chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Vaccine coadministration
Clinical narrative: patient received PENTACEL and VAXELIS at the same time with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (MENIGOCOCCAL PROTEIN), Pertussis vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus vaccine Toxoid (VAXELIS) at the same time 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 Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus Vaccine Toxoid (Vaxelis) and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) both for Prophylactic vaccination.  On 19-Jul-2023, the patient received 0.5ml dose (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ842AA and expiry: 22-Feb-2024 via intramuscular route in the right vastus lateralis for immunization and at the same time the patient received Vaxelis with no reported adverse event (vaccine coadministration) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccine coadministration.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: accidentally left the refrigerator door open too long due to Human error, 3 separate excursions with the same vaccine Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; administered to the patient post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old female patient who received the vaccine IPV (VERO) [IPOL] from the refrigerator, of which the door open too long due to human error, 3 separate excursions with the same vaccine total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes and administered to the patient post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Jun-2023, accidentally left the refrigerator door open too long due to human error, 3 separate excursions with the same vaccine IPV (VERO) and total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) and the vaccine IPV (VERO) administered at a dose of 0.5 ml (Frequency = Once) of standard strength suspension for injection with (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization to the patient post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
Age: 0.92
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: IPOL (opened) exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: Yes, with no reported adverse event; IPOL (opened) exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 months old female patient who was administered IPV (VERO) [IPOL] (opened), which was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jul-2023, the patient received 0.5 ml dose of suspect IPV (VERO) (frequency: once; strength: standard) Suspension for injection of lot V1A021M and expiry: 27-Feb-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, it was reported that the suspect IPV (VERO) (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event (product storage error) (unknown latency).  On 11-Jul-2023, the patient was administered IPV (VERO) (opened) exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality product administered.   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.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient receiving a dose of YF-VAX which was inadvertently reconstituted with sterile water with no adverse event; dose was repeated on the same day reconstituting with proper diluent as patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient who was administered Yellow Fever vaccine - US [YF-VAX] which was inadvertently reconstituted with sterile water and dose was repeated on the same day reconstituting with proper diluent as patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Chronic back pain.  Concomitant vaccine included Hepatitis A vaccine for Prophylactic vaccination.  On 22-Jul-2023, the patient received a 0.5ml dose of suspect Yellow Fever vaccine - Solution for injection; expiry: 09-Aug-2023 (lot number: not reported) via subcutaneous route in the left arm for immunization, which was inadvertently reconstituted with sterile water with no reported adverse event (product preparation error) (Latency: Same day) and then on the same day, 0.5 ml dose of the same vaccine with an unknown batch number and expiry date via subcutaneous route in the left arm for immunization, was repeated reconstituting with proper diluent as the patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no reported adverse event (off label use) (Latency: Same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error and off label use.   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.
Age: 76.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired TENIVAC to a patient with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 76 years old and unknown gender patient who was administered an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jul-2023, the patient received 0.5 mL dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (batch number: U7092AA; Expiry date: 24-Jun-2023) via unknown route in unknown administration site for Immunization, with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired tenivac to a patient with no reported adverse event.  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:  US-SA-2023SA228200:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a vaccine that was expired with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves an unknown age and unknown gender patient who was administered a vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date, lot number: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient was administered a vaccine that was expired with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was unknown if nay lab data/tests available.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown for the event.  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.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: warmth at the site of injection; small red dot at the site of injection, patient presented to clinic with redness the size of "cupping hand in the shape of a C"; soreness at the site after vaccination; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old female patient who experienced warmth at the site of injection, soreness at the site after vaccination and small red dot at the site of injection, patient presented to clinic with redness the size of "cupping hand in the shape of a c" after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s) and family history were not provided. List concomitant or "no other vaccines": NO OTHER VACCINES.    On 20-Jul-2023, the patient received 1 ML (Milliliter) dose of suspect RABIES (HDC) VACCINE (Powder and solvent for suspension for injection) (1ST Dose in series) (Frequency: once), (Strength: Standard) (lot V1D643M and expiry date: 06-Sep-2024) via intramuscular route in the right arm for Immunization pre-exposure (Immunization).  On 20-Jul-2023, the patient developed soreness at the site after vaccination (vaccination site pain) (Latency: same day) following the administration of RABIES (HDC) VACCINE.  On 21-Jul-2023, the patient developed warmth at the site of injection (vaccination site warmth) and on Friday small red dot at the site of injection and in the afternoon patient presented to clinic with redness the size of "cupping hand in the shape of a c" (vaccination site erythema) 1 day following the administration of RABIES (HDC) VACCINE.  No further information provided by the reporter.   Action taken: Not applicable.  The patient was prescribed Cetirizine 10mg oral daily for 30 days and Cephalexin 500mg one capsule oral 4 times daily for 7 days. Caller also reporting patient was given instructions to use Benadryl OTC, caller unsure if topical or oral or dosage, also Pepcid OTC for Vaccination site erythema, Vaccination site warmth and Vaccination site pain.  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: IPV
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was not prescribed IPOL but was prescribed TB skin test and received IPOL in error with no reported adverse event; IPOL was administered intradermally in error with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and demographics who was not prescribed IPV (VERO) [IPOL] but was prescribed tb skin test and received IPOL in error with no reported adverse event and IPOL was administered intradermally in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (strength, lot number and expiry: not reported) via intradermal route in unknown administration site as prophylactic vaccination (immunization); but the patient was not prescribed IPOL but was prescribed tb skin test and received IPOL which was administered intradermally in error with no reported adverse event (wrong product administered) (incorrect route of product administration) (latency: same day) following the administration of IPV (VERO). Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events wrong product administered and incorrect route of product administration.  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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Gait disturbance, Intervertebral disc protrusion, Muscular weakness, Paraesthesia
Clinical narrative: Presents with a 2 week history of worsening left lower extremity paresthesias and weakness with increasing difficulty ambulating; admitted for lumbar disc herniation with discussion of potential surgery; preprocedure COVID-19 swab positive; pt w/o symptoms.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presents with a 2 week history of worsening left lower extremity paresthesias and weakness with increasing difficulty ambulating; admitted for lumbar disc herniation with discussion of potential surgery; preprocedure COVID-19 swab positive; pt w/o symptoms.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dialysis, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID-19 at the nursing home and brought to hospital for dialysis.  Remained asymptomatic and on room air from COVID.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Death, Intensive care
Clinical narrative: Admitted for septic shock; treated in the ICU for acute respiratory failure due to aspiration pneumonia and  COPD exacerbation; Patient also was diagnosed with COVID-19; tx w/abx & steroids; despite treatment, prognosis remained poor; family opted for comfort care & pt expired 1/16.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia aspiration, Septic shock
Clinical narrative: Admitted for septic shock; treated in the ICU for acute respiratory failure due to aspiration pneumonia and  COPD exacerbation; Patient also was diagnosed with COVID-19; tx w/abx & steroids; despite treatment, prognosis remained poor; family opted for comfort care & pt expired 1/16.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Presented with c/o fever, chills, shortness of breath along with cough and chest congestion.  Patient tested positive for COVID-19. Tx w/steroids, zinc, VitC; did not require O2. Dc'd home.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Presented with c/o fever, chills, shortness of breath along with cough and chest congestion.  Patient tested positive for COVID-19. Tx w/steroids, zinc, VitC; did not require O2. Dc'd home.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Presented to the emergency room via EMS from a group home with complaints mental status change. Admitted for appendicitis and COVID-19 infection; Tx w/remdesivir & zinc; did not require O2. Discharged by to group home where pt is resident.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Encephalopathy, Endotracheal intubation, Gastrostomy, Hypercalcaemia of malignancy
Clinical narrative: Admitted for COVID pneumonia, bacterial pneumonia, acute encephalopathy, hypoxic respiratory failure and hypercalcemia due to malignancy; tx w/abx, steroids, O2 (required intubation); PEG tube placed for failed ST; Dc'd to rehab.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia bacterial, Respiratory failure
Clinical narrative: Admitted for COVID pneumonia, bacterial pneumonia, acute encephalopathy, hypoxic respiratory failure and hypercalcemia due to malignancy; tx w/abx, steroids, O2 (required intubation); PEG tube placed for failed ST; Dc'd to rehab.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia
Clinical narrative: Presented with cough, shortness breath, malaise.  Tested positive for COVID19 outpatient, was started on Z-Pak and steroids by her PCP with no improvement in symptoms.  She presented to the ER, found to be hypoxic, chest x-ray showed patchy infiltrates, COVID19 positive. Tx w/steroids, remdesivir, O2, zinc; weaned off O2 for DC home.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lung infiltration, Malaise, SARS-CoV-2 test positive
Clinical narrative: Presented with cough, shortness breath, malaise.  Tested positive for COVID19 outpatient, was started on Z-Pak and steroids by her PCP with no improvement in symptoms.  She presented to the ER, found to be hypoxic, chest x-ray showed patchy infiltrates, COVID19 positive. Tx w/steroids, remdesivir, O2, zinc; weaned off O2 for DC home.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling
Clinical narrative: anaphylaxis; throat closes
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, UNK, UNK, DTPPVHBHPB, UNK, UNK
Symptoms: Erythema, Pyrexia
Clinical narrative: fever persisting for 5 days; red spots on skin appeared 48 hours after receiving vaccines. (not sure if either symptom is related to vaccines)
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Patient started having difficulty breathing, rapid heart rate, dizziness, headache, and fatigue about 20 minutes after injection.  Patient was monitored, antihistamine was given and patient recovered.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered
Clinical narrative: Pentacel not reconstituted resulting in patient only receiving DTaP/IPV component of vaccine and no Hib.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiogenic shock, Hypoxia
Clinical narrative: HYPOXIA CARDIOGENIC SHOCK
Age: 88.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Reports right shoulder pain since the Twinrix vaccine on 7/12/23.  Reports mild pain at 2/10 that comes and goes.  Able to do his normal activities.  Denies any fever, redness, warmth or any other issues.  Reports he had never had shoulder pain last this long after a vaccine so wanted to let provider know.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paresis
Clinical narrative: LEFT BELLS PALSY RIGHT FACIAL MUSCLE WEAKNESS
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Pt came in for initial dose and was administered an expired vaccine. No adverse reaction, just trying to follow up with documentation from clinic for system record to be accurate.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid breakthrough Infection
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Polyneuropathy
Clinical narrative: DRUG INDUCED POLYNEUROPATHY
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Arthralgia, Blood test normal, Contusion, Facial wasting
Clinical narrative: Extreme fatigue, fewer periods and shorter periods, insomnia, joint paint, joint swelling, joint abscesses, facial fat loss, muscle soreness. Extreme swelling at the site of bruises, bug bites, and longer recovery times. Receding hairline yet more facial hair.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Hair growth abnormal, Insomnia, Joint abscess, Joint swelling
Clinical narrative: Extreme fatigue, fewer periods and shorter periods, insomnia, joint paint, joint swelling, joint abscesses, facial fat loss, muscle soreness. Extreme swelling at the site of bruises, bug bites, and longer recovery times. Receding hairline yet more facial hair.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation irregular, Muscle atrophy, Swelling, Urine analysis normal
Clinical narrative: Extreme fatigue, fewer periods and shorter periods, insomnia, joint paint, joint swelling, joint abscesses, facial fat loss, muscle soreness. Extreme swelling at the site of bruises, bug bites, and longer recovery times. Receding hairline yet more facial hair.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immunisation reaction, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came in to receive the vaccines above on 07/24/2023. The next day patient started experiencing pain, redness, and mild heat in her left lateral thigh . Patient was seen by PA for the vaccine reaction on 07/26/2023. PA counseled the mother about the reaction. Patient was prescribed benadryl allergy liquid, and ibuprofen. And to follow up if the reaction spreads or symptoms get worse.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypoxia, Myocardial ischaemia, Respiratory failure, Symptom recurrence
Clinical narrative: DEMAND ISCHEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/9/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: SHOT WAS GIVEN 2 DAYS AFTER THE BEYOND USE DATE. THE DEYOND USE DATE W 11/22/2022. WE HAVE CONTACTED PFIZER.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 10/3/2022,  10/15/2022,  11/11/2022,  2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: administered Monovalent vaccine after the recall of this vaccine on 04/18/2023
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray, Chest pain, Dehydration, Dizziness, Dysgeusia
Clinical narrative: Following day,  had metallic taste in mouth, headache, extreme nausea, light headed, heart palpitations, chest pain
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Electrocardiogram, Essential hypertension, Headache, Hypotension, Laboratory test
Clinical narrative: Following day,  had metallic taste in mouth, headache, extreme nausea, light headed, heart palpitations, chest pain
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Palpitations
Clinical narrative: Following day,  had metallic taste in mouth, headache, extreme nausea, light headed, heart palpitations, chest pain
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE MI 9/18/2022,  9/20/2022,  11/11/2022,  2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: administered Monovalent vaccine after the recall of this vaccine on  04/18/2023. Pt did not report any symptoms
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Administered primary series dose vaccine to patient. No adverse event noted at time of injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19 pneumonia, Confusional state, Dyspnoea, Lethargy
Clinical narrative: Patient was seen at the local ER for c/o abdominal pain, fever, nausea, generalized body aches, SOB, lethargy and confusion.  Dx of Covid Pneumonia.  Patient was stable throughout admission and was discharged home on 7-29-23 to follow up with primary physician within 7-10 days.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Patient was seen at the local ER for c/o abdominal pain, fever, nausea, generalized body aches, SOB, lethargy and confusion.  Dx of Covid Pneumonia.  Patient was stable throughout admission and was discharged home on 7-29-23 to follow up with primary physician within 7-10 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Erythema, Fatigue, Influenza like illness
Clinical narrative: He got his vaccine, the first day was fine other than arm soreness.  That evening he started feeling almost like flu-type symptoms with light chills, felt like he had a fever, discomfort.  He wasn't nauseated.  Probably Sunday he took a shower and he noticed that he had a rash under his arms on both sides, going down his chest on both sides.  It was a fine rash.  Then the next stage he had big hives around his back, belt line/kidney area.  Then his hands started having rashes, palms of his hands and the wrists.  Then he dealt with this with over the counter medicines Allegra for hives and rash which helped a little bit.  He was taking it as directed, and then took it every 12 hours and it cooled it off a little bit. Last sunday he went to the Clinic, and he was given Prednisone, tapering dose starting with 4.  When he took the big dose the 4 tablets and it calmed it down a bit, and then with the tapering it would not go away it stayed with him, and actually got worse.  So he then had an APT with his PCP this past Thursday, 7/27/23 for his regular check up, and the first thing he did was took his shirt off and showed him that he had a reaction from the vaccine.  His opinion was that he got into some chemicals and he told him that was not it.  He gave him another pack of Medrol dose pack and Saturday night he slept about 2 hours as he was red rashy.  His top lip started swelling on Friday.  He had hives on the back of his neck, down  his legs to his ankles, his torso, around his private parts and was itching like crazy and was more red than white.  On Sunday he would wet himself down and had a rash with Epsom salts which did calm the itch down, but it is receeding.  He is still blotchy, still itching, but not as red as he was on Saturday or Sunday.  He was told to go back to his doctor in 10 days.  He has an appointment with his dermatologist on 8/8/23.    He has never had a reaction to any type of vaccine, COVID or flu vaccines.  He had had COVID before the vaccines were out and was in the hospital for about 3 days of that, and had gone through that and was given stuff to bring him back as he was tired, but then got the vaccines 3 of them, and had no reactions to those.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: He got his vaccine, the first day was fine other than arm soreness.  That evening he started feeling almost like flu-type symptoms with light chills, felt like he had a fever, discomfort.  He wasn't nauseated.  Probably Sunday he took a shower and he noticed that he had a rash under his arms on both sides, going down his chest on both sides.  It was a fine rash.  Then the next stage he had big hives around his back, belt line/kidney area.  Then his hands started having rashes, palms of his hands and the wrists.  Then he dealt with this with over the counter medicines Allegra for hives and rash which helped a little bit.  He was taking it as directed, and then took it every 12 hours and it cooled it off a little bit. Last sunday he went to the Clinic, and he was given Prednisone, tapering dose starting with 4.  When he took the big dose the 4 tablets and it calmed it down a bit, and then with the tapering it would not go away it stayed with him, and actually got worse.  So he then had an APT with his PCP this past Thursday, 7/27/23 for his regular check up, and the first thing he did was took his shirt off and showed him that he had a reaction from the vaccine.  His opinion was that he got into some chemicals and he told him that was not it.  He gave him another pack of Medrol dose pack and Saturday night he slept about 2 hours as he was red rashy.  His top lip started swelling on Friday.  He had hives on the back of his neck, down  his legs to his ankles, his torso, around his private parts and was itching like crazy and was more red than white.  On Sunday he would wet himself down and had a rash with Epsom salts which did calm the itch down, but it is receeding.  He is still blotchy, still itching, but not as red as he was on Saturday or Sunday.  He was told to go back to his doctor in 10 days.  He has an appointment with his dermatologist on 8/8/23.    He has never had a reaction to any type of vaccine, COVID or flu vaccines.  He had had COVID before the vaccines were out and was in the hospital for about 3 days of that, and had gone through that and was given stuff to bring him back as he was tired, but then got the vaccines 3 of them, and had no reactions to those.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: He got his vaccine, the first day was fine other than arm soreness.  That evening he started feeling almost like flu-type symptoms with light chills, felt like he had a fever, discomfort.  He wasn't nauseated.  Probably Sunday he took a shower and he noticed that he had a rash under his arms on both sides, going down his chest on both sides.  It was a fine rash.  Then the next stage he had big hives around his back, belt line/kidney area.  Then his hands started having rashes, palms of his hands and the wrists.  Then he dealt with this with over the counter medicines Allegra for hives and rash which helped a little bit.  He was taking it as directed, and then took it every 12 hours and it cooled it off a little bit. Last sunday he went to the Clinic, and he was given Prednisone, tapering dose starting with 4.  When he took the big dose the 4 tablets and it calmed it down a bit, and then with the tapering it would not go away it stayed with him, and actually got worse.  So he then had an APT with his PCP this past Thursday, 7/27/23 for his regular check up, and the first thing he did was took his shirt off and showed him that he had a reaction from the vaccine.  His opinion was that he got into some chemicals and he told him that was not it.  He gave him another pack of Medrol dose pack and Saturday night he slept about 2 hours as he was red rashy.  His top lip started swelling on Friday.  He had hives on the back of his neck, down  his legs to his ankles, his torso, around his private parts and was itching like crazy and was more red than white.  On Sunday he would wet himself down and had a rash with Epsom salts which did calm the itch down, but it is receeding.  He is still blotchy, still itching, but not as red as he was on Saturday or Sunday.  He was told to go back to his doctor in 10 days.  He has an appointment with his dermatologist on 8/8/23.    He has never had a reaction to any type of vaccine, COVID or flu vaccines.  He had had COVID before the vaccines were out and was in the hospital for about 3 days of that, and had gone through that and was given stuff to bring him back as he was tired, but then got the vaccines 3 of them, and had no reactions to those.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Administered primary series vaccine. No adverse events noted at the time.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Swelling, Swelling face
Clinical narrative: Swollen arm, neck and face on left side. More pronounced 2 days after vaccine.  2 weeks later, still swollen, but not as noticeable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/23/2023 ACUTE EXACERBATION OF COPD
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, INFERIOR WALL
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: 2 days after receiving the Shingrix, the patient developed an itchy rash to the back of her neck. since that time, she has continued to have itchy rashes to her neck, arms, legs, buttocks. these last about 4 days.   Oral steroids initially seemed to help but the rash recurred. of note, her father had rash with Shingrix.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Lightheaded, pale and weak. Brought pt back to room layed him down. Once he could sit up  gave him juice. Mom was able to take him home.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Skin discolouration
Clinical narrative: Me and my husband are have light patches forming on our skin. Like early stage of Vitiligo.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE RESPIRATORY FAILURE HYPOXIA
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA HYPOTENSION
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: After vaccine was administered, it was later discovered that the medication had been out of the deep freezer for longer than the recommended 70 days, even though it was not past it's expiration date. Pzifer ultimately determined that it should be considered not a valid dose since it was out of the deep freezer for longer than the recommended period of time.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site mass, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Pt here with concerns about leg pain. Had bexsero immunization on 7/20/23. Did get this in her left thigh (per her request). States can't remember if it was the same day or the day after but wanted to go out but felt lightheaded and just didn't feel well. Did also have a little fever and had left thigh pain. Did lay in bed the next day. 2 days later, got an itchy rash to the back side of her left leg - started on calf but also reports rash was on the same place on the right side. Did use an OTC cream and that made it better. Rash only lasted a day. Leg continues to hurt and still has a lump where the shot was given. Admits she has been working out quite a bit - lifting/running/ect.. Doesn't think it has gotten any better. Has taken some ibuprofen - usually before bed because she lays on her stomach.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt here with concerns about leg pain. Had bexsero immunization on 7/20/23. Did get this in her left thigh (per her request). States can't remember if it was the same day or the day after but wanted to go out but felt lightheaded and just didn't feel well. Did also have a little fever and had left thigh pain. Did lay in bed the next day. 2 days later, got an itchy rash to the back side of her left leg - started on calf but also reports rash was on the same place on the right side. Did use an OTC cream and that made it better. Rash only lasted a day. Leg continues to hurt and still has a lump where the shot was given. Admits she has been working out quite a bit - lifting/running/ect.. Doesn't think it has gotten any better. Has taken some ibuprofen - usually before bed because she lays on her stomach.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired: 07/13/2023 Administered an expired vaccine to the patient on 7/31/23. No reactions at this time but was just given this morning. Will monitor the patient. Merck has data showing extended potency and does not recommend re-vaccinating the child.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This vaccine was given too early.  The child is age 14. This should be given at age 16.   Spoke with mother, and the child had  no reaction, or injury.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: After all 3 shots were given and bandaids were being applied the patient turned white and got light headed.   I grabbed him and laid him down on the table.   Dr came in and checked on him.   We had patient lay there for awhile then he sat up for awhile on the table.   When he felt better he walked to the chair in the room and sat down for the rest of the 20 minutes.    Patient was able to walk out on his own with dad.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 0.17
Sex: F
Vaccine: HPV9, PNC15, RV5
Symptoms: Wrong product administered
Clinical narrative: Patient was given HPV instead of Vaxelis
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Hypotension
Clinical narrative: HYPOTENSION 4/17/2023 HTN (HYPERTENSION)
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Full blood count abnormal, Neutropenia, Neutrophil count decreased
Clinical narrative: found to have neutropenia with an ANC of 470 on CBC obtained 7/26/23 during work up for icterus- baby doing well and asymptomatic as of today
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 11/8/2022,  1/15/2023,  1/7/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given past BUD
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given past BUD
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Cocid Breakthrough Infection
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given past BUD
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given past BUD
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Deep vein thrombosis, Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE DVT, UNSPECIFIED VEIN 2/1/2023 &  3/13/2023  -- PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness and immediate vomiting .
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer COVID Vaccine was not diluted prior to administration. 0.2ml of undiluted vaccine was administered. No reaction/side effects as of 07/28.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: After receiving the vaccine as patient stood up and got ready to leave clinic became dizzy, clammy to touch / pale, and nauseous. Patient was sat down in chair with feet elevated, a cool cloth was given for neck and forehead, and after nausea passed  a snack was given. After a minute are two patients color returned to patient's face was alert and oriented and was able to leave clinic.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.