chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had covid; Had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), 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".  Clinical course: My whole family is vaccinated w/all 3, my son has had covid 2 times, my other son and husband had both had it Had covid twice. Had covid twice. 1st time was not bad, 2nd time was worse and prescribed Paxlovid after 3rd shot ,I had frozen shoulder, went to therapy and still have  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: Somnolence
Clinical narrative: After my first covid vaccine dose, I slept; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) 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: SOMNOLENCE (non-serious), outcome "unknown", described as "After my first covid vaccine dose, I slept".  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: Arthralgia, Gait inability
Clinical narrative: severe hip pain; could not walk; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 29-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: ARTHRALGIA (medically significant), outcome "unknown", described as "severe hip pain"; GAIT INABILITY (medically significant), outcome "unknown", described as "could not walk". The patient experienced severe hip pain, to the point that she could not walk, after Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Products were exposed to a high of 47.4F and a low of 31.4F with no reported adverse event; The patient received Menactra exposed to a high of 47.4 and a low of 31.4 degree Fahrenheit.; Initial information received on 01-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 60 years old female patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to a high of 47.4 F and a low of 31.4 F with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a dose of 0.5 mL of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE exposed to a high of 47.4 and a low of 31.4 degree Fahrenheit with no reported adverse event (with lot U7492AB, expiry date: 26 Oct 2023) (strength, formulation: unknown) via intramuscular route in unknown administration site for immunization (poor quality product administered).  On an unknown date the reporter reported a non-serious products were exposed to a high of 47.4 F and a low of 31.4 F with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  At time of reporting, the outcome was Unknown for the event products were exposed to a high of 47.4f and a low of 31.4f with no reported adverse event and was Unknown for the event the patient received menactra exposed to a high of 47.4 and a low of 31.4 degree fahrenheit..     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 guidelines. 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.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of pentacel that was administered, with no reported adverse event; Initial information received on 03-Feb-2023 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case involves a 1 year old female patient to whom expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination.  On 03-Feb-2023, the patient received Dose 3; at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: U7198AA and expiry date: 28-Jan-2023) in the lateral thigh for Immunization and expired dose of pentacel that was administered, with no reported adverse event (expired product administered) (latency: same day).  It was reported, what should we watch for or know with respect to an expired dose of Pentacel that was administered today? She mentioned that the ink for the lot and expiry as printed on the vial is lighter in shade than the ink printed on the rest of the vial. First time product used : Yes Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, PNC13, PNC13
Symptoms: Body temperature increased, Febrile convulsion, Postictal state, Respiratory pathogen panel
Clinical narrative: Simple febrile seizure lasting approximately 3 minutes at 0210; transient post-ictal period with return to appropriate baseline prior to arrival at hospital. Rectal temperature 103.8 on arrival to ED. Treated with 15mg/kg acetaminophen PR on arrival and 10mg/kg ibuprofen PO 1hr later with appropriate decrease in fever.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pain
Clinical narrative: Body aches; Rapid heart rate; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2023, less than a day after receiving Shingrix, the patient experienced general body pain and heart rate increased. On an unknown date, the outcome of the general body pain and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and heart rate increased to be related to Shingrix.     Additional Information: GSK receipt date: 02-FEB-2023 Reporter comment: The patient self-reported this case. The patient received first dose of Shingrix vaccine and started to feel body aches and rapid heart rate. The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Vertigo
Clinical narrative: He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now; He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now) and DIZZINESS (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jan-2023, the patient experienced VERTIGO (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now) and DIZZINESS (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now). At the time of the report, VERTIGO (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now) and DIZZINESS (He took it on 20JAN2023 and started having dizzy spells about 8 days later that just progressed to vertigo, dizziness, and he has been on his back for about 5 days now) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Illness
Clinical narrative: dizzy / third shot dizzy; allergy attack; second shot sick two days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days). At the time of the report, DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; VARIVAX administered after temperature excursion; This spontaneous report as received from a from a medical assistant refers to a 15 month old male patient. The patient had no siblings. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W021740 exp date 10-JUL-2024) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040:
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chest discomfort, Chest pain, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: On 28 November 2023 at 3:00 AM I was experiencing chest pain, sensation of chest sucking into spine and chest tightness. I arrived at the ER at 3:40
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myopericarditis, Sensory disturbance, Troponin increased
Clinical narrative: On 28 November 2023 at 3:00 AM I was experiencing chest pain, sensation of chest sucking into spine and chest tightness. I arrived at the ER at 3:40
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Surgery
Clinical narrative: Pt admitted for surgery and tested positive for covid infection. No information on vaccine including manufacturer, date, location, etc.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna monovalent dose #3 given in stead of bivalent dose. As of today, 2/8/23, there have been no reports of adverse reaction from parents/guardian.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization-transfer to Hospital transitional care from Hospital.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna Monovalent was given as dose #3, instead of bivalent dose. As of today, 02/08/23, there have been no reports of adverse reaction.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna Monovalent was given as dose #3, instead of bivalent dose. As of today, 02/08/23, there have been no reports of adverse reaction by parent/guardian.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna Monovalent was given as dose #3, instead of bivalent dose. As of today, 02/08/23, there have been no reports of adverse reaction by parent/guardian.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder catheterisation, COVID-19, Endotracheal intubation, Hypertension, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted and tested positive for covid. NO VACCINE INFO AVAILABLE including dose, manufacturer, location, date, etc.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Vaccinated pt admitted and tested positive for covid. NO VACCINE INFO AVAILABLE including dose, manufacturer, location, date, etc.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Medication administration error.  On 2/3/2023 patient came to primary care office to receive vaccinations to enter CNA program. MA thought that patient had already received Covid primary series vaccinations and patient was administered  Pfizer BioNTech bivalent booster.  After reviewing paperwork, MA discovered that patient had not received their primary series Covid vaccinations.  Error reported to myself, RN at clinic and to pharmacist at hospital.  Notification sent to CDC and response received.  Patient's primary provider notified of error.  Patient notified and scheduled to continue with second dose of Pfizer BioNTech Monovalent vaccine to complete her primary series.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Facial pain, Fall, Feeling abnormal
Clinical narrative: Vaccinated pt admitted with covid infection. NO VACCINE INFO AVAILABE
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Productive cough
Clinical narrative: Vaccinated pt admitted with covid infection. NO VACCINE INFO AVAILABE
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest discomfort, Chest pain, Electrocardiogram normal, Pain
Clinical narrative: Chest pain, tightness, sharp pains.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Auscultation, COVID-19, Chest X-ray normal, Chest pain, Cough
Clinical narrative: Vaccinated pt admitted for covid infection> NO VACCINE INFO AVAILABLE
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Electrocardiogram normal, Laboratory test normal, SARS-CoV-2 test positive, Sinus rhythm
Clinical narrative: Vaccinated pt admitted for covid infection> NO VACCINE INFO AVAILABLE
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Vaccinated pt admitted for covid infection> NO VACCINE INFO AVAILABLE
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on both feet, itching.  Benadryl, alternate vaccinator-mother will do no more IPV
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy irregular menstrual cycles , large blood clots. Treatment: put on progesterone to try and stop the bleeding.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Lethargy, Nausea
Clinical narrative: Rash (appeared as though I had a sunburn all over my legs and feed) with Hives all over my body, Sore arm at injection site, swelling of feet and legs, headache, lethargy, nausea.  Received Pfizer Covid 19 Vaccination at 3pm, March 19th, 2021, injection in the left arm.  Waited 15 minutes at vaccination site.  No issues and was released.  Approximately 4 hours later, side effects began (listed above).   My sister in law is a registered nurse and she said, do not to take benedryl as the pharmacist told me to do, on Sunday,  March 21, 2021.  She said, if it got worse to call my physician.  The rash went away but the hives are still there and I itch.  I'm still exhausted.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Rash (appeared as though I had a sunburn all over my legs and feed) with Hives all over my body, Sore arm at injection site, swelling of feet and legs, headache, lethargy, nausea.  Received Pfizer Covid 19 Vaccination at 3pm, March 19th, 2021, injection in the left arm.  Waited 15 minutes at vaccination site.  No issues and was released.  Approximately 4 hours later, side effects began (listed above).   My sister in law is a registered nurse and she said, do not to take benedryl as the pharmacist told me to do, on Sunday,  March 21, 2021.  She said, if it got worse to call my physician.  The rash went away but the hives are still there and I itch.  I'm still exhausted.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test positive
Clinical narrative: 01/11/23 presents to ED for "generalized body aches". PMHx of "ESRD on dialysis"
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Surgery
Clinical narrative: 12/03/22 went to urgent care, accute appendicits, then went to hospital for surgery within 2 hrs
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid Vaccine after the 10 week refrigeration time
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Full blood count, Hypophagia, Irritability, Laboratory test
Clinical narrative: Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Blood culture, Culture urine, Diarrhoea, Full blood count, Hypophagia
Clinical narrative: Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Irritability, Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Full blood count, Hypophagia, Irritability, Laboratory test
Clinical narrative: Within about 4 hours he had a fever of 102.9 F and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within about 4 hours he had a fever of 102.9 F and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Blood culture, Culture urine, Diarrhoea, Full blood count, Hypophagia
Clinical narrative: Within about 4 hours he had a fever of 102.9 F and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Irritability, Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within about 4 hours he had a fever of 102.9 F and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Within about 4 hours he had a fever of 102.9 F and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 01/12/23 presents to ED for "breathing problem". PMHx of "COPD, chronic hypoxic respiratory failure on 3L NC QHS, Atrial fibrillation with hx pacemaker not on AC, CKD stage 3a, HTN, AAA, OSA, HTN"
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid below the injection is hot, red, and inflamed. The area has spread from a baseball size spot to covering approximately 80% of his upper left arm. Day two appears to be less red. Redness is lessening as it spreads.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I contracted COVID-19 on 9SEP2022 and my symptoms were fever, bad cough, aching, and a very bad sore throat. I had congestion as well, I was positive until 16SEP2022.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19 on 9SEP2022 and my symptoms were fever, bad cough, aching, and a very bad sore throat. I had congestion as well, I was positive until 16SEP2022.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Middle insomnia
Clinical narrative: During the night while sleeping, was awakened with a severe pain in my back that felt like a very bad brush burn around the area of my right shoulder blade.  Was unable to sleep on my back for the rest of the night.  It is still there this morning although it doesn't hurt so bad unless I lean back against something.
Age: 82.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test, Sinus congestion
Clinical narrative: I received my Covid-19 vaccine on 11/02/2022. On 01/19/2023 I came down with chills, fever, cough and sinus congestion. The next day I contacted my doctor and was prescribed PAXLOVID. Took medication for 5 days however on the 3rd day I rapidly improved. Symptoms gradually went away however I still have a slight cough.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient is a resident at local LTC (long term care). He was given bivalent vaccine on 12/8/22 from the local County Health Dept. Local County Health Dept. returned to site on 2/7/23. Resident was inadvertently given the same vaccine a second time.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was given the primary series instead of the Bivalent booster. The patient has had no adverse effects from this.
Age: 44.0
Sex: M
Vaccine: UNK, TDAP
Symptoms: Bacterial test negative, Choking, Dyspnoea, Retching, Uvulitis
Clinical narrative: Uvulitis - Uvula swelled to aproximately 15 times normal sized. Obstruction of breathing. Gagging and chocking occurred. Went to ER, admitted. Screened for all viruses and bacterial infections. Everything negative. Given high doses of benedryl and steroids to reduce swelling. No other symptoms
Age: 44.0
Sex: M
Vaccine: UNK, TDAP
Symptoms: Viral test negative
Clinical narrative: Uvulitis - Uvula swelled to aproximately 15 times normal sized. Obstruction of breathing. Gagging and chocking occurred. Went to ER, admitted. Screened for all viruses and bacterial infections. Everything negative. Given high doses of benedryl and steroids to reduce swelling. No other symptoms
Age: 44.0
Sex: M
Vaccine: UNK, TDAP
Symptoms: Differential white blood cell count, Dysphagia, Dyspnoea, Full blood count, Retching
Clinical narrative: Uvulitis - Uvula swelled to aproximately 15 times normal sized. Obstruction of breathing. Gagging and chocking occurred. Went to ER, admitted. Screened for all viruses and bacterial infections. Everything negative. Given high doses of benedryl and steroids to reduce swelling. No other symptoms
Age: 44.0
Sex: M
Vaccine: UNK, TDAP
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Uvulitis - Uvula swelled to aproximately 15 times normal sized. Obstruction of breathing. Gagging and chocking occurred. Went to ER, admitted. Screened for all viruses and bacterial infections. Everything negative. Given high doses of benedryl and steroids to reduce swelling. No other symptoms
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Muscle spasms, Palpitations, Pyrexia
Clinical narrative: Severe chills, fever, muscular spasm in back, inability to move, sever heart palpitations - 48 hour reaction
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I received my 4th Pfizer Bivalent booster on 10/13/2022. My COVID-19 infection started on 12/29/2022 in the morning. I woke up with headaches. When I tested positive on 01/02/2023 with a home test I had sinus congestions, chest congestions, body aches, fatigue, and low grade fever. I called my doctor on the evening of January 2nd and I got a call back on 01/03/2023. I did a telehealth with my doctor on 01/03/2023 at 12:50pm. He prescribed me with PAXLOVID for 5 days. I tested negative on 01/08/2023.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I received my 4th Pfizer Bivalent booster on 10/13/2022. My COVID-19 infection started on 12/29/2022 in the morning. I woke up with headaches. When I tested positive on 01/02/2023 with a home test I had sinus congestions, chest congestions, body aches, fatigue, and low grade fever. I called my doctor on the evening of January 2nd and I got a call back on 01/03/2023. I did a telehealth with my doctor on 01/03/2023 at 12:50pm. He prescribed me with PAXLOVID for 5 days. I tested negative on 01/08/2023.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 2/25/21 Lot# 031L20A;  Moderna 12/9/21 Lot# 005C21A
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Death, Hyperhidrosis, Hypotension
Clinical narrative: 3RD COVID DOSE, MODERNA, GIVEN 11/22/21, LOT #027H21B; Pt tested positive for COVID on 8/5/21 in Hospital; no cough, no dyspnea, on RA, lungs clear; dc'd to SNF on 8/10/22; weakness; suffered hypotension with diaphoresis, weakness, slightly lethargic; elevated WBC; requested UA but unable to obtain, gave pt a shot of Rocephin; pt transitioned to DNR/DNI, comfort measures only; he passed away in the SNF (Center for Rehab and Healing.)
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: 3RD COVID DOSE, MODERNA, GIVEN 11/22/21, LOT #027H21B; Pt tested positive for COVID on 8/5/21 in Hospital; no cough, no dyspnea, on RA, lungs clear; dc'd to SNF on 8/10/22; weakness; suffered hypotension with diaphoresis, weakness, slightly lethargic; elevated WBC; requested UA but unable to obtain, gave pt a shot of Rocephin; pt transitioned to DNR/DNI, comfort measures only; he passed away in the SNF (Center for Rehab and Healing.)
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Dr. wanted the patient to have a Pneumonia Vaccine, this nurse checked the chart to see when the last vaccine had been given and the patient had a PCV 13 on 6/19/2019 and per Care Gaps needed a Pneumovax-23. This nurse went into the Immunization room and pulled a Pneumovax 23 went back to Pod 4 and verified with CMA and this nurse had the right vaccine of Pneumovax-23, went into the patient's room and verified the correct patient by name and DOB and gave injection into the Right Deltoid. Went back out to desk to document and while entering the Vaccine error message entered that the Vaccine was expired, this nurse went back to immunization room to verify vaccine and that the vaccine had expired on 1/13/23, pulled out remaining dose and given to Immunization nurse LPN.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Back pain, Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This is my 5th shot and I had no reaction to. This shot I had nothing. It started like a cold. I had a slight sore throat and runny nose. I developed a cough that was really bad. It became painful and hurt in my abdomen and back. I was given additional medication from my doctor. MUCINEX DM. The congestion and cough were still bad. I went into the doctor yesterday and she prescribed a ZPAK. I actually am feeling better today. I think it's virus that has been going around. I have this cough that I'm treating it with regular cough medicine.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This is my 5th shot and I had no reaction to. This shot I had nothing. It started like a cold. I had a slight sore throat and runny nose. I developed a cough that was really bad. It became painful and hurt in my abdomen and back. I was given additional medication from my doctor. MUCINEX DM. The congestion and cough were still bad. I went into the doctor yesterday and she prescribed a ZPAK. I actually am feeling better today. I think it's virus that has been going around. I have this cough that I'm treating it with regular cough medicine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the primary series instead of the bivalent booster. The patient has had no adverse effects from this.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeding disorder, Fungal infection, Gait disturbance
Clinical narrative: First vaccine: When I took the vaccine at pharmacy , they followed protocal. When I went home, there was slight soreness in my right shoulder, I took a tylenol advised by my mom. I took it an hour after, I was fine. And then the next morning when I was suppose to go to work, I could not come out of bed. My muscles ached all over my body, head to toe. I told my job I could not come to work cause of the shot, I stayed home that day. I made that call at 5 am, so then because of the pain from my neck on down, I could not get out of bed until 2:30pm on the 25th. I could not eat all day. My body ache so much, I said to myself OMG I cant believe what I am experiencing right now. I was holding on to the walls walking, I was able to make me some lunch. That evening I warmed up my dinner, and with that I was able to sit at my table and eat, and then after I was done with that. Approximately a quarter to 4, I had to fight to get in the shower. I said to myself, that If this is what covid is, I dont want to ever have the real thing. Back pain, elbow, shoulder. When I was done taking the shower, it took me like 30 mins to get dress. Second Vaccine (COVID PFIZER LOT# EW0177): June 14, 2021 I went back to the same pharmacy, I was able to go to work, I went to work at 7am. At 11am, I made it back to my office at work, It made me very drowsy. I couldnt work, I was so drowsy, I couldnt hardly keep my eyes open. I took a light nap, sitting in the chair, I was able to clock out and come home. I went to bed after dinner and shower.  THIRD VACCINE (COVIDPFIZER LOT# FK9829): February 1st, 2022, It was this one when I arrived home, that night I went to bed and that entire night, I tossed and turned, my epidermis was itching me, from head to toe, and I tossed and turned,  I couldnt scratch cause it was internal. Itching underneath my skin. It was my body trying to push it out. I developed a little rash, which is very itchy. I went back to her approximately in October of 2021, and I didnt know what was causing it then, then I went to her on Sept of 2022 reporting this itching I was having, and it went to my scalp. She said it's like a fungus and gave me meds, and it didnt work, so I was hospitalized throughout this process.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Insomnia, Mobility decreased, Myalgia
Clinical narrative: First vaccine: When I took the vaccine at pharmacy , they followed protocal. When I went home, there was slight soreness in my right shoulder, I took a tylenol advised by my mom. I took it an hour after, I was fine. And then the next morning when I was suppose to go to work, I could not come out of bed. My muscles ached all over my body, head to toe. I told my job I could not come to work cause of the shot, I stayed home that day. I made that call at 5 am, so then because of the pain from my neck on down, I could not get out of bed until 2:30pm on the 25th. I could not eat all day. My body ache so much, I said to myself OMG I cant believe what I am experiencing right now. I was holding on to the walls walking, I was able to make me some lunch. That evening I warmed up my dinner, and with that I was able to sit at my table and eat, and then after I was done with that. Approximately a quarter to 4, I had to fight to get in the shower. I said to myself, that If this is what covid is, I dont want to ever have the real thing. Back pain, elbow, shoulder. When I was done taking the shower, it took me like 30 mins to get dress. Second Vaccine (COVID PFIZER LOT# EW0177): June 14, 2021 I went back to the same pharmacy, I was able to go to work, I went to work at 7am. At 11am, I made it back to my office at work, It made me very drowsy. I couldnt work, I was so drowsy, I couldnt hardly keep my eyes open. I took a light nap, sitting in the chair, I was able to clock out and come home. I went to bed after dinner and shower.  THIRD VACCINE (COVIDPFIZER LOT# FK9829): February 1st, 2022, It was this one when I arrived home, that night I went to bed and that entire night, I tossed and turned, my epidermis was itching me, from head to toe, and I tossed and turned,  I couldnt scratch cause it was internal. Itching underneath my skin. It was my body trying to push it out. I developed a little rash, which is very itchy. I went back to her approximately in October of 2021, and I didnt know what was causing it then, then I went to her on Sept of 2022 reporting this itching I was having, and it went to my scalp. She said it's like a fungus and gave me meds, and it didnt work, so I was hospitalized throughout this process.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Somnolence
Clinical narrative: First vaccine: When I took the vaccine at pharmacy , they followed protocal. When I went home, there was slight soreness in my right shoulder, I took a tylenol advised by my mom. I took it an hour after, I was fine. And then the next morning when I was suppose to go to work, I could not come out of bed. My muscles ached all over my body, head to toe. I told my job I could not come to work cause of the shot, I stayed home that day. I made that call at 5 am, so then because of the pain from my neck on down, I could not get out of bed until 2:30pm on the 25th. I could not eat all day. My body ache so much, I said to myself OMG I cant believe what I am experiencing right now. I was holding on to the walls walking, I was able to make me some lunch. That evening I warmed up my dinner, and with that I was able to sit at my table and eat, and then after I was done with that. Approximately a quarter to 4, I had to fight to get in the shower. I said to myself, that If this is what covid is, I dont want to ever have the real thing. Back pain, elbow, shoulder. When I was done taking the shower, it took me like 30 mins to get dress. Second Vaccine (COVID PFIZER LOT# EW0177): June 14, 2021 I went back to the same pharmacy, I was able to go to work, I went to work at 7am. At 11am, I made it back to my office at work, It made me very drowsy. I couldnt work, I was so drowsy, I couldnt hardly keep my eyes open. I took a light nap, sitting in the chair, I was able to clock out and come home. I went to bed after dinner and shower.  THIRD VACCINE (COVIDPFIZER LOT# FK9829): February 1st, 2022, It was this one when I arrived home, that night I went to bed and that entire night, I tossed and turned, my epidermis was itching me, from head to toe, and I tossed and turned,  I couldnt scratch cause it was internal. Itching underneath my skin. It was my body trying to push it out. I developed a little rash, which is very itchy. I went back to her approximately in October of 2021, and I didnt know what was causing it then, then I went to her on Sept of 2022 reporting this itching I was having, and it went to my scalp. She said it's like a fungus and gave me meds, and it didnt work, so I was hospitalized throughout this process.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cough, Death, Dysphonia
Clinical narrative: 3RD DOSE PFIZER COVID VACCINE GIVEN 11/6/21, LOT #32030BD;  pt brought to hospital via EMS with cough, SOB, hoarse throat, nausea, tachycardia; found to be positive for COVID; O2 supplementation; admitted with AHRF secondary to COVID 19 infection; superimposed bacterial pneumonia; FTT; fed through NG tube; transitioned pt to comfort measures and she passed away in the hospital
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Failure to thrive, Gastrointestinal tube insertion, Nausea, Pneumonia bacterial
Clinical narrative: 3RD DOSE PFIZER COVID VACCINE GIVEN 11/6/21, LOT #32030BD;  pt brought to hospital via EMS with cough, SOB, hoarse throat, nausea, tachycardia; found to be positive for COVID; O2 supplementation; admitted with AHRF secondary to COVID 19 infection; superimposed bacterial pneumonia; FTT; fed through NG tube; transitioned pt to comfort measures and she passed away in the hospital
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Superinfection, Tachycardia
Clinical narrative: 3RD DOSE PFIZER COVID VACCINE GIVEN 11/6/21, LOT #32030BD;  pt brought to hospital via EMS with cough, SOB, hoarse throat, nausea, tachycardia; found to be positive for COVID; O2 supplementation; admitted with AHRF secondary to COVID 19 infection; superimposed bacterial pneumonia; FTT; fed through NG tube; transitioned pt to comfort measures and she passed away in the hospital
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines MOderna 3/24/21 Lot# 045A21A;  Moderna 4/21/21 Lot# 016B21A;  Moderna 11/1/21 LOt# 939903;  Pfizer 9/19/22 Lot# GJ5342
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: no symtoms
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: I was feeling a little out of it and I had surgery coming up. As a precautionary measure, I took a home test and I was positive. I was unsure of if it was a valid test because the liquid in the vile was not at the level described in the instructions. Because of that, I went to the urgent care and got another test and it came back positive. For treatment, I called my PCP Monday morning and let him know that I was positive for COVID-19. He prescribed Paxlovid just in case. I took that and I had no other symptoms. I just sat and waited until the necessary time frame and retested and came back negative.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Ear pain, Gastric disorder, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: I was having stomach problems and I assumed it was my reflux as I have had this happen before except this time it is dragging on and on, more so I have a lingering cough and it feels like something is dripping there and my throat gets sore and it starts hurting behind ears from coughing. I feel like I have to clear my throat often.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat clearing
Clinical narrative: I was having stomach problems and I assumed it was my reflux as I have had this happen before except this time it is dragging on and on, more so I have a lingering cough and it feels like something is dripping there and my throat gets sore and it starts hurting behind ears from coughing. I feel like I have to clear my throat often.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: tired, joint pain, headache, arm swollen, arm itching, arm pain, arm tender, overall feeling of unwell
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Pruritus, Tenderness
Clinical narrative: tired, joint pain, headache, arm swollen, arm itching, arm pain, arm tender, overall feeling of unwell
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 2/26/21 Lot# EN6202;  Pfizer 3/19/21 Lot# EN6204
Age: 55.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Condition aggravated, Malaise, Pain, Pyrexia, Seizure
Clinical narrative: Malaise, body aches, fever to 104F, exacerbation of seizure, although no treatment sought at the time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/26/21 Lot# 002B21A;  Moderna 4/23/21 Lot# 030A21A
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Pfizer 3/2/21 Lot# EN6202;  Pfizer 3/23/21 Lot# ER8727;  Pfizer 10/23/21 Lot# 30155BA
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Mobility decreased, SARS-CoV-2 test positive
Clinical narrative: Found in home by friend who said patient was unable to get off the couch. Test positive for COVID on admission. Treatment includes admission with isolation, assessment and lovenox.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Pfizer 2/17/21 Lot# EL9267;  Pfizer 3/9/21 Lot# EN6199;  Pfizer 10/19/21 Lot# EW0164;  Pfizer 8/3/22 Lot# FMQ173;  Pfizer 10/5/22 Lot# GH9702
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Antiplatelet therapy, Anxiety, Blood creatinine increased, Blood pressure systolic increased
Clinical narrative: Provider d/c note: "63-year-old female past medical history of poorly controlled hypertension and medical noncompliance.  She presented on 12/20 for chief complaint of altered mental status.  On presentation patient was noted to be hypertensive systolics in the 240s creatinine 2.8 hypokalemic, complete blood count notable for leukocytosis.  CT was performed showing nonspecific low attenuation in both cerebral hemispheres.  Patient was admitted for workup of strokes and altered mental status.  See initially admitted to the intensive care unit requiring IV blood pressure medications transferred to progressive care unit once titrated off of IV medications.  Patient continued to be noncompliant with oral medications throughout her stay requiring IV supplementation to her blood pressure regimen.  Patient was tested positive for COVID-19, family declined remdesivir and she was not requiring oxygen.  Initial repeat CT was concerning for acute CVA right caudate head lacunar infarct, question microhemorrhage.  Initial MRI was a poor study secondary to patient agitation.  Repeat studies were obtained with IV medications for anxiety/sedation.  MRI showed small attenuated acute infarcts right caudate nucleus right lateral ventricle, left temporal lobe.  Patient was started on dual antiplatelets and seen by Neurology.  MRI was obtained without large vessel occlusion or stenosis.  Patient required prolonged stay secondary to encephalopathy edema secondary to new CVAs, COVID, metabolic encephalopathy.  Renal function improved following IV fluids.  Blood pressure regimen was titrated up former she no longer required IV medications.  She was seen by PT and OT with recommendations for rehab.  Family declined wanting to take patient home.  Patient will be discharged on 21 day therapy dual antiplatelets followed by aspirin monotherapy.  Discharge was delayed secondary to holiday difficulty with coordination of home care.  Family choosing to pursue home care from primary outpatient.  Patient had dysphagia which improved prior to discharge patient was able to eat normal diet."