chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product quality issue
Clinical narrative: Pharmacist discovered vial did not have enough serum to draw a sixth and final dose. Another pharmacist had done two prior vaccines. Pharmacist has made patient aware there is a possibility (however unlikely) that she may have received a larger dose than intended (0.3 ml). Pharmacist was waiting to try and confirm through camera footage but not able to be done. It is also not known if different calibrated syringes were used thus making easier to waste product. Product could also have been a quality issue as well.  Pharmacist is brain storming all possibilities even if an error has not occurred but treating as such due to nature of vaccine and EUA.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Pt reported Red Raised Itchy Bumps mainly on legs, but was all over. She stated it started on 3/22/23 at around 8pm. She received the vaccine on around 3pm on 3/21/23.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: Full body hives, itching, tingling.
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Child was due for first Covid monovalent vaccine and was mistakenly administered a Bivalent Covid vaccine intended for 6-11 yr olds. No adverse effects reported.  Clinic realized the mistake when child returned for 2nd dose.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Biopsy pericardium abnormal, Cardiac tamponade, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: She was admitted to the hospital with new onset A fib with RVR, pericardial effusion with early tamponade requiring pericardial window with pathology showing inflammation consistent with pericarditis.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pericardial effusion, Pericardial excision, Pericarditis
Clinical narrative: She was admitted to the hospital with new onset A fib with RVR, pericardial effusion with early tamponade requiring pericardial window with pathology showing inflammation consistent with pericarditis.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Blister, Gianotti-Crosti syndrome
Clinical narrative: Multiple vesicles that developed on my son?s  arms, hands and legs but spared his torso. Was told this is a Gianotti Crosti Syndrome. Lasted 2-3 weeks.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient stated she started itching shortly after receiving the Covid vaccine. The next day she started itching all over her body. No rash noted. Nurse recommended that patient follows up with her doctor and go to the emergency room if she experiences any shortness of breath, throat swelling, or fever.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp 103F. Treated & resolved no other
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Tdap given in L deltoid on 3/20/2023, next day localized swelling & redness wheal about 3.5 inches, per dad. On 3/22/23, sat pt. with diffuse Redness about 3inx4.5in with induration in the center, mild warm to touch, no tenderness to touch, fill ROM BUE without pain; no signs of body rash normal facial swelling.
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Swelling face
Clinical narrative: Tdap given in L deltoid on 3/20/2023, next day localized swelling & redness wheal about 3.5 inches, per dad. On 3/22/23, sat pt. with diffuse Redness about 3inx4.5in with induration in the center, mild warm to touch, no tenderness to touch, fill ROM BUE without pain; no signs of body rash normal facial swelling.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: Patient was given 0.4ml of undiluted Pfizer vaccine. Patient contacted, denies any adverse or local effects, merely a sore arm for 1 1/2 days after receiving vaccine. No treatment needed.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm remains sore, randomly sensitivity/pain at injection site and/or lower in same arm but not reaching elbow.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Back pain, Blood culture, COVID-19, Central venous catheterisation
Clinical narrative: Admission Date: 3/8/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: T12-L1 disc space infection   HOSPITAL COURSE: Patient is a 91 year old male with Hx of HTN, Afib, chronic diastolic HF, CAD, DM type II, CKD Stage III, BPH, rectal Ca, and GERD who presented to the ED with chills, shortness of breath, and cough as well as worsening back pain.   He tested positive for COVID-19 and was admitted to the hospitalist service. CTA with groundglass opacities. He was requiring 3L NC O2 on admission and weaned to room air after completing 5 days of remdesivir and 6 days of dexamethasone. Pt did have steroid induced hyperglycemia, treated with insulin which improved significantly after steroids were completed.   Regarding the patient's back pain, CT T/L spine concerning for T12-L1 discitis/osteomyelitis. MRI of the thoracic/lumbar spine showed discitis/osteomyelitis at T12-L1 as well as small abscess within anterior right psoas. Echo was completed showing normal EF and no valvular vegetation but pulmonic valve difficult to visualize. Spine surgery was consulted but did not recommend surgical intervention. IR was consulted and performed biopsy of T12-L1 intervertebral disc but cultures remained negative. Initial blood cultures 1/2 positive for micrococcus luteus, suspect contaminant, per ID. He was treated with ceftriaxone/vancomycin IV with all subsequent blood cultures negative. Due to improvement in back pain and negative blood cultures, ID recommended ceftriaxone/vancomycin to complete 6 weeks (3/12-4/23) with ID follow up in 4-6 weeks. His pain was controlled with tramadol, zanaflex, lidocaine patch, and gabapentin. PT/OT recommend SAR. Pt and facility were in agreement with SAR as pt desired to recover and eventually return home. They did have hospice informational meeting on 3/16 but did not yet feel that pt's goals were in alignment with hospice.   PICC placed by vascular access team prior to discharge. He discharged to SAR in stable condition on 3/17/2023.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram spine abnormal, Condition aggravated, Cough, Culture negative
Clinical narrative: Admission Date: 3/8/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: T12-L1 disc space infection   HOSPITAL COURSE: Patient is a 91 year old male with Hx of HTN, Afib, chronic diastolic HF, CAD, DM type II, CKD Stage III, BPH, rectal Ca, and GERD who presented to the ED with chills, shortness of breath, and cough as well as worsening back pain.   He tested positive for COVID-19 and was admitted to the hospitalist service. CTA with groundglass opacities. He was requiring 3L NC O2 on admission and weaned to room air after completing 5 days of remdesivir and 6 days of dexamethasone. Pt did have steroid induced hyperglycemia, treated with insulin which improved significantly after steroids were completed.   Regarding the patient's back pain, CT T/L spine concerning for T12-L1 discitis/osteomyelitis. MRI of the thoracic/lumbar spine showed discitis/osteomyelitis at T12-L1 as well as small abscess within anterior right psoas. Echo was completed showing normal EF and no valvular vegetation but pulmonic valve difficult to visualize. Spine surgery was consulted but did not recommend surgical intervention. IR was consulted and performed biopsy of T12-L1 intervertebral disc but cultures remained negative. Initial blood cultures 1/2 positive for micrococcus luteus, suspect contaminant, per ID. He was treated with ceftriaxone/vancomycin IV with all subsequent blood cultures negative. Due to improvement in back pain and negative blood cultures, ID recommended ceftriaxone/vancomycin to complete 6 weeks (3/12-4/23) with ID follow up in 4-6 weeks. His pain was controlled with tramadol, zanaflex, lidocaine patch, and gabapentin. PT/OT recommend SAR. Pt and facility were in agreement with SAR as pt desired to recover and eventually return home. They did have hospice informational meeting on 3/16 but did not yet feel that pt's goals were in alignment with hospice.   PICC placed by vascular access team prior to discharge. He discharged to SAR in stable condition on 3/17/2023.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction normal, Hyperglycaemia, Insulin therapy
Clinical narrative: Admission Date: 3/8/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: T12-L1 disc space infection   HOSPITAL COURSE: Patient is a 91 year old male with Hx of HTN, Afib, chronic diastolic HF, CAD, DM type II, CKD Stage III, BPH, rectal Ca, and GERD who presented to the ED with chills, shortness of breath, and cough as well as worsening back pain.   He tested positive for COVID-19 and was admitted to the hospitalist service. CTA with groundglass opacities. He was requiring 3L NC O2 on admission and weaned to room air after completing 5 days of remdesivir and 6 days of dexamethasone. Pt did have steroid induced hyperglycemia, treated with insulin which improved significantly after steroids were completed.   Regarding the patient's back pain, CT T/L spine concerning for T12-L1 discitis/osteomyelitis. MRI of the thoracic/lumbar spine showed discitis/osteomyelitis at T12-L1 as well as small abscess within anterior right psoas. Echo was completed showing normal EF and no valvular vegetation but pulmonic valve difficult to visualize. Spine surgery was consulted but did not recommend surgical intervention. IR was consulted and performed biopsy of T12-L1 intervertebral disc but cultures remained negative. Initial blood cultures 1/2 positive for micrococcus luteus, suspect contaminant, per ID. He was treated with ceftriaxone/vancomycin IV with all subsequent blood cultures negative. Due to improvement in back pain and negative blood cultures, ID recommended ceftriaxone/vancomycin to complete 6 weeks (3/12-4/23) with ID follow up in 4-6 weeks. His pain was controlled with tramadol, zanaflex, lidocaine patch, and gabapentin. PT/OT recommend SAR. Pt and facility were in agreement with SAR as pt desired to recover and eventually return home. They did have hospice informational meeting on 3/16 but did not yet feel that pt's goals were in alignment with hospice.   PICC placed by vascular access team prior to discharge. He discharged to SAR in stable condition on 3/17/2023.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc biopsy, Intervertebral discitis, Lung opacity, Magnetic resonance imaging spinal abnormal, Osteomyelitis
Clinical narrative: Admission Date: 3/8/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: T12-L1 disc space infection   HOSPITAL COURSE: Patient is a 91 year old male with Hx of HTN, Afib, chronic diastolic HF, CAD, DM type II, CKD Stage III, BPH, rectal Ca, and GERD who presented to the ED with chills, shortness of breath, and cough as well as worsening back pain.   He tested positive for COVID-19 and was admitted to the hospitalist service. CTA with groundglass opacities. He was requiring 3L NC O2 on admission and weaned to room air after completing 5 days of remdesivir and 6 days of dexamethasone. Pt did have steroid induced hyperglycemia, treated with insulin which improved significantly after steroids were completed.   Regarding the patient's back pain, CT T/L spine concerning for T12-L1 discitis/osteomyelitis. MRI of the thoracic/lumbar spine showed discitis/osteomyelitis at T12-L1 as well as small abscess within anterior right psoas. Echo was completed showing normal EF and no valvular vegetation but pulmonic valve difficult to visualize. Spine surgery was consulted but did not recommend surgical intervention. IR was consulted and performed biopsy of T12-L1 intervertebral disc but cultures remained negative. Initial blood cultures 1/2 positive for micrococcus luteus, suspect contaminant, per ID. He was treated with ceftriaxone/vancomycin IV with all subsequent blood cultures negative. Due to improvement in back pain and negative blood cultures, ID recommended ceftriaxone/vancomycin to complete 6 weeks (3/12-4/23) with ID follow up in 4-6 weeks. His pain was controlled with tramadol, zanaflex, lidocaine patch, and gabapentin. PT/OT recommend SAR. Pt and facility were in agreement with SAR as pt desired to recover and eventually return home. They did have hospice informational meeting on 3/16 but did not yet feel that pt's goals were in alignment with hospice.   PICC placed by vascular access team prior to discharge. He discharged to SAR in stable condition on 3/17/2023.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Psoas abscess, SARS-CoV-2 test positive
Clinical narrative: Admission Date: 3/8/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: T12-L1 disc space infection   HOSPITAL COURSE: Patient is a 91 year old male with Hx of HTN, Afib, chronic diastolic HF, CAD, DM type II, CKD Stage III, BPH, rectal Ca, and GERD who presented to the ED with chills, shortness of breath, and cough as well as worsening back pain.   He tested positive for COVID-19 and was admitted to the hospitalist service. CTA with groundglass opacities. He was requiring 3L NC O2 on admission and weaned to room air after completing 5 days of remdesivir and 6 days of dexamethasone. Pt did have steroid induced hyperglycemia, treated with insulin which improved significantly after steroids were completed.   Regarding the patient's back pain, CT T/L spine concerning for T12-L1 discitis/osteomyelitis. MRI of the thoracic/lumbar spine showed discitis/osteomyelitis at T12-L1 as well as small abscess within anterior right psoas. Echo was completed showing normal EF and no valvular vegetation but pulmonic valve difficult to visualize. Spine surgery was consulted but did not recommend surgical intervention. IR was consulted and performed biopsy of T12-L1 intervertebral disc but cultures remained negative. Initial blood cultures 1/2 positive for micrococcus luteus, suspect contaminant, per ID. He was treated with ceftriaxone/vancomycin IV with all subsequent blood cultures negative. Due to improvement in back pain and negative blood cultures, ID recommended ceftriaxone/vancomycin to complete 6 weeks (3/12-4/23) with ID follow up in 4-6 weeks. His pain was controlled with tramadol, zanaflex, lidocaine patch, and gabapentin. PT/OT recommend SAR. Pt and facility were in agreement with SAR as pt desired to recover and eventually return home. They did have hospice informational meeting on 3/16 but did not yet feel that pt's goals were in alignment with hospice.   PICC placed by vascular access team prior to discharge. He discharged to SAR in stable condition on 3/17/2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Cardiac stress test normal, Chest X-ray abnormal, Chest pain, Echocardiogram abnormal
Clinical narrative: Admission Date: 3/18/2023 Discharge Date: Mar 21, 2023  PRESENTING PROBLEM: Chest pain [R07.9]   HOSPITAL COURSE: 67-year-old with past medical history significant for COPD, T2DM, HLD, CHF, HTN, OSA, alcoholic liver cirrhosis initially presented from Ludington on 03/14 for cardiology evaluation of nonexertional typical chest pain on 3/18.  Was recently discharged after treatment for COVID-19 from 03/8-3/11. Presented back to the emergency department on 03/14/2023 with substernal chest pain.  Was diuresed and discharged home on bronchodilators.  Presented to the emergency department again on 03/17/2023 with similar symptoms, labs showed mild elevation tropes (17->59) and chest x-ray showing pulmonary vascular congestion.  Patient was diuresed with IV Bumex and given nebulizers.  Case was discussed with Cardiology who recommended starting the patient on heparin and transferring to Butterworth for additional recommendations.  Repeated troponins were flat. Echo on 3/19 with EF 65% and no WMA however suboptimal acoustic windows.  Etiology recommended stress test.  Lexiscan on 3/21 with no evidence for myocardial ischemia.  Cardiology felt that elevated troponins was likely myocardial and really related to recent COVID infection.  Did not recommend any further cardiac workup or follow-up at this time.  Chest pain resolved.  Patient was transitioned back to home Bumex with continued good diureses.  Patient discharged home in stable condition.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary congestion, Troponin increased
Clinical narrative: Admission Date: 3/18/2023 Discharge Date: Mar 21, 2023  PRESENTING PROBLEM: Chest pain [R07.9]   HOSPITAL COURSE: 67-year-old with past medical history significant for COPD, T2DM, HLD, CHF, HTN, OSA, alcoholic liver cirrhosis initially presented from Ludington on 03/14 for cardiology evaluation of nonexertional typical chest pain on 3/18.  Was recently discharged after treatment for COVID-19 from 03/8-3/11. Presented back to the emergency department on 03/14/2023 with substernal chest pain.  Was diuresed and discharged home on bronchodilators.  Presented to the emergency department again on 03/17/2023 with similar symptoms, labs showed mild elevation tropes (17->59) and chest x-ray showing pulmonary vascular congestion.  Patient was diuresed with IV Bumex and given nebulizers.  Case was discussed with Cardiology who recommended starting the patient on heparin and transferring to Butterworth for additional recommendations.  Repeated troponins were flat. Echo on 3/19 with EF 65% and no WMA however suboptimal acoustic windows.  Etiology recommended stress test.  Lexiscan on 3/21 with no evidence for myocardial ischemia.  Cardiology felt that elevated troponins was likely myocardial and really related to recent COVID infection.  Did not recommend any further cardiac workup or follow-up at this time.  Chest pain resolved.  Patient was transitioned back to home Bumex with continued good diureses.  Patient discharged home in stable condition.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Drug ineffective, Myelitis transverse, Suspected COVID-19
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Malaise, Myelitis transverse, Wheelchair user
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Myelitis transverse, Spinal stroke
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Computerised tomogram thorax, Diplegia, Dysstasia, Laboratory test
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Spinal cord infarction, Walking aid user
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Wheelchair user
Clinical narrative: I have transverse myelitis and in a wheelchair. I have had all of the Pfizer vaccines for Covid and I am saying that I am sick because of these shots.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Drug ineffective, Myelitis transverse, Suspected COVID-19
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Malaise, Myelitis transverse, Wheelchair user
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Myelitis transverse, Spinal stroke
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Computerised tomogram thorax, Diplegia, Dysstasia, Laboratory test
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Spinal cord infarction, Walking aid user
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Wheelchair user
Clinical narrative: stroke of spinal cord; Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: Pfizer EL0140), administration date: 23Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/ Lot number: Pfizer EL3246), administration date: 13Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer EW0177), administration date: 13Sep2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Pfizer FJ4991), administration date: 14Jun2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: SPINAL STROKE (medically significant), outcome "unknown", described as "stroke of spinal cord"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis".
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Initially, I had upper respiratory congestion, fever, chills, and cough. Later that day, I contacted my doctor's office by phone, and I was prescribed Paxlovid. I took the Paxlovid for the prescribed five days. On the sixth day, I tested negative for COVID-19. On the eighth day, I tested negative again. On the ninth day, I began to feel bad again. It felt like a bad cold with a fever and runny nose. I tested myself and got a positive result. Basically, I just went five days with cold-like symptoms and a mild fever. I isolated for seven days. I then tested again and got a negative result after my rebound seemed to pass. I tested again two days later and got a negative result. At this point, I felt normal again.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Chills, Cough, Feeling abnormal, Pyrexia
Clinical narrative: Initially, I had upper respiratory congestion, fever, chills, and cough. Later that day, I contacted my doctor's office by phone, and I was prescribed Paxlovid. I took the Paxlovid for the prescribed five days. On the sixth day, I tested negative for COVID-19. On the eighth day, I tested negative again. On the ninth day, I began to feel bad again. It felt like a bad cold with a fever and runny nose. I tested myself and got a positive result. Basically, I just went five days with cold-like symptoms and a mild fever. I isolated for seven days. I then tested again and got a negative result after my rebound seemed to pass. I tested again two days later and got a negative result. At this point, I felt normal again.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Initially, I had upper respiratory congestion, fever, chills, and cough. Later that day, I contacted my doctor's office by phone, and I was prescribed Paxlovid. I took the Paxlovid for the prescribed five days. On the sixth day, I tested negative for COVID-19. On the eighth day, I tested negative again. On the ninth day, I began to feel bad again. It felt like a bad cold with a fever and runny nose. I tested myself and got a positive result. Basically, I just went five days with cold-like symptoms and a mild fever. I isolated for seven days. I then tested again and got a negative result after my rebound seemed to pass. I tested again two days later and got a negative result. At this point, I felt normal again.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Chills, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: It is very itchy/ The itchiness has subsided; Rash over entire body/ consistent with dermatomes/but still has rash; Rash over his entire body/The rash is primarily on his trunk, back and arm; This non-serious case was reported by a physician via call center representative and described the occurrence of pruritus in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose was received on unknown date and also he had experienced pain, refer case - US2023037539).  In JAN-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: It is very itchy/ The itchiness has subsided), macular rash (Verbatim: Rash over entire body/ consistent with dermatomes/but still has rash) and generalized rash (Verbatim: Rash over his entire body/The rash is primarily on his trunk, back and arm). The patient was treated with steroids nos (Steroids) and steroids nos (Steroid Injection (Drug Name Unknown)). The outcome of the pruritus was recovered/resolved and the outcome of the macular rash and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, macular rash and generalized rash to be related to Shingrix.  It was unknown if the company considered the pruritus, macular rash and generalized rash to be related to Shingrix.  Linked case(s) involving the same patient:  US2023037539  Additional Information: GSK Receipt Date: 09-MAR-2023 The physician reported that, he had received the Shingrix series. After the 2nd dose in January 2023, he had experienced a rash over his entire body. After the first round of steroids it had subsided, but after a week it came back even worsen to the point, that he needed to go to the emergency room (ER) and had received steroid injections. The rash was primarily on his trunk, back and arm. It was very itchy. The itchiness had subsided, but still had rash at the moment of reporting. In addition, he also reported that, the rash was consistent with dermatomes.  The reporter had consented to follow-up via email. The reporter had specifically mentioned about macular rash and hence, it was coded as an adverse event conservatively.; Sender's Comments:  US-GSK-US2023037539:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: It is very itchy/ The itchiness has subsided; Rash over entire body/ consistent with dermatomes/but still has rash; Rash over his entire body/The rash is primarily on his trunk, back and arm; This non-serious case was reported by a physician via call center representative and described the occurrence of pruritus in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose was received on unknown date and also he had experienced pain, refer case - US2023037539).  In JAN-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: It is very itchy/ The itchiness has subsided), macular rash (Verbatim: Rash over entire body/ consistent with dermatomes/but still has rash) and generalized rash (Verbatim: Rash over his entire body/The rash is primarily on his trunk, back and arm). The patient was treated with steroids nos (Steroids) and steroids nos (Steroid Injection (Drug Name Unknown)). The outcome of the pruritus was recovered/resolved and the outcome of the macular rash and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, macular rash and generalized rash to be related to Shingrix.  It was unknown if the company considered the pruritus, macular rash and generalized rash to be related to Shingrix.  Linked case(s) involving the same patient:  US2023037539  Additional Information: GSK Receipt Date: 09-MAR-2023 The physician reported that, he had received the Shingrix series. After the 2nd dose in January 2023, he had experienced a rash over his entire body. After the first round of steroids it had subsided, but after a week it came back even worsen to the point, that he needed to go to the emergency room (ER) and had received steroid injections. The rash was primarily on his trunk, back and arm. It was very itchy. The itchiness had subsided, but still had rash at the moment of reporting. In addition, he also reported that, the rash was consistent with dermatomes.  The reporter had consented to follow-up via email. The reporter had specifically mentioned about macular rash and hence, it was coded as an adverse event conservatively.; Sender's Comments:  US-GSK-US2023037539:Same reporter
Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: She had COVID after the vaccines.; She had COVID after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Mar2023 as dose 5 (booster), single (Lot number: GJ6796, Expiration Date: Jul2023) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533, Expiration Date: Jul2021), on 21Apr2021 as dose 2, single (Lot number: EW017, Expiration Date: Aug2021), on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7135, Expiration Date: 17Aug2022) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2007 (ongoing); "Hashimoto's disease" (ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" and all described as "She had COVID after the vaccines.". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Low, notes: her TSH was too low; Embolism: Unknown results; Haemoglobin: 6.5. Clinical course: Synthroid: related to Hashimoto's, She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She is pre diabetic and has lost 35 lbs between diet and exercise. She gained weight due to stress of being a care taker. Her A1C is now 6.5. She has hypothyroid from hashimoto's diagnosed in 2007. She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She had COVID after the vaccines. Prior Vaccinations (within 4 weeks) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119765 same patient, different dose and event;
Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Body height, Chills, Diarrhoea
Clinical narrative: She had COVID after the vaccines.; She had COVID after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Mar2023 as dose 5 (booster), single (Lot number: GJ6796, Expiration Date: Jul2023) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533, Expiration Date: Jul2021), on 21Apr2021 as dose 2, single (Lot number: EW017, Expiration Date: Aug2021), on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7135, Expiration Date: 17Aug2022) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2007 (ongoing); "Hashimoto's disease" (ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" and all described as "She had COVID after the vaccines.". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Low, notes: her TSH was too low; Embolism: Unknown results; Haemoglobin: 6.5. Clinical course: Synthroid: related to Hashimoto's, She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She is pre diabetic and has lost 35 lbs between diet and exercise. She gained weight due to stress of being a care taker. Her A1C is now 6.5. She has hypothyroid from hashimoto's diagnosed in 2007. She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She had COVID after the vaccines. Prior Vaccinations (within 4 weeks) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119765 same patient, different dose and event;
Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Eating disorder, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Stress, Vomiting
Clinical narrative: She had COVID after the vaccines.; She had COVID after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Mar2023 as dose 5 (booster), single (Lot number: GJ6796, Expiration Date: Jul2023) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533, Expiration Date: Jul2021), on 21Apr2021 as dose 2, single (Lot number: EW017, Expiration Date: Aug2021), on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7135, Expiration Date: 17Aug2022) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2007 (ongoing); "Hashimoto's disease" (ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" and all described as "She had COVID after the vaccines.". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Low, notes: her TSH was too low; Embolism: Unknown results; Haemoglobin: 6.5. Clinical course: Synthroid: related to Hashimoto's, She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She is pre diabetic and has lost 35 lbs between diet and exercise. She gained weight due to stress of being a care taker. Her A1C is now 6.5. She has hypothyroid from hashimoto's diagnosed in 2007. She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She had COVID after the vaccines. Prior Vaccinations (within 4 weeks) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119765 same patient, different dose and event;
Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Weight, Weight increased
Clinical narrative: She had COVID after the vaccines.; She had COVID after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Mar2023 as dose 5 (booster), single (Lot number: GJ6796, Expiration Date: Jul2023) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533, Expiration Date: Jul2021), on 21Apr2021 as dose 2, single (Lot number: EW017, Expiration Date: Aug2021), on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7135, Expiration Date: 17Aug2022) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2007 (ongoing); "Hashimoto's disease" (ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" and all described as "She had COVID after the vaccines.". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Low, notes: her TSH was too low; Embolism: Unknown results; Haemoglobin: 6.5. Clinical course: Synthroid: related to Hashimoto's, She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She is pre diabetic and has lost 35 lbs between diet and exercise. She gained weight due to stress of being a care taker. Her A1C is now 6.5. She has hypothyroid from hashimoto's diagnosed in 2007. She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She had COVID after the vaccines. Prior Vaccinations (within 4 weeks) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119765 same patient, different dose and event;
Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood thyroid stimulating hormone, COVID-19, Embolism, Haemoglobin, Vaccination failure
Clinical narrative: She had COVID after the vaccines.; She had COVID after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Mar2023 as dose 5 (booster), single (Lot number: GJ6796, Expiration Date: Jul2023) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533, Expiration Date: Jul2021), on 21Apr2021 as dose 2, single (Lot number: EW017, Expiration Date: Aug2021), on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7135, Expiration Date: 17Aug2022) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2007 (ongoing); "Hashimoto's disease" (ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" and all described as "She had COVID after the vaccines.". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Low, notes: her TSH was too low; Embolism: Unknown results; Haemoglobin: 6.5. Clinical course: Synthroid: related to Hashimoto's, She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She is pre diabetic and has lost 35 lbs between diet and exercise. She gained weight due to stress of being a care taker. Her A1C is now 6.5. She has hypothyroid from hashimoto's diagnosed in 2007. She did take Synthroid 112mcg , but now her doctor reduced her dose to 100mcg because her TSH was too low. She had COVID after the vaccines. Prior Vaccinations (within 4 weeks) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119765 same patient, different dose and event;