chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Vomiting
Clinical narrative: I threw up 2 days later. Fatigue.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Hypoaesthesia, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Severe nerve pain, numbness & tingling in front hip/right quadriceps area. I did have a slight low back hip strain a week or so earlier so reaction is in a weak area of the body at the time.
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: NAUSEA; POUNDING HEADACHE; BODY ACHES; SLIGHT FEVER
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram abnormal, Hyperhidrosis, Paraesthesia, Sinus bradycardia, Syncope
Clinical narrative: While seated waiting the recommended 15 minutes,  At around the 10 min mark, I began feeling increasing tingling in right arm, then sweating profusely, then vision became vertigo-like. I slowly stood up to walk away and try to step outside to catch some air, but soon after had syncope (first episode in my life though I?ve had vertigo-like symptoms after donating blood, reason for which I?ve always remained lying down for at least an hour after donating). I woke up to bystander who apparently assisted me during the fall (fortunately no injuries resulted). Pharmacy employee showed up and began to assist bystander. I brought myself to a sitting position by they asked me to try and stand up to walk back to vaccination room. As I entered that room I again had another syncope episode. Regained consciousness with bystander and employee assisting me off the floor and on to a chair. Employee informed me that I shook briefly while on the floor. I began to feel better but still unstable. A friend picked me up and took me to the ER, where an EKG was performed. Vitals were normal but minor sinus bradycardia diagnosed. I am athletic with BMI under 25 so resting BPM has been 57-60 for at least few years per fitness watch.   I have no allergies or fear of needles.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor, Visual impairment
Clinical narrative: While seated waiting the recommended 15 minutes,  At around the 10 min mark, I began feeling increasing tingling in right arm, then sweating profusely, then vision became vertigo-like. I slowly stood up to walk away and try to step outside to catch some air, but soon after had syncope (first episode in my life though I?ve had vertigo-like symptoms after donating blood, reason for which I?ve always remained lying down for at least an hour after donating). I woke up to bystander who apparently assisted me during the fall (fortunately no injuries resulted). Pharmacy employee showed up and began to assist bystander. I brought myself to a sitting position by they asked me to try and stand up to walk back to vaccination room. As I entered that room I again had another syncope episode. Regained consciousness with bystander and employee assisting me off the floor and on to a chair. Employee informed me that I shook briefly while on the floor. I began to feel better but still unstable. A friend picked me up and took me to the ER, where an EKG was performed. Vitals were normal but minor sinus bradycardia diagnosed. I am athletic with BMI under 25 so resting BPM has been 57-60 for at least few years per fitness watch.   I have no allergies or fear of needles.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, Cough, Dyspnoea, Pneumonia bacterial
Clinical narrative: The patient was brought to the ED by EMS on 9/2/23 for shortness of breath and difficulty breathing. Additionally, she reported a cough that has been ongoing for about a week. She is a current smoker. She tested positive for COVID-19 by PCR. Ultimately, the patient was admitted to the hospital on 9/2/23 - 9/8/23 for acute hypoxemic respiratory failure due to COVID-19 infection with superimposed bacteremia pneumonia. Initially, O2 sats were at 84% and so she was placed on 4L O2 via NC. Of note, the patient has received the primary COVID vaccine series and three boosters.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Superinfection
Clinical narrative: The patient was brought to the ED by EMS on 9/2/23 for shortness of breath and difficulty breathing. Additionally, she reported a cough that has been ongoing for about a week. She is a current smoker. She tested positive for COVID-19 by PCR. Ultimately, the patient was admitted to the hospital on 9/2/23 - 9/8/23 for acute hypoxemic respiratory failure due to COVID-19 infection with superimposed bacteremia pneumonia. Initially, O2 sats were at 84% and so she was placed on 4L O2 via NC. Of note, the patient has received the primary COVID vaccine series and three boosters.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Nausea
Clinical narrative: PT RECEIVED THE VACCINE 091823, HE WAS IN THE PHARMACY 092723 FOR ANOTHER VACCINE AND MENTIONED HE WAS HAVING SOME NAUSEA THAT STARTED 2 DAYS AGO AND HE WASN'T SURE IF THAT WAS RELATED TO THE YELLOW FEVER VACCINE
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chills, Headache, Pain, Vertigo
Clinical narrative: The evening of 9/22/23 pt developed a severe headache.  She said it felt like a migraine but much worse.  Pain level up to 9/10.  Required a doctor's visit on 9/27 because she is still having the headache.  She does have vertigo also.  The night of the vaccine, she did have body aches and chills.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of Tdap after receiving a dose 1 month prior. No adverse reactions reported at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Tachycardia high heart rate alert triggered on Apple Watch at rest  103-109 Sep 27 at 1:29 PM 103-111 Sep 27 at 12:07 PM 101-106 Sep 27 at 11:54 AM 100-109 Sep 27 at 10:34 AM
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: The patient was brought to the ED by EMS on 9/2/23 with 3-4 days of congestion, sore throat, productive cough, headache, and fever of 101.7 F. She had two at-home COVID tests which were both negative, however a COVID-19 PCR test performed in the ED resulted positive. The patient was admitted 9/2/23 - 9/5/23 with sepsis secondary to COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sepsis
Clinical narrative: The patient was brought to the ED by EMS on 9/2/23 with 3-4 days of congestion, sore throat, productive cough, headache, and fever of 101.7 F. She had two at-home COVID tests which were both negative, however a COVID-19 PCR test performed in the ED resulted positive. The patient was admitted 9/2/23 - 9/5/23 with sepsis secondary to COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction, vaccine was expired by 8 days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Tendonitis
Clinical narrative: tendonitis as diagnosed by physician
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess drainage, Aspiration pleural cavity, COVID-19, Liver abscess, Pancytopenia
Clinical narrative: Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Per provider discharge note, "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient was readmitted with pancytopenia in setting of linezolid use and hepatic abscess. Admitted, given blood, antibiotics changed and abscess re-drained. Found to have covid and recurrent pleural effusion, drained repeatedly, found to be transudate and from inadequate volume removal. Will dc with micofungin, daptomycin and zosyn through 10/6/23, ct abdomen pelvis on 10/2 and follow up with ID."
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, SARS-CoV-2 test positive, Transfusion
Clinical narrative: Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Per provider discharge note, "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient was readmitted with pancytopenia in setting of linezolid use and hepatic abscess. Admitted, given blood, antibiotics changed and abscess re-drained. Found to have covid and recurrent pleural effusion, drained repeatedly, found to be transudate and from inadequate volume removal. Will dc with micofungin, daptomycin and zosyn through 10/6/23, ct abdomen pelvis on 10/2 and follow up with ID."
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: Left arm cellulitis,  lymph node enlargement left neck/collar bone.  Pt scheduled and seen by provider. Prescribed cephalexin 500 mg  every 6 hours for 7 days.  IF no improvement in next 1-2 days will consider ultrasound.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Feeling of body temperature change, Flushing
Clinical narrative: The patient has a history of CKD stage III and history of kidney transplant on immunosuppressive therapy. She was seen in the ED on 9/11/23 for nausea, body aches, and hot/cold flashes that started a few days prior. A COVID-19 PCR test was done which resulted positive. Ultimately, the patient was admitted 9/11/23 - 9/13/23 with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia/pneumonitis, among other diagnoses. During admission she initially required 3 liters of supplemental O2, however by discharge she was able to wean to room air. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: The patient has a history of CKD stage III and history of kidney transplant on immunosuppressive therapy. She was seen in the ED on 9/11/23 for nausea, body aches, and hot/cold flashes that started a few days prior. A COVID-19 PCR test was done which resulted positive. Ultimately, the patient was admitted 9/11/23 - 9/13/23 with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia/pneumonitis, among other diagnoses. During admission she initially required 3 liters of supplemental O2, however by discharge she was able to wean to room air. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Breath sounds abnormal, COVID-19, Chest X-ray normal, Cognitive disorder
Clinical narrative: Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dementia, Diarrhoea, Fibrin D dimer increased, Loss of personal independence in daily activities
Clinical narrative: Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic encephalopathy, Nausea, Oxygen saturation decreased, Pyrexia
Clinical narrative: Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure, Rhonchi, SARS-CoV-2 test positive, Sepsis, Tachypnoea
Clinical narrative: Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Decreased appetite, Dyspnoea, Dyspnoea exertional
Clinical narrative: The patient has a history of stage III kidney disease and diet-controlled diabetes. She was seen in the ED on 9/12/23 for three weeks of congestion, sore throat, cough, and loss of appetite. She additionally endorsed shortness of breath on exertion, headache, right ear pain, a rash that started 6 days ago. In the ED, a COVID-19 PCR test was done which resulted positive. Ultimately, she was admitted 9/12/23 - 9/15/23 for COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pain, Headache, Oropharyngeal pain, Rash, Respiratory tract congestion
Clinical narrative: The patient has a history of stage III kidney disease and diet-controlled diabetes. She was seen in the ED on 9/12/23 for three weeks of congestion, sore throat, cough, and loss of appetite. She additionally endorsed shortness of breath on exertion, headache, right ear pain, a rash that started 6 days ago. In the ED, a COVID-19 PCR test was done which resulted positive. Ultimately, she was admitted 9/12/23 - 9/15/23 for COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: The patient has a history of stage III kidney disease and diet-controlled diabetes. She was seen in the ED on 9/12/23 for three weeks of congestion, sore throat, cough, and loss of appetite. She additionally endorsed shortness of breath on exertion, headache, right ear pain, a rash that started 6 days ago. In the ED, a COVID-19 PCR test was done which resulted positive. Ultimately, she was admitted 9/12/23 - 9/15/23 for COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Appointment scheduled too early for 2nd dose of Influenza. Computer scanner was not working and nurse waiting for restart of computer and scanner. All questions asked of mother while waiting for computer. Influenza dose administered before scanner available. 2nd dose of Influenza was too early for vaccine schedule. No negative outcomes reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain
Clinical narrative: Body aches Light headed
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: PATIENT BROKE OUT IN SHINGLES BLISTERS ON NECK AND LEFT SIDE OF HEAD.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: My right arm in which I received the shot got sort of numb, sore and tingly from the shoulder all the way down to the finger tips. The whole arm really aches and I t can feel really badly. The first couple of days it lasted a couple of minutes and subsided., but it happened three or four times a day  Gradually, the symptoms were only once or twice a day for a shorter period of time and less severe. The symptoms seem to occur without cause and effect, meaning I can?t see anything that caused the reaction.   The symptoms continue but are much diminished in discomfort.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial pain, Headache, Neuralgia
Clinical narrative: Left side of my face hurts. Nerve pain. Headache
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Peripheral swelling, Skin warm
Clinical narrative: Patient called stating that she was at a rountine Cardiologist appointment and had told her, her symptoms and issues taking place. The Cardiologist told her to call and report her symptoms and reaction to Health Dept. Patient stated that she received her High Dose Flu Vaccine one 09/25/2023 and after receiving waited in the lobby for 20 mins and then left. Patient stated that she felt fine when she left. Then about 2 hours after vaccination she stated she started to feel bad and had a little difficulty breathing but was not concerned enough to go to Emergency Room. Patient also stated that they had sprayed bug spray in house and thought that might have been what contibribute to the breathing issues. However today 09/27/2023 her arm is redden and swollen and warm to touch. Patient was informed that this can be a normal side effect and encouraged to use cool/ warm compressed to help with the reddness and swelling. Patitnet stated that she was not concerned about the reddness or swelling that they has happened in the past when she received her Pneumonia vaccine. But due to her Cardioloist telling her to report she thought she would call and inform health department. Patient was let known that a report would be filled with VAERS.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Pruritus
Clinical narrative: Patient stated she developed severe itching on her hands and feet/between toes today. She stated there is not a physical rash on her body. Itching is confined to hands and feet. Denies any difficulty breathing. Reaction only started today.
Age: 17.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness to site area. Patient and parent denied fever
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site urticaria, Rash, Urticaria, Vomiting
Clinical narrative: Patient developed red whelps/urticaria on left arm, then left leg, then right arm and leg within 2-3 minutes after vaccines were administered. Benadryl was given po and rash began to resolve within 10 minutes. No further symptoms developed that day. 3 days after the vaccines, patient had vomiting that lasted a few hours .
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Loss of personal independence in daily activities, Pruritus, Rash, Urticaria
Clinical narrative: Shot given just before 12pm on the 19th of September. Woke up the morning of 21st and noticed rashes on back of right thigh, as well as back and chest. She seemed to be acting totally normal and I read that sometimes vaccines can cause eczema to flare so I thought that was the case and since she acted fine I let her go to school. Complained of her butt itching when I dropped her off to school at 12:45 on the 21st. Was called to pick her up from school around 2pm because the rashes/hives were spreading. Upon getting there and seeing her she had rashes/hives on her arms now and a little on her face. Took her home and she went to my wife?s work later that day around 5pm and at that time the rashes/hives on her face had gotten worse. Doctor prescribed Zyrtec to control the issue. Symptoms cleared very quickly. Was told to continue Zyrtec for 4 days. The rashes/hives did come back the next day and cleared after another dose of Zyrtec. Same thing again the next day but less severe. As of today (5th day - no Zyrtec) it seems to be done with.
Age: 82.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given the flu and Spikevax twice, the first shot was given on 9/20/23 and the second shot was given 09/27/23. The residence coordinator did not recall him getting any shots and patient was administer another dose. However it was later discovered that patient had received it already.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiac stress test, Chest pain, Electrocardiogram, Magnetic resonance imaging heart
Clinical narrative: Chest pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Chest pain
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: PER PATIENT, HE EXPERIENCED A SORE THROAT, RUNNY NOSE ONLY IN THE LEFT NOSTRIL AND  TROUBLE SWALLOWING POST VACCINE ; ADVISED PT TO FOLLOW UP WITH DOCTOR
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cold sweat, Crying, Dizziness, Endometriosis, Pain
Clinical narrative: After I got the two shots, I felt woozy and lightheaded. I had to take a seat and I started to have cold sweats. It took me like 5 minutes to finally be able to stand up. I went home and soon after, I start to get the absolute worst uterine cramps I have ever gotten on my entire life. It was on the level of a contraction pain, the absolute most horrendous pain I've ever had. I am diagnosed with endometriosis but even then, not even the worst cramp compared to the pain I was going through. I was almost crying because of the agonizing pain and I put warm compresses on my lower abdomen and took 1000 MG of acetaminophen. I wanted to go to the emergency room, but I was in too much pain to even get out od bed. It took a full 30 minutes for the pain to die down. It was traumatizing.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Uterine spasm
Clinical narrative: After I got the two shots, I felt woozy and lightheaded. I had to take a seat and I started to have cold sweats. It took me like 5 minutes to finally be able to stand up. I went home and soon after, I start to get the absolute worst uterine cramps I have ever gotten on my entire life. It was on the level of a contraction pain, the absolute most horrendous pain I've ever had. I am diagnosed with endometriosis but even then, not even the worst cramp compared to the pain I was going through. I was almost crying because of the agonizing pain and I put warm compresses on my lower abdomen and took 1000 MG of acetaminophen. I wanted to go to the emergency room, but I was in too much pain to even get out od bed. It took a full 30 minutes for the pain to die down. It was traumatizing.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 17 year old patient received Proquad combination dose instead of MMR and varicella. Patient had no adverse reaction upon observation for one hour. Client informed of nurse error and agrees to return 10/30/2023 for administration of approved vaccines.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: HAS BEEN EXPERIENCING TRIGGER FINGER IN LEFT HAND AFTER COVID VACCINATIONS. MOST OFFTENC OCCURING AFTER HOLDING FORKS AND KNIFFS (FINE MOTOR ACTIVITIES) HAS HAPPENED UP TO 4 TIMES DURING ONE MEAL. OCCASIONALLY RIGHT HAND HAS SIMILAR ISSUES AND PAIN. PATIENT HAS BEEN USING A BRACE AS WELL. HAS HAD SOME UPPER ARM PAIN AS WELL, MORE IN THE LEFT ARM THAN IN THE RIGHT.  Had a friend report similar events after the vaccines prompting her to come in for the same.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hunger, Loss of consciousness, Syncope
Clinical narrative: administered injection right deltoid.  Approximately 2 minutes after injection, patient c/o dizziness.  Patient then experienced syncopal episode lasting 5-10 seconds before regaining consciousness.  Patient reported that she had not eaten prior to arriving at clinic today.  Given popsicle and water after she was awake.  Monitored patient 30 minutes after episode.  Patient the reported that she "felt fine" and was just "really hungry."  Patient released from clinic.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient reported having a sore arm and said it felt sore in her joint
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Inflammation, Loss of personal independence in daily activities, Lymphoedema, Mobility decreased
Clinical narrative: Lymphatic swelling in neck, underarms, primarily and other sites so badly I could not wear a bra or put my arms down. Simultaneously development  of lateral left thigh neuropathy so bad the pain hurt when walking.  Put on course of strong 800mg ibuprofen to help with inflammation and additional monitoring of thigh. Eventually after about 2 months the lymphatic swelling went down and began physical therapy for thigh and back compression hoping it was neurological. Thigh persists to the present with minor improvements with continued bilateral poly neuropathy development and frequent full body inflammation.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Polyneuropathy
Clinical narrative: Lymphatic swelling in neck, underarms, primarily and other sites so badly I could not wear a bra or put my arms down. Simultaneously development  of lateral left thigh neuropathy so bad the pain hurt when walking.  Put on course of strong 800mg ibuprofen to help with inflammation and additional monitoring of thigh. Eventually after about 2 months the lymphatic swelling went down and began physical therapy for thigh and back compression hoping it was neurological. Thigh persists to the present with minor improvements with continued bilateral poly neuropathy development and frequent full body inflammation.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache,  nausea, vomiting
Age: 13.0
Sex: F
Vaccine: HEP, MMR
Symptoms: No adverse event
Clinical narrative: Patients vaccine record from her home country was incorrectly read as far as how many vaccines she already had in this series. No signs or symptoms of a physiological or physical reaction noted
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: When I arrived to the pharmacy there was a backlog of immunizations needing to be administered. So I started to process the immunizations that were pending. Because of the patients age they should  of received FluQuad and not the FluzoneHD. The issue was not caught until the insurance billing information became available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Tooth infection
Clinical narrative: right maxillary odontogenic infection and pain
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE.; RECOMBIVAX given during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 01-SEP-2023, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, one time, lot #W038227, expiration date reported as 23-MAY-2023, but upon internal validation established as 23-MAY-2025, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). It was reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was given during a temperature excursion. Temperature excursions were on 02-AUG-2023 and 04-AUG-2023. There were no adverse events reported (no adverse event).
Age: 29.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Hernia repair, Product storage error
Clinical narrative: 29 YO received 1st vaccines; hernia surgery; This spontaneous report has been received from a licensed vocational nurse (LVN), referring to a 29 years old male patient. The reporter stated patient had unknown vaccination history and needed vaccines. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown by reporter.  On 26-JUL-2023, the patient was vaccinated the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) (lot # W022943 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 06-APR-2024) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W025274 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-AUG-2024), both for vaccinations (product administered to patient of inappropriate age). On the same day, the patient was also vaccinated with hepatitis b vaccine rhbsag (yeast) (ENGERIX B) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) (lot number and expiration date were not reported for both suspect vaccines), both for vaccinations. The route, dose and strength were unknown for all suspect vaccines.  In 2023 (reported as last week), the patient received hernia surgery. The patient sought medical attention and received treatment. It was unknown if the laboratory diagnostics or studies performed. The outcome of hernia surgery was reported as unknown. The causality assessment between the hernia surgery and all suspect vaccines was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; Information was received from a Medical Assistant referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.        On 27-JUN-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # W026137, expiration date 05-FEB-2024, oral (strength, dose, and dose number were not reported), for prophylaxis (product storage error). The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) underwent a temperature excursion in a time frame of 35 minutes with a 8.74 Celsius Degrees of temperature. No previous temperature excursions occurred. No adverse event was reported. No more medical relevant information was reported.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No AE reported; HCP called to report inadvertent administration of a third dose of PEDVAX HIB to a 6-month-old patient. The patient received PEDVAX HIB on 05/23/2023, 07/21/2023, and inadvertently on 09/21/2023. No additional AE/PQC.; This spontaneous report was received from a nurse, concerning a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 23-MAY-2023, the patient was vaccinated with the first dose of  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). On 21-JUL-2023, the patient received the second dose of  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).    On 21-SEP-2023, it was reported an inadvertent administration of a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, dose unknown by reporter/third dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  to a 6-month-old patient.  No additional AE/PQC.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: vaccinated for shingles and has had it for 20 weeks/suspected vaccination failure; He has been miserable; vaccinated for shingles and has had it for 20 weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccinated for shingles and has had it for 20 weeks/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: vaccinated for shingles and has had it for 20 weeks) and feeling miserable (Verbatim: He has been miserable).  The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 20 weeks) and the outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The reported stated his/her friend had shingles for 20 weeks even after administration of shingles vaccine. The patient was miserable. 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: Eye swelling, Head injury, Smallpox, Swelling of eyelid
Clinical narrative: Smallpox; hit the head; Eye swelling; This serious case was reported by a consumer via interactive digital media and described the occurrence of smallpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included smallpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced smallpox (Verbatim: Smallpox) (serious criteria GSK medically significant), head injury (Verbatim: hit the head) and eye swelling (Verbatim: Eye swelling).The outcome of the smallpox was not resolved and the outcome of the head injury and eye swelling were not reported.   It was unknown if the reporter considered the smallpox, head injury and eye swelling to be related to Shingles vaccine.     It was unknown if the company considered the smallpox, head injury and eye swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via (social media) interactive digital media. The reporter stated that whoever had smallpox as a child could get it again after 50 but he/she believed it and they gave him/her the shingles vaccine almost 4 years ago and he/she still had problems.  They injected the virus, he/she hit his/her head, one eye swollen shut, he/she went to A and E (emergency department) twice.  The reporter further stated that it did more harm to the body than good.  The patient met so many elderly people and no one got it.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/ had it now; had it now; already vaccinated 3 times; Pain; This serious 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In AUG-2023, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain (Verbatim: Pain). On an unknown date, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/ had it now) (serious criteria GSK medically significant), shingles (Verbatim: had it now) and extra dose administered (Verbatim: already vaccinated 3 times).  The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient's children via interactive digital media. The patient had it now and she had already been vaccinated 3 times. The reporter stated that it was unbelievable that the patient got it.  The physician said that the vaccine was 80 percent effective but she fell into the 20 percent  that was not. Poor thing, she had pain for 3 weeks now that would not go away. The patient received shingles vaccine, which led to extra dose administered. 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.