chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: full adult dose was administered; grandchildren accidentally received Pfizer covid vaccine first dose instead of Flu vaccine; headache; right arm hurts; This is a spontaneous report from a contactable consumer (patients's grandmother) via medical information team. This is the second of two reports. A 5-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right, at age 5 years, on 04Oct2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; and influenza vaccine (FLU VACCINE), via an unspecified route of administration from 04Oct2021 (Batch/Lot number was not reported) to 04Oct2021, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Relevant medical history includes ADHD but patient have not been diagnosed with that. She reports she is small for her age. The patient's concomitant medications were none. The patient historically received flu vaccine every year for immunization and was whiny or feeling bad after. The patient's grandmother reported that the 5-year-old female grandchild accidentally received Pfizer COVID vaccine first dose instead of flu vaccine on 04Oct2021 around 4pm at redacted. On the night of 04Oct2021, the patient went for flu vaccines and received the Pfizer COVID 19 vaccine instead. The patient received a full adult dose. Card was not given because the pharmacy believed the flu vaccine had been given not the COVID-19 vaccine. The pharmacy called about an hour and a half after the vaccines were given to let the mother know a mistake had been made. The patient experienced sore arm/right arm hurt and headache in 2021. The reporter was reaching out to Pfizer because poison control, the pediatrician, and the emergency department didn't know what to do. The reporter was advised to just keep an eye on the child. The reporter stated that the patient's mother has been keeping the patient pumped full of Tylenol. Giving the child Tylenol was the only suggestion that was given when calling for advice last night. No emergency room and physician office visit required. Vaccination Facility Type was at a pharmacy or drug store, . The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101316635 same reporter/drug, similar events, different patients
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain, Wrong product administered
Clinical narrative: full adult dose was administered; grandchildren accidentally received Pfizer covid vaccine first dose instead of Flu vaccine; headache; right arm hurts; This is a spontaneous report from a contactable consumer (patients's grandmother) via medical information team. This is the second of two reports. A 5-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right, at age 5 years, on 04Oct2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; and influenza vaccine (FLU VACCINE), via an unspecified route of administration from 04Oct2021 (Batch/Lot number was not reported) to 04Oct2021, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Relevant medical history includes ADHD but patient have not been diagnosed with that. She reports she is small for her age. The patient's concomitant medications were none. The patient historically received flu vaccine every year for immunization and was whiny or feeling bad after. The patient's grandmother reported that the 5-year-old female grandchild accidentally received Pfizer COVID vaccine first dose instead of flu vaccine on 04Oct2021 around 4pm at redacted. On the night of 04Oct2021, the patient went for flu vaccines and received the Pfizer COVID 19 vaccine instead. The patient received a full adult dose. Card was not given because the pharmacy believed the flu vaccine had been given not the COVID-19 vaccine. The pharmacy called about an hour and a half after the vaccines were given to let the mother know a mistake had been made. The patient experienced sore arm/right arm hurt and headache in 2021. The reporter was reaching out to Pfizer because poison control, the pediatrician, and the emergency department didn't know what to do. The reporter was advised to just keep an eye on the child. The reporter stated that the patient's mother has been keeping the patient pumped full of Tylenol. Giving the child Tylenol was the only suggestion that was given when calling for advice last night. No emergency room and physician office visit required. Vaccination Facility Type was at a pharmacy or drug store, . The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101316635 same reporter/drug, similar events, different patients
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out in clumps
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Visual impairment
Clinical narrative: Approximately 11 minutes after administration of the first dose of the Pfizer COVID 19 vaccine, I became lightheaded, dizzy, and clammy. I was sitting on a chair and was able to maneuver my way to a lying position on the floor. Periodically I attempted to rise to a sitting position, but continued to feel dizzy and lightheaded and was unable to sit for more than a couple minutes. This continued for approximately one and a half hours. The Dr. quickly assessed me to make sure that my heart rate was normal. I did not have any shortness of breath. Dr. recommended I go to the ER since the episode was lasting for an extended period of time.  I went to the ER and waited there for about 45 minutes before I left, as I was able to stand and walk out without feeling dizzy or lightheaded.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dizziness, Visual impairment
Clinical narrative: Approximately 11 minutes after administration of the first dose of the Pfizer COVID 19 vaccine, I became lightheaded, dizzy, and clammy. I was sitting on a chair and was able to maneuver my way to a lying position on the floor. Periodically I attempted to rise to a sitting position, but continued to feel dizzy and lightheaded and was unable to sit for more than a couple minutes. This continued for approximately one and a half hours. The Dr. quickly assessed me to make sure that my heart rate was normal. I did not have any shortness of breath. Dr. recommended I go to the ER since the episode was lasting for an extended period of time.  I went to the ER and waited there for about 45 minutes before I left, as I was able to stand and walk out without feeling dizzy or lightheaded.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: Approximately 11 minutes after administration of the first dose of the Pfizer COVID 19 vaccine, I became lightheaded, dizzy, and clammy. I was sitting on a chair and was able to maneuver my way to a lying position on the floor. Periodically I attempted to rise to a sitting position, but continued to feel dizzy and lightheaded and was unable to sit for more than a couple minutes. This continued for approximately one and a half hours. The Dr. quickly assessed me to make sure that my heart rate was normal. I did not have any shortness of breath. Dr. recommended I go to the ER since the episode was lasting for an extended period of time.  I went to the ER and waited there for about 45 minutes before I left, as I was able to stand and walk out without feeling dizzy or lightheaded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Immunodeficiency, Tachycardia
Clinical narrative: Evening starting with tachycardia and was in atrial fibrillation. ECG done to confirm; Evening starting with tachycardia and was in atrial fibrillation. ECG done to confirm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 56-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 27Oct2021 at 13:30 (Lot Number: 30145BA) (at the age of 56-year-old) as single dose for COVID-19 immunisation.  The patient medical history was not reported. No known allergies. The patient did not experienced COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. Concomitant medications included apixaban (ELIQUIS); metoprolol and pravastatin, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 administered in arm left on 27Feb2021 at 10:00 (Batch/Lot Number: EN6198) (at the age of 56-year-old) and dose 1 administered in arm left on 06Feb2021 (Batch/Lot Number: EL9264) (at the age of 56-year-old), both as single dose for COVID-19 immunisation. The clinical course was reported as follows: got booster in afternoon. Feeling great prior. Evening (on 27Oct2021 at 20:00) starting with tachycardia and was in atrial fibrillation. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included electrocardiogram (ECG): tachycardia and was in atrial fibrillation. The patient outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Tachycardia
Clinical narrative: Evening starting with tachycardia and was in atrial fibrillation. ECG done to confirm; Evening starting with tachycardia and was in atrial fibrillation. ECG done to confirm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 56-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 27Oct2021 at 13:30 (Lot Number: 30145BA) (at the age of 56-year-old) as single dose for COVID-19 immunisation.  The patient medical history was not reported. No known allergies. The patient did not experienced COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. Concomitant medications included apixaban (ELIQUIS); metoprolol and pravastatin, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 administered in arm left on 27Feb2021 at 10:00 (Batch/Lot Number: EN6198) (at the age of 56-year-old) and dose 1 administered in arm left on 06Feb2021 (Batch/Lot Number: EL9264) (at the age of 56-year-old), both as single dose for COVID-19 immunisation. The clinical course was reported as follows: got booster in afternoon. Feeling great prior. Evening (on 27Oct2021 at 20:00) starting with tachycardia and was in atrial fibrillation. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included electrocardiogram (ECG): tachycardia and was in atrial fibrillation. The patient outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenopia, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Multiple sclerosis, Ocular discomfort
Clinical narrative: Optic Neuritis of the right eye; Multiple sclerosis with 2 lesions; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533) via an unspecified route of administration, administered in left arm on 23Apr2021 16:00 (55-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included allergy. There were no known allergies for past drug. Concomitant medications (patient received within 2 weeks of vaccination) included rosuvastatin and unspecified vitamins. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) administered in left arm on 02Apr2021 16:30 (55-year-old at time of vaccination) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Jul2021 the patient was diagnosed with optic neuritis of the right eye and MRI identified multiple sclerosis with 2 lesions.  The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for the events for 6 days (Seriousness criteria: Caused hospitalization). The patient underwent MRIs and spinal tap. Treatment received for the events included high dose of IV Steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Optic neuritis, Scan with contrast abnormal, Visual impairment, White matter lesion
Clinical narrative: Optic Neuritis of the right eye; Multiple sclerosis with 2 lesions; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533) via an unspecified route of administration, administered in left arm on 23Apr2021 16:00 (55-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included allergy. There were no known allergies for past drug. Concomitant medications (patient received within 2 weeks of vaccination) included rosuvastatin and unspecified vitamins. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) administered in left arm on 02Apr2021 16:30 (55-year-old at time of vaccination) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Jul2021 the patient was diagnosed with optic neuritis of the right eye and MRI identified multiple sclerosis with 2 lesions.  The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for the events for 6 days (Seriousness criteria: Caused hospitalization). The patient underwent MRIs and spinal tap. Treatment received for the events included high dose of IV Steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Multiple sclerosis, Optic neuritis
Clinical narrative: Optic Neuritis of the right eye; Multiple sclerosis with 2 lesions; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533) via an unspecified route of administration, administered in left arm on 23Apr2021 16:00 (55-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included allergy. There were no known allergies for past drug. Concomitant medications (patient received within 2 weeks of vaccination) included rosuvastatin and unspecified vitamins. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) administered in left arm on 02Apr2021 16:30 (55-year-old at time of vaccination) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Jul2021 the patient was diagnosed with optic neuritis of the right eye and MRI identified multiple sclerosis with 2 lesions.  The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for the events for 6 days (Seriousness criteria: Caused hospitalization). The patient underwent MRIs and spinal tap. Treatment received for the events included high dose of IV Steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, COVID-19, SARS-CoV-2 test positive
Clinical narrative: diagnosed with COVID was unable to say when his symptoms had begun. did become hypoxic and febrile during his hospitalization. He was treated with a 10 day course of dexamethasone for COVID pneumonia. He did receive remdesivir on 11/2/21, as well. He had a new oxygen requirement of 2L at the time of his discharge. He declined going to a skilled nursing facility despite requiring 2-person assist.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Hypoxia, Malaise, Mobility decreased
Clinical narrative: diagnosed with COVID was unable to say when his symptoms had begun. did become hypoxic and febrile during his hospitalization. He was treated with a 10 day course of dexamethasone for COVID pneumonia. He did receive remdesivir on 11/2/21, as well. He had a new oxygen requirement of 2L at the time of his discharge. He declined going to a skilled nursing facility despite requiring 2-person assist.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: diagnosed with COVID was unable to say when his symptoms had begun. did become hypoxic and febrile during his hospitalization. He was treated with a 10 day course of dexamethasone for COVID pneumonia. He did receive remdesivir on 11/2/21, as well. He had a new oxygen requirement of 2L at the time of his discharge. He declined going to a skilled nursing facility despite requiring 2-person assist.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, SARS-CoV-2 test positive
Clinical narrative: diagnosed with COVID was unable to say when his symptoms had begun. did become hypoxic and febrile during his hospitalization. He was treated with a 10 day course of dexamethasone for COVID pneumonia. He did receive remdesivir on 11/2/21, as well. He had a new oxygen requirement of 2L at the time of his discharge. He declined going to a skilled nursing facility despite requiring 2-person assist.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Eye swelling
Clinical narrative: Patient received 2nd dose of pfizer-BNT COVID vaccine and 20 minutes after the injection developed "itching and throat swelling" EMS was called. Patient was given 50mg PO diphenhydramine and 0.3 mg IM epinephrine. Patient was still symptomatic upon arrival to the ECC. Patient was given IV 20 mg famotidine and 125 mg of methylprednisolone and observed for 3 hours. Symptoms had improved at that time, and sent home with PO prednisone.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pruritus, Swelling face, Swollen tongue, Throat irritation
Clinical narrative: Patient received 2nd dose of pfizer-BNT COVID vaccine and 20 minutes after the injection developed "itching and throat swelling" EMS was called. Patient was given 50mg PO diphenhydramine and 0.3 mg IM epinephrine. Patient was still symptomatic upon arrival to the ECC. Patient was given IV 20 mg famotidine and 125 mg of methylprednisolone and observed for 3 hours. Symptoms had improved at that time, and sent home with PO prednisone.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Patient received 2nd dose of pfizer-BNT COVID vaccine and 20 minutes after the injection developed "itching and throat swelling" EMS was called. Patient was given 50mg PO diphenhydramine and 0.3 mg IM epinephrine. Patient was still symptomatic upon arrival to the ECC. Patient was given IV 20 mg famotidine and 125 mg of methylprednisolone and observed for 3 hours. Symptoms had improved at that time, and sent home with PO prednisone.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pharyngeal swelling, Throat irritation
Clinical narrative: Patient received 2nd dose of pfizer-BNT COVID vaccine and 20 minutes after the injection developed "itching and throat swelling" EMS was called. Patient was given 50mg PO diphenhydramine and 0.3 mg IM epinephrine. Patient was still symptomatic upon arrival to the ECC. Patient was given IV 20 mg famotidine and 125 mg of methylprednisolone and observed for 3 hours. Symptoms had improved at that time, and sent home with PO prednisone.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: There was no adverse event however a 5 yo received a shot for 12 and over. According to protocol vaers needs to be notified
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There was no adverse event however a 5 yo received a shot for 12 and over. According to protocol vaers needs to be notified
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Injection site swelling
Clinical narrative: As soon as needle went into my arm, started dripping blood. Person administering shot kept wiping blood off my arm. As soon as I left the booth my partner noticed the injection site was raised like a bump. I started feeling ?off?- hot/ sweaty. Passed out. Came to. Passed out again. Ambulance took me to the local Hospital. I was released after about 3 hours
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: As soon as needle went into my arm, started dripping blood. Person administering shot kept wiping blood off my arm. As soon as I left the booth my partner noticed the injection site was raised like a bump. I started feeling ?off?- hot/ sweaty. Passed out. Came to. Passed out again. Ambulance took me to the local Hospital. I was released after about 3 hours
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Electrocardiogram normal, Feeling abnormal, Feeling hot
Clinical narrative: As soon as needle went into my arm, started dripping blood. Person administering shot kept wiping blood off my arm. As soon as I left the booth my partner noticed the injection site was raised like a bump. I started feeling ?off?- hot/ sweaty. Passed out. Came to. Passed out again. Ambulance took me to the local Hospital. I was released after about 3 hours
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Injection site haemorrhage, Injection site swelling, Loss of consciousness, SARS-CoV-2 test negative
Clinical narrative: As soon as needle went into my arm, started dripping blood. Person administering shot kept wiping blood off my arm. As soon as I left the booth my partner noticed the injection site was raised like a bump. I started feeling ?off?- hot/ sweaty. Passed out. Came to. Passed out again. Ambulance took me to the local Hospital. I was released after about 3 hours
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Dizziness, Dyspnoea, Laboratory test normal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Pt. states that after receiving the 3rd Booster of Phizer 11/08/2021 (High-Dose Influenza also) , started experiencing symptoms 10 minutes after of fainting *few seconds. Paramedics evaluated *BP, EKG transported to local Emergency Room Department for observation. Discharged 2 hours after evaluation = Normal. Still experiencing fatigue with no other underlying symptoms. Primary visit scheduled for Follow-Up 11/12/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Electrocardiogram, Fatigue, Syncope
Clinical narrative: Pt. states that after receiving the 3rd Booster of Phizer 11/08/2021 (High-Dose Influenza also) , started experiencing symptoms 10 minutes after of fainting *few seconds. Paramedics evaluated *BP, EKG transported to local Emergency Room Department for observation. Discharged 2 hours after evaluation = Normal. Still experiencing fatigue with no other underlying symptoms. Primary visit scheduled for Follow-Up 11/12/2021.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FC3184), via intramuscular route on 02Sep2021 (at the age of 41-year-old) as dose 3 (booster), single dose, and dose 1 via intramuscular route on 23Feb2021 (Batch/Lot Number: EL3247) as dose 1, single and dose 2 via intramuscular route on 17Mar2021 (Batch/Lot Number: EN6203) as dose 2, single, all the doses for COVID-19 immunisation. Medical history included vitiligo and Hashimoto's thyroiditis. Concomitant medication included tofacitinib citrate (XELJANZ). On 27Oct2021, the patient was positive COVID-19 test with symptoms i.e. fever, headaches, sore throat, cough, cold, chills, sinus pain, sinus pressure, dizziness lasting more than a week. The patient went to doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: fever on 27Oct2021, RT-PCR (SARS-COV-2 test): positive on 28Oct2021 via nasal swab. As therapeutic measure Sotrovimab was taken as a result for the reported event. The outcome was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Death, Headache, Malaise, Myocardial infarction, Pain in extremity
Clinical narrative: CLIENT COMPLAINED OF RIGHT CALF PAIN THAT STARTED 11/2/21 NIGHT, HE TOLD HIS DOCTOR HE HAD A BLOOD CLOT LAST YEAR PER MEDICAL RECORD. CLIENT WAS WALKING IN TO SEE HIS  DOCTOR WHEN HE COLLAPSED AFTER CPR AND 4 ROUNDS OF EPINEPHRINE CLIENT TIME OF DEATH 11:34 A.M.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Pulmonary embolism, Syncope
Clinical narrative: CLIENT COMPLAINED OF RIGHT CALF PAIN THAT STARTED 11/2/21 NIGHT, HE TOLD HIS DOCTOR HE HAD A BLOOD CLOT LAST YEAR PER MEDICAL RECORD. CLIENT WAS WALKING IN TO SEE HIS  DOCTOR WHEN HE COLLAPSED AFTER CPR AND 4 ROUNDS OF EPINEPHRINE CLIENT TIME OF DEATH 11:34 A.M.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Death, Pain in extremity, Resuscitation, Syncope
Clinical narrative: CLIENT COMPLAINED OF RIGHT CALF PAIN THAT STARTED 11/2/21 NIGHT, HE TOLD HIS DOCTOR HE HAD A BLOOD CLOT LAST YEAR PER MEDICAL RECORD. CLIENT WAS WALKING IN TO SEE HIS  DOCTOR WHEN HE COLLAPSED AFTER CPR AND 4 ROUNDS OF EPINEPHRINE CLIENT TIME OF DEATH 11:34 A.M.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling hot, Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain
Clinical narrative: small cellulite in area of injection red; pain to the touch; small cellulite in area of injection red; Saturday a little hot; after 24 hours discomfort on the body with slight punches on the skin; This is a spontaneous report from a contactable Nurse. This 51-year-old male nurse (patient) reported for himself. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841) via an intramuscular route, administered in Arm Left on an unspecified date (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included Allergic rhinitis sinusitis and the patient previously received clinoril and skelaxine experienced drug hypersensitivity. Concomitant medications included influenza vaccine inact split 4v (FLUARIX QUADRIVALENT, Lot number: NDC: 58160-0887-52) taken for an unspecified indication in the left arm on 29Sep2021 and multivitamin ascorbic acid (VITAMIN C) 1000 mg and free move taken for an unspecified indication. Prior to vaccination, patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19. On 21Oct2021 at 11:00, after 24 hours patient experienced discomfort on the body with slight punches on the skin and then it went away with Tylenol in the night but on the third day (unspecified date) small cellulite in area of the injection red with pain to the touch and on 23Oct2021 today Saturday a little hot, but it was already disappearing the red in the injection area only pain to the touch. Patient did not receive any treatment for the events except after 24 hours discomfort on the body with slight punches on the skin for which patient took Tylenol. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was administered from open vial of over 12 hours being opened.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from open vial of over 12 hours being opened.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     The patient's past medical history included Esophageal varices, Pancreatic cancer and Esophagitis. Concurrent medical conditions included Anemia.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from open vial of over 12 hours being opened.). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from open vial of over 12 hours being opened.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was administered Moderna vaccine from a vial having been opened for over 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder and Impaired fasting glucose.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Was administered Moderna vaccine from a vial having been opened for over 12 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was administered from a vial having been opened for over 12 hours.; Moderna vaccine was administered from a vial having been opened for over 12 hours.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction, Hypothyroidism, Colon operation, Wrist fracture and Gastric ulcer (Over 20 years ago.). Concurrent medical conditions included Hypertension, Diabetes, Hyperlipidemia, Obesity, GERD, Insomnia, Lipoma, After-cataract and Diverticulosis.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 01-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.). On 01-Nov-2021, PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information provided. Patient age over 65, Immunocompromised
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was administered from a vial having been opened for over 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; No adverse event; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T030707, expiration date: 14-APR-2023 (dose number, dose and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA001290: US-009507513-2110USA003605: US-009507513-2110USA003604: US-009507513-2110USA003603: US-009507513-2110USA003602: US-009507513-2110USA003601: US-009507513-2110USA003599:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; No adverse event; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T030707, expiration date: 14-APR-2023 (dose number, dose and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2110USA003602: US-009507513-2110USA003603: US-009507513-2110USA003604: US-009507513-2110USA003605: US-009507513-2110USA003599: US-009507513-2109USA001290:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; No adverse event; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T030707, expiration date: 14-APR-2023 (dose number, dose and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2110USA003601: US-009507513-2110USA003603: US-009507513-2110USA003604: US-009507513-2110USA003605: US-009507513-2110USA003599: US-009507513-2109USA001290:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; an expired dose of PNEUMOV AX 23 was administered today/expired vaccine administered; This spontaneous report was received from a nurse, referring to a 72-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 13-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T021329 was confirmed to be valid, expiry date 03-OCT-2021 (route of administration, vaccination site were not specified) for prophylaxis. No additional adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 03-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot number: U002534, expiration date: 24-JUL-2022, for prophylaxis (route of administration was not provided) after a temperature excursion occurred (incorrect product storage).   The vaccine experienced temperature excursion of 10.7 degree Fahrenheit for 30 minutes on an unknown date, and of 6 to 14 degree Fahrenheit for 9 hours and 15 minutes, 14 degree Fahrenheit to 46 degree Fahrenheit for 1 hour and 45 minutes on 23-JUL-2021.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: consumer did not receive his 3rd dose per prescribing information (PI) recommendations and is now requesting the 3rd dose today; No additional adverse events reported; This spontaneous report was received from a Nurse Practitioner (NP) and refers to a currently 70-year-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in September 2019, the patient was vaccinated with the first dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX)1 ml, (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in October 2019, the patient was vaccinated with the second dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX) 1 ml, (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that the consumer did not receive his 3rd dose per prescribing information (PI) recommendations and was then requesting the 3rd dose on 14-OCT-2021, outside the recommendations of the PI. NP stated while she was making a plan of care and calling the company for recommendations for administering the 3rd dose, the consumer grabbed his paper work and left without the 3rd dose being administered (inappropriate schedule of drug administration). No additional adverse effect was reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Allergy to vaccine, Milk allergy, Product dose omission issue
Clinical narrative: a new allergy to milk; a possible allergy alert to ROTATEQ in the patient chart due to the milk allergy; This spontaneous report was received from a pediatrician and refers to a 6-month-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unspecified date in 2021, at 2 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, dose/frequency reported as 1st dose, lot # 1741377, expiration date: 07-MAR-2022 (exact dose was not reported) for prophylaxis. At 4 months old, she received her second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, dose/frequency reported as 2nd dose, lot # 1707591, expiration date 11-MAR-2022 (exact dose was not reported) for the same indication.  On an unknown date in 2021, the patient experienced a new allergy to milk (milk allergy). The reporter stated, that they received a possible allergy alert to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (allergy to vaccine) in the patient's chart due to the milk allergy and the third dose of vaccine which was scheduled on 06-OCT-2021 was held. They were going to schedule the patient for the third dose soon so that she would still be 6-months-old at the time of the 3rd dose. It was confirmed that the patient did not have any other adverse events that occurred with the previous 2 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of allergy to milk and allergy to vaccine was unknown.  The causality assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided, however a possible allergy alert to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was considered to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Age: 59.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: no symptoms following event time; Adult Patient was inadvertently administered the V AQT A Pediatric and Adolescent Formulation; V AQT A Pediatric and Adolescent Formulation; This spontaneous report as received from a a certified medical assistant and refers to a 59-year-old patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.    On 20-SEP-2021, the patient was inadvertently vaccinated with pediatric and adolescent formulation of hepatitis a vaccine, inactivated (VAQTA) lot # T037329 was confirmed to be valid, expiry date 30-APR-2022; intramuscular in the right deltoid (exact dose was not reported for both; lot # and expiration date were not reported for the second vaccine) for prophylaxis (product administered to patient of inappropriate age and accidental overdose). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROT ATEQ that experienced a temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 18-OCT-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # T040207 was confirmed to be valid with expiration date 18-JUL-2022, 2 milliliter, orally (dose number were not provided) for prophylaxis. The temperature excursions were 33 degrees Fahrenheit for 15 minutes and 10 minutes. There were no previous excursions reported. No adverse effects were reported.