numbness under her right arm and under the right side of her neck and the right part of her jaw felt numb. It was reported that it went away maybe after 2-3 hours. Today (02Mar2021), her right arm is a little sore, which is to be expected. And she want to know if that is normal? She states that she doesn't want to get any neurological problems if she gets the second vaccine. Also states that she was a little sleepy and woozy after the vaccine but is better. She states that she slept a little more yesterday. And also clarifies that the only thing she is still experiencing is a sore arm. PCP Information: Declines to Provide. Caller clarifies that the numbness in her jaw felt like a numbing sensation that you would get at the dentist after anaesthesia. She clarifies that the numbness lasted 4-5 hours and went away. Caller states that she is a Restaurant Worker and that is why she got the vaccine; she doesn't even get the flu shot. Caller declines further questions at this time and requests to be transferred to Medical Information to have her question answered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Discomfort, Gait disturbance
Clinical narrative: Angina; Patient had palpitations; Patient has chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Patient had palpitations), CHEST PAIN (Patient has chest pain) and ANGINA PECTORIS (Angina) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included AMLODIPINE and METOPROLOL for Blood pressure, SIMVASTATIN for Cholesterol.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (Patient had palpitations) (seriousness criterion hospitalization) and CHEST PAIN (Patient has chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANGINA PECTORIS (Angina) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Apr-2021 due to ANGINA PECTORIS, CHEST PAIN and PALPITATIONS. The patient was treated with HEPARIN for Heart attack, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Patient had palpitations), CHEST PAIN (Patient has chest pain) and ANGINA PECTORIS (Angina) outcome was unknown.            This is a spontaneous case concerning a 71-year-old male patient with hypercholesterolemia and hypertension, who experienced the serious  unexpected events chest pain, palpitations and angina. Patient was hospitalized for two days 10 days after the second  dose of mRNA-1273 due to chest pain and palpitations. Catheterization was performed and was diagnosed as "angina" and treated with heparin.  The medical history of hypertension and hypercholesterolemia could be a potentially confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Non-drug treatment included was catheterization. He begins to suspect that it was a symptom of myocarditis or pericarditis, for which he wants to know if he should put on the booster since he did not want to suffer the same symptoms again.   This case was linked to MOD-2021-399928 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient with hypercholesterolemia and hypertension, who experienced the serious  unexpected events chest pain, palpitations and angina. Patient was hospitalized for two days 10 days after the second  dose of mRNA-1273 due to chest pain and palpitations. Catheterization was performed and was diagnosed as "angina" and treated with heparin.  The medical history of hypertension and hypercholesterolemia could be a potentially confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Catheterisation cardiac abnormal, Chest pain, Palpitations
Clinical narrative: Angina; Patient had palpitations; Patient has chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Patient had palpitations), CHEST PAIN (Patient has chest pain) and ANGINA PECTORIS (Angina) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included AMLODIPINE and METOPROLOL for Blood pressure, SIMVASTATIN for Cholesterol.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (Patient had palpitations) (seriousness criterion hospitalization) and CHEST PAIN (Patient has chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANGINA PECTORIS (Angina) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Apr-2021 due to ANGINA PECTORIS, CHEST PAIN and PALPITATIONS. The patient was treated with HEPARIN for Heart attack, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Patient had palpitations), CHEST PAIN (Patient has chest pain) and ANGINA PECTORIS (Angina) outcome was unknown.            This is a spontaneous case concerning a 71-year-old male patient with hypercholesterolemia and hypertension, who experienced the serious  unexpected events chest pain, palpitations and angina. Patient was hospitalized for two days 10 days after the second  dose of mRNA-1273 due to chest pain and palpitations. Catheterization was performed and was diagnosed as "angina" and treated with heparin.  The medical history of hypertension and hypercholesterolemia could be a potentially confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Non-drug treatment included was catheterization. He begins to suspect that it was a symptom of myocarditis or pericarditis, for which he wants to know if he should put on the booster since he did not want to suffer the same symptoms again.   This case was linked to MOD-2021-399928 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient with hypercholesterolemia and hypertension, who experienced the serious  unexpected events chest pain, palpitations and angina. Patient was hospitalized for two days 10 days after the second  dose of mRNA-1273 due to chest pain and palpitations. Catheterization was performed and was diagnosed as "angina" and treated with heparin.  The medical history of hypertension and hypercholesterolemia could be a potentially confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Hereditary optic atrophy
Clinical narrative: Lost her vision; Leder Hereditary Optic Neuropathy (LHON); This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLINDNESS (Lost her vision) and HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS (Lost her vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Lost her vision) and HEREDITARY OPTIC ATROPHY (Leder Hereditary Optic Neuropathy (LHON)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter The doctor does not believe that it had something to do with the vaccine, but the reporter's sister states otherwise. The patient thinks that the vaccine has ignited her visual problem.  Treatment information was not reported  Company comment: This case concerns a 62-year-old, female patient, with no reported medical history, who experienced the serious, unexpected events of hereditay optic atrophy and blindness. The patient had blindness on unknown date after unspecified dose of mRNA 1273 vaccine, then 8 months after the vaccine, she was diagnosed with Leder Hereditary Optic Neuropathy (LHON) which is a genetic condition. The doctor does not believe that the vision loss was due to the vaccine, however patient thinks otherwise as she feels the vaccine ignited her condition. The rechallenge is not applicable as dose number is unknown. The genetic condition Leder Hereditary Optic Neuropathy remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient, with no reported medical history, who experienced the serious, unexpected  events of hereditay optic atrophy and blindness. The patient had blindness on unknown date after unspecified dose of mRNA 1273 vaccine, then 8 months after the vaccine, she was diagnosed with Leder Hereditary Optic Neuropathy (LHON) which is a genetic condition. The doctor does not believe that the vision loss was due to the vaccine, however patient thinks otherwise as she feels the vaccine ignited her condition. The rechallenge is not applicable as dose number is unknown. The genetic condition Leder Hereditary Optic Neuropathy remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation, Sleep disorder
Clinical narrative: scratch marks all over; Keeps me up at night; It got so irritating; itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body), SCRATCH, SLEEP DISORDER and SKIN IRRITATION in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body). On an unknown date, the patient experienced SCRATCH, SLEEP DISORDER and SKIN IRRITATION. The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Itch, at an unspecified dose and frequency; GABAPENTIN for Wakefulness, at an unspecified dose and frequency and PRAMOCAINE HYDROCHLORIDE (CERAVE ITCH RELIEF) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body) had not resolved and SCRATCH (scratch marks all over), SLEEP DISORDER (Keeps me up at night) and SKIN IRRITATION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood test: normal (normal) normal. In September 2021, Computerised tomogram: normal (normal) normal. In September 2021, Magnetic resonance imaging: normal (normal) normal.         The patient stated that he started experiencing itching at the beginning of Apr-2021. It started initially in his arms, then moved on to his stomach, and then his legs. He said that the itching was internal and not on the skin. It had gotten progressively worse and he still experiences it. The itching moves to different parts of his body. It has gotten so bad that it keeps him up at night.  The patient saw his doctor in Sep-2021.  The patient also said that he tried some over the counter creams and other treatments, none of which helped him in subsiding the itching. He tried some OTC Claritin and allergy medicines, which didn't work, Gabapentin - doesn't help itching, helped him sleep, and Cerave itch relieving moisturizing cream - didn't work.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Pain very unbearable/pain wont go away ever since Day 1; Severe muscle ache left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain very unbearable/pain wont go away ever since Day 1) and MYALGIA (Severe muscle ache left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 010M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Severe muscle ache left arm). On an unknown date, the patient experienced PAIN (Pain very unbearable/pain wont go away ever since Day 1). At the time of the report, PAIN (Pain very unbearable/pain wont go away ever since Day 1) outcome was unknown and MYALGIA (Severe muscle ache left arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product information was not provided. Treatment information was not provided. Patient had hold his arm close to chest just to relieve the pain.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Like tiredness and he can't get over that/ real real tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Like tiredness and he can't get over that/ real real tired) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Like tiredness and he can't get over that/ real real tired). At the time of the report, FATIGUE (Like tiredness and he can't get over that/ real real tired) had not resolved.            No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Administered GARDASIL 9 following a non-supported temperature excursion; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 03-NOV-2021, the patient was vaccinated with a non-supported temperature excursion (improperly stored dose) (product storage error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number U007652, and expiration date 14-APR-2023 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of -0.45 degrees Celsius (°C) for 1 hour. There was previous excursions reported of 0 °C for 3 hours.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA002695:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 03-NOV-2021, the patient was vaccinated with a non-supported temperature excursion (improperly stored dose) (product storage error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number T030749 and expiration date 16-MAR-2023 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of -0.45 degrees Celsius (°C) for 1 hour. There was previous excursions reported of 0 °C for 3 hours. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2111USA002691.
Age: 75.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: GARDASIL 9 was administered to a 75 year old patient due to recurrent abnormal pap smears; GARDASIL 9 was administered to a 75 year old patient due to recurrent abnormal pap smears; This spontaneous report was received from an office manager referring to a 75 years old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.  On an unknown date, the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) due to recurrent abnormal pap smears (Product use in unapproved indication, Inappropriate age at vaccine administration).   The reporter could not confirm if the product was not administered and did not have any patient information. The reporter did not have any further information at this time.
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Headache, Myalgia
Clinical narrative: This literature marketed report has been received from authors of the literature article entitled as stated above and refers to a 52-year-old African American female with end-stage renal disease on dialysis with a medical history of obesity, obstructive sleep apnea, antiphospholipid syndrome, bilateral pulmonary emboli, and multiple deep venous thrombosis presented to the dialysis unit with 5 days of headache, myalgia, and progressive shortness of breath. No information regarding the patient's reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (recombinant) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had not mounted an antibody response. The outcome of the event was unknown. The author considered the event to be related to suspect vaccine. This is one of two reports derived from the same literature article. A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: patient received a second dose PNEUMOVAX 23 2 years after receiving her first dose; now can't lift arm; arm (...) throbbing; her arm feels hot; swelling; This spontaneous report was received from a pharmacist and refers to a 47-year-old female patient. Her pertinent medical history included hypertension. Concomitant therapies included influenza vaccine (reported as "flu shot'). She had no drug reactions or allergies.  On an unknown date in approximately 2019 (reported as 2 years ago), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, via intramuscular route (injection site, lot # and expiration date were not reported) for prophylaxis. On an unknown date in approximately 2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe injection, 0.5 milliliter, via intramuscular route, lot # U003306, expiration date 15-OCT-2022 (injection site was not reported) for prophylaxis (inappropriate schedule of vaccine administered).   On 05-NOV-2021 (also reported as "now"), the patient could not lift arm, her arm felt hot, and was swelling and throbbing. No treatment was given fo the adverse events and no lab diagnostics and studies were performed. The patient sought medical attention. The outcome of the events was reported as not recovered. There was no causality assessment provided by the reporter.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: The patient supposed to receive V ARlV AX and MMR II but the patient received V ARlV AX and PROQUAD; The patient supposed to receive V ARlV AX and MMR II but the patient received V ARlV AX and PROQUAD; This spontaneous report as received from a Licensed Practical Nurse refers to a 13-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-NOV-2021, the patient was supposed to receive varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) but due to human error the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032932 was confirmed to be valid, expiration date 28-SEP-2022, 0.5 milliliter once (route of administration, anatomical location were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter once (route of administration, anatomical location, lot # and expiration date were not reported); both for prophylaxis (wrong product administered and accidental overdose).