chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: pt to hospital with generalized weakness and fatigue; acute encephalopathy; pt had a positive COVID test; admitted for management of sepsis due to COVID vs UTI; tachcardia/hypotension; AKI due to dehydration; acute on chronic IDA requiring transfusion; electrolyte abnormalities; started on broad spectrum ABX, steroids, remdesivir; pt's condition worsened; DNR/DNI; transitioned to hospice where she passed away
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: wrong drug. no adverse reaction. gave pediatric dose to adult patient.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Cough, Malaise, Nasopharyngitis
Clinical narrative: I had a sore arm after receiving the vaccine and it was warm to the touch. On 12/04/2022, I began feeling sick with cold like symptoms with a sore throat.  My symptoms stayed the same for several days and I had a terrible cough.  I went to an urgent care and received a prescription for Zithromax and a steroid. I went to my doctor on 01/03/2023 because I could not smell or taste. I was sick for six weeks, but I never tested positive for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test negative, Skin warm
Clinical narrative: I had a sore arm after receiving the vaccine and it was warm to the touch. On 12/04/2022, I began feeling sick with cold like symptoms with a sore throat.  My symptoms stayed the same for several days and I had a terrible cough.  I went to an urgent care and received a prescription for Zithromax and a steroid. I went to my doctor on 01/03/2023 because I could not smell or taste. I was sick for six weeks, but I never tested positive for COVID-19.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus discomfort, Speech disorder
Clinical narrative: I was speaking with some workers that I had hired and all of a sudden I wasn't making any sense. I was saying words that didn't make sense. I've never experienced something like this. I just sat and waited for my wife. I mentioned I was having some issues. I also that a headache in the front of my head over my left eye. A sinus type of pressure.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: COVID-19, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I started experiencing symptoms of a fever in the back of my throat. My father had tested positive the week prior even though he was asymptomatic. Over the next couple of days, I started experiencing body aches, fever and congestion. I tested myself at home and the test came back positive within 30 seconds for COVID-19. I went to the local clinic at a pharmacy and was prescribed PAXLOVID. I slept a lot over the next four days, but on day five of PAXLOVID, I felt a lot better.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Chills, Cough, Fatigue
Clinical narrative: I woke up exhausted, chills, sinus infection, cough, upper respiratory congestion, and low-grade fever for 2 days. I tested positive for COVID-19. I went to the urgent care, and they did an x-ray to check for pneumonia and it was clear. She prescribed prednisone and antibody. I still have a cough and upper respiratory congestion.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sinusitis, Upper respiratory tract congestion
Clinical narrative: I woke up exhausted, chills, sinus infection, cough, upper respiratory congestion, and low-grade fever for 2 days. I tested positive for COVID-19. I went to the urgent care, and they did an x-ray to check for pneumonia and it was clear. She prescribed prednisone and antibody. I still have a cough and upper respiratory congestion.
Age: 42.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Anosmia, COVID-19, Diarrhoea, Fatigue, Pain
Clinical narrative: COVID positive on 12/17/2022. Began with constant runny nose, two days later lost sense of smell, no fever, mild diarrhea, body aches, general fatigue. Began PaxLovid 12/18/2022. Symptom free and tested negative 12/26/2022. Symptoms returned full-force 12/28/2022. Doctor advised rest and home care with no further PaxLovid as it was likely a rebound of the prior infection.
Age: 42.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Symptom recurrence
Clinical narrative: COVID positive on 12/17/2022. Began with constant runny nose, two days later lost sense of smell, no fever, mild diarrhea, body aches, general fatigue. Began PaxLovid 12/18/2022. Symptom free and tested negative 12/26/2022. Symptoms returned full-force 12/28/2022. Doctor advised rest and home care with no further PaxLovid as it was likely a rebound of the prior infection.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: COVID-19, Death
Clinical narrative: Decedent had COVID -19 during the last week of November 2022  Forensic Pathologist requested that this be reported to you since the Pfizer Bivalent Booster was administered on 11?14/2022.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Covid vaccine was Pfizer-BioNTech (would not let me choose it from drop down) The patient did not have an allergic reaction. The patient was given a single dose from an expired Lot. The Lot expired 1/27/23 and was given today, 1/30/23. Our pharmacist at the hospital advised our office to file a report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Was given monovalent vaccine instead of bivalent booster.  Would have been 4th dose.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Pfizer Bivalent vaccine was given to the patient as a first dose per Provider.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal behaviour, Atelectasis, Bacterial test negative, Blood lactic acid increased, Chest X-ray abnormal
Clinical narrative: delirium, behavioral issues, fever of 100.4, tachycardia (132 at presentation to ER),
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Delirium, Influenza virus test negative, Lung infiltration, Pneumonia, Pyrexia
Clinical narrative: delirium, behavioral issues, fever of 100.4, tachycardia (132 at presentation to ER),
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Tachycardia, Urine analysis normal, White blood cell count normal
Clinical narrative: delirium, behavioral issues, fever of 100.4, tachycardia (132 at presentation to ER),
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebral haemorrhage, Haemorrhagic stroke
Clinical narrative: ICH stroke ER -> hospitalization -> skilled nursing
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A child dose of the Hep B vaccine was pulled and given should had gotten the  adult Hep b
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Chest congestion, runny nose and tired
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging head normal
Clinical narrative: 2 days after receiving my 2nd covid booster shot I experienced total deafness in my left ear. my first 3 shots were Moderna, this 2nd booster was Pfizer.   I have seen my regular physician and an ENT for evalutation.  I have still not gotten my hearing back.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: THIS IS NOT AN ADVERSE EVENT. JUST MADE AND AN ERROR BY GIVING PATIENT MODERNA THAT WAS BEYOND USE DATE BY 1 DAY.  ALREADY CALLED MODERNA TO SEE IF WE NEED TO REVACCINATE PT AGAIN. PATIENT IS FINE, HAS NOT COMPLAIN ABOUT ANY SIDE EFFECTS
Age: 1.17
Sex: M
Vaccine: PNC13
Symptoms: Feeling hot, Injection site swelling, Irritability, Listless, Rash macular
Clinical narrative: Approximately 4 hours after vaccine administration, child became extremely listless. Started screaming uncontrollably every time he tried to move. Right thigh was notably swollen and progressively got worse. Ibuprofen was administered and after 1.5 hours child finally settled down. Still very fussy but improved. Ibuprofen was continued for 24 hours. Right thigh continued to swell until it was approximately 1 inch larger in diameter compared to the left thigh. Small amount of heat noted but no redness. Blotchy redness began on the evening of 1/28. Child returned to normal on 1/29.
Age: 1.17
Sex: M
Vaccine: PNC13
Symptoms: Screaming
Clinical narrative: Approximately 4 hours after vaccine administration, child became extremely listless. Started screaming uncontrollably every time he tried to move. Right thigh was notably swollen and progressively got worse. Ibuprofen was administered and after 1.5 hours child finally settled down. Still very fussy but improved. Ibuprofen was continued for 24 hours. Right thigh continued to swell until it was approximately 1 inch larger in diameter compared to the left thigh. Small amount of heat noted but no redness. Blotchy redness began on the evening of 1/28. Child returned to normal on 1/29.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 1/27/2023.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NOT AN ADVERSE EVENT. ERROR DONE BY GIVING MODERNA THAT IS 2 DAYS BEYOND USE DATE IN THE REFRIDGERATOR. CALLED MODERNA TO FOLLOW UP AND IF WE WILL NEED TO RE-VACCINATE PT. PT HAS NOT ISSUES OR ADVERSE EFFECTS AT THIS TIME.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, CSF protein increased, Diplopia
Clinical narrative: Patient states he received a COVID vaccine injection December 27, 2022 and experienced left eye lid droop, with intermittent diplopia and axillary lymph node enlargement the following day. Patient went to an optometrist on Dec 29 and was instructed to go to the Emergency Department. Patient presented to the ED on Jan 1, 2023.  -Brain MRI and MRA negative for acute process -esr, crp, tsh, ana wnl -rapid meningitis panel neg -f/u musk ab and AchR ab/MG panel -LP today, showed increased protein, otherwise unremarkable -mri of orbits negative  Patient subsequently evaluated by Neurologist and Ophthalmologist and diagnosed with post Covid 19 vaccination vasculitic syndrome. Patient treated with IV methylprednisolone 1g IVPB  followed by oral methylprednisolone (Medrol Dosepak) as an outpatient. Patient discharged on Jan 3, 2023.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Laboratory test normal, Lumbar puncture abnormal, Lymphadenopathy, Magnetic resonance imaging head normal
Clinical narrative: Patient states he received a COVID vaccine injection December 27, 2022 and experienced left eye lid droop, with intermittent diplopia and axillary lymph node enlargement the following day. Patient went to an optometrist on Dec 29 and was instructed to go to the Emergency Department. Patient presented to the ED on Jan 1, 2023.  -Brain MRI and MRA negative for acute process -esr, crp, tsh, ana wnl -rapid meningitis panel neg -f/u musk ab and AchR ab/MG panel -LP today, showed increased protein, otherwise unremarkable -mri of orbits negative  Patient subsequently evaluated by Neurologist and Ophthalmologist and diagnosed with post Covid 19 vaccination vasculitic syndrome. Patient treated with IV methylprednisolone 1g IVPB  followed by oral methylprednisolone (Medrol Dosepak) as an outpatient. Patient discharged on Jan 3, 2023.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Red blood cell sedimentation rate normal, Vasculitis
Clinical narrative: Patient states he received a COVID vaccine injection December 27, 2022 and experienced left eye lid droop, with intermittent diplopia and axillary lymph node enlargement the following day. Patient went to an optometrist on Dec 29 and was instructed to go to the Emergency Department. Patient presented to the ED on Jan 1, 2023.  -Brain MRI and MRA negative for acute process -esr, crp, tsh, ana wnl -rapid meningitis panel neg -f/u musk ab and AchR ab/MG panel -LP today, showed increased protein, otherwise unremarkable -mri of orbits negative  Patient subsequently evaluated by Neurologist and Ophthalmologist and diagnosed with post Covid 19 vaccination vasculitic syndrome. Patient treated with IV methylprednisolone 1g IVPB  followed by oral methylprednisolone (Medrol Dosepak) as an outpatient. Patient discharged on Jan 3, 2023.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: I'm not reporting an adverse event, but rather a vaccination error. This patient wanted to get the Pfizer Bivalent booster dose, but instead was inadvertently given a dose of an UNDILUTED Pediatric Pfizer Booster dose of 0.3mL. I spoke to a Pfizer representative who confirmed that the undiluted concentration is the same as that of the adult vials, so because the patient received 0.3 mL of the undiluted dose it was equivalent to 30mcg, which is the same as 0.3 mL = 30mcg of the adult vial. I also contacted out counter public health department and spoke to Dr. who advised not to revaccinate the patient because they received the intended dose.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NOT AN ADVERSE EVENT. ERROR MADE BY GIVING PATIENT MODERNA THAT WAS BEYOND USE DATE BY 2 DAYS. CALLED MODERNA TO FOLLOW UP AND IF PT WILL NEED TO BE RE-VACCINATED. PT ISSUE  OR CONCERN FROM THE PATIENT AT THIS TIME. MODERNA WAS KEEP IN THE APPROPRIATE TEMPERATURE
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: I'm not reporting an adverse event, but rather a vaccination error. This patient wanted to get the Pfizer Bivalent booster dose, but instead was inadvertently given a dose of an UNDILUTED Pediatric Pfizer Booster dose of 0.3mL. I spoke to a Pfizer representative who confirmed that the undiluted concentration is the same as that of the adult vials, so because the patient received 0.3 mL of the undiluted dose it was equivalent to 30mcg, which is the same as 0.3 mL = 30mcg of the adult vial. I also contacted out counter public health department and spoke to Dr. who advised not to revaccinate the patient because they received the intended dose.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, Cough, Oropharyngeal pain, Productive cough, SARS-CoV-2 test negative
Clinical narrative: On the 24th I started developing a tickle in my throat, no other symptoms that day. The same thing on the 25th, until about 2:30 that afternoon and that's when I developed a cough. No other symptoms until later that night, I started coughing up a lot of dark colored phlegm. On the 26th, I had a sore throat and still coughing up the phlegm, I got a COVID-19 test later that morning and it was negative. By that evening still a sore throat and nonproductive cough. The 27th I went to see the doctor, I got two shots, a steroid shot and an antibiotic shot as well as some prescriptions. The doctor said I have bronchitis, there is also a virus going around at work so I believe it may have something to do with that as well.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sputum discoloured, Throat irritation
Clinical narrative: On the 24th I started developing a tickle in my throat, no other symptoms that day. The same thing on the 25th, until about 2:30 that afternoon and that's when I developed a cough. No other symptoms until later that night, I started coughing up a lot of dark colored phlegm. On the 26th, I had a sore throat and still coughing up the phlegm, I got a COVID-19 test later that morning and it was negative. By that evening still a sore throat and nonproductive cough. The 27th I went to see the doctor, I got two shots, a steroid shot and an antibiotic shot as well as some prescriptions. The doctor said I have bronchitis, there is also a virus going around at work so I believe it may have something to do with that as well.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Severe Cerebral Stroke on 10/23/22 leading to death.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Patients reports about 30 hours after receiving vaccines she started running a fever, had a headache, nausea and diarrhea.  She states this lasted for 3 days.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cough, Feeling abnormal, Pyrexia
Clinical narrative: I had a fever and feeling foggy. I tested positive for COVID-19. I talked to the doctor, and he prescribed me Paxlovid. I started feeling better. After taking Paxlovid I had a horrible headache. I also started having a cough and raspy throat which is still happening.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Pt in need of Pneumovax vaccine, LN inadvertently administered Expired Immunization. LN informed PCP of inadvertent vaccine administration and clinical/medical director, LN called Merck& Co in and spoke with medial staff in regards to inadvertent vaccine administration staff stated they would call this LN in 1 business day with more information on inadvertent vaccine administration.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute sinusitis, Back pain, COVID-19, Chest X-ray normal, Cough
Clinical narrative: I started to experience symptoms of a sore throat. I didn't think much of it because I was doing a lot of running around. I started to develop a runny nose and a cough a day later. I tested for COVID-19 and the test came back positive. I also started to experience lower back pain and a headache that went from the base of my neck to the top of my head. I went to an urgent care because of the back pain and headache that I was experiencing. I felt that there was more than the virus that was causing this pain. They found an unspecified acute sinusitis and hypertension. I was given amoxicillin and cough medicine with codeine for the sinusitis. I also experienced two spells of fainting and vomiting following dizziness.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram normal, Headache, Hypertension, Neck pain
Clinical narrative: I started to experience symptoms of a sore throat. I didn't think much of it because I was doing a lot of running around. I started to develop a runny nose and a cough a day later. I tested for COVID-19 and the test came back positive. I also started to experience lower back pain and a headache that went from the base of my neck to the top of my head. I went to an urgent care because of the back pain and headache that I was experiencing. I felt that there was more than the virus that was causing this pain. They found an unspecified acute sinusitis and hypertension. I was given amoxicillin and cough medicine with codeine for the sinusitis. I also experienced two spells of fainting and vomiting following dizziness.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Syncope, Vomiting
Clinical narrative: I started to experience symptoms of a sore throat. I didn't think much of it because I was doing a lot of running around. I started to develop a runny nose and a cough a day later. I tested for COVID-19 and the test came back positive. I also started to experience lower back pain and a headache that went from the base of my neck to the top of my head. I went to an urgent care because of the back pain and headache that I was experiencing. I felt that there was more than the virus that was causing this pain. They found an unspecified acute sinusitis and hypertension. I was given amoxicillin and cough medicine with codeine for the sinusitis. I also experienced two spells of fainting and vomiting following dizziness.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram normal, Laboratory test normal, Loss of consciousness, Mobility decreased
Clinical narrative: Had been feeling dizzy the day after the vaccine; Then 2 weeks after vaccination, passed out in the shower; Became conscious again, and crawled to the toilet to throw up; His pupils were dilated and he had a hard time seeing; Called 911 and was taken to the ER, and was given an EKG along with lab work.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mydriasis, Visual impairment, Vomiting
Clinical narrative: Had been feeling dizzy the day after the vaccine; Then 2 weeks after vaccination, passed out in the shower; Became conscious again, and crawled to the toilet to throw up; His pupils were dilated and he had a hard time seeing; Called 911 and was taken to the ER, and was given an EKG along with lab work.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THIS IS NOT AN ADVERSE EFFECT , WE USED THE MODERNA ONE DAY AFTER THE BEYOND USED DATE  , THE LOT NUMBER DID NOT EXPIRE , WE HAVE CALLED MODERNA, PATIENT HAVE NOT REPORTED ANY ADVERSE EFFETS
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Asthenia, COVID-19, Pain, SARS-CoV-2 test positive, Somnolence
Clinical narrative: Worse than a cold but not like the flu.  No fever, body aches not like the flu, felt weak and wanted to sleep.  I felt a little better everyday.  By Monday I felt better but by the afternoon felt weak and went home.  I started taking Paxlovid on Monday.  Didn't lose taste or smell.
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: VACCINE STORAGE TEMP ISSUE. HEALTH DEPARTMENT ADVISED TO REPEAT.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THIS IS NOT AN ADVERSE EFFECT , WE USED THE MODERNA ONE DAY AFTER THE BEYOND USE  DATE  , THE LOT NUMBER DID NOT EXPIRE , WE HAVE CALLED MODERNA, PATIENT HAVE NOT REPORTED ANY ADVERSE EFFETS
Age: 33.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, Health department advised to repeat.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Cough, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I tested positive for COVID-19 on 01/05/2023 after traveling. My throat was getting scratchy before coming home. I came home and wore my mask. My sister had called me and she noted she tested positive, and my husband tested positive later that evening. I had a sore throat, congestion, and coughing. I called my doctor right away on the 01/05/2023, and I spoke to someone right away. I took PAXLOVID and I went out of the house the following Wednesday 01/11/2023. I tested negative that Tuesday before 01/10/2023 and that Friday 01/13/2023.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I tested positive for COVID-19 on 01/05/2023 after traveling. My throat was getting scratchy before coming home. I came home and wore my mask. My sister had called me and she noted she tested positive, and my husband tested positive later that evening. I had a sore throat, congestion, and coughing. I called my doctor right away on the 01/05/2023, and I spoke to someone right away. I took PAXLOVID and I went out of the house the following Wednesday 01/11/2023. I tested negative that Tuesday before 01/10/2023 and that Friday 01/13/2023.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram, Injected limb mobility decreased, Injection site oedema, Injection site pain, Limb discomfort
Clinical narrative: Patient complained at time of injection that he felt as if injection was going right through his arm, major pain at time of injection.  Following this as patient left, arm felt as if he was punched very hard in the arm.  Since then, patient has lost the use of his arm, patient cannot pick up a gallon of water, range of motion is limited, still extremely painful at site of injection as if someone is sticking a knife in his arm.  Patient had an EMG test for nerve issue as well as MRI on same arm due to discomfort.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Musculoskeletal disorder
Clinical narrative: Patient complained at time of injection that he felt as if injection was going right through his arm, major pain at time of injection.  Following this as patient left, arm felt as if he was punched very hard in the arm.  Since then, patient has lost the use of his arm, patient cannot pick up a gallon of water, range of motion is limited, still extremely painful at site of injection as if someone is sticking a knife in his arm.  Patient had an EMG test for nerve issue as well as MRI on same arm due to discomfort.
Age: 53.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Sex: U
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; VARIVAX was administered to a patient on 12/20/2022 after a supported temperature excursion that took place on 12/1/202; This spontaneous report was received from the Medical assistant, and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 20-DEC-2022, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # W021741 and expiration date: 10-JUL-2024 or lot# W018825 and expiry date: 14-JUN-2024 (two possible lot numbers provided), administered subcutaneously for prophylaxis at right thigh (strength was not provided), after temperature excursion, which took place on 01-DEC-2022. Event occurred due freezer probe was switched out, and it took longer for probe to start working (19.47 F for 30-40 minutes or 50 minutes, discrepancy information). The vaccine was purchased with public funds, and the patient was vaccinated at Private Doctor's Office/ Hospital. No additional adverse event information was provided.   This in one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2301USA001100: US-009507513-2301USA000947: US-009507513-2301USA000926: US-009507513-2301USA001204: US-009507513-2301USA001215: US-009507513-2301USA001055: US-009507513-2301USA000912:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; VARIVAX was administered to a patient on 12-DEC-2022 after a supported temperature excursion that took place on 01-DEC-2022.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-DEC-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W018825 with expiration date 14-JUN-2024 (dose, route and anatomical location were not reported) which was exposed to temperature excursion (/product storage error) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to temperature of 19.4 degrees Fahrenheit for 50 minutes. There was no previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2301USA001031:
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported pediatric dose of VAQTA was administered to a 19 year old.; This spontaneous report was received from a medical assistant referring to a 19-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 13-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml (pediatric dose), strength: 25/0.5 (unit not reported), lot #W007375, expiration date: 16-JAN-2023, intramuscularly for prophylaxis (incorrect dose administered). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtional AE; Inbound call from HBP who stated VAQTA was inadvertently administered after a supported temp excursion. No additional AE details or PQC.         ?    Names of vaccines involved (including lot/exp) VAQTA W017819 12/27/2023        ?    Temperature; This spontaneous report as received from an unspecified reporter, mentioned as HPB concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  09-JAN-2023, the patient was vaccinated inadvertently with a dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, lot # W017819, expiration date: 27-DEC-2023 for prophylaxis, after supported temperature excursion (Product storage error). No additional adverse events  or PQC were reported.  The administered dose of the vaccine experienced a temperature of 35.2degress Fahrenheit for 9 hours with no previous temperature excursion.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of PEDVAXHIB was administered to an adult patient; No adverse event; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. There was information regarding the patient's medical history, concurrent condition or concomitant therapies details.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional details were provided. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Expired product administered, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: no AE; Caller reported 3rd dose of GARDASIL 9 was administered on 1/10/2020 but was expired. Lot and expiration docume; patient received GARDASIL on 7/16/2015 and GARDASIL 9 on 8/12/2015.; interchange of vaccine product; patient received GARDASIL on 7/16/2015 and GARDASIL 9 on 8/12/2015/Caller reported 3rd dose of GARDASIL 9 was administered on 1/10/2020; This spontaneous report was received from a physician and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 16-JUL-2015, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date was not provided) for prophylaxis. On 12-AUG-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date was not provided) for prophylaxis (Interchange of vaccine products, Inappropriate schedule of vaccine administered). On 10-JAN-2020, the patient was vaccinated with the second (also reported as the third) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R022422, expiration date 25-NOV-2019 (Expired vaccine used,Inappropriate schedule of vaccine administered). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided and no additional AE's were reported; An HCP is reporting an AE on behalf of a patient. The HCP reports that a patient was administered a dose of VARIVAX after it expired. The HCP did not wish to be contacted so no letter is being sent. No additional AE details were provided and no addit; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), administered subcutaneously (strength and anatomical site of vaccination were not reported; lot number U002400, expiration date reported and validated as 22-JAN-2023) as prophylaxis (expired product administered). No additional adverse events were reported.
Age: 51.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: with a prescription from her HCP for GARDASIL 9. At that time the patient was 52 years old; No additional AE information was provided; received the second dose of GARDASIL 9 on an unspecified date in January 2023; patient received her first dose of GARDASIL 9 on April 21, 2022; This spontaneous report was received from pharmacist (who is also the pharmacy manager) and refers to a currently 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022 the 51-year-old (also reported as 52, conflicting information) patient came to the pharmacy with a prescription from her health care professional (HCP) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Product prescribing issue). On the same date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). In January 2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). The pharmacist reported he did not have the lot/expiration dates of the vaccines because they were currently in storage. No additional adverse event information was provided.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient did not experience any type of adverse reactions; twins were given an "extra dose" of "varicella" due to receiving the PROQUAD vaccine; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) subcutaneous injection, 0.5 ml, lot number: W029547, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that this was an extra dose of "varicella" that was not needed (extra dose administered). The nurse reported that the patient did not experience any type of adverse reactions (no adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2301USA010043:Same reporter
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Dysgeusia, Pain in extremity, Paraesthesia
Clinical narrative: she experienced pain and tingling in her arm; tingling in her arm; metallic tasted in her mouth; This spontaneous report has been received from a physician via company representative concerning to a 37-year-old female. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were unknown by the reporter.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dosage, scheme vaccination frequency, lot number, expiration date, and route of administration were not provided) for prophylaxis. Then, on the same date, within 3 minutes, she experienced pain and tingling in her arm (paraesthesia)(pain in extremity) and metallic tasted in her mouth (dysgeusia). The patient was kept in the office for observation for 20 minutes and was sent home after all of the symptoms were resolved (recovered).  The causality assessment between the suspect vaccine regarding the events was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Got both doses, had a shinlges-like rash/Suspected vaccination failure; Shinlges-like rash, mild case; Shinlges-like rash, mild case; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 23-Jan-2023 Reporter's comment: The reporter spoke with the front desk coordinator and she shared with him/her that she got both doses of Shingrix and after the 2nd dose, she developed a shingles-like rash but stated it was very mild. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.  In worst approach shingles and rash both events were coded as no clarification could be obtained from the reporter as reporter denied for the follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure/I have had it 5 times, even got the vaccine twice; Shingles (mild)/I have had it 5 times, even got the vaccine twice; still burned, itched and felt awful just not as bad as before; still burned, itched and felt awful just not as bad as before; still burned, itched and felt awful just not as bad as before; 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first case of shingles when the patient was 7).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation, pruritus and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and feels awful to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received from the patient via (Facebook) interactive digital media. The patient have had them 5 times now and even got the vaccine twice. Each time they were getting worse, except for the last time it was more mild.  The patient stated that they were still burned, itched and felt awful just not as bad as before. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per the reported verbatim,' it still burned, itched and felt awful just not as bad as before', outcome for all adverse events were captured as not recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine,gave me shigles/Suspected vaccination failure; Shingles/gave me shingles; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received form the patient via interactive digital  media. The patient got the vaccine and gave him/her shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shot didn't work on me/suspected vaccination failure; Shot didn't work on me; 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. On an unknown date, unknown 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: 24-Jan-2023 Reporter's comment: The case was received from the patient via  interactive digital media. The patient stated that the shot (Shingrix 2020) did not work for him/her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingles vaccine) (batch number 4S37J, expiry date unknown) for prophylaxis.   On 13th January 2023, the patient received Shingles vaccine .5 ml. On 14th January 2023, 1 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 20-Jan-2023. Reporter's Comments: The symptoms were treated. The reporter requesting consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Received Vx after temp excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date : 20 Jan 2023 Reporters comment: The physician reported that the patient received Engerix B after a temperature excursion of too cold. All patients were one day old. Reporter consented to follow up. Additional supportive information: As patient received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023008733:Same reporter US-GSK-US2023008735:Same reporter US-GSK-US2023AMR009449:same reporter - female patient US-GSK-US2023AMR009450:same reporter - female case US-GSK-US2023008733:same reporter - female patient
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Muscular weakness
Clinical narrative: muscle weakness, side effects; tiredness; general malaise; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness, tiredness and general malaise. On an unknown date, the outcome of the muscle weakness, tiredness and general malaise were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, tiredness and general malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The case was reported by the patient. The patient had been given Shingrix and had been experiencing muscle weakness, tiredness and general malaise. The reporter wanted to know how long it would take for these side effects to end. Additional Supportive Information: As the future vaccination date was reported so it was not captured and clarification was raised for the same.