chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: CD30 expression, Condition aggravated, Histology, Lymphomatoid papulosis, SARS-CoV-2 test
Clinical narrative: Lymphomatoid papulosis type A; Dose 2, Progressed(Multiple papules); In the initial version the case was assessed as Invalid, Upon follow up the case is assessed as valid.   This is a literature report for the following literature source(s).  A female patient in her 20's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,Single), for COVID-19 immunisation. The following information was reported: LYMPHOMATOID PAPULOSIS (medically significant), outcome "recovering", described as "Lymphomatoid papulosis type A"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: positive; Histology: Performed; SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of lymphomatoid papulosis, condition aggravated.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200032690 Same article/ drug and different patient/event.;US-PFIZER INC-202201018007 Same article/ drug and different patient/event.;US-PFIZER INC-202201018008 Same article/ drug and different patient/event.;US-PFIZER INC-202201018009 Same article/ drug and different patient/event.;US-PFIZER INC-202201018010 Same article/ drug and different patient/event.;
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Cough, Depression, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A 50-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  , unknown manufacturer), for COVID-19 Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "the booster scared me, I coughed for 4 months"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it flipped me/ I'm scared to death of a booster"; DEPRESSION (non-serious), outcome "unknown", described as "it's depression but now they call it mental illness"; ANXIETY (non-serious), outcome "unknown", described as "I got depression really bad and anxiety". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Suspect Product(s): (provide Name / Indication/Dosage/Start and Stop date where possible): Arthrotec, Pfizer BioNTech COVID-19 Vaccine. Verbatim and Event Description:  Patient called in with questions about a letter the patient received informing the patient they were enrolled in the program for the medication Arthrotec. During the call patient stated."I gotta lawyer that's working on my disability, it's depression but now they call it mental illness. I got depression really bad and anxiety... Patient later stated on the call." Do you know anything about the Pfizer shots...? I'm not gonna do another booster because it flipped me out when I did the booster, last year before I can't remember. The booster scared me, I coughed for 4 months, and I didn't know what to think about the situation I'm scared to death of a booster." The following information was not confirmed during the call, but retrieved from the system: Reporter phone No. The following information was not provided during the call: Patient gender, The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: CD30 expression, CD4/CD8 ratio, Condition aggravated, Histology, Pityriasis lichenoides et varioliformis acuta
Clinical narrative: pityriasis lichenoides et varioliformis acuta; Dose 2, Progressed(Multiple papules); This is a literature report for the following literature source(s):  A female patient in her 50's received BNT162b2 (BNT162B2), as dose 1. single (Batch/Lot number: unknown) and as dose 2. single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "transverse myelitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 14 days after the suspect product(s) administration, outcome "recovering"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: positive; CD4/CD8 ratio: 2:1, notes: Unknown unit; Histology: Performed; SARS-CoV-2 test: Unknown result; T-cell receptor gene rearrangement test: negative. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta, condition aggravated.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, T-cell receptor gene rearrangement test
Clinical narrative: pityriasis lichenoides et varioliformis acuta; Dose 2, Progressed(Multiple papules); This is a literature report for the following literature source(s):  A female patient in her 50's received BNT162b2 (BNT162B2), as dose 1. single (Batch/Lot number: unknown) and as dose 2. single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "transverse myelitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 14 days after the suspect product(s) administration, outcome "recovering"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: positive; CD4/CD8 ratio: 2:1, notes: Unknown unit; Histology: Performed; SARS-CoV-2 test: Unknown result; T-cell receptor gene rearrangement test: negative. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta, condition aggravated.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID like symptoms; COVID like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID like symptoms".  Clinical course: It was reported that young female patient experienced COVID like symptoms after the Covid vaccine. Event experienced after the use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482235-00 (RA).  A 46-year-old male patient received BNT162b2 (BNT162B2), 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19 virus test positive" related to BNT162b2.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Pallor, Vomiting
Clinical narrative: Clammy; pale; vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 3-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COLD SWEAT (non-serious), outcome "unknown", described as "Clammy"; PALLOR (non-serious), outcome "unknown", described as "pale"; VOMITING (non-serious), outcome "unknown", described as "vomited".  Additional information: Parent reported my 3yo daughter received her second Covid shot in the primary series and within 5 minutes became clammy, pale, and vomited. There were no reoccurring episodes or any other symptoms after that. I'm working with her dr to determine likelihood it was a reaction for reporting purposes and further knowledge.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: acute kidney renal failure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "acute kidney renal failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Atrial fibrillation, Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: atrial fibrillation; had Moderna COVID-19 vaccination and the shingles shot, one in each arm, both were painful; Diarrhea; Nausea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4483452-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation; ibrutinib (IMBRUVICA), (Batch/Lot number: unknown), oral for chronic lymphocytic leukaemia; varicella zoster vaccine rge (cho) (SHINGRIX), (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "had Moderna COVID-19 vaccination and the shingles shot, one in each arm, both were painful"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious), outcome "unknown". The action taken for ibrutinib was unknown.  The reporter considered "atrial fibrillation", "had moderna covid-19 vaccination and the shingles shot, one in each arm, both were painful", "diarrhea" and "nausea" related to BNT162b2.  Clinical Course: Causality for Imbruvica, the reporter's causality for the event(s) of Had Moderna Covid-19 Vaccination and The Shingles Shot, One in each Arm, Both were painful, Atrial Fibrillation, Diarrhea and Nausea was not provided and Causality for Moderna Covid-19 Vaccine, causality for events reported as Possible. Causality for Pfizer Biontech COVID-19 Vaccine, causality for the events reported as Possible and for shingrix, events causality reported as Possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events atrial fibrillation, vaccination site pain, diarrhea and nausea and the suspect product bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus vulgaris; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PEMPHIGUS (medically significant), outcome "unknown", described as "pemphigus vulgaris". Clinical course: During a podium presentation a doctor described his experience with a patient developed pemphigus vulgaris 2 days after receiving the Pfizer Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, C-reactive protein increased, COVID-19, Chest X-ray normal, Hypotension
Clinical narrative: Patient  was admitted on 1/5/2022 for chief complaint of behavioral change and low blood pressure. Patient has past medical history of developmental/cognitive delay and is non-verbal at baseline. Patient resides at AFC home and was noted to have behavioral changes. He was found to be positive for Covid-19 1 day prior to presentation. He was hypotensive on presentation and required vasopressor support and ICU admission. He was noted to be hypoxic and was placed on supplemental O2 and started on dexamethasone and remdesivir for Covid-19. His blood pressures improved and he was transferred out of ICU. His respiratory status improved and he was weaned to room air. Lisinopril was stopped during this admission due to low-normal BP.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Intensive care, SARS-CoV-2 test positive, Ultrasound Doppler normal
Clinical narrative: Patient  was admitted on 1/5/2022 for chief complaint of behavioral change and low blood pressure. Patient has past medical history of developmental/cognitive delay and is non-verbal at baseline. Patient resides at AFC home and was noted to have behavioral changes. He was found to be positive for Covid-19 1 day prior to presentation. He was hypotensive on presentation and required vasopressor support and ICU admission. He was noted to be hypoxic and was placed on supplemental O2 and started on dexamethasone and remdesivir for Covid-19. His blood pressures improved and he was transferred out of ICU. His respiratory status improved and he was weaned to room air. Lisinopril was stopped during this admission due to low-normal BP.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Exposure to SARS-CoV-2
Clinical narrative: Patient presented to ED with fever.  Patient's family reported that he was exposed to COVID-19 3 days prior to admission after which he started developing fever.  In ER patient was having temp spike of 102.2, he was tested positive for COVID-19, chest x-ray showed moderate bilateral airspace disease consistent with COVID-19 pneumonia. Patient was on room air saturating more than 92%.  He tolerated monoclonal antibody .  No temp spikes overnight.    PT OT evaluated recommended post acute rehab. He was discharged to a nursing home.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient presented to ED with fever.  Patient's family reported that he was exposed to COVID-19 3 days prior to admission after which he started developing fever.  In ER patient was having temp spike of 102.2, he was tested positive for COVID-19, chest x-ray showed moderate bilateral airspace disease consistent with COVID-19 pneumonia. Patient was on room air saturating more than 92%.  He tolerated monoclonal antibody .  No temp spikes overnight.    PT OT evaluated recommended post acute rehab. He was discharged to a nursing home.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Stuffy nose
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID-19; hospitalization.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Asymptomatic COVID-19, Computerised tomogram head, Computerised tomogram spine, Dizziness
Clinical narrative: Patient was admitted on 1/27/2022  with complaints of fatigue, dizziness and 3 episodes of fall. In the ER EKG showed sinus tachycardia with PACs.  Workup showed unremarkable, screen for COVID-19 was positive, CTA chest, CT head, cervical spine and facial bones were unremarkable. Patient was started on oral antibiotics for possible UTI, IV fluids and was admitted to hospitalist service . Pt remained asymptomatic from COVID-19 infection.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fall, Fatigue, Laboratory test normal, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted on 1/27/2022  with complaints of fatigue, dizziness and 3 episodes of fall. In the ER EKG showed sinus tachycardia with PACs.  Workup showed unremarkable, screen for COVID-19 was positive, CTA chest, CT head, cervical spine and facial bones were unremarkable. Patient was started on oral antibiotics for possible UTI, IV fluids and was admitted to hospitalist service . Pt remained asymptomatic from COVID-19 infection.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Supraventricular extrasystoles
Clinical narrative: Patient was admitted on 1/27/2022  with complaints of fatigue, dizziness and 3 episodes of fall. In the ER EKG showed sinus tachycardia with PACs.  Workup showed unremarkable, screen for COVID-19 was positive, CTA chest, CT head, cervical spine and facial bones were unremarkable. Patient was started on oral antibiotics for possible UTI, IV fluids and was admitted to hospitalist service . Pt remained asymptomatic from COVID-19 infection.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Vaccination site pain, Vaccination site warmth
Clinical narrative: Extreme pain in left arm, cannot sleep on left side because of the pain. Pain has been continuous since vaccinations in April of 2021. Arm throbs randomly, is extremely sore periodically throughout the day. There are random bursts of heat from vaccination site on the arm. Hurts to lift the arm and use the arm periodically throughout the day. Spot where vaccine was administered is very tender generally 24/7. Have not seen a medical professional because an overnight nurse line said it will go away. There is nothing that can be done.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chest X-ray abnormal, Hypervolaemia, Lung infiltration
Clinical narrative: Patient was admitted on 1/15/2022 because of acute hypoxic respiratory failure likely multifactorial .  Patient was found to have positive COVID-19 infection as well as evidence of volume overload both of which contain should be due to his hypoxic respiratory failure.  Patient was started on the usual regimen for COVID-19 infection including Dexamethasone and also was treated for possible secondary bacterial pneumonia. Patient was cleared for discharge and he was comfortable going home with home health care.  A
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted on 1/15/2022 because of acute hypoxic respiratory failure likely multifactorial .  Patient was found to have positive COVID-19 infection as well as evidence of volume overload both of which contain should be due to his hypoxic respiratory failure.  Patient was started on the usual regimen for COVID-19 infection including Dexamethasone and also was treated for possible secondary bacterial pneumonia. Patient was cleared for discharge and he was comfortable going home with home health care.  A
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization of fully vaccinated covid positive pt
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Headache, Pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: Sore arm developed next day ? still ongoing Sox days out 2 days out - very strong anche ache developed ? still ongoing 6 days out intermittent headache and congestion developed 4-5 days out ? still ongoing
Age: 12.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: MA pulled from the wrong stock incorrect vaccine and was administered to patient.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Cytokine test, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: chronic 10/10 head pain, dizziness, blurriness, orthostatic hypotension, bradycardia, tachycardia, overstimulation, vasodilatation, brain fog, exhaustion, pooling, hot/cold sensitivity, tinnitus.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Gene mutation identification test, Headache, Immunosuppression, Orthostatic hypotension, Sensory processing disorder
Clinical narrative: chronic 10/10 head pain, dizziness, blurriness, orthostatic hypotension, bradycardia, tachycardia, overstimulation, vasodilatation, brain fog, exhaustion, pooling, hot/cold sensitivity, tinnitus.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Temperature intolerance, Tinnitus, Vascular endothelial growth factor assay, Vasodilatation
Clinical narrative: chronic 10/10 head pain, dizziness, blurriness, orthostatic hypotension, bradycardia, tachycardia, overstimulation, vasodilatation, brain fog, exhaustion, pooling, hot/cold sensitivity, tinnitus.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: chronic 10/10 head pain, dizziness, blurriness, orthostatic hypotension, bradycardia, tachycardia, overstimulation, vasodilatation, brain fog, exhaustion, pooling, hot/cold sensitivity, tinnitus.
Age: 4.0
Sex: F
Vaccine: COVID19, HEP, HIBV, MMRV, PNC13, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Inadvertent administration of Covid vaccine (Orange Cap) for 5-11 years to patient who should have received Covid Maroon cap since age 4 years. Contacted parent, no adverse events or symptoms observed. Declines enrollment in V-safe. States will observe patient and notify clinic if any symptoms develop.
Age: 4.0
Sex: F
Vaccine: COVID19, HEP, HIBV, MMRV, PNC13, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertent administration of Covid vaccine (Orange Cap) for 5-11 years to patient who should have received Covid Maroon cap since age 4 years. Contacted parent, no adverse events or symptoms observed. Declines enrollment in V-safe. States will observe patient and notify clinic if any symptoms develop.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Lipoma, Ultrasound Doppler
Clinical narrative: Lipoma developed in between carotid artery and jugular vein. 9.6 cm SI x3.3 cm AP x2.3 cm TV.
Age: 19.0
Sex: M
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive Hep B vaccination final dose in series but was accidentally given the pediatric HIB vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had previously had a single dose of Pfizer vaccine, this was not disclosed to the pharmacist.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient given a booster shot based on her last booster being given in December. It was found she received a dose in May, making the dose given to her an extra dose. She was not technically eligible for the booster dose given, as she had already received her 2nd booster.
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Incorrect dose administered, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient was inadvertently given adult dose of Hep A.  Error was noticed right away, mom was notified and site was consulted as well as the nurse on duty.  The website advised to monitor the child, the dose given counts as dose #1 and does not affect the timing on dose #2.  Mom called 2 days later  (7/28/22) and reported diarrhea and some crankiness. Nurse advised BRAT diet for diarrhea, and continue monitoring.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Body temperature increased, COVID-19, Headache, Nasopharyngitis
Clinical narrative: 06/28/2022 My temperature began to spike up to 101 degrees right after midnight. Before that I had felt fine.  I went to sleep, because other than the fever, I felt fine.  The next morning, I still had a fever which stayed around 100.5 for two days. I started feeling like I had a head cold, so I did a home COVID test, and it was positive.   I called my doctor and asked about the Paxlovid which she did not recommend because of the side effects and my medical history. Also, since I was double boosted, she suggested I forego the medication. I have slept a lot and my throat was very sore.  I have seem to weather the virus just fine. Today I have a light headache left, no smell, my tasted seems dulled, slightly congested and my throat is raspy. My energy, however, seems fine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: 06/28/2022 My temperature began to spike up to 101 degrees right after midnight. Before that I had felt fine.  I went to sleep, because other than the fever, I felt fine.  The next morning, I still had a fever which stayed around 100.5 for two days. I started feeling like I had a head cold, so I did a home COVID test, and it was positive.   I called my doctor and asked about the Paxlovid which she did not recommend because of the side effects and my medical history. Also, since I was double boosted, she suggested I forego the medication. I have slept a lot and my throat was very sore.  I have seem to weather the virus just fine. Today I have a light headache left, no smell, my tasted seems dulled, slightly congested and my throat is raspy. My energy, however, seems fine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 06/28/2022 My temperature began to spike up to 101 degrees right after midnight. Before that I had felt fine.  I went to sleep, because other than the fever, I felt fine.  The next morning, I still had a fever which stayed around 100.5 for two days. I started feeling like I had a head cold, so I did a home COVID test, and it was positive.   I called my doctor and asked about the Paxlovid which she did not recommend because of the side effects and my medical history. Also, since I was double boosted, she suggested I forego the medication. I have slept a lot and my throat was very sore.  I have seem to weather the virus just fine. Today I have a light headache left, no smell, my tasted seems dulled, slightly congested and my throat is raspy. My energy, however, seems fine.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, Diarrhoea, Dyspnoea, Dysuria
Clinical narrative: Patient presents with worsening shortness of breath and issues urinating. She said her breathing "is just not doing well" but was unable to elaborate further. She usually uses 3L of O2 at home and is on baseline oxygen here in the hospital. She says she that for the past few days she hasn't been making much urine and has been going a lot less frequently. It has hurt a little bit when urinating but denies any hematuria. Denies any abdominal pain, fevers/chills, nausea, vomiting, flank pain. She has been having some diarrhea but when questioned further this is a chronic problem and is at baseline.   Hospitalization course:  - Patient oxygenating well on close to baseline O2 requirement - Started dexamethasone 6mg for 10 days, not a candidate for remdesivir with AKI - Completed with azithromycin 500mg for 3 days. She may benefit from chronic Azithromycin use, defer to outpatient follow up - Goal O2 >88% - Incentive spirometry Q4, Duonebs Q4 PRN, home dulera, singulair - Continue monitoring CBC with improvement prior discharge, will recheck in a week.  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, SARS-CoV-2 test positive, Urine output decreased
Clinical narrative: Patient presents with worsening shortness of breath and issues urinating. She said her breathing "is just not doing well" but was unable to elaborate further. She usually uses 3L of O2 at home and is on baseline oxygen here in the hospital. She says she that for the past few days she hasn't been making much urine and has been going a lot less frequently. It has hurt a little bit when urinating but denies any hematuria. Denies any abdominal pain, fevers/chills, nausea, vomiting, flank pain. She has been having some diarrhea but when questioned further this is a chronic problem and is at baseline.   Hospitalization course:  - Patient oxygenating well on close to baseline O2 requirement - Started dexamethasone 6mg for 10 days, not a candidate for remdesivir with AKI - Completed with azithromycin 500mg for 3 days. She may benefit from chronic Azithromycin use, defer to outpatient follow up - Goal O2 >88% - Incentive spirometry Q4, Duonebs Q4 PRN, home dulera, singulair - Continue monitoring CBC with improvement prior discharge, will recheck in a week.  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Gave vaccine to patient with incomplete vaccine consent form--asked the patient questions about allergies and reactions but did not document them on the form before giving the vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid 19 positive pt after vaccines
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site swelling, Irritability, Pyrexia, Rash
Clinical narrative: pts mother called w/ complaints of hive like rash on 12mth old 3 days after receiving vaccines along with fever and fussiness. later that day pt had left knee swelling with difficulty walking.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: pts mother called w/ complaints of hive like rash on 12mth old 3 days after receiving vaccines along with fever and fussiness. later that day pt had left knee swelling with difficulty walking.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported on adverse reactions.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of adminstration".  Patient reported no adverse reactions.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus a the time of administration".   Patient reported no adverse reactions.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 8/2/22
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Irritability
Clinical narrative: 10 month old received first Pfizer-Biotech 6 month to 4 years 0.2ml IM vaccine in primary series 22 July 2022. Patient received second Pfizer-Biotech 6 month to 4 years 0.2ml IM vaccine in primary series on 2 August 2022. The first vaccine and second vaccine are to close together. Mother of Child on 3 Aug reports patient fussy but no dyspnea, wheezing, vomiting, and angioedema. No changes in eating or drinking.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine. No temperature excursion occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V 2 virus at the time of administration." No adverse reactions reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Injection site erythema
Clinical narrative: Next day swelling and redness at injection site lasting for 3-4 days. Tested positive for COVID-19 7/26/2022. Developed symptoms 7/27/2022. Cough, runny nose, aches, chills and tiredness.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Next day swelling and redness at injection site lasting for 3-4 days. Tested positive for COVID-19 7/26/2022. Developed symptoms 7/27/2022. Cough, runny nose, aches, chills and tiredness.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Contusion, Vascular pain
Clinical narrative: No redness, warmth at injection site. States under the arm, a vein hurts, runs down his arm, it looks bruised. Started hurting day after injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autoimmune thyroiditis, Blood test abnormal, Blood thyroid stimulating hormone, Decreased appetite
Clinical narrative: With in 5 minutes my tongue felt weird. They gave me oral Benadryl and had me wait longer. Felt a little better and left. With in 2 hours my tongue felt strange and the left side of my mouth and face felt numb. My heart was racing and I started feeling intense itching everywhere.  Went to the ER and was feeling out of it. Heart racing red lines up my arms and entire body itching.  Was given IV Benadryl, iv Pepcid and IV  steroids. After a couple of hours symptoms were better and I was sent home on the oral of those meds.  The itching continued for 4 days. Lack of appetite, weight loss and acid reflux started. Anxiety increased and a weird vibration in my chest daily for weeks.  In march my GP diagnosed me with gastritis and prescribed omeprazole. Continued losing weight and feeling revved up. Blood work shows hyperthyroid - synthroid dosage has been reduced and I am still hyper thyroid and diagnosis is saying auto immune thyroiditis now. I have had a consult with a GI dr but the earliest they can get me in for an endoscopy and colonoscopy is September.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Full blood count, Gastritis, Gastrooesophageal reflux disease
Clinical narrative: With in 5 minutes my tongue felt weird. They gave me oral Benadryl and had me wait longer. Felt a little better and left. With in 2 hours my tongue felt strange and the left side of my mouth and face felt numb. My heart was racing and I started feeling intense itching everywhere.  Went to the ER and was feeling out of it. Heart racing red lines up my arms and entire body itching.  Was given IV Benadryl, iv Pepcid and IV  steroids. After a couple of hours symptoms were better and I was sent home on the oral of those meds.  The itching continued for 4 days. Lack of appetite, weight loss and acid reflux started. Anxiety increased and a weird vibration in my chest daily for weeks.  In march my GP diagnosed me with gastritis and prescribed omeprazole. Continued losing weight and feeling revved up. Blood work shows hyperthyroid - synthroid dosage has been reduced and I am still hyper thyroid and diagnosis is saying auto immune thyroiditis now. I have had a consult with a GI dr but the earliest they can get me in for an endoscopy and colonoscopy is September.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Hypoaesthesia, Hypoaesthesia oral, Palpitations, Pruritus
Clinical narrative: With in 5 minutes my tongue felt weird. They gave me oral Benadryl and had me wait longer. Felt a little better and left. With in 2 hours my tongue felt strange and the left side of my mouth and face felt numb. My heart was racing and I started feeling intense itching everywhere.  Went to the ER and was feeling out of it. Heart racing red lines up my arms and entire body itching.  Was given IV Benadryl, iv Pepcid and IV  steroids. After a couple of hours symptoms were better and I was sent home on the oral of those meds.  The itching continued for 4 days. Lack of appetite, weight loss and acid reflux started. Anxiety increased and a weird vibration in my chest daily for weeks.  In march my GP diagnosed me with gastritis and prescribed omeprazole. Continued losing weight and feeling revved up. Blood work shows hyperthyroid - synthroid dosage has been reduced and I am still hyper thyroid and diagnosis is saying auto immune thyroiditis now. I have had a consult with a GI dr but the earliest they can get me in for an endoscopy and colonoscopy is September.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine, Vibratory sense increased, Weight decreased
Clinical narrative: With in 5 minutes my tongue felt weird. They gave me oral Benadryl and had me wait longer. Felt a little better and left. With in 2 hours my tongue felt strange and the left side of my mouth and face felt numb. My heart was racing and I started feeling intense itching everywhere.  Went to the ER and was feeling out of it. Heart racing red lines up my arms and entire body itching.  Was given IV Benadryl, iv Pepcid and IV  steroids. After a couple of hours symptoms were better and I was sent home on the oral of those meds.  The itching continued for 4 days. Lack of appetite, weight loss and acid reflux started. Anxiety increased and a weird vibration in my chest daily for weeks.  In march my GP diagnosed me with gastritis and prescribed omeprazole. Continued losing weight and feeling revved up. Blood work shows hyperthyroid - synthroid dosage has been reduced and I am still hyper thyroid and diagnosis is saying auto immune thyroiditis now. I have had a consult with a GI dr but the earliest they can get me in for an endoscopy and colonoscopy is September.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Complication of device removal, Computerised tomogram head normal, Condition aggravated
Clinical narrative: Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 1/29/21, 2/26/21, 8/19/21, and 4/1/22. Presented to outside ER c/o progressive confusion since Covid infection 6/19/22. Vaccinated 4x, last booster 4/1/22. DX'd w/Covid 6/28/22, rec'd Paxlovid x 5/days. Normal head CT and CXR with multifocal PNA. Transferred to the ICU 7/6 for worsening mental status. Intubated failed attempts at extubation. Refractory shock w/worsening P/F ratios requiring max doses of multiple vasopressors c/b encephalopathy. Transitioned to DNR/AND. Patient treated with Paxlovid, Merrem, bactrim, micafungin, cefepime, and vancomycin. Expired 7/28/22.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Confusional state, Death, Encephalopathy, Endotracheal intubation, Intensive care
Clinical narrative: Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 1/29/21, 2/26/21, 8/19/21, and 4/1/22. Presented to outside ER c/o progressive confusion since Covid infection 6/19/22. Vaccinated 4x, last booster 4/1/22. DX'd w/Covid 6/28/22, rec'd Paxlovid x 5/days. Normal head CT and CXR with multifocal PNA. Transferred to the ICU 7/6 for worsening mental status. Intubated failed attempts at extubation. Refractory shock w/worsening P/F ratios requiring max doses of multiple vasopressors c/b encephalopathy. Transitioned to DNR/AND. Patient treated with Paxlovid, Merrem, bactrim, micafungin, cefepime, and vancomycin. Expired 7/28/22.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, PaO2/FiO2 ratio decreased, Pneumonia, SARS-CoV-2 test positive, Shock
Clinical narrative: Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 1/29/21, 2/26/21, 8/19/21, and 4/1/22. Presented to outside ER c/o progressive confusion since Covid infection 6/19/22. Vaccinated 4x, last booster 4/1/22. DX'd w/Covid 6/28/22, rec'd Paxlovid x 5/days. Normal head CT and CXR with multifocal PNA. Transferred to the ICU 7/6 for worsening mental status. Intubated failed attempts at extubation. Refractory shock w/worsening P/F ratios requiring max doses of multiple vasopressors c/b encephalopathy. Transitioned to DNR/AND. Patient treated with Paxlovid, Merrem, bactrim, micafungin, cefepime, and vancomycin. Expired 7/28/22.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT in lower left leg in posterior tibial vein.