chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Oropharyngeal pain, Pneumonia, Pseudomonal bacteraemia, Pulmonary embolism
Clinical narrative: Patient initially tested positive for COVID-19 on 7/31/2022. Her symptoms were fevers, chills, fatigue, weakness, headache, nasal congestion, and shortness of breath; All her symptoms resolved except for the weakness, fatigue, and shortness of breath.  FIRST HOSPITALIZATION:  On 9/6/2022, patient presented to the emergency department for evaluation of acute and chronic shortness of breath. She was given a COVID-19 NAA test in the ED which resulted positive; Her chest x-ray showed a new right mid alveolar infiltrate. Patient's oxygen saturation was 87% on room air; She was started on supplemental oxygen. Patient was diagnosed with acute hypoxemic respiratory failure, and pneumonia of right lung due to infectious organism. She was admitted to the hospital for further evaluation and treatment.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.  SECOND HOSPITALIZATION:  On 12/5/2022, patient presented to the emergency department for evaluation of dyspnea that increased over the past week, hypoxia, and sore throat. She had a respiratory viral panel done and it was positive for COVID, suggesting recurrent COVID; Her chest x-ray showed patchy bibasilar parenchymal opacities likely related to the patient's known COVID infection. Patient's oxygen saturation was 82% with exertion on room air and 88% at rest on room air; She was started on supplemental oxygen which brought her oxygen saturation up to the mid 90s. Patient was diagnosed with dyspnea, COVID-19, hypoxia, and thrush. She was admitted to the hospital for further evaluation and treatment. Patient died on 12/28/2022 while an inpatient at the hospital. Her death abstract listed immediate cause of death as acute hypoxemic respiratory failure, interstitial lung disease exacerbation, COVID-19 pneumonia; with other significant conditions listed to be cardiac arrest, stroke, obstructive sleep apnea, diabetes mellitus type 2, pulmonary embolism, acute kidney injury, heart failure with preserved ejection fraction, and pseudomonas bacteremia.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory viral panel, SARS-CoV-2 test positive, Type 2 diabetes mellitus
Clinical narrative: Patient initially tested positive for COVID-19 on 7/31/2022. Her symptoms were fevers, chills, fatigue, weakness, headache, nasal congestion, and shortness of breath; All her symptoms resolved except for the weakness, fatigue, and shortness of breath.  FIRST HOSPITALIZATION:  On 9/6/2022, patient presented to the emergency department for evaluation of acute and chronic shortness of breath. She was given a COVID-19 NAA test in the ED which resulted positive; Her chest x-ray showed a new right mid alveolar infiltrate. Patient's oxygen saturation was 87% on room air; She was started on supplemental oxygen. Patient was diagnosed with acute hypoxemic respiratory failure, and pneumonia of right lung due to infectious organism. She was admitted to the hospital for further evaluation and treatment.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.  SECOND HOSPITALIZATION:  On 12/5/2022, patient presented to the emergency department for evaluation of dyspnea that increased over the past week, hypoxia, and sore throat. She had a respiratory viral panel done and it was positive for COVID, suggesting recurrent COVID; Her chest x-ray showed patchy bibasilar parenchymal opacities likely related to the patient's known COVID infection. Patient's oxygen saturation was 82% with exertion on room air and 88% at rest on room air; She was started on supplemental oxygen which brought her oxygen saturation up to the mid 90s. Patient was diagnosed with dyspnea, COVID-19, hypoxia, and thrush. She was admitted to the hospital for further evaluation and treatment. Patient died on 12/28/2022 while an inpatient at the hospital. Her death abstract listed immediate cause of death as acute hypoxemic respiratory failure, interstitial lung disease exacerbation, COVID-19 pneumonia; with other significant conditions listed to be cardiac arrest, stroke, obstructive sleep apnea, diabetes mellitus type 2, pulmonary embolism, acute kidney injury, heart failure with preserved ejection fraction, and pseudomonas bacteremia.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized, one of the admitting conditions was COVID 19.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dizziness, Fatigue, Oxygen saturation decreased
Clinical narrative: On the 16th in the morning I began with body aches, cough, skin hypersensitivity, more tired than usual. It was all mild. I had no fever. The next day on 17th my O2 sat dropped from 97 to 81. I went to the emergency room and they sent me home on home oxygen at 2 LPM. On the 18th the cough and body aches ended. I did start on PAXLOVID 3/17/2023 to 3/22/2023. On Friday night and the rest of the time I was on PAXLOVID I had pretty intense dizziness and had to use a walker and PHENERGAN. My O2 sats were fine so I wasn't dizzy for lack of oxygen. May have been related to PAXLOVID or may have been a coincidence. The dizziness went away after I finished the PAXLOVID. I went down to 1 LPM yesterday. Today I did a 6 minute walk test at the doctors office and have been discharged off of oxygen. I had had major abdominal surgery March 3rd which may have played a factor in all of this.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive, Sensitive skin, Walking aid user, Walking distance test
Clinical narrative: On the 16th in the morning I began with body aches, cough, skin hypersensitivity, more tired than usual. It was all mild. I had no fever. The next day on 17th my O2 sat dropped from 97 to 81. I went to the emergency room and they sent me home on home oxygen at 2 LPM. On the 18th the cough and body aches ended. I did start on PAXLOVID 3/17/2023 to 3/22/2023. On Friday night and the rest of the time I was on PAXLOVID I had pretty intense dizziness and had to use a walker and PHENERGAN. My O2 sats were fine so I wasn't dizzy for lack of oxygen. May have been related to PAXLOVID or may have been a coincidence. The dizziness went away after I finished the PAXLOVID. I went down to 1 LPM yesterday. Today I did a 6 minute walk test at the doctors office and have been discharged off of oxygen. I had had major abdominal surgery March 3rd which may have played a factor in all of this.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test abnormal, Blood urine present, Computerised tomogram normal, Positron emission tomogram normal, Prostate cancer
Clinical narrative: October 19, 2022, I saw blood in my urine. I ended up in the ER and they did a CT scan, Pet scan, and urine sample. The CT and Pet scan which both came back negative, but the urine sample indicated that I did have blood in my urine. I got back from a trip and went to a urologist. My blood work came back that I had evidence of Prostate Cancer. My PSA score was 4.8 on Oct. 17, came back elevated in January which confirmed Prostate Cancer.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Prostatic specific antigen increased, Urine analysis abnormal
Clinical narrative: October 19, 2022, I saw blood in my urine. I ended up in the ER and they did a CT scan, Pet scan, and urine sample. The CT and Pet scan which both came back negative, but the urine sample indicated that I did have blood in my urine. I got back from a trip and went to a urologist. My blood work came back that I had evidence of Prostate Cancer. My PSA score was 4.8 on Oct. 17, came back elevated in January which confirmed Prostate Cancer.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered as primary series dose
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased, Joint stiffness, Nausea, Neck pain
Clinical narrative: Severe Headache, Moderate neck ache, nauseous, very stiff joints. We are on day 3 with no relief from them. Also had on night two rapid heart beat/heart racing.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Severe Headache, Moderate neck ache, nauseous, very stiff joints. We are on day 3 with no relief from them. Also had on night two rapid heart beat/heart racing.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Illness, Injection site pain
Clinical narrative: I had arm tenderness at the injection site for about a day. I have a history of degenerative disease. After my vaccine, the disease did not get worse.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Viral upper respiratory tract infection
Clinical narrative: I was diagnosed with a viral lung infection with difficulty breathing and upper respiratory infection.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arrhythmia, Electrocardiogram ambulatory abnormal, Extrasystoles, SARS-CoV-2 test negative, Superior vena cava syndrome
Clinical narrative: My adverse event started after 3 month of receiving  my  5th  Pfizer Bivalent Booster which is on 12/11/2022 at noon.  I felt my heart skipping beats. I called  my doctor on Monday 12/12/2022  and schedule an appointment on  01/25/2023. They called and scheduled an appointment with the Cardiologist the same day. They ordered an Holter Monitor which I wore for a week. They diagnosed me with PBCC on 02/28/2023.  They told me that I had Premature Ventricular contractions, TAC of a low burden and some episodes of SVCS. They advised  me to take Metoprolol as per needed, increase potassium and stay hydrated.   I get Arrhythmia every once in a while. It's really annoying.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: My adverse event started after 3 month of receiving  my  5th  Pfizer Bivalent Booster which is on 12/11/2022 at noon.  I felt my heart skipping beats. I called  my doctor on Monday 12/12/2022  and schedule an appointment on  01/25/2023. They called and scheduled an appointment with the Cardiologist the same day. They ordered an Holter Monitor which I wore for a week. They diagnosed me with PBCC on 02/28/2023.  They told me that I had Premature Ventricular contractions, TAC of a low burden and some episodes of SVCS. They advised  me to take Metoprolol as per needed, increase potassium and stay hydrated.   I get Arrhythmia every once in a while. It's really annoying.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Illness, Vaccination failure
Clinical narrative: Got 3 shingles shots, still get shingles/Suspected vaccination failure; Mild shingles; Sick; Got 3 shingles shots; This serious 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 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. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 3 shingles shots, still get shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Mild shingles), sickness (Verbatim: Sick) and extra dose administered (Verbatim: Got 3 shingles shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and sickness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she mistakenly received three doses of Shingles vaccine and still occassionaly experienced mild shingles. The patient stated that all of the vaccine doses are made him/her sick, just about every vaccine he/she ever took made him/her sick, that's why he/she stooped at the shingles vaccine. The patient do not want the next one dose to be the that kills him/her. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingles vaccine in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR039171:Same reporter same patient - invalid case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Stress, Vaccination failure
Clinical narrative: Major case of shingles after the vaccine/suspected vaccination failure; Shingles in ears; Shingles on face/scalp; Stressed; 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.   Family history included shingles (almost 18 years before date of reporting patient brother have very mild case of shingles broke out in his armpit) and post herpetic neuralgia (patient brother still have nerve pain in his feet and back).   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: Major case of shingles after the vaccine/suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles in ears) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on face/scalp) and stress (Verbatim: Stressed). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, shingles and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that he nagged his sister to receive the Shingles vaccine. The patient after received Shingles vaccine experienced broke out with major case of shingles on her face, scalp and in her ears. The reporter stated that it was horrendous and anytime the patient got stressed she broke out with the shingles again. The reporter stated that he was not getting the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shingles after getting shot/suspected vaccination failure; Shingles; Intense pain; Anguish; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 80-year-old female 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: Got shingles after getting shot/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Intense pain) and anguish (Verbatim: Anguish). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and anguish were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and anguish to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and anguish to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her friend an 80 years old female patient received shingles vaccine and experienced shingles, it was very bad. The reporter stated that it has been going on as of two years now and the patient has been under the physician care and the whole time there was no improvement. The patient received Gabapentin as a treatment but it does not helped her at all. The patient was in intense pain and anguish. The patient all can do to function. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: received the shingles vaccination still got them/suspected vaccination failure; Shingles on shoulder and hip; Painful; Itchy; This serious 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.   Family history included shingles (mother).   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: received the shingles vaccination still got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on shoulder and hip), pain (Verbatim: Painful) and pruritus (Verbatim: Itchy). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that his/her mother had shingles so he/she received Shingles vaccine and still experienced shingles on his/her right shoulder and hip. The patient stated that the shingles are not as painful as his/her mother but they are still itchy and painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Delivery, Herpes zoster, Pain, Uterine malposition, Vaccination failure
Clinical narrative: pain; Shingles now after shots in 2017/suspected vaccination failure; I now have SHINGLES again; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles now after shots in 2017/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I now have SHINGLES again). On an unknown date, the patient experienced pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Mar-2023 The case was received from the patient via interactive digital media. The patient had an almost natural child birth because the opening to her wound was upside down and they kept telling her that she was not labor. The patient had taken her shots since 2017 and now had shingles again. The patient stated that well she was but the pain was not as bad as this bout of the shingles. The patient mentioned 5 drugs (RXs) and nothing works. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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: had the shot before I got shingles/suspected Vaccination failure; I got shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot before I got shingles/suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she forgot to mention that he/she had the shot before got shingles This case was considered as suspected vaccination failure, since the details regarding vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Burning sensation, Eczema, Pruritus, Rash
Clinical narrative: On 01/30/2023, we noticed a rash on her face.  Itchy, burning, along the hairline, cheeks, neck and it was patchy and blotchy. We went to the dermatologist and she was diagnosed with Eczema. She gave her a prescription for two topical medications as well as over the counter cream. She is much better. She also had stomach pain twenty four hours after the vaccine for twelve hours, on 09/23/2022.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash macular
Clinical narrative: On 01/30/2023, we noticed a rash on her face.  Itchy, burning, along the hairline, cheeks, neck and it was patchy and blotchy. We went to the dermatologist and she was diagnosed with Eczema. She gave her a prescription for two topical medications as well as over the counter cream. She is much better. She also had stomach pain twenty four hours after the vaccine for twelve hours, on 09/23/2022.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Influenza B virus test positive, Pyrexia
Clinical narrative: I positive for COVID-19 on 18FEB2023, I had a slight cough at the time. The next day I ran a low fever for couple of days and felt very tired. I didn't know I had COVID until I got tested. I also, was positive for influenzas type B at the same time. I was prescribed PAXLOVID, I started feeling better about 2 days after.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I positive for COVID-19 on 18FEB2023, I had a slight cough at the time. The next day I ran a low fever for couple of days and felt very tired. I didn't know I had COVID until I got tested. I also, was positive for influenzas type B at the same time. I was prescribed PAXLOVID, I started feeling better about 2 days after.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, Malignant melanoma, Maternal exposure before pregnancy, Melanocytic naevus, Skin neoplasm excision
Clinical narrative: In January 2023, I had to go get my normal skin check. My doctor found that one of my moles had changed and did a biopsy. The result of the biopsy indicated that it was melanoma, which I had to get excised on 2/14/2023. I would like to add that I am currently pregnant, and my daughter is due 8/16/2023. At the time of this writing, I am doing well. I am just waiting for the site of the mole excision to heal.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram, Differential white blood cell count, Fatigue, Full blood count, Headache
Clinical narrative: Patient is a 11y.o. female who arrived by car presented to the emergency department for possible seizure. Noncontributory past medical history. Patient presents with mother who provides a portion of the history via an interpreter. Reportedly, 1 hour ago the patient was getting her immunizations for school and after the third immunization the patient fainted and went stiff with some shaking movements for roughly 6 seconds and then regained consciousness following this. Mother reports that she was somewhat slow and ?not really herself? for roughly 20 minutes which gradually improved spontaneously. By the time of my evaluation, the patient states that outside of a headache and generalized fatigue she feels asymptomatic. Specifically denies any chest pain or cardiopulmonary complaints. No trauma or incontinence during the episode. No history of similar episodes previously.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Metabolic function test, Musculoskeletal stiffness, Platelet count, Syncope
Clinical narrative: Patient is a 11y.o. female who arrived by car presented to the emergency department for possible seizure. Noncontributory past medical history. Patient presents with mother who provides a portion of the history via an interpreter. Reportedly, 1 hour ago the patient was getting her immunizations for school and after the third immunization the patient fainted and went stiff with some shaking movements for roughly 6 seconds and then regained consciousness following this. Mother reports that she was somewhat slow and ?not really herself? for roughly 20 minutes which gradually improved spontaneously. By the time of my evaluation, the patient states that outside of a headache and generalized fatigue she feels asymptomatic. Specifically denies any chest pain or cardiopulmonary complaints. No trauma or incontinence during the episode. No history of similar episodes previously.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Patient is a 11y.o. female who arrived by car presented to the emergency department for possible seizure. Noncontributory past medical history. Patient presents with mother who provides a portion of the history via an interpreter. Reportedly, 1 hour ago the patient was getting her immunizations for school and after the third immunization the patient fainted and went stiff with some shaking movements for roughly 6 seconds and then regained consciousness following this. Mother reports that she was somewhat slow and ?not really herself? for roughly 20 minutes which gradually improved spontaneously. By the time of my evaluation, the patient states that outside of a headache and generalized fatigue she feels asymptomatic. Specifically denies any chest pain or cardiopulmonary complaints. No trauma or incontinence during the episode. No history of similar episodes previously.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Covid-19 I tested positive for Covid-19 on January 23, 2023 I experienced a cough for 3 days. I was prescribe Paxlovid for my symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased
Clinical narrative: I had my annual gynecology appointment on March 6, 2023, they noticed that my blood pressure was elevated. They took it again when the appointment was ending, my blood pressure was still elevated. I was advised to see my primary care physician to get checked. The next day my PCP, had me come in to check my blood pressure and again it was elevated. I am now taking Amlodipine/Besylate to help keep my blood pressure regulated. I have a follow up visit on March 30, 2023, to see if this medication is keeping my blood pressure steady.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Product administration error
Clinical narrative: Received an unnecessary dose of Hepatitis B.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Nasopharyngitis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 03/08/2023- I had mild cold symptoms; coughing and a low grade fever. I contacted Urgent Care and was prescribed a course of Paxlovid. I still have a lingering cough.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Cardiac murmur, Condition aggravated, Cough
Clinical narrative: 12/19/2022 I was still on a cruise and I developed minor symptoms at this time. When we got back home, on 12/21/2022, I had the left over test available at my mother's home so I took that test. I also had a virtual visit and I was positive for COVID-19. I was prescribed PAXLOVID and took that and improved some. I returned home on 12/24/2022. The following Monday, I was getting worse and had to do constant nebulizers. I had some left over steroids and other medications to take. I tested positive twice when I was first sick. On 01/02/2023, I took another COVID-19 test and it was negative and I returned to work. I was still having frequent coughing and asthma attacks for a month and I would say it took about 2 months before getting back to base line. I would still need an inhaler a few times a week. I decided to see a pulmonologist back in January but was finally able to see her on 03/09/2023. I had a pulmonary function test and was formally diagnosed with asthma and started on medication. The pulmonologist also noted a new heart murmur that had not been noted before. I am scheduled for an upcoming echocardiogram on 04/19/2023.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired work ability, Pulmonary function test abnormal, SARS-CoV-2 test positive
Clinical narrative: 12/19/2022 I was still on a cruise and I developed minor symptoms at this time. When we got back home, on 12/21/2022, I had the left over test available at my mother's home so I took that test. I also had a virtual visit and I was positive for COVID-19. I was prescribed PAXLOVID and took that and improved some. I returned home on 12/24/2022. The following Monday, I was getting worse and had to do constant nebulizers. I had some left over steroids and other medications to take. I tested positive twice when I was first sick. On 01/02/2023, I took another COVID-19 test and it was negative and I returned to work. I was still having frequent coughing and asthma attacks for a month and I would say it took about 2 months before getting back to base line. I would still need an inhaler a few times a week. I decided to see a pulmonologist back in January but was finally able to see her on 03/09/2023. I had a pulmonary function test and was formally diagnosed with asthma and started on medication. The pulmonologist also noted a new heart murmur that had not been noted before. I am scheduled for an upcoming echocardiogram on 04/19/2023.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both shots then got shingles/Suspected vaccination failure; Shingles; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got both shots then got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient got both shingles shots, then got shingles afterwards.  The reporter stated that no thank you to both. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dermatitis, Dry skin, Rash, Rash pruritic
Clinical narrative: I had dermatitis. I had a dry and itchy rash on my lower legs, chest, upper body, and upper arms. I went to the doctor, and they prescribed me 3 doses of oral medication. The medication helped and I no longer have this problem.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Started feeling really tired and congested, and took a COVID-19 test and was positive. Was prescribed PAXLOVID. Started feeling better a few days later. Then a week later I started getting cold symptoms again and retook the COVID-19 test and was positive. Rested at home with OTC medications. Tested negative but still feel more tired than I did before testing positive.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Incorrect product formulation administered, Malaise
Clinical narrative: Pt received first Moderna dose 12/04/2021 and accidently received bivalent dose instead of second dose in series.  Pt states that she feels unwell / weak; stating that the booster should not make her feel this unwell. She spoke with her friends and no they did not feel under the weather with the booster. Pt states she feels unwell because she did not receive the second dose of the primary series first.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product use issue, Wrong product administered
Clinical narrative: patient called the office on 3/23/23 and reported a discrepancy on her immunizations record.  Patient stated she was in the office on 2/17/23 and received a pneumonia vaccine but it is in her chart as a COVID vaccine. I checked her immunization record and the documentation indicates she received a COVID bivalent booster on the date in question, the lot number and manufacturer documented are consistent with COVID vaccine and  not pneumococcal.  Patient had previously received 5 doses of Moderna Covid vaccine and was up to date with COVID vaccine and thus received an unapproved dose of COVID vaccine and will now need to return to receive the pneumovax.
Age: 62.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fatigue, headache, overall crappy feeling.  Lasted for about 4 - 5 days.  I had a little fever but not bad.  I felt intensely crappy on a scale of 1 - 10, I was about a 5.  The last vaccine was worse than the others.  After the vaccine, I had joint pain, low grade fever, fatigue, headache, and an overall crappy feeling.  On a scale of 1 - 10 I was about a 7 right after the vaccine.  Having seconds thoughts about getting any future vaccines.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt given Bivalent Covid vaccination instead of Monovalent. No adverse reaction
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered as 1st dose in primary series
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I positive for COVID-19 on 14FEB2023, I had a sore throat, coughing and a little vomiting. I was pretty fatigued. I contacted my doctor in telehealth and prescribed me paxlovid. I started feeling better after 1 day, now I am feeling very good.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: I positive for COVID-19 on 14FEB2023, I had a sore throat, coughing and a little vomiting. I was pretty fatigued. I contacted my doctor in telehealth and prescribed me paxlovid. I started feeling better after 1 day, now I am feeling very good.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram abnormal, Aortic aneurysm, Aphasia, Atrial fibrillation, COVID-19
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac pacemaker insertion, Cerebrovascular accident, Chills, Computerised tomogram head normal
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Diarrhoea, Dizziness, Facial paralysis
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Gaze palsy, Hyperlipidaemia, Hypotension, Hypoxia, Malaise
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Respiratory failure, SARS-CoV-2 test positive, Stent-graft endoleak, Syncope
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Tachypnoea, Transient ischaemic attack, Unresponsive to stimuli
Clinical narrative: Presented to the hospital 12/23/2022 with syncopal event. Family reported diffuse diarrhea the morning of admission. Earlier in the day patient was complaining of lightheadedness and also chills. Patient suffered a second syncopal event. EMS was called and found him unresponsive slumped over with left-sided lateral gaze and left-sided facial droop. In the ED he was diagnosed with COVID-19 viral infection. Family reports he recently got over COVID-19 pneumonia in late September. Problems:  TIA versus CVA: expressive aphasia, syncope, left facial droop. Head CT without intracranial bleeding.  Atrial fibrillation: Pacemaker, continue anticoagulation  Hypertension  COVID-19 viral syndrome: Vaccinated, recently diagnosed with COVID-19 a few months ago with only mild symptoms. Starting remdesivir 200 mg bolus followed by 100 mg for 4 days as symptoms are less than 5 days. Since symptoms started today. Holding off on steroids as satting greater than 90% on room air. RT. Contact precautions. Check CRP, LDH. Starting vitamin C, D and D.  Hyperlipidemia  On the evening of December 25, 2025 patient again had a nonresponsive event, was found to be tachypneic, hypotensive and hypoxic. Family chose comfort measures. Patient expired 7:48AM on December 26, 2022. Cause of death hospital report: abdominal aortic aneurysm  death report: respiratory failure due to Covid pneumonia. Submitter does not have access to complete medical record. If additional information is needed, contact Hospital.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I, Medical assistant, administered the Vaccine 2 weeks too early