chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Exposure to SARS-CoV-2, Respiratory symptom
Clinical narrative: Narrative: Patient presented to ED on 1/8/2023 with chief complaint of upper respiratory symptoms for 2-3 days. Patient was admitted and placed in observation for mild acute hypoxemic respiratory failure secondary to acute COVID19 infection in setting of multiple sick contacts. She was on room air during evaluation. Treated with PRN nebulizers, IV steroids, vitamin C, and vitamin D.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Pneumonia, Productive cough
Clinical narrative: Narrative: 78yoM admitted for multifocal pneumonia on 1/3/2023. Diagnosed with COVID on 12/23/2022. Per H&P, Patient feeling better after COVID treatment, but then developed cough with sputum production, fever, chills and SOB. Treated with supportive oxygen, Rocephin, and azithromycin.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Narrative: 78yoM admitted for multifocal pneumonia on 1/3/2023. Diagnosed with COVID on 12/23/2022. Per H&P, Patient feeling better after COVID treatment, but then developed cough with sputum production, fever, chills and SOB. Treated with supportive oxygen, Rocephin, and azithromycin.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Cardio-respiratory arrest, Decubitus ulcer, Electrocardiogram, Gangrene
Clinical narrative: Narrative: Per 10/31/22 Specialty Clinic Nurse Note, Patient presents to Podiatry Clinic appt for evaluation for gangrenous right third toe and decubitus bilateral heel ulcerations. Patient transfers via wheel chair pushed by wife who is accompanying patient at this appt. Patient is alert and oriented x3, able to verbalize needs, and VSS. Patient and wife agreed to have the flu vaccine at this time. Fluad vaccine was administered to left deltoid. Approximately 5 minutes after vaccination was received, the patient slumped his head backward loosing consciousness in wheel chair. Code Blue was called over head and he was taken to triage room for evaluation by code blue provider. EKG done, and facility police notified. He was taken to hospital via ambulance and wife  was to meet them there. Per 10/31/22 Cardiology Follow-Up Note, 82-year-old patient with history of heart transplant due to severe cardiomyopathy, a stage III chronic kidney disease, type 2 diabetes mellitus, essential hypertension and previous history of pulmonary embolism. He was given an IM INFLUENZA VIS vaccine to the left deltoid and within 5 minutes of the injection had an episode of unresponsiveness. When evaluated in the triage room, he was only responding to deep stimuli but within minutes he was following commands . He has generalized weakness but not of ipsilateral weakness and was alert in time and space. Episode of unresponsiveness : Needs to consider TIA unlikely to represent an allergic reaction to the flue vaccine but still needs to be consider. Vomiting could be one of the side effect of the flu Vaccine . Per staff, nausea and vomiting are documented as ADRs to the influenza vaccine and syncope is a documented postmarketing ADR. While multiple postmarketing neurologic  ADRs have been reported, disorientation was not one of them.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Loss of consciousness, Posture abnormal, Unresponsive to stimuli, Wheelchair user
Clinical narrative: Narrative: Per 10/31/22 Specialty Clinic Nurse Note, Patient presents to Podiatry Clinic appt for evaluation for gangrenous right third toe and decubitus bilateral heel ulcerations. Patient transfers via wheel chair pushed by wife who is accompanying patient at this appt. Patient is alert and oriented x3, able to verbalize needs, and VSS. Patient and wife agreed to have the flu vaccine at this time. Fluad vaccine was administered to left deltoid. Approximately 5 minutes after vaccination was received, the patient slumped his head backward loosing consciousness in wheel chair. Code Blue was called over head and he was taken to triage room for evaluation by code blue provider. EKG done, and facility police notified. He was taken to hospital via ambulance and wife  was to meet them there. Per 10/31/22 Cardiology Follow-Up Note, 82-year-old patient with history of heart transplant due to severe cardiomyopathy, a stage III chronic kidney disease, type 2 diabetes mellitus, essential hypertension and previous history of pulmonary embolism. He was given an IM INFLUENZA VIS vaccine to the left deltoid and within 5 minutes of the injection had an episode of unresponsiveness. When evaluated in the triage room, he was only responding to deep stimuli but within minutes he was following commands . He has generalized weakness but not of ipsilateral weakness and was alert in time and space. Episode of unresponsiveness : Needs to consider TIA unlikely to represent an allergic reaction to the flue vaccine but still needs to be consider. Vomiting could be one of the side effect of the flu Vaccine . Per staff, nausea and vomiting are documented as ADRs to the influenza vaccine and syncope is a documented postmarketing ADR. While multiple postmarketing neurologic  ADRs have been reported, disorientation was not one of them.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Narrative: Patient given Pfizer Bivalent instead of Pfizer Monovalent vaccine. Pharmacy contacted. Talked with patient, explained what happened. Per pharmacy patient to return for second Monovalent Pfizer in 28 days, patient agreed to come back on 11/11/2022 for her 2nd Pfizer Monovalent Pfizer vaccine. Pharmacist contacted Pfizer Inc. for clarifcation, per Pfizer patient does not have to return for second dose of Monovalent Pfizer, one dose Monovalent Pfizer and one dose of Bivalent Pfizer is sufficient, Patient was contacted by phone and notified of change of plan. Patient is in agreement and will not return for second dose of Monovalent Pfizer.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Narrative: Patient was admitted on 12/02/2022 for COVID pneumonia. Per H&P by inpatient provider, no hypoxia or noted respiratory distress per her exam.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Dyspnoea
Clinical narrative: Narrative: 82yoM admitted due to COVID. Presented to ED with complaints of generalized weakness, fever Tmax 102, chills, cough, and slow onset SOB with wheezing. Patient has received 3 COVID vaccinations. Treated with IV methylprednisolone 125mg x1 dose and continuing on dexamethasone 6mg IV daily.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Narrative: 82yoM admitted due to COVID. Presented to ED with complaints of generalized weakness, fever Tmax 102, chills, cough, and slow onset SOB with wheezing. Patient has received 3 COVID vaccinations. Treated with IV methylprednisolone 125mg x1 dose and continuing on dexamethasone 6mg IV daily.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received received 1st dose of Moderna COVID-19 Vaccine on 27Feb2021, 2nd dose on 16May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received received 1st dose of Moderna COVID-19 Vaccine on 27Feb2021, 2nd dose on 16May2021) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received received 1st dose of Moderna COVID-19 Vaccine on 27Feb2021, 2nd dose on 16May2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received received 1st dose of Moderna COVID-19 Vaccine on 27Feb2021, 2nd dose on 16May2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received received 1st dose of Moderna COVID-19 Vaccine on 27Feb2021, 2nd dose on 16May2021).    Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2023-696764 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vaccination site discomfort
Clinical narrative: severe discomfort on my left(injection) side for roughly a week; Since my booster, I have significantly less to zero soreness in my left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV positivity" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY. Vaccination history included: BNT162b2 (Prev dose product=COVID 19,, Prev dose brand=Pgizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details,, Prev dose administration date=01May2022,, Prev dose dose number=1,, Prev dose vaccine location=Right arm), administration date: 01May2022, when the patient was 51-year-old, for Covid-19 immunization; BNT162b2 (Previous dose details, Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details,, Prev dose administration date=01Sep2021,, Prev dose dose number=2,, Prev dose vaccine location=Left arm,), administration date: 01Sep2021, when the patient was 51-year-old, for Covid-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 14Dec2022, 1 day after the suspect product(s) administration, outcome "recovered with sequelae", described as "Since my booster, I have significantly less to zero soreness in my left side"; VACCINATION SITE DISCOMFORT (non-serious) with onset 14Dec2022, 1 day after the suspect product(s) administration, outcome "recovered with sequelae", described as "severe discomfort on my left(injection) side for roughly a week". Therapeutic measures were not taken as a result of vaccination site discomfort, therapeutic response unexpected.  Additional information: patient stated that this really was not an adverse event and he was HIV positive and taking Biktarvy for entirety of time of all COVID vaccinations. The patient received bivalent booster and experienced rather severe discomfort on his left (injection) side for roughly a week. HIV infection and subsequent medication revealed soreness in lymphoid centers through the body. Since booster, he had significantly less to zero soreness in his left side. It might be great to had another bivalent booster on his right side. No know allergies. Patient didn't receive other vaccine in four weeks. Patient had covid prior vaccination. The patient hadn't covid tested post vaccination.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Electrocardiogram, Fall
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Heart rate, Heart rate increased, Hypotension, Investigation, Lymphadenopathy
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Heart rate, Heart rate increased, Hypotension, Lymphadenopathy, Pain
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Pyrexia
Clinical narrative: dizziness; low Blood pressure; elevated heart rate; fever; diarrhea; chills; swollen lymph glands; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (hospitalization, medically significant), outcome "unknown"; HYPOTENSION (hospitalization, medically significant), outcome "unknown", described as "low Blood pressure"; HEART RATE INCREASED (hospitalization, medically significant), outcome "unknown", described as "elevated heart rate"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; CHILLS (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph glands"; PAIN (non-serious), outcome "not recovered", described as "achy". The events "dizziness", "low blood pressure" and "elevated heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: low Blood pressure; Electrocardiogram: Unknown results, notes: EKG performed in ambulance and at hospital; Heart rate: elevated.  Clinical course: Received a Pfizer bivalent booster after 3 previous doses of Comirnaty. 17 minutes later had dizziness, low Blood pressure, and elevated heart rate. Walked back to pharmacist and laid down. Pharmacist took blood pressure and heart rate and called ambulance and taken to Hospital. EKG performed in ambulance and at hospital. Patient was sent home and then had fever chills swollen lymph glands achy and diarrhea. Event took place after use of product.  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: 64.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident, Intensive care, Laboratory test
Clinical narrative: Stroke less than 24 hours of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 30Nov2022 at 02:00, outcome "not recovered", described as "Stroke less than 24 hours of injection". The patient underwent the following laboratory tests and procedures: Scan: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: No other vaccine in four weeks. AE treatment: ICU, numerous scans. No covid prior vaccination and not tested post vaccination.  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: 64.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident, Scan
Clinical narrative: Stroke less than 24 hours of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 30Nov2022 at 02:00, outcome "not recovered", described as "Stroke less than 24 hours of injection". The patient underwent the following laboratory tests and procedures: Scan: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: No other vaccine in four weeks. AE treatment: ICU, numerous scans. No covid prior vaccination and not tested post vaccination.  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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: Other medical history: DM; "RA" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Cipro for Known allergies: Cipro.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID rebound symptoms and testing positive (Ag test) after full course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not take other medication in 2weeks. Patient received COVID 19 Treatment from 18May2022 to23May2022.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective, COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reported that a 35 year old patient was administered a dose of PROQUAD at another facility.; No additional AEs/no PQCs.; This spontaneous report was received from a pharmacist referring to a 35-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection for prophylaxis (1 dosage form, strength, lot #, expiration date and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient who was previously administered 1st GARDASIL 9 Dose on 09/07/2022 had missed 2nd GARDASIL 9 Dose/had never received 2nd GARDASIL 9 Dose.; No additional AE reported; This spontaneous report has been received from a pharmacist, referring to a 40-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions, or allergies were not reported.  On 07-SEP-2022, the patient was vaccinated the first with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, vaccination scheme, anatomical location, lot number or expiration date were not provided) for prophylaxis. The patient had missed the second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose and had never received it (product dose omission issue). No further information provided.  No additional adverse event (AE) reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Coma, Fear, Herpes zoster
Clinical narrative: Got 2 vaccines and turned out it was shingles,suspected vaccination failure; Got it, turned out it was shingles, it sent me to hospital; horrible  burning sensation, body was burned all over; coma for 3 months; blisters on buttocks; feel fear,scares me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), coma (serious criteria hospitalization and GSK medically significant), burning sensation (serious criteria hospitalization), blister and fear. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, blister and fear were unknown and the outcome of the coma was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, coma, burning sensation, blister and fear to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, blister and fear to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she got it (shingles) and it he/she sent him/her to the hospital it was like if all his/her body was burned all over.  The patient went to the doctor and supposedly they gave him/her the wrong medication and it turned out that they sent him/her to another hospital where patient fell in a coma for 3 months and at the end it turned out that it was shingles.  The patient get blisters from time to time on buttocks and that was it, the patient the 2 vaccines but nothing to worry about, he/she heal quickly because it scares him/her, when they come out the patient thought he/she was in a horrible burning oven. Additional Supportive information: 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 could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Got 2 vaccines and turned out it was shingles,suspected vaccination failure; Got it, turned out it was shingles, it sent me to hospital; horrible  burning sensation, body was burned all over; coma for 3 months; blisters on buttocks; feel fear,scares me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), coma (serious criteria hospitalization and GSK medically significant), burning sensation (serious criteria hospitalization), blister and fear. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, blister and fear were unknown and the outcome of the coma was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, coma, burning sensation, blister and fear to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, blister and fear to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she got it (shingles) and it he/she sent him/her to the hospital it was like if all his/her body was burned all over.  The patient went to the doctor and supposedly they gave him/her the wrong medication and it turned out that they sent him/her to another hospital where patient fell in a coma for 3 months and at the end it turned out that it was shingles.  The patient get blisters from time to time on buttocks and that was it, the patient the 2 vaccines but nothing to worry about, he/she heal quickly because it scares him/her, when they come out the patient thought he/she was in a horrible burning oven. Additional Supportive information: 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 could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: neighbors that tested positive on 29Dec2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (neighbors that tested positive on 29Dec2023) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced COVID-19 (neighbors that tested positive on 29Dec2023). At the time of the report, COVID-19 (neighbors that tested positive on 29Dec2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had had less symptoms. Treatment medication was not reported.  This case contains information for the 3rd of 3 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696687 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696687: Reporters case
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Interchange of vaccine products
Clinical narrative: Caller was coughing over the phone; He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete; He previously received all the Moderna vaccines), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Sep2022, outcome "unknown", described as "He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine"; COUGH (non-serious), outcome "not recovered", described as "Caller was coughing over the phone".  Additional information: Reporter explained that he had received the booster dose in September last year (Sep2022). Despite receiving all the vaccines against COVID he got COVID about three weeks ago. His doctor informed him that he was fortunate enough to get all the boosters and all the vaccines because the COVID symptoms could have been a lot worse. He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine. He was told that it was ok to receive the booster dose of Pfizer. Reporter was coughing over the phone and mentioned that was the after effect of COVID. Reporter stated that he would like to stay most up to date with his immunization status hence the reason why he was calling to get information on the most up-to-date booster. He wanted to know whether he was eligible or not.   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. Sender's Comments: Linked Report(s) : PFIZER INC-202300016074 same product, patient, different events;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Caller was coughing over the phone; He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete; He previously received all the Moderna vaccines), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Sep2022, outcome "unknown", described as "He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine"; COUGH (non-serious), outcome "not recovered", described as "Caller was coughing over the phone".  Additional information: Reporter explained that he had received the booster dose in September last year (Sep2022). Despite receiving all the vaccines against COVID he got COVID about three weeks ago. His doctor informed him that he was fortunate enough to get all the boosters and all the vaccines because the COVID symptoms could have been a lot worse. He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine. He was told that it was ok to receive the booster dose of Pfizer. Reporter was coughing over the phone and mentioned that was the after effect of COVID. Reporter stated that he would like to stay most up to date with his immunization status hence the reason why he was calling to get information on the most up-to-date booster. He wanted to know whether he was eligible or not.   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. Sender's Comments: Linked Report(s) : PFIZER INC-202300016074 same product, patient, different events;