chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000002650.  A patient in their 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and 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 "had COVID". Product was reported as Pfizer Biontech Covid-19 Vaccine. It was also reported that a patient received 2 shots of an mRNA, either the MODERNA or PFIZER, on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US179782_NS (RA). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "felt hot and cold". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Muscle twitching
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history not reported. No concomitant medications. The patient had muscle twitching (muscle twitches/first dose last May and still have them), with outcome of not recovered. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient is healthy and not on any medication at the time of report. Information on batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  3-year-old male patient received BNT162b2 (COMIRNATY), on 10Aug2022 at 15:35 as dose 1 (maroon cap), single (Lot number: FL2757) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 10Aug2022 at 16:10, outcome "recovering". Additional information: First pediatric dose of Comirnaty administered at physician's office at 3:35pm. After 15 minute observation, we went to grocery store. While there, he seemed fine before suddenly vomiting at 4:10pm. He had no other symptoms before and has previously not had any adverse reactions to vaccines. It was reported that the pregnant and breastfeeding was no. It was reported as booster as no.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I had Covid to for awhile. I just got over it; I had Covid to for awhile. I just got over it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 74-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 "recovered" and all described as "I had Covid to for awhile. I just got over it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I had Covid to for awhile. I just got over it.  Clinical course: Patient called to check on Premarin cream re enrolment and order status. During call patient stated how much going on I had Covid to for awhile. I just got over it. I had the booster shots and this and that and whatever you still get it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 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-163-4498686-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till Jul2022 at unk, citrate free and second regimen since Aug2022 (ongoing) (Batch/Lot number: unknown) at unk, citrate free, all subcutaneous for rheumatoid arthritis. 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 Jul2022, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage not changed. Clinical course: Solicited report by a consumer of a 64-year-old female with an event of non-serious COVID with Humira (Adalimumab). There was no reported medical history. In Jul2022, the patient experienced COVID Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. 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. Concomitant drugs and Other Relevant History were not reported. Events abate after stopping drug was NA.  Causality for Humira (Adalimumab): The reporter causality for the event(s) of COVID with Humira(Adalimumab) was no reasonable possibility. Causality: COVID-19: (COVID-19). Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not related. Dechallenge: N/A Causality: COVID-19: (COVID-19), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible. Dechallenge: N/A.  The reporter considered "covid-19" related to BNT162b2.  Additional information: 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.  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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Dysuria, Epstein-Barr virus test, Laboratory test, Mycoplasma test
Clinical narrative: dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; This is a literature report.  A 16-year-old female patient 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: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VULVAL ULCERATION (medically significant), DYSURIA (medically significant), VULVOVAGINAL PRURITUS (medically significant), VAGINAL DISCHARGE (medically significant), VULVOVAGINAL SWELLING (medically significant), all with latency 4 days after the suspect product(s) administration, outcome "recovered" and all described as "dysuria, vulvar pruritus, vulvar discharge, and labial swelling". The events "dysuria, vulvar pruritus, vulvar discharge, and labial swelling" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; HSV1/2: Negative; Mycoplasma test: Negative. Therapeutic measures were taken as a result of vulval ulceration, dysuria, vulvovaginal pruritus, vaginal discharge, vulvovaginal swelling.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vulval ulceration, dysuria, vulvar pruritus, vulvar discharge, and labial swelling and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vulval ulceration, Vulvovaginal pruritus, Vulvovaginal swelling
Clinical narrative: dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; This is a literature report.  A 16-year-old female patient 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: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VULVAL ULCERATION (medically significant), DYSURIA (medically significant), VULVOVAGINAL PRURITUS (medically significant), VAGINAL DISCHARGE (medically significant), VULVOVAGINAL SWELLING (medically significant), all with latency 4 days after the suspect product(s) administration, outcome "recovered" and all described as "dysuria, vulvar pruritus, vulvar discharge, and labial swelling". The events "dysuria, vulvar pruritus, vulvar discharge, and labial swelling" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; HSV1/2: Negative; Mycoplasma test: Negative. Therapeutic measures were taken as a result of vulval ulceration, dysuria, vulvovaginal pruritus, vaginal discharge, vulvovaginal swelling.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vulval ulceration, dysuria, vulvar pruritus, vulvar discharge, and labial swelling and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Illness, Pneumonia
Clinical narrative: pneumonia; chest pain; SOB; been ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.), for Covid-19 immunization. The following information was reported: PNEUMONIA (hospitalization, medically significant), outcome "not recovered"; CHEST PAIN (hospitalization), outcome "not recovered"; DYSPNOEA (hospitalization), outcome "not recovered", described as "SOB"; ILLNESS (non-serious), outcome "not recovered", described as "been ill".  Clinical course: It was reported that, Pfizer booster been I'll since 1 month sob 3 days later with chest pain 3 weeks later sob chest pain hospitalized with pneumonia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid/a little sinus congestion, and a minor cough; tested positive for Covid/a little sinus congestion, and a minor cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 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) for covid-19 immunisation. The patient's relevant medical history included: "colds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive for Covid/a little sinus congestion, and a minor cough". The patient reported that after a trip to (place name), his wife and he tested positive for Covid. He thanks to Pfizer vaccinations and booster shots, they breezed through recovery. Except for a little sinus congestion, and a minor cough, they had no others symptoms. No fever, no loss of taste, no tiredness, nothing. They had had colds that were worse. Considering over a million died from this virus, they feel very fortunate. The vaccine works. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200042416 Same reporter/product, similar events in different patients;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my wife and I tested positive for Covid; my wife and I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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) 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), COVID-19 (medically significant), outcome "unknown" and all described as "my wife and I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: my wife and I.  Clinical course: The patient and his wife get tested positive for Covid and breezed through recovery. Except for a little sinus congestion and a minor cough, we had no other symptoms. No fever, no loss of taste, no tiredness, nothing. Both had colds that were worse.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200042415 same reporter/drug, different patient;
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: presumptive Cellulitis; Initial information received on 08-Aug-2022 regarding an unsolicited valid  serious case received from a physician.  This case is linked to 2022SA318109.  This case involves a 2 years old patient of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.25 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE , with an unknown formulation and strength, (frequency: once) (lot : C5816AA ; expiry date: not reported) in an unknown administration site for immunization. or TB skin test (tuberculin test).  On an unknown date the patient had presumptive cellulitis (cellulitis) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that 3 kids received the suspect vaccine and 2 out of the 3 were started on antibiotics for presumptive cellulitis. All three kids were doing better.   Action taken : not applicable.  Corrective treatment: antibiotics for cellulitis  At time of reporting, the outcome was Recovering for the event presumptive cellulitis.; Sender's Comments: Sanofi company comment date 09-Aug-2022: This case involves a 2 year old patient of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Other medication, current illness, preexisting conditions and allergies were not reported. Also,  the time to onset of event and latency is not provided to assess the role of the vaccine. Further information such as circumstances leading to and patient's health status directly preceding the reported event and the results of investigations to research an alternative etiology such as infectious check-up is missing to fully assess the case
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 20.7 F( -6.2C) for 71 hours 30 minutes with no reported AE; ADACEL was administered to one patient post excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who was administered Adacel post excursion with no reported adverse event and max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported adverse event, while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  On 08-Aug-2022, the patient received a  dose number 1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE( lot U67093AA and expiration date: 18-Jun-20223) at a dose of 0.5ml via intramuscular route in the left deltoid for immunization.  On an unknown date, the reporter stated that refrigerator malfunction and vaccine max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported ae (product storage error).   On 08-Aug-2022 (latency: same day),the patient developed a non-serious event of  adacel was administered post excursion with no reported adverse event (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01228270:
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early administration of MENQUADFI booster dose with no reported AE; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient who had early administration of menquadfi booster dose with no reported adverse event , while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 09-Aug-2022, the patient received a 2nd dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE( lot U7299AA and expiration date: 01-Aug-2024) at an unknown dose (total) via intramuscular route in the deltoid nos for immunization.  On 09-Aug-2022 (latency: same day), the patient developed a non-serious event of early administration of menquadfi booster dose with no reported adverse event (inappropriate schedule of product administration) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported "the patient first received their dose of MENACTRA at 8 years old due to high risk travel and is now 14 years old and was asking if they were to give the second dose (MENQUADFI) today would that complete the series or will the patient receive a booster shot when the child turns 16 years old. They were informed that the primary dose was valid and that the 2nd dose given was actually considered as too early as per agency."  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01228446:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: softball sized lump under left armpit, sore neck
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Feeling abnormal, Flushing
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: feeling of floating in the air per patient account-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: pt sudden onset within 2 minute of injection of flu with covid . Rph to administer the epi pen but Parent stop it . Pt was given water after she requested for it. after 15 minutes Rph observed and responsive to question and prompt of rph
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Nausea, Tremor, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: feeling of floating in the air per patient account-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: pt sudden onset within 2 minute of injection of flu with covid . Rph to administer the epi pen but Parent stop it . Pt was given water after she requested for it. after 15 minutes Rph observed and responsive to question and prompt of rph
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: feeling of floating in the air per patient account-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: pt sudden onset within 2 minute of injection of flu with covid . Rph to administer the epi pen but Parent stop it . Pt was given water after she requested for it. after 15 minutes Rph observed and responsive to question and prompt of rph
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Weakness, cough, SOB
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain in head, body, eyes and arm. Fever, chills and large painful swelling at injection site.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain in head, body, eyes and arm. Fever, chills and large painful swelling at injection site.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 4/2/21, 4/29/21, 12/29,21. Positive on 8/15/22
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 6/8/21, 6/29/21. Positive on 8/16/22
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine. No temperature excursion occurred. Moderna determined vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse event reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Upon admission pt was already on hospice, brought into the ED via MMR for concerns of an accidental opioid overdose.   patient to be unresponsive.  They then called EMS for further assistance.  When EMS arrived, patient was unresponsive in the administered 4 mg of Narcan intranasally, with improvement of patient's mental status.  He was found to be 84% on room air, so he was placed on a non-rebreather. Found to be COIVD positive, placed in isolation.  Pt will be discharged to SNF on hospice.
Age: 80.0
Sex: F
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 administration".  Patient reported no adverse reactions.
Age: 76.0
Sex: F
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 administration".  Patient reported no adverse reactions.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine. No temperature excursion occurred. Moderna determined vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse events reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 1/14/21 025J20A dose 2 2/11/21 012L20
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, C-reactive protein increased, COVID-19, Chills
Clinical narrative: Patient was admitted due to loss of consciousness with shortness of breath and productive that started 4 days prior to presentation with fever and chills.  Found to be COVID-19 positive.  He was empirically placed on steroids antibiotics and Remdesivir. Seen in acute renal failure creatinine elevated to 2.2 was placed on IV hydration. He was asymptomatic at the time of discharge.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of consciousness, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted due to loss of consciousness with shortness of breath and productive that started 4 days prior to presentation with fever and chills.  Found to be COVID-19 positive.  He was empirically placed on steroids antibiotics and Remdesivir. Seen in acute renal failure creatinine elevated to 2.2 was placed on IV hydration. He was asymptomatic at the time of discharge.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Arthropod sting, Dyspnoea, Electrocardiogram QT prolonged, Electrocardiogram ST segment depression
Clinical narrative: Event:  Anaphylactic shock   49-year-old female without known significant past medical history, who presents with concern for anaphylactic shock.  Patient was reportedly stung 2-3 times on the left buttocks by what she thinks was a yellowjacket while mowing the lawn.  She states that she had onset of shortness of breath, nausea, vomiting her 13-year-old daughter has an EpiPen, and administered it in her left thigh.  On EMS arrival, the patient reportedly had a blood pressure of.  40/20 initially.  She appeared altered and in distress.  Patient was loaded and brought to the emergency department.  She also was given Benadryl in route.  On arrival, the patient is alert, diaphoretic, tremulous after having received epinephrine. Normotensive on manual pressure. She is given Solu-Medrol, Pepcid, additional dose of epinephrine given her report of a sensation that her throat was closing.  She did not have any hives, nausea, vomiting, hypotension at that time.    EKG after the patient was given epinephrine showed some ST depressions in the inferior leads and lateral precordial leads.  This is likely secondary to epi, but given this, will obtain troponins.  Troponins normal.  Subject will be released on 4 days of prednisone and emergent follow up with Cardiology.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram T wave abnormal, Electrocardiogram T wave inversion, Emotional distress, General physical condition abnormal, Hyperhidrosis
Clinical narrative: Event:  Anaphylactic shock   49-year-old female without known significant past medical history, who presents with concern for anaphylactic shock.  Patient was reportedly stung 2-3 times on the left buttocks by what she thinks was a yellowjacket while mowing the lawn.  She states that she had onset of shortness of breath, nausea, vomiting her 13-year-old daughter has an EpiPen, and administered it in her left thigh.  On EMS arrival, the patient reportedly had a blood pressure of.  40/20 initially.  She appeared altered and in distress.  Patient was loaded and brought to the emergency department.  She also was given Benadryl in route.  On arrival, the patient is alert, diaphoretic, tremulous after having received epinephrine. Normotensive on manual pressure. She is given Solu-Medrol, Pepcid, additional dose of epinephrine given her report of a sensation that her throat was closing.  She did not have any hives, nausea, vomiting, hypotension at that time.    EKG after the patient was given epinephrine showed some ST depressions in the inferior leads and lateral precordial leads.  This is likely secondary to epi, but given this, will obtain troponins.  Troponins normal.  Subject will be released on 4 days of prednisone and emergent follow up with Cardiology.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Nausea, Sinus tachycardia, Throat tightness, Tremor
Clinical narrative: Event:  Anaphylactic shock   49-year-old female without known significant past medical history, who presents with concern for anaphylactic shock.  Patient was reportedly stung 2-3 times on the left buttocks by what she thinks was a yellowjacket while mowing the lawn.  She states that she had onset of shortness of breath, nausea, vomiting her 13-year-old daughter has an EpiPen, and administered it in her left thigh.  On EMS arrival, the patient reportedly had a blood pressure of.  40/20 initially.  She appeared altered and in distress.  Patient was loaded and brought to the emergency department.  She also was given Benadryl in route.  On arrival, the patient is alert, diaphoretic, tremulous after having received epinephrine. Normotensive on manual pressure. She is given Solu-Medrol, Pepcid, additional dose of epinephrine given her report of a sensation that her throat was closing.  She did not have any hives, nausea, vomiting, hypotension at that time.    EKG after the patient was given epinephrine showed some ST depressions in the inferior leads and lateral precordial leads.  This is likely secondary to epi, but given this, will obtain troponins.  Troponins normal.  Subject will be released on 4 days of prednisone and emergent follow up with Cardiology.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal, Vomiting
Clinical narrative: Event:  Anaphylactic shock   49-year-old female without known significant past medical history, who presents with concern for anaphylactic shock.  Patient was reportedly stung 2-3 times on the left buttocks by what she thinks was a yellowjacket while mowing the lawn.  She states that she had onset of shortness of breath, nausea, vomiting her 13-year-old daughter has an EpiPen, and administered it in her left thigh.  On EMS arrival, the patient reportedly had a blood pressure of.  40/20 initially.  She appeared altered and in distress.  Patient was loaded and brought to the emergency department.  She also was given Benadryl in route.  On arrival, the patient is alert, diaphoretic, tremulous after having received epinephrine. Normotensive on manual pressure. She is given Solu-Medrol, Pepcid, additional dose of epinephrine given her report of a sensation that her throat was closing.  She did not have any hives, nausea, vomiting, hypotension at that time.    EKG after the patient was given epinephrine showed some ST depressions in the inferior leads and lateral precordial leads.  This is likely secondary to epi, but given this, will obtain troponins.  Troponins normal.  Subject will be released on 4 days of prednisone and emergent follow up with Cardiology.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Blood test, Contusion, Electrocardiogram normal, Impaired work ability, Mobility decreased
Clinical narrative: She got her vaccine, she had pain, slight fever. She woke up to go to work and she was not able to due to pain in her arms, not able to lift her arm and pain. She continues to have the pain, has been taking Tylenol which helps a little bit, but still not able to work due to the reaction. She went to an UC on 7/5/22 and had an EKG because the pain was in her left arm and she thought that she may have been having a heart attack, they said her EKG was fine.  She had a very red bruise on my right arm, and it went away. She was prescribed OTC medication but she did not get it as she did not want to take so much medication when she is already taking prescription medication. She has an APT to see her PCP on 9/21/2022. She believes her reaction is to the shingles shot as she did not hit herself or fall or do anything to her arm, just has the pain and not able to fold sheets or do much of anything.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: She got her vaccine, she had pain, slight fever. She woke up to go to work and she was not able to due to pain in her arms, not able to lift her arm and pain. She continues to have the pain, has been taking Tylenol which helps a little bit, but still not able to work due to the reaction. She went to an UC on 7/5/22 and had an EKG because the pain was in her left arm and she thought that she may have been having a heart attack, they said her EKG was fine.  She had a very red bruise on my right arm, and it went away. She was prescribed OTC medication but she did not get it as she did not want to take so much medication when she is already taking prescription medication. She has an APT to see her PCP on 9/21/2022. She believes her reaction is to the shingles shot as she did not hit herself or fall or do anything to her arm, just has the pain and not able to fold sheets or do much of anything.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Decreased appetite, Epstein-Barr virus infection reactivation, Fatigue, Impaired work ability
Clinical narrative: Patient developed a fever of 100 degrees on 7/31 that persisted the whole week. The week prior to that she started feeling extra fatigued and nauseous. She lost 6 lbs. due to loss of appetite from the nausea. She went to urgent care and received a CT which showed no PE and lungs were clear. Fatigue was so severe some days it was difficult to sit and do work in her chair. Patient came into our office on 8/12 and labs showed reactivation of Epstein Barr virus.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Nausea, Pyrexia, Weight decreased
Clinical narrative: Patient developed a fever of 100 degrees on 7/31 that persisted the whole week. The week prior to that she started feeling extra fatigued and nauseous. She lost 6 lbs. due to loss of appetite from the nausea. She went to urgent care and received a CT which showed no PE and lungs were clear. Fatigue was so severe some days it was difficult to sit and do work in her chair. Patient came into our office on 8/12 and labs showed reactivation of Epstein Barr virus.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nausea, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I did not have an adverse reaction to the vaccine.  I tested positive for COVID-19 on 08/07/2022 with a home test.  My symptoms where nasal blockage; coughing really bad; nauseated and a sore throat. I contacted my doctor on 08/10/2022 and due to my current medication I was advised not to take Plaxovid so they said to take Tylenol, Mucinex and throat lozenges. As of today I still have congestion, runny nose and cough. The cough is not as bad but I still have it.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sinonasal obstruction
Clinical narrative: I did not have an adverse reaction to the vaccine.  I tested positive for COVID-19 on 08/07/2022 with a home test.  My symptoms where nasal blockage; coughing really bad; nauseated and a sore throat. I contacted my doctor on 08/10/2022 and due to my current medication I was advised not to take Plaxovid so they said to take Tylenol, Mucinex and throat lozenges. As of today I still have congestion, runny nose and cough. The cough is not as bad but I still have it.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient Hospitalized with COVID even though vaccinated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, COVID-19, Depressed level of consciousness, Encephalopathy, Hyperammonaemia
Clinical narrative: Patient presented to the ED via EMS for evaluation following a loss of consciousness and syncopal episode  and seizure-like activity. Bystanders performed CPR as he was noted to be pulseless and the patient was bradycardic after once ROSC was obtained. En route to the ED the patient was nonresponsive and his eyes were tracking. Per EMS the patient is now more alert, but not at baseline. At baseline the patient can communicate and answer questions. The patient is prescribed Tramadol but is not prescribed seizure medications. History is otherwise limited given the patient's altered mental status. Neuro consulted. Found to be COVID positive, placed in isolation. Pt received a course of Dexamethasone 6mg and vancomycin. Pt stable and will be discharged home.    Discharge Diagnoses: COVID - stable  Breakthrough seizure  Post-ictal  Hyperammonemia  Acute encephalopathy
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Mental status changes, Postictal state, Pulse absent, Resuscitation
Clinical narrative: Patient presented to the ED via EMS for evaluation following a loss of consciousness and syncopal episode  and seizure-like activity. Bystanders performed CPR as he was noted to be pulseless and the patient was bradycardic after once ROSC was obtained. En route to the ED the patient was nonresponsive and his eyes were tracking. Per EMS the patient is now more alert, but not at baseline. At baseline the patient can communicate and answer questions. The patient is prescribed Tramadol but is not prescribed seizure medications. History is otherwise limited given the patient's altered mental status. Neuro consulted. Found to be COVID positive, placed in isolation. Pt received a course of Dexamethasone 6mg and vancomycin. Pt stable and will be discharged home.    Discharge Diagnoses: COVID - stable  Breakthrough seizure  Post-ictal  Hyperammonemia  Acute encephalopathy
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Seizure, Seizure like phenomena, Syncope, Unresponsive to stimuli
Clinical narrative: Patient presented to the ED via EMS for evaluation following a loss of consciousness and syncopal episode  and seizure-like activity. Bystanders performed CPR as he was noted to be pulseless and the patient was bradycardic after once ROSC was obtained. En route to the ED the patient was nonresponsive and his eyes were tracking. Per EMS the patient is now more alert, but not at baseline. At baseline the patient can communicate and answer questions. The patient is prescribed Tramadol but is not prescribed seizure medications. History is otherwise limited given the patient's altered mental status. Neuro consulted. Found to be COVID positive, placed in isolation. Pt received a course of Dexamethasone 6mg and vancomycin. Pt stable and will be discharged home.    Discharge Diagnoses: COVID - stable  Breakthrough seizure  Post-ictal  Hyperammonemia  Acute encephalopathy
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after being vaccinated.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after receiving vaccination
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after receiving vaccination.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization unrelated to COVID, tested at d/c prior to d/c to SNF.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after receiving vaccinations.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after receiving vaccinations.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID after receiving vaccinations
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adenocarcinoma of appendix, Biopsy, Blood loss anaemia, Colonoscopy abnormal
Clinical narrative: Patient is an 69 y.o. female with PMHx/PSHx of HTN, CKD, hypothyroidism, left vocal cord paralysis, presenting with and admitted to the medicine service for syncope and epigastric abdominal pain (4/11), whom we are consulted for 2cm malignant appearing cecal mass identified on colonoscopy (obtained following abnormal CT imaging). Surgical oncology was consulted due to concern for malignancy. Tumor markers (CEA and CA 19-9 were ordered as well as a staging CT chest. CT chest showed no findings of pulmonary metastatic disease. A thyroid nodule was incidentally noted and FNA revealed a Bethesda 2, benign, nodule. CEA was 1.09. CA 19-9 34.0. Biopsy of the tissue from colonoscopy on 4/18 revealed invasive adenocarcinoma of the appendix. Postoperative course was significant for acute blood loss anemia necessitating 1 unit. The patient continued to convalesce and was discharge on 4/25/2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Mass, Pulmonary mass, Syncope
Clinical narrative: Patient is an 69 y.o. female with PMHx/PSHx of HTN, CKD, hypothyroidism, left vocal cord paralysis, presenting with and admitted to the medicine service for syncope and epigastric abdominal pain (4/11), whom we are consulted for 2cm malignant appearing cecal mass identified on colonoscopy (obtained following abnormal CT imaging). Surgical oncology was consulted due to concern for malignancy. Tumor markers (CEA and CA 19-9 were ordered as well as a staging CT chest. CT chest showed no findings of pulmonary metastatic disease. A thyroid nodule was incidentally noted and FNA revealed a Bethesda 2, benign, nodule. CEA was 1.09. CA 19-9 34.0. Biopsy of the tissue from colonoscopy on 4/18 revealed invasive adenocarcinoma of the appendix. Postoperative course was significant for acute blood loss anemia necessitating 1 unit. The patient continued to convalesce and was discharge on 4/25/2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion, Tumour marker test
Clinical narrative: Patient is an 69 y.o. female with PMHx/PSHx of HTN, CKD, hypothyroidism, left vocal cord paralysis, presenting with and admitted to the medicine service for syncope and epigastric abdominal pain (4/11), whom we are consulted for 2cm malignant appearing cecal mass identified on colonoscopy (obtained following abnormal CT imaging). Surgical oncology was consulted due to concern for malignancy. Tumor markers (CEA and CA 19-9 were ordered as well as a staging CT chest. CT chest showed no findings of pulmonary metastatic disease. A thyroid nodule was incidentally noted and FNA revealed a Bethesda 2, benign, nodule. CEA was 1.09. CA 19-9 34.0. Biopsy of the tissue from colonoscopy on 4/18 revealed invasive adenocarcinoma of the appendix. Postoperative course was significant for acute blood loss anemia necessitating 1 unit. The patient continued to convalesce and was discharge on 4/25/2022.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: There was no side effects, or bad outcome. We erroneously gave vaccine earlier than recommended 4 months gap from the last Booster