chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Ammonia normal, Blood gases normal, Blood pressure increased
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, COVID-19, Cardiomegaly, Chest X-ray abnormal, Computerised tomogram abdomen normal
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax normal, Diuretic therapy, Dyspnoea, Echocardiogram normal
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction normal, Electroencephalogram abnormal, Hypoxia, Lethargy, Lung infiltration
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Pulmonary congestion, Pyrexia, SARS-CoV-2 test positive, Swelling face
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea, Urine analysis normal, Vitamin B12 normal
Clinical narrative: COVID+ 12/28/22.  Vaccination status- J&J x1, Pfizer x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2022 Discharge Date: 12/31/2022     Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus    DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE:   Patient is a 51-year-old female with history of COVID-19 pneumonia in 02/2022, mild intermittent asthma, mild OSA, history of brain tumor status post resection in childhood, seizure disorder, anoxic brain injury, developmental delay, dysphagia with feeding tube in place, wheelchair-bound, nonverbal who presented to the ER with cough, shortness of breath and difficulty in breathing.  Patient's mother/caregiver reported patient had bouts of cough and shortness of breath about 2 weeks ago.  Patient was given prednisone she had in the home with some improvement.  Since then, patient did have increased work of breathing and home COVID test was positive the day of admission.  In the emergency department, patient was hypoxic requiring 2 L O2.  Chest x-ray revealed perihilar opacities.  She tested positive for COVID.  She was admitted for further management.   Patient was quickly weaned off of oxygen.  She was treated for pneumonia due to COVID-19 with Decadron and remdesivir.  Patient's mentation were improved posterior to baseline and dyspnea and cough improved with supportive care. Patinet was discharged late in the evening on 12/31/22 in improving condition. HHC was arranged and arrangements made for Transition to Home Program. She was prescribed Decadron to complete 10 day course.    Addendum: Of note, Decadron was sent to her regular pharmacy which was closed at time of discharge and on 1/1, so new prescription was sent to requested pharmacy.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/10/21, 3/17/21, 11/3/21. Positive on 1/3/23
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood cholesterol increased, Bronchoscopy
Clinical narrative: High Cholesterol; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Relapsing polychondritis", start date: 26Apr2022 (ongoing); "Tracheomalacia", start date: 24Apr2022 (ongoing); "Inappropriate sinus Tachycardia", start date: Aug2022 (ongoing). Concomitant medication(s) included: FLU VACCINE VII intramuscular taken for immunisation, on 06Oct2022 as dose 1, single; PREDNISONE oral taken for polychondritis, start date: Apr2022 (ongoing); METHOTREXATE subcutaneous taken for polychondritis, start date: May2022 (ongoing); ACTEMRA subcutaneous taken for polychondritis, start date: Jul2022 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Anatomical Site of Injection: L Arm, Route of administration: Intramuscular, Lot number: EW0151), administration date: 05Apr2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID"; BNT162b2 (Dose: 2, Anatomical Site of Injection: L Arm, Route of administration: Intramuscular, Lot number: ER8735), administration date: 26Apr2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID"; BNT162b2 (Dose: 3, Anatomical Site of Injection: L Arm, Route of administration: Intramuscular, Lot number: FF2587), administration date: 04Nov2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID"; BNT162b2 (Dose: 4, Anatomical Site of Injection: L Arm, Route of administration: Intramuscular, Lot number: 33036BD), administration date: 26May2022, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "COVID". The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset Nov2022, outcome "not recovered", described as "High Cholesterol". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood cholesterol increased.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: had passed away from a heart attack; chest pains; The initial case was missing the following minimum criteria: [Unspecified product] Upon receipt of follow-up information on [29Dec2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 at 13:00 as dose 2, single (Lot number: FC3184) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Paralyzed" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Leg Right, Vaccine Administration Time: 01:00 PM), administration date: 07Aug2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (death) with onset 31Aug2021, outcome "fatal", described as "chest pains"; MYOCARDIAL INFARCTION (death, medically significant) with onset 04Sep2021, outcome "fatal", described as "had passed away from a heart attack". The event "chest pains" required emergency room visit. Therapeutic measures were taken as a result of chest pain. The patient date of death was 04Sep2021. Reported cause of death: "chest pains", "heart failure", "had passed away from a heart attack". No autopsy was performed.  Clinical course: On 28Aug2021 my mother was vaccinated with your product and not even a week later she passed away. My loving mother passed away on 04Sep2021. Not long after being injected with the vaccine she complained about chest pains. The pain got so severe that she called for an ambulance to be transported to the emergency department on 03Sep2021. Later that day mother was released from the hospital, by the morning of 04Sep2021 my mother had passed away from a heart attack. She has never had any issues with her heart and or do we have a history of it in our family. Autopsy was not performed, patient did not had COVID prior vaccination and was not tested for COVID post vaccination: No.; Reported Cause(s) of Death: chest pains; heart failure; had passed away from a heart attack
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Myocardial infarction
Clinical narrative: had passed away from a heart attack; chest pains; The initial case was missing the following minimum criteria: [Unspecified product] Upon receipt of follow-up information on [29Dec2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 at 13:00 as dose 2, single (Lot number: FC3184) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Paralyzed" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Leg Right, Vaccine Administration Time: 01:00 PM), administration date: 07Aug2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (death) with onset 31Aug2021, outcome "fatal", described as "chest pains"; MYOCARDIAL INFARCTION (death, medically significant) with onset 04Sep2021, outcome "fatal", described as "had passed away from a heart attack". The event "chest pains" required emergency room visit. Therapeutic measures were taken as a result of chest pain. The patient date of death was 04Sep2021. Reported cause of death: "chest pains", "heart failure", "had passed away from a heart attack". No autopsy was performed.  Clinical course: On 28Aug2021 my mother was vaccinated with your product and not even a week later she passed away. My loving mother passed away on 04Sep2021. Not long after being injected with the vaccine she complained about chest pains. The pain got so severe that she called for an ambulance to be transported to the emergency department on 03Sep2021. Later that day mother was released from the hospital, by the morning of 04Sep2021 my mother had passed away from a heart attack. She has never had any issues with her heart and or do we have a history of it in our family. Autopsy was not performed, patient did not had COVID prior vaccination and was not tested for COVID post vaccination: No.; Reported Cause(s) of Death: chest pains; heart failure; had passed away from a heart attack
Age: 38.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Biopsy bone marrow abnormal, Blast cells present, Fibrosis, Thrombocytopenia
Clinical narrative: profound thrombocytopenia; concern for acute leukemia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Sickle cell anaemia" (unspecified if ongoing), notes: other medical history: sickle cell anemia. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FG3527, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 37-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8732, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 36-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6198, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: ACUTE LEUKAEMIA (hospitalization, medically significant) with onset 21Nov2022, outcome "not recovered", described as "concern for acute leukemia"; THROMBOCYTOPENIA (hospitalization, medically significant) with onset 21Nov2022, outcome "not recovered", described as "profound thrombocytopenia". The patient was hospitalized for thrombocytopenia, acute leukaemia (hospitalization duration: 5 day(s)). The events "profound thrombocytopenia" and "concern for acute leukemia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of thrombocytopenia, acute leukaemia. The clinical course was reported as follows: developed profound thrombocytopenia less than 1 month after the last dose of vaccine with now concern for acute leukemia. No known allergies.; Sender's Comments: Based on the available information in the case, the causal association between the reported events acute leukemia, thrombocytopenia and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Acute leukaemia, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: profound thrombocytopenia; concern for acute leukemia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Sickle cell anaemia" (unspecified if ongoing), notes: other medical history: sickle cell anemia. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FG3527, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 37-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8732, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 36-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6198, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: ACUTE LEUKAEMIA (hospitalization, medically significant) with onset 21Nov2022, outcome "not recovered", described as "concern for acute leukemia"; THROMBOCYTOPENIA (hospitalization, medically significant) with onset 21Nov2022, outcome "not recovered", described as "profound thrombocytopenia". The patient was hospitalized for thrombocytopenia, acute leukaemia (hospitalization duration: 5 day(s)). The events "profound thrombocytopenia" and "concern for acute leukemia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of thrombocytopenia, acute leukaemia. The clinical course was reported as follows: developed profound thrombocytopenia less than 1 month after the last dose of vaccine with now concern for acute leukemia. No known allergies.; Sender's Comments: Based on the available information in the case, the causal association between the reported events acute leukemia, thrombocytopenia and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Arthralgia, Shoulder injury related to vaccine administration, X-ray normal
Clinical narrative: Got the vaccine at 3pm, by 9pm I was in excruciating pain  on my shoulder, which kept me up all night. I took 2 Ibuprofen at 200 mg each, which did nothing for the pain. Saw doctor the following day.
Age: 67.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Arthralgia, Insomnia, Tendonitis
Clinical narrative: Got the vaccine at 3pm, by 9pm I was in excruciating pain  on my shoulder, which kept me up all night. I took 2 Ibuprofen at 200 mg each, which did nothing for the pain. Saw doctor the following day.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong vaccine indicated for patient's age was given to the patient. Patient's mother was informed but stated that patient was fine.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Influenza like illness, Mechanical urticaria, Pruritus, Pyrexia
Clinical narrative: I had no Reactions to the first three Moderna shots I took (series 1, series 2, booster). However, with this fourth shot (bivalent booster) I had strong flu like symptoms that night, including a fever.   What was worse, was I broke out in hives all over my back, legs, and chest. I?ve never had an allergic reaction before so I wasn?t sure what was happening. Very itchy. Also developed ?dermatographia? which I had never heard of or experienced before.   I?ve mostly been able to manage the hives by taking Zyrtec every night. Though I start to feel itchy as I near the 24 hour mark each night.   However, nothing seems to help the dermatographia. Slight pressure, heat, or soft touch all triggers my skin to turn red and produce itchy wheals. It?s been over a month now with no relief, so I will be going to urgent care soon (since I don?t have a primary care doctor). I really hope this isn?t a lifelong disorder from the Moderna booster.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sensitive skin, Urticaria
Clinical narrative: I had no Reactions to the first three Moderna shots I took (series 1, series 2, booster). However, with this fourth shot (bivalent booster) I had strong flu like symptoms that night, including a fever.   What was worse, was I broke out in hives all over my back, legs, and chest. I?ve never had an allergic reaction before so I wasn?t sure what was happening. Very itchy. Also developed ?dermatographia? which I had never heard of or experienced before.   I?ve mostly been able to manage the hives by taking Zyrtec every night. Though I start to feel itchy as I near the 24 hour mark each night.   However, nothing seems to help the dermatographia. Slight pressure, heat, or soft touch all triggers my skin to turn red and produce itchy wheals. It?s been over a month now with no relief, so I will be going to urgent care soon (since I don?t have a primary care doctor). I really hope this isn?t a lifelong disorder from the Moderna booster.
Age: 26.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Angioedema, Chronic spontaneous urticaria, Dermatitis contact, Hypersensitivity, Mechanical urticaria
Clinical narrative: 10 days after vaccination, hives and itching began. Initially diagnosed as contact dermatitis (confined to waistline) and treated with Benadryl and a steroidal topical cream. Within 48 hours, progressed to severe full-body hives and itching, with dermatographia and intermittent angioedema. Went to clinic and diagnosed with an allergic reaction; given a course of oral steroids and a steroid injection (administered in buttock). Relief lasted ~3 days. Saw allergist, who diagnosed idiopathic urticaria and prescribed treatment of 4 Allegra per day. 2 Tagamet per day were added to the Allegra regimen, because symptoms persisted. Then, Singulair was added to the regimen when symptoms continued to persist. A second round of oral steroids was prescribed approximately 6 weeks after the initial Allergist visit (7 weeks after symptom onset). The allergist revised the diagnosis to Chronic Idiopathic Urticaria at that point. Approximately 8 weeks after symptom onset, the first Xolair injection was administered. These injections will continue monthly. Patient continues to take Allegra and has been unable to wean off Tagamet or Singulair; two Xolair injections have been administered thus far. A link between the urticaria and the COVID and flu vaccines was not confirmed, although the allergist indicated  that it could be related, in theory.
Age: 26.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: 10 days after vaccination, hives and itching began. Initially diagnosed as contact dermatitis (confined to waistline) and treated with Benadryl and a steroidal topical cream. Within 48 hours, progressed to severe full-body hives and itching, with dermatographia and intermittent angioedema. Went to clinic and diagnosed with an allergic reaction; given a course of oral steroids and a steroid injection (administered in buttock). Relief lasted ~3 days. Saw allergist, who diagnosed idiopathic urticaria and prescribed treatment of 4 Allegra per day. 2 Tagamet per day were added to the Allegra regimen, because symptoms persisted. Then, Singulair was added to the regimen when symptoms continued to persist. A second round of oral steroids was prescribed approximately 6 weeks after the initial Allergist visit (7 weeks after symptom onset). The allergist revised the diagnosis to Chronic Idiopathic Urticaria at that point. Approximately 8 weeks after symptom onset, the first Xolair injection was administered. These injections will continue monthly. Patient continues to take Allegra and has been unable to wean off Tagamet or Singulair; two Xolair injections have been administered thus far. A link between the urticaria and the COVID and flu vaccines was not confirmed, although the allergist indicated  that it could be related, in theory.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus- still experiencing as of 1/05/2023
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness postural, Exercise tolerance decreased, Headache, Palpitations
Clinical narrative: Multiple symptoms that had include chest discomfort, palpitations, headache, exercise intolerance, positional changes dizziness, vitiligo,. Chest discomfort, palpitations, postional changes dizziness had resolved.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Multiple symptoms that had include chest discomfort, palpitations, headache, exercise intolerance, positional changes dizziness, vitiligo,. Chest discomfort, palpitations, postional changes dizziness had resolved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX (also reported as PROQUAD) was administered to 1 patient following a temperature excursion; This spontaneous report was received from a customer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039947, expiration date: 16-DEC-2023 (dose, strength, route of administration were not provided) as prophylaxis.  The vaccine underwent a temperature excursion of 27.9 degrees Fahrenheit (F) for a period of 1 hour and 35 minutes. The vaccine did not undergo any previous temperature excursion. The office manager reported that the patient did not experience any adverse event.
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: eye feels irritated; squirted some of the VARIVAX in his eye.; Occupational exposure while preparing product for administration; This spontaneous report was received from a 49-year-old male physician reporting on himself.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. The physician reported that he had never had chicken pox, but he was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) in the past and received approximately 6 doses over the years because the results of his titers were always equivocal.   On 07-DEC-2022, while the physician was preparing a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); in combination with sterile diluent (strength, dose description, lot #, expiry date, route of administration, and indication were not provided), he inadvertently squirted some of the vaccine in his eye. He reported that his eye felt irritated (Eye irritation) and that after the exposure he immediately irrigated with an unspecified eye wash.   At the time of reporting, the patient had not recovered from the event of eye irritation and he did not receive any other medical treatment for his eye since it was flushed.   The causal relationship between the event of Eye irritation and varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored PROQUAD.  Diluent was not involved in the temperature excursion.   No additional AEs were reported, no further information provided.  Names of vaccines involved (including l; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported  On 15-DEC-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot #W023866, expiration date: 24-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine underwent a temperature excursion of 19.3 degrees Fahrenheit (F) for a period of 2 hours and 30 minutes. The vaccine did not undergo any previous temperature excursion. The heath care worker reported that the patient did not experience any adverse event.
Age: 6.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; 6 years of age was administered MMRII on 9/3/2021 and VARIVAX on 9/21/2021, when there should have been a minimum of 28 days between doses of live vaccines; This spontaneous report was received from a nurse and refers to a 6-year-old patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, quantity: 1, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided). On 21-SEP-2021, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, quantity: 1, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided). The patient received varicella virus vaccine live (oka/merck) (VARIVAX) while there was no minimum of 28 days between doses as it should with live vaccines (inappropriate schedule of product administration).  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP states that PEDVAX HIB and ROTATEQ vaccines that underwent a supported temperature excursion were administered to a patient on 27DEC2022.; No additional AE information provided.; This spontaneous report was received from nurse referring to a patient of unknown age, gender, and ethnicity. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 27-DEC-2022, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1892784 (Lot # has been verified to be a valid lot number), (expiration date: 03-DEC-2023) (strength, dose, and frequency were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #W006596 (Lot # has been verified to be a valid lot number) (expiration date: 11-OCT-2024) (strength, dose, route of administration, and frequency were not provided) for prophylaxis.  On that date, vaccines that underwent a supported temperature excursion (product storage error) for 1 hour and 2 minutes at 8.5 degree Celsius (C). No additional adverse event (AE) information provided. Vaccines had no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP states that ROTATEQ vaccine that underwent a supported temperature excursion on Dec 26, 2022 was administered to a patient on Dec 27, 2022.; This spontaneous report has been received from a nurse, referring a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 27-DEC-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1837127 has been verified to be a valid lot number, expiry date 14-OCT-2023) (strength, dose, and frequency were not reported) indicated as prophylaxis (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine was stored at a temperature of 15.4 °C for a time frame of 8 hours. The re was no previous temperature excursion.  No additional adverse event were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event
Clinical narrative: 3 children were partially vaccinated either on MMR II or PROQUAD; No additional AE reported; This spontaneous report was received from a Company Representative and refers to a child patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was partially vaccinated either with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). No additional adverse events reported.   This is one of 3 reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got Vx and it did't work/suspected vaccination failure; It did'nt work; so much pain, can´t stand it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The case was received the patient via interactive digital media. The patient stated that oh my god, he/she was in so much pain everyday that he/she could not stand them none of the pills he/she took helped. The patient stated that what was wrong with the people how could they give a vaccine and then it did not work and did not know why you did but the patient need some help something had to get rid of this pain. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This case was reported by a consumer via patient support programs and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for infusion for systemic lupus erythematosus.   On 26th December 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Benlysta at an unknown dose and frequency. On 27th December 2022, 1 days after receiving Shingrix and unknown after starting Benlysta, the patient experienced chills. The action taken with Benlysta was unknown. On an unknown date, the outcome of the chills was not recovered/not resolved.   It was unknown if the reporter considered the chills to be related to Shingrix and Benlysta.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: This case was reported by a patient via patient support programs. The patient stated that she received her shingles vaccine the day before reporting and was experiencing chills at the time of reporting. The reporter consent to contact was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swollen left arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR195995   Additional Information: GSK Receipt Date: 30-DEC-2022  Reporter's Comments: The patient received her dose of Shingrix and experienced a swollen left arm, which lasted for about a week before it resolved. No consent to follow up was given. Additional Supportive Information: For tolerance to 2nd dose, refer case US2022AMR195995.; Sender's Comments:  US-GSK-US2022AMR195995:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: achey; This case was reported by a consumer via sales rep and described the occurrence of pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR197019   Additional Information: GSK Receipt date: 29-Dec-2022 Reporter's Comment: The patient was reporter's friend's husband. Reporter stated that the patient had any issues with first dose but thought he mentioned he was achy. The reporter was not sure when patient received first dose. Additional Supportive Information: For the tolerance of 2nd dose refer case US2022AMR197019, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR197019:Same reporter
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix  administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: The reporter was health care provider. The reporter called to report that a patient received an expired dose of Havrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email. Additional Supportive Information: The reporter called to report that a patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: 1st dose 24Sep2022, 2nd 27Dec2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 57-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On 27th December 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: The medical assistant reports that the patient received the Sanofi flu vaccine at a different facility on 24 Sep2022, and she was administered a dose of FluLaval QIV on 27th December 2022.  The reporter consent to follow up. Additional Supportive Information: The patient received extra FluLaval Quadrivalent, which led to extra dose administered.