chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Cough, Dizziness, Fatigue
Clinical narrative: I began feeling symptoms on October 13, 2022.  It started as sneezing like a cold.  By Sunday my fever was 101.  I was tired, coughing, sore throat.  I was having pain in my ribs and hurt to breath because of all the sneezing.  I tested with a home test, and it was positive for COVID-19.  I called the doctor the next day and went in and tested positive as well.  I got a prescription for an inhaler with Albuterol, and Decadron I was told to talk Mucinex and Tylenol for fever.  I started Decadron on the 19th.  I started feeling a little better by the 22nd.  My company policy is that I must work back in the office, but I was allowed to work from home.  I have been feeling dizzy this week.  My fever stopped about Friday the 22nd.  As of today, I am still coughing and so tired.  I feel like I have I am on a boat and cannot keep balance, ?swimmy headed? and somewhat like vertigo but not vertigo.  I have read about COVID-19 fog and that may be what I am experiencing.  Just two months ago I changed prescriptions to Metoprolol Levocetirizine, Atryastatin and Gabapentin and stopped taking Ozempic.  I started Rybelsus last week (in the middle of my infection) but I stopped taking it and will continue after I recover.  I also started taking Lunesta.  I also wear a digital watch and noticed my heart rate went down to 40 at night.  I didn?t realize this until the next morning when I got an alert on my app.  In addition, I began checking my oxygen level would be low and the lowest it got was 93.  My cough will not go away and it is not productive, it is a dry, hacky, cough.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate decreased, Malaise, Motion sickness, Musculoskeletal chest pain
Clinical narrative: I began feeling symptoms on October 13, 2022.  It started as sneezing like a cold.  By Sunday my fever was 101.  I was tired, coughing, sore throat.  I was having pain in my ribs and hurt to breath because of all the sneezing.  I tested with a home test, and it was positive for COVID-19.  I called the doctor the next day and went in and tested positive as well.  I got a prescription for an inhaler with Albuterol, and Decadron I was told to talk Mucinex and Tylenol for fever.  I started Decadron on the 19th.  I started feeling a little better by the 22nd.  My company policy is that I must work back in the office, but I was allowed to work from home.  I have been feeling dizzy this week.  My fever stopped about Friday the 22nd.  As of today, I am still coughing and so tired.  I feel like I have I am on a boat and cannot keep balance, ?swimmy headed? and somewhat like vertigo but not vertigo.  I have read about COVID-19 fog and that may be what I am experiencing.  Just two months ago I changed prescriptions to Metoprolol Levocetirizine, Atryastatin and Gabapentin and stopped taking Ozempic.  I started Rybelsus last week (in the middle of my infection) but I stopped taking it and will continue after I recover.  I also started taking Lunesta.  I also wear a digital watch and noticed my heart rate went down to 40 at night.  I didn?t realize this until the next morning when I got an alert on my app.  In addition, I began checking my oxygen level would be low and the lowest it got was 93.  My cough will not go away and it is not productive, it is a dry, hacky, cough.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Oxygen saturation decreased, Painful respiration, Pyrexia
Clinical narrative: I began feeling symptoms on October 13, 2022.  It started as sneezing like a cold.  By Sunday my fever was 101.  I was tired, coughing, sore throat.  I was having pain in my ribs and hurt to breath because of all the sneezing.  I tested with a home test, and it was positive for COVID-19.  I called the doctor the next day and went in and tested positive as well.  I got a prescription for an inhaler with Albuterol, and Decadron I was told to talk Mucinex and Tylenol for fever.  I started Decadron on the 19th.  I started feeling a little better by the 22nd.  My company policy is that I must work back in the office, but I was allowed to work from home.  I have been feeling dizzy this week.  My fever stopped about Friday the 22nd.  As of today, I am still coughing and so tired.  I feel like I have I am on a boat and cannot keep balance, ?swimmy headed? and somewhat like vertigo but not vertigo.  I have read about COVID-19 fog and that may be what I am experiencing.  Just two months ago I changed prescriptions to Metoprolol Levocetirizine, Atryastatin and Gabapentin and stopped taking Ozempic.  I started Rybelsus last week (in the middle of my infection) but I stopped taking it and will continue after I recover.  I also started taking Lunesta.  I also wear a digital watch and noticed my heart rate went down to 40 at night.  I didn?t realize this until the next morning when I got an alert on my app.  In addition, I began checking my oxygen level would be low and the lowest it got was 93.  My cough will not go away and it is not productive, it is a dry, hacky, cough.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sneezing, Vertigo
Clinical narrative: I began feeling symptoms on October 13, 2022.  It started as sneezing like a cold.  By Sunday my fever was 101.  I was tired, coughing, sore throat.  I was having pain in my ribs and hurt to breath because of all the sneezing.  I tested with a home test, and it was positive for COVID-19.  I called the doctor the next day and went in and tested positive as well.  I got a prescription for an inhaler with Albuterol, and Decadron I was told to talk Mucinex and Tylenol for fever.  I started Decadron on the 19th.  I started feeling a little better by the 22nd.  My company policy is that I must work back in the office, but I was allowed to work from home.  I have been feeling dizzy this week.  My fever stopped about Friday the 22nd.  As of today, I am still coughing and so tired.  I feel like I have I am on a boat and cannot keep balance, ?swimmy headed? and somewhat like vertigo but not vertigo.  I have read about COVID-19 fog and that may be what I am experiencing.  Just two months ago I changed prescriptions to Metoprolol Levocetirizine, Atryastatin and Gabapentin and stopped taking Ozempic.  I started Rybelsus last week (in the middle of my infection) but I stopped taking it and will continue after I recover.  I also started taking Lunesta.  I also wear a digital watch and noticed my heart rate went down to 40 at night.  I didn?t realize this until the next morning when I got an alert on my app.  In addition, I began checking my oxygen level would be low and the lowest it got was 93.  My cough will not go away and it is not productive, it is a dry, hacky, cough.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient should have received Shingrix not Varicella. Advised by Team to vaccinate with Shingrix in 8 weeks then repeat in 2 to 6 months
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Deafness, Ear discomfort, Fatigue, Hyperacusis, Lymphadenopathy
Clinical narrative: I experienced sore throat 2 days after the dose, and swollen lymph nodes and glands on day 3, stuffy ears, postnasal drip, congestion, sinus pressure, productive cough, with fatigue and body aches. On October 20, 2022, I began to experience hearing loss, with some sounds more amplified at times. I had a visit with my physician where both ears looked normal, congestion, mucous membrane was moist, lymph glands swollen, and I was diagnosed with acute reoccurring sinusitis, and chronic pansinusitis, and was prescribed prednisone  along with cefuroxime. My symptoms have not resolved, and my hearing has not recovered yet.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Oropharyngeal pain, Pain, Paranasal sinus discomfort, Productive cough, Respiratory tract congestion
Clinical narrative: I experienced sore throat 2 days after the dose, and swollen lymph nodes and glands on day 3, stuffy ears, postnasal drip, congestion, sinus pressure, productive cough, with fatigue and body aches. On October 20, 2022, I began to experience hearing loss, with some sounds more amplified at times. I had a visit with my physician where both ears looked normal, congestion, mucous membrane was moist, lymph glands swollen, and I was diagnosed with acute reoccurring sinusitis, and chronic pansinusitis, and was prescribed prednisone  along with cefuroxime. My symptoms have not resolved, and my hearing has not recovered yet.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Sinusitis, Upper-airway cough syndrome
Clinical narrative: I experienced sore throat 2 days after the dose, and swollen lymph nodes and glands on day 3, stuffy ears, postnasal drip, congestion, sinus pressure, productive cough, with fatigue and body aches. On October 20, 2022, I began to experience hearing loss, with some sounds more amplified at times. I had a visit with my physician where both ears looked normal, congestion, mucous membrane was moist, lymph glands swollen, and I was diagnosed with acute reoccurring sinusitis, and chronic pansinusitis, and was prescribed prednisone  along with cefuroxime. My symptoms have not resolved, and my hearing has not recovered yet.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cardiogenic shock, Condition aggravated, Coronary artery disease
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 01/27/2021, 02/24/2021, and 01/06/2022. They tested positive for COVID-19 on 07/08/2022. They died on 07/21/2022. They had co-occurring conditions and complications of: cardiogenic shock, myocardial infarction, ventricular fatal defect, coronary artery disease, COVID-19 pneumonia.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Myocardial infarction, SARS-CoV-2 test positive, Vaccine breakthrough infection, Ventricular septal defect
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 01/27/2021, 02/24/2021, and 01/06/2022. They tested positive for COVID-19 on 07/08/2022. They died on 07/21/2022. They had co-occurring conditions and complications of: cardiogenic shock, myocardial infarction, ventricular fatal defect, coronary artery disease, COVID-19 pneumonia.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I received vaccine this day and put all of them in baskets and labeled and ready to give and put the wrong vaccine vial (Moderna 5-11 booster only). Patient received 0.5ml of this dose and she has been informed this was the wrong one and action has been put in to call patient to come in two months for the bivalent.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Vaccinated with Varivax. Should have been vaccinated with Shingrix. Instructed by Team to vaccinate with Shingrix in 8 weeks and 2nd dose in 2 to 6 months
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: I had persistent cough, slight fever, lots of congestion, extreme tiredness. I went to the ER and they tested me for COVID-19 and I was positive. They gave me azithromycin and a steroid.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had persistent cough, slight fever, lots of congestion, extreme tiredness. I went to the ER and they tested me for COVID-19 and I was positive. They gave me azithromycin and a steroid.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: CLIENT RCVD INCORRECT VACCINE BRAND.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: RESIDENT DEVELOPED GENERALIZED BODY RASH.MD ORDERED HYDROXYZINE 10 MG VIA GTUBE AND  HYDROCORTISONE CREAM 1% FOR 3 DAYS
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait inability, Mobility decreased, Muscular weakness
Clinical narrative: Lower body muscle weakness causing me to lie on the floor for 7 hours unable get up. Couldn't walk.  Phone was on the bed, cane was not reachable, wheelchair not reachable. My calls for help couldn't be heard. My wife came about 5:30 when we called 911.  EMT's got me off the floor into the walker & I was able to move into the living room.  Symptoms were subsiding throughout the day.  Now, after a week, I feel ok.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Continued Hives, itchiness
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Ear pain, Feeling hot, Neck pain, Pruritus
Clinical narrative: Intense itching and pain on chest, neck and inside of right ear. The pain and itching on the right side of my chest started 2 hours after injection and I felt hot. Took an antihistamine and it resolved only to come back about 8 hours later on the other side of my chest moving up on my neck to my chin and inside of the opposite side ear. Another antihistamine did not help. The doctor prescribed Benadryl, Allegra and hydrocortisone cream. He said it might be an allergic reaction to the new shot or a beginning of shingles. It has gotten better the last two days, one of which I had not taken any meds.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Tinnitus
Clinical narrative: Immediate ringing in both ears, continues to current date 1.5 years later
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Laboratory test normal, Palpitations
Clinical narrative: Heart Palpatations. Tests, blood work, medication. Still have them all test negative for heart problems.
Age: 8.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: When documenting  I realized that I had administered vaccines that were not due for this patient.   Attempts have been made to notify parents but have not been able to reach parents.  Clinic provider has been notified.   CDC was contacted and recommendation to repeat vaccines at recommended ages was advised.  Will continue to attempt to reach parents to provide that information.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered a Bivalent 12+ Covid booster to an 11-year-old
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Syncope
Clinical narrative: Patient got light headed, fainted and had an upset stomach
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cardiomegaly, Chest X-ray abnormal, Diarrhoea
Clinical narrative: Presented to ED 10/24/2022 with increased generalized weakness for past several days. Fell on the 10/13 and was seen and evaluated. Denied chest pains or shortness of breath. Reported copious amounts of diarrhea which is new for her. Complained of low-grade headache. No fevers or chills.  Submitted does not have access to any other medical records for this client. If further information is needed, please contact the Hospital.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Headache, Lung opacity, SARS-CoV-2 test positive
Clinical narrative: Presented to ED 10/24/2022 with increased generalized weakness for past several days. Fell on the 10/13 and was seen and evaluated. Denied chest pains or shortness of breath. Reported copious amounts of diarrhea which is new for her. Complained of low-grade headache. No fevers or chills.  Submitted does not have access to any other medical records for this client. If further information is needed, please contact the Hospital.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna was given 5 days post expiration date.  no treatment needed. Contacted moderna and was advice no additional shot needed within 30 days of expiration. Family was contacted and patient tolerated vaccination well with no adverse effect.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Diplopia, Electromyogram
Clinical narrative: Leg weakness, Numbness in hands and feet, weight loss, Jaw soreness, Muscle loss, Headache, Loss of mobility, Drop foot, Double Vision, In a wheelchair,  Diagnosed with CIPD after 72 days, in Intensive care at local Hospital 10days, On IVIG drips every 3 weeks, on Predisone, Gabipentan, Norco and Physical Therapy  . Outcome is he will never be the same there is no cure and his life is forever changed he can not dress himself, open a bottle, eat with fork or spoon, brush his teeth, walk without assistants, do any physical work or even take a walk.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Headache, Hypoaesthesia, Intensive care, Laboratory test
Clinical narrative: Leg weakness, Numbness in hands and feet, weight loss, Jaw soreness, Muscle loss, Headache, Loss of mobility, Drop foot, Double Vision, In a wheelchair,  Diagnosed with CIPD after 72 days, in Intensive care at local Hospital 10days, On IVIG drips every 3 weeks, on Predisone, Gabipentan, Norco and Physical Therapy  . Outcome is he will never be the same there is no cure and his life is forever changed he can not dress himself, open a bottle, eat with fork or spoon, brush his teeth, walk without assistants, do any physical work or even take a walk.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Muscle atrophy, Muscular weakness, Pain in jaw
Clinical narrative: Leg weakness, Numbness in hands and feet, weight loss, Jaw soreness, Muscle loss, Headache, Loss of mobility, Drop foot, Double Vision, In a wheelchair,  Diagnosed with CIPD after 72 days, in Intensive care at local Hospital 10days, On IVIG drips every 3 weeks, on Predisone, Gabipentan, Norco and Physical Therapy  . Outcome is he will never be the same there is no cure and his life is forever changed he can not dress himself, open a bottle, eat with fork or spoon, brush his teeth, walk without assistants, do any physical work or even take a walk.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Peroneal nerve palsy, Wheelchair user, X-ray
Clinical narrative: Leg weakness, Numbness in hands and feet, weight loss, Jaw soreness, Muscle loss, Headache, Loss of mobility, Drop foot, Double Vision, In a wheelchair,  Diagnosed with CIPD after 72 days, in Intensive care at local Hospital 10days, On IVIG drips every 3 weeks, on Predisone, Gabipentan, Norco and Physical Therapy  . Outcome is he will never be the same there is no cure and his life is forever changed he can not dress himself, open a bottle, eat with fork or spoon, brush his teeth, walk without assistants, do any physical work or even take a walk.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cyanosis, Dyspnoea, Electroencephalogram, Magnetic resonance imaging head
Clinical narrative: 12 yo female with history of ADHD presents with new onset seizure. Family was watching a movie and then she went to bed. Family heard her gasping and went into the room. She was on her side and had GTC movements of her arms and legs. Associated with blue color change to face. Lasted about 1 minute and stopped on its own. Color improved. Patient then sleepy after. Now back to baseline on arrival. Discharged from ER.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Somnolence, Tonic clonic movements
Clinical narrative: 12 yo female with history of ADHD presents with new onset seizure. Family was watching a movie and then she went to bed. Family heard her gasping and went into the room. She was on her side and had GTC movements of her arms and legs. Associated with blue color change to face. Lasted about 1 minute and stopped on its own. Color improved. Patient then sleepy after. Now back to baseline on arrival. Discharged from ER.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a breakthrough infection, positive COVID test on 12/30/2021. Patient passed away.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE's; inadequate dose of the vaccine due to the loss volume; This spontaneous report was received from a physician concerning her son of unknown age. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 20-OCT-2022, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not provided), when vaccinated there were three large drops that dripped out of the syringe after the syringe was removed from the patient's thigh and the reporter considered that this could be an inadequate dose of the vaccine due to loss volume (Underdose). No additional adverse events were reported (No adverse event).
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 1-year-old female of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 30-AUG-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter. ; Sender's Comments:  009507513-2210USA004932: 009507513-2210USA009380: 009507513-2210USA009378: 009507513-2210USA009379:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 2-years-old male of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 22-AUG-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported. ; Sender's Comments:  US-009507513-2210USA004932:MSD US-009507513-2210USA009380:MSD US-009507513-2210USA009377:MSD US-009507513-2210USA009379:MSD
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 5-months-old female of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 22-AUG-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent oral liquid (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number 1742420 has been verified to be valid; expiration date reported and established as 31-JAN-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA004932:MSD US-009507513-2210USA009377:MSD US-009507513-2210USA009380:MSD US-009507513-2210USA009378:MSD
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 2-years-old male of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 09-SEP-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter.  ; Sender's Comments:  009507513-2210USA009377: 009507513-2210USA004932: 009507513-2210USA009378: 009507513-2210USA009379:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report that a dose of PNEUMOVAX23(pfs) with a labeled expiry of 10/15/2022 was administered to a patient on 10/25/2022.; This spontaneous report has been received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with a labeled expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliter (ml) (strength, route of administration and vaccination scheme frequency were not provided; lot number U003306 that was verified to be a valid lot number with an expiration date reported as and established as 15-OCT-2022) (expired product administered) for prophylaxis.  By the reporting time, the caller confirmed that she was not know if a temperature excursion was involved.   No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received Shingrix vaccines in 2019, got an outbreak 2 weeks ago/suspected vaccination failure; Got an outbreak anyway; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In October 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix vaccines in 2019 and paid full price for them at great expense. The patient states that, two weeks ago from reporting he/she got an outbreak of shingles anyway. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: 1st shot made her seriously sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness (serious criteria other: Serious by reporter). On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments:  This case was received from consumer via  interactive digital media. The reporter's wife had the first shot and made her seriously sick. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: You can get shingle shots and still get shingles, I did it/Suspected vaccination failure; Still get shingles, I did it; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still contracted shingles despite getting the Shingrix vaccine. The reporter stated that, if you could get the Shingles shots and still got shingles and she know that as she did it and painful. The reporter thought that the event might had been related to the drug. The reporter did not agree to contact her healthcare professional. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness from Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   The reporter considered the erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she had redness from Shingrix vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeding disorder, Injection site pain, Nausea
Clinical narrative: For four hours: nausea, shivering, can't eat, very tired, injection site pain Still feeling: tired, injection site pain
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Fall, General physical health deterioration, Head injury
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/17/2021, 03/17/2021, and 12/29/2021. They tested positive for COVID-19 on 08/25/2022, when they presented to emergency department for assessment after a fall.  They were admitted to hospital. They were found to be severely hypoglycemic and to have suffered a head injury with loss of consciousness, subdermal hematoma, and a subarachnoid hemorrhage. Their condition declined and they died in the hospital on 09/04/2022.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoglycaemia, Loss of consciousness, SARS-CoV-2 test positive, Subarachnoid haemorrhage, Subdural haematoma
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/17/2021, 03/17/2021, and 12/29/2021. They tested positive for COVID-19 on 08/25/2022, when they presented to emergency department for assessment after a fall.  They were admitted to hospital. They were found to be severely hypoglycemic and to have suffered a head injury with loss of consciousness, subdermal hematoma, and a subarachnoid hemorrhage. Their condition declined and they died in the hospital on 09/04/2022.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/17/2021, 03/17/2021, and 12/29/2021. They tested positive for COVID-19 on 08/25/2022, when they presented to emergency department for assessment after a fall.  They were admitted to hospital. They were found to be severely hypoglycemic and to have suffered a head injury with loss of consciousness, subdermal hematoma, and a subarachnoid hemorrhage. Their condition declined and they died in the hospital on 09/04/2022.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Moderna vial best use date 10/17/22. Administered on 10/22/22. Contacted moderna and was advice repeated dose is not necessary, because its within 30 days window. Family was contacted and notified, and no adverse effect was noted.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, COVID-19, Cough, Diarrhoea, Fatigue
Clinical narrative: On 7/29/2022, I started having like a head cold, stuffy head, not a big deal and a cough.  Around 3 days later, I took a COVID-19 home test and it was positive with 5 seconds. I reported online to my doctor's office that I had COVID-19. A doctor called me back and prescribed a specialized reduced prescription of Paxlovid because I have a reduced kidney function.  I had diarrhea and I was extremely tired during that time.  Five days later, I tested again, and the results were negative, and symptoms were gone. I just recently started having recurring diarrhea about every 10 or 15 days.  It started in September. The doctor thought that maybe there is a relation with me having COVID-19, because I had the diarrhea when I had COVID-19.  I have an appointment with my doctor to follow up on this.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nasopharyngitis, Renal impairment, SARS-CoV-2 test positive
Clinical narrative: On 7/29/2022, I started having like a head cold, stuffy head, not a big deal and a cough.  Around 3 days later, I took a COVID-19 home test and it was positive with 5 seconds. I reported online to my doctor's office that I had COVID-19. A doctor called me back and prescribed a specialized reduced prescription of Paxlovid because I have a reduced kidney function.  I had diarrhea and I was extremely tired during that time.  Five days later, I tested again, and the results were negative, and symptoms were gone. I just recently started having recurring diarrhea about every 10 or 15 days.  It started in September. The doctor thought that maybe there is a relation with me having COVID-19, because I had the diarrhea when I had COVID-19.  I have an appointment with my doctor to follow up on this.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a breakthrough infection with a positive COVID -19 PCR test on 2/20/2022.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Incorrect dose administered, Product preparation issue, Pyrexia
Clinical narrative: ADMINISTERED VACCINE WITHOUT DILUTING . PARENT STATED CHILD HAS HAD FEVER FOR 2 DAYS AND IS TIRED
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Fatigue, Feeling abnormal
Clinical narrative: I tested positive for COVID-19 on 10/3/22. I woke with a scratchy throat, fatigue, feverish, and overall body aches and sore joints. I didn't have a cough at that time, but I did get one later. I just felt bad in general. I was traveling so it was terrible. I was traveling when I tested positive and couldn't get Paxlovid, so, I was prescribed Dextromethorphan, Trotipront Max and Paracetamol. I feel much better now, but still have a little bit of a lingering cough.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I tested positive for COVID-19 on 10/3/22. I woke with a scratchy throat, fatigue, feverish, and overall body aches and sore joints. I didn't have a cough at that time, but I did get one later. I just felt bad in general. I was traveling so it was terrible. I was traveling when I tested positive and couldn't get Paxlovid, so, I was prescribed Dextromethorphan, Trotipront Max and Paracetamol. I feel much better now, but still have a little bit of a lingering cough.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 10/25/2022.  No adverse reaction.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Pyrexia
Clinical narrative: Developed a fever that night, and today had fever to 102 and constant cough.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: THE DOSE WAS GIVEN FROM A BOTTLE THAT WAS LEFT IN THE REFRIGERATOR OVERNIGHT, AND 5 HOURS AFTER THE 12 HOUR BEYOND USE TIME. WHEN REALIZED WE RECALLED THE PATIENT TO GIVE AN ADDITIONAL DOSE FROM A FRESHLY OPENED VIAL.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Swelling
Clinical narrative: Patient had pain and swelling.  The patient reported to an ED and was given and unknown antibiotic.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: THE PATIENT CAME FOR A FLU SHOT, AND COVID BOOSTER. THE PATIENT ALONG WITH THE TWO SHOTS REQUESTED GOT AN ADDITIONAL DOSE OF FLU SHOT. PATIENT WAS INFORMED AND A PHARMACY INCIDENT WAS REPORTED TO PHARMACY. PATIENT IS DOING FINE, AND WILL REPORT IF ANY ADVERSE REACTIONS
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.  Patient went home early due to GI complications N&V. Spoke to her on the phone. Advised to go thru ER if symptoms worsened or unimproved.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT STATES THAT APPROXIMATELY 1 WEEK AFTER HE RECEIVED THE SHINGRIX VACCINATION, HE BEGAN HAVING ACHES AND PAINS IN HIS RIGHT ARM (SAME ARM THAT HE RECEIVED HIS SHOT IN).  HE SAID THAT HE SOMETIMES HAS TINGLING IN HIS ARM AS WELL.  THE PAIN TRAVELS FROM HIS ELBOW TO HIS SHOULDER, AND TO HIS WRIST.  HE SAID THAT ONE DAY THE PAIN MAY BE WORSE IN HIS ELBOW, AND THE NEXT IT MAY BE WORSE IN HIS WRIST.  HE STATES THAT HE DOES NOT HAVE CONSTANT PAIN, THAT IT COMES AND GOES.  THE PAIN IS ONLY IN HIS RIGHT ARM.  HE IS NOT EXPERIENCING ANY OTHER SYMPTOMS.  HE WENT TO THE URGENT CARE ON 9/28/22, AND THEY GOT AN X-RAY, AND SENT HIS FOR AN ULTRASOUND.  HE ALSO SAW AN ORTHOPEDIC PHYSICAN, AND THEY CAN NOT DETERMINE WHAT IS WRONG.  HE IS GOING TO FOLLOW UP WITH HIS PRIMARY CARE PHYSICAN NEXT WEEK.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan, X-ray
Clinical narrative: PATIENT STATES THAT APPROXIMATELY 1 WEEK AFTER HE RECEIVED THE SHINGRIX VACCINATION, HE BEGAN HAVING ACHES AND PAINS IN HIS RIGHT ARM (SAME ARM THAT HE RECEIVED HIS SHOT IN).  HE SAID THAT HE SOMETIMES HAS TINGLING IN HIS ARM AS WELL.  THE PAIN TRAVELS FROM HIS ELBOW TO HIS SHOULDER, AND TO HIS WRIST.  HE SAID THAT ONE DAY THE PAIN MAY BE WORSE IN HIS ELBOW, AND THE NEXT IT MAY BE WORSE IN HIS WRIST.  HE STATES THAT HE DOES NOT HAVE CONSTANT PAIN, THAT IT COMES AND GOES.  THE PAIN IS ONLY IN HIS RIGHT ARM.  HE IS NOT EXPERIENCING ANY OTHER SYMPTOMS.  HE WENT TO THE URGENT CARE ON 9/28/22, AND THEY GOT AN X-RAY, AND SENT HIS FOR AN ULTRASOUND.  HE ALSO SAW AN ORTHOPEDIC PHYSICAN, AND THEY CAN NOT DETERMINE WHAT IS WRONG.  HE IS GOING TO FOLLOW UP WITH HIS PRIMARY CARE PHYSICAN NEXT WEEK.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Fall, General physical health deterioration, Hypoxia
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 02/11/2021, 03/10/2021, and 09/04/2021. They were also vaccinated with the Pfizer product on 03/17/2022.  They presented to emergency department on 08/09/2022. Primary complaint was congestion and body aches. Upon further examination, they admitted to having fallen earlier the day and having tested positive for COVID-19 same day. They were found to be hypoxic upon admission to hospital. Lab workups revealed severe kidney problems; they had received a kidney transplant previously. The individual refused to be treated with hemodialysis. Their condition continued to deteriorate and they died on 08/11/2022 in the hospital.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test abnormal, Pain, Renal disorder, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 02/11/2021, 03/10/2021, and 09/04/2021. They were also vaccinated with the Pfizer product on 03/17/2022.  They presented to emergency department on 08/09/2022. Primary complaint was congestion and body aches. Upon further examination, they admitted to having fallen earlier the day and having tested positive for COVID-19 same day. They were found to be hypoxic upon admission to hospital. Lab workups revealed severe kidney problems; they had received a kidney transplant previously. The individual refused to be treated with hemodialysis. Their condition continued to deteriorate and they died on 08/11/2022 in the hospital.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 02/11/2021, 03/10/2021, and 09/04/2021. They were also vaccinated with the Pfizer product on 03/17/2022.  They presented to emergency department on 08/09/2022. Primary complaint was congestion and body aches. Upon further examination, they admitted to having fallen earlier the day and having tested positive for COVID-19 same day. They were found to be hypoxic upon admission to hospital. Lab workups revealed severe kidney problems; they had received a kidney transplant previously. The individual refused to be treated with hemodialysis. Their condition continued to deteriorate and they died on 08/11/2022 in the hospital.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Chills, Pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: One week before testing positive, start feeling achy with chills and congestion. Took home COVID-19 test and tested negative for about 3 days; then finally tested positive, almost 1 month after 5th vaccine. Had a telehealth appointment and was only given prednisone. Doctor said it was too late to get PAXLOVID. Wasn't prescribed anything because was symptomatic for more than a week. Hasn't tested negative yet.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: One week before testing positive, start feeling achy with chills and congestion. Took home COVID-19 test and tested negative for about 3 days; then finally tested positive, almost 1 month after 5th vaccine. Had a telehealth appointment and was only given prednisone. Doctor said it was too late to get PAXLOVID. Wasn't prescribed anything because was symptomatic for more than a week. Hasn't tested negative yet.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pallor, Rash erythematous, Rash maculo-papular, Vaccination site erythema
Clinical narrative: Erythematous blanching maculopapular rash affecting face, trunk, arms and legs with most intense erythema at site of vaccine administration, left upper arm
Age: 15.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient and his entire family came to our pharmacy and requested a seasonal flu vaccine and the Pfizer bivalent booster. He was mistakenly given 2 seasonal flu vaccines. He received 2 flucelvax vaccines (one on each arm) and then a pfizer bivalent booster in his left arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cervicogenic headache, Chills, Cough, Oropharyngeal pain
Clinical narrative: I had a headache that felt like a sinus headache that would not go away, it progressed to a sore throat. I used a home COVID-19 test on Saturday that came back negative. On Sunday the sore throat got worse and by Monday I could not, I also had a runny nose and a cough. I used a home COVID-19 test that came back negative. By Tuesday my symptoms progressed to body aches and chills. I tested myself with a home COVID-19 test on Wednesday and it came back positive. I called into work and had a PCR test ordered and that also showed positive. I was advised to take TYLENOL and get bed rest. I still have a lingering headache that is uncomfortable but is going away. It is at the base of my head, at the head neck area.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive, Sinus headache
Clinical narrative: I had a headache that felt like a sinus headache that would not go away, it progressed to a sore throat. I used a home COVID-19 test on Saturday that came back negative. On Sunday the sore throat got worse and by Monday I could not, I also had a runny nose and a cough. I used a home COVID-19 test that came back negative. By Tuesday my symptoms progressed to body aches and chills. I tested myself with a home COVID-19 test on Wednesday and it came back positive. I called into work and had a PCR test ordered and that also showed positive. I was advised to take TYLENOL and get bed rest. I still have a lingering headache that is uncomfortable but is going away. It is at the base of my head, at the head neck area.