chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received the Fluzone quadrivalent (prefilled) instead of the Fluzone HDQ with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received the influenza quadrival A-B vaccine [fluzone quadrivalent] instead of the  influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] 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 a 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT8129JA, Expiry date: 30-Jun-2024 with unknown strength) via unknown route in unknown administration site as immunization instead of influenza quadrival A-B high dose HV vaccine with no reported adverse event (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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: 49.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: experiencing a rash after receiving yf-vax; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 49 years old female patient who experiencing a rash after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2023, the patient received a dose 0.5 ml of suspect Yellow Fever Vaccine - Solution for injection lot UJ8308C expiry date: 31-Jul-2024 via unknown route in unknown administration site for immunization.  On an unknown date the patient developed experiencing a rash after receiving yf-vax (rash) (unknown latency) following the administration of Yellow Fever Vaccine.  Reportedly, Pharmacist called in to report that one of their patients has been experiencing a rash after receiving YF-VAX. They wanted to understand the potential causes and incidence of rashes during clinical trials. They mentioned that the patient had contacted them on the night of September 27, 2023, stating that they were still experiencing the rash. She mentioned they are unsure if the patient is taking any medication for the rash.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event experiencing a rash after receiving yf-vax.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event experiencing a rash after receiving yf-vax.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received the fluzone quadrivalent np instead of the fluzone high-dose quadrivalent with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient patient received the influenza quadrival A-B vaccine [Fluzone Quadrivalent] np instead of the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] 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 suspect influenza quadrival A-B vaccine suspension for injection and influenza quadrival A-B high dose HV vaccine (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) and patient received the fluzone quadrivalent np instead of the fluzone high-dose quadrivalent with no reported adverse event (wrong product administered) (latency: same day). Information on batch number was requested.  It was unknown if any lab data/test results available  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) and quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given an extra dose of DTaP via PENTACEL administration with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient who was given an extra dose of dtap after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] And Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Pneumococcal Vaccine 13v (Pneumococcal 13 Valent Vaccine) For Prophylactic Vaccination.  On 28-Sep-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once and lot UJ8068A) (expiry date: unknown) via intramuscular route in the left thigh, also received a unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, expiry date, and lot number not reported) via unknown route in unknown administration site as immunization and given an extra dose of dtap via pentacel administration with no reported adverse event (extra dose administered) (same day latency). Information on he batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: IPV
Symptoms: Device data issue, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Data logger went out Max temperature reached: 48.2°F Low temperature reached: 40.3°F with no reported adverse event; Administered to a patient? Yes, to 26 patients with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 26 patient of unknown demographics who were administered vaccine IPV (VERO) [IPOL] which experienced data logger went out max temperature reached: 48.2°f low temperature reached: 40.3°f 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 a dose of suspect IPV (VERO) Suspension for injection dose, strength: not reported lot W1B511M expiry date: 08-sep-2025 (1 patient) Lot Number: W1A191M, Expiration Date :2025-02-16 (23 patients) Lot Number: Z1A021M, Expiration Date :2024-02-17 (2 patients) via unknown route in unknown administration site for prophylactic vaccination (immunization) and data logger went out max temperature reached: 48.2°f low temperature reached: 40.3°f with no reported adverse event (product storage error) and administered to a patient? yes, to 26 patients with no reported adverse event (poor quality product administered) on the same day.  Reportedly, She would like to know if the vaccine is still viable for use. She said that the vaccine was exposed to 13 temperature excursions from 07Sep2023 until today. She also said that the vaccine was administered to 26 different patients from 07Sep2023 until today. She currently does not have the patient list with her as it was her first day at the site. Product/s: IPOL Opened products? Yes Reason: Data logger went out Max temperature reached: 48.2°F Low temperature reached: 40.3°F Human error? No Does extended stability data cover the excursion? Administered to a patient? Yes, to 26 patients.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for 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: 69.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adacel was administered to three 65 year old and higher patients with no adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 25-Sep-2023, the patient of 69 years old received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (lot U7905AA, Expiry date: 30-Oct-2025 with unknown strength) via intramuscular route in the deltoid nos (not otherwise specified) as immunization with no adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved 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: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adacel administered to a 67 years old patient with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2023SA300988 and 2023SA300995.  This case involves a 67 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 influenza vaccine INACT SAG 3V (FLUAD), varicella zoster vaccine RGE (CHO) (SHINGRIX) and pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 25-Sep-2023, the patient received a 0.5 ml dose (once) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot U7905AA, expiry date: 03-Oct-2025, Strength; standard) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization (product administered to patient of inappropriate age) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: FLU4
Symptoms: Product distribution issue
Clinical narrative: they had administered the fluzone qiv-np tp 6 patients prior receiving the email with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced who was administered the Influenza Quadrival A-B Vaccine [Fluzone QIV] prior receiving the email 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 a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number, strength, expiry date not reported) via unknown route in unknown administration site as immunization prior receiving the email with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that vaccine was shipped on Saturday, 23-Sep-2023 and was received on Tuesday, 26-Sep-2023. The vaccines are not suitable to use due to a shipping excursion was received on 27Sep2023.   Action taken: not applicable.  At time of reporting, the outcome was 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: 56.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of tenivac that was expired for 1 day with no adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old male patient who was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine Inact Split 4v (Fluzone Quadrivalent) for Prophylactic vaccination.  On 25-Sep-2023, the patient received 0.5 ml total (1 X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) (Frequency: Once, Strength: Standard) via intramuscular route in the left arm for prophylactic vaccination (Immunisation).  On 25-Sep-2023, the patient was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day with no adverse event (expired product administered) (Latency: same day).  It was reported, HCP called to report about the administration of TENIVAC that was expired for 1 day. No adverse reaction was reported by the patient.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patients got the IPOL dose that was not viable after the temperature excursion with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 years old male patient and reporter reported that 2 patients got the IPV (Vero) [IPOL].dose that was not viable after the temperature excursion 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, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix); And Meningococcal Vaccine A/C/Y/W Conj (Crm197) (Menveo), NMR, and Varisela .  On 27-Sep-2023, the patient received a 0.5 ml dose of suspect IPV (Vero) Suspension for injection (strength: standard, frequency: once and lot W1A191M) (expiry date: 16-FEB-2025) via intramuscular route in the right deltoid as immunization and patients got the ipol dose that was not viable after the temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was 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: 0.75
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: patient got the IPOL dose that was not viable after the temperature excursion with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA303379.  This case involves a 9 months old male patient who patient got the IPV (VERO) [IPOL] dose that was not viable after the temperature excursion 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, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Immunisation.  On 27-Sep-2023, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- W1A191M and expiration date- 16-Feb-2025) via intramuscular route in the right thigh (strength: not provided) for Immunisation (poor quality product administered) (latency- same day).  Only 2 patients got the IPOL dose that was not viable after the temperature excursion.  Action taken- not applicable.  At time of reporting, the outcome was 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: 8.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse called reported that tenivac was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA301831.  This case involves a 8 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 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 HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; and POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination.  On 29-Sep-2023, the patient received 0.5 ml total (1x) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation).  On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired act-hib vaccine with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient to whom administered an expired Hib (PRP/T) Vaccine [ACT-HIB]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 Influenza Vaccine for Prophylactic vaccination.  On 29-Sep-2023, the patient received an expired dose 4 at a dose of 0.5 ml of suspect Hib (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 10-Sep-2023, lot UJ797AA) via intramuscular route in the left thigh as immunization (expired product administered) (same day latency)  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: M
Vaccine: FLUA4
Symptoms: Injection site rash
Clinical narrative: Rash at local site of injection ever since he got vaccine; This spontaneous case  was retrieved on 29-Sep-2023 from a physician via Communications (reference number: SEQW23-02821) and concerned elderly (over 65 years old), male patient.  The patient's concurrent conditions included high blood pressure and heart failure. The patient's concomitant medications included allopurinol, amlodipine, atenolol, Lipitor (atorvastatin calcium), Proscar (finasteride), and omeprazole, all used for an unreported indication.  On an unspecified date in Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as every year shot, as reported. The batch number was not reported.  On an unspecified date in Oct-2022, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced rash at a local site of injection ever since he got vaccine. The patient was treated with topical steroids like betamethasone.   The outcome of the event was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The event of vaccination site rash is assessed as possibly related to Fluad Quadrivalent due to anatomical plausibility; Sender's Comments: The event of vaccination site rash is assessed as possibly related to Fluad Quadrivalent due to anatomical plausibility
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave flublok to 17 year old when only approved for 18 years and older. No symptoms or side effects known.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Nausea
Clinical narrative: On September 30,2023, the donor reported feeling dizzy and nauseous while waiting in the donor recovery area approximately 10 minutes after receiving the rabies booster immunization.  Donor stated nausea subsided after consuming one 16-ounce Gatorade and all symptoms resolved after rest, elevating his legs and consuming a 2nd 16-ounce Gatorade. Donor left the center in good condition.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose given outside age range approved. Patient is under 65. No symptoms were reported.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: We received the childrens vaccine on 10/6/2023 when I was not at work.  I was not aware that we received the childrens vaccine.  In an effort to do the most efficient thing for our store due to being behind on all the rx ques I thought using the single dose vials would be most efficient when the most staff was one hand to use them up.  It was discovered when using the NDC for another patient that this was the children's dose due to the rx adjudicating. the patient returned and received the adult dosage according the CDC recommendations.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: Patient recieved COVID-19 and Flu shots on 10/06/2023. According to immunizer pharmacy technician, after vaccinated patient did not bleed. After a few minutes, patient presented to pharmacy counter with excessive bleeding from right arm. Patient stated that she is taking Aspirin and Clopidogrel. Patient was taken inside the immunitazion room once again and pressure was applied to the injection site until patient stopped bleeding.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo, Viral infection
Clinical narrative: On the early morning of March 16 (4 months after the vaccination), I woke up with terrible vertigo symptoms.  Through a Telemed visit, I received a prescription for meclizine.  A few days later, I went to urgent care and the doctor confirmed vertigo caused by a virus (not positional vertigo caused by crystals).  I'm not sure if this could have been a reaction to the vaccination I had in November, but I've never had vertigo before in my life.  I thought I should report it to you.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray normal, Condition aggravated, Dyspnoea, Electrocardiogram normal
Clinical narrative: no reaction to the vaccine, but patient presented to the ED on 8/2/2023 complaining of shortness of breath and flu symptoms.  At-home COVID test was positive (8/1/23). Confirmed by lab test.  O2 sats on room air 89%.  Started paxlovid 8/1/23.  Given 6mg dexamethasone and 2L O2 in ED.     Admitted to the Adult Care Unit on 8/2/23 due to exacerbation of interstitial lung disease due to COVID.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count abnormal, Influenza, Interstitial lung disease, Leukopenia, Metabolic function test normal
Clinical narrative: no reaction to the vaccine, but patient presented to the ED on 8/2/2023 complaining of shortness of breath and flu symptoms.  At-home COVID test was positive (8/1/23). Confirmed by lab test.  O2 sats on room air 89%.  Started paxlovid 8/1/23.  Given 6mg dexamethasone and 2L O2 in ED.     Admitted to the Adult Care Unit on 8/2/23 due to exacerbation of interstitial lung disease due to COVID.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Troponin normal
Clinical narrative: no reaction to the vaccine, but patient presented to the ED on 8/2/2023 complaining of shortness of breath and flu symptoms.  At-home COVID test was positive (8/1/23). Confirmed by lab test.  O2 sats on room air 89%.  Started paxlovid 8/1/23.  Given 6mg dexamethasone and 2L O2 in ED.     Admitted to the Adult Care Unit on 8/2/23 due to exacerbation of interstitial lung disease due to COVID.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: lump and pain at injection site lasting at least 3 weeks
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Pain in extremity, Underdose
Clinical narrative: I WAS ONLY ABLE TO ADMINISTER ONE-HALF OF THE DOSE OF THE FLU VACCINE. PATIENT EXPERIENCED EXTREME PAIN IN RIGHT ARM AND PULLED AWAY. PAIN EVENTUALLY SUBSIDED. I SPOKE TO PATIENT AT 4:25 PM (45 MINUTES LATER) ON PHONE AND PATIENT STATED SHE DID NOT FEEL PAIN ANYMORE.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2.5? x 5? raised, swollen, red area on upper left arm, at injection site Painful and hot to touch Low grade fever and myalgia, headache, stiff neck
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: 2.5? x 5? raised, swollen, red area on upper left arm, at injection site Painful and hot to touch Low grade fever and myalgia, headache, stiff neck
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Oropharyngeal pain
Clinical narrative: Patient noted sore throat with no fever after receiving vaccination
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Was given too high near the shoulder. Patient has pain and numbness down the arm
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, COVID-19, COVID-19 pneumonia, Cardiac failure congestive
Clinical narrative: Patient is a 88 y.o. male patient of MD with history of HTN, HLD, COPD, chronic hypoxemic respiratory failure, who presented to Hospital with SOB.   Acute CHF: Elevated troponin: Type II Demand ischemia secondary to hypoxia from COVID, MI ruled out CAD: HTN: HLD: Troponin 326 Pro-BNP 534 CXR demonstrates changes consistent with COPD and scarring involving the left costophrenic angle. IV Lasix Nitropaste Plavix, statin Heparin infusion for 48 hour  Continue home spironolactone Seen by cardiology " Patient without chest pain.  Can continue heparin gtt for 48 hrs post peak troponin.  Confirmed that patient is DNR CCA as documented in the ED admission notes. Suspect troponin type II leak from the hypoxia and COVID infection.  No additional testing needed . Continue current medical management, plavix and statin. "        COPD Chronic hypoxemic respiratory failure: COVID-19 pneumonia Low flow oxygen protocols Spiriva and Dulera Albuterol PRN Consult ID, started on remdesivir Start on dexamethasone 6 mg IV daily, received for 5 days we will discontinue at  discharge    Generalized weakness and Debilitation  PT/OT consult  DC to ECF
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Coronary artery disease, Dyspnoea
Clinical narrative: Patient is a 88 y.o. male patient of MD with history of HTN, HLD, COPD, chronic hypoxemic respiratory failure, who presented to Hospital with SOB.   Acute CHF: Elevated troponin: Type II Demand ischemia secondary to hypoxia from COVID, MI ruled out CAD: HTN: HLD: Troponin 326 Pro-BNP 534 CXR demonstrates changes consistent with COPD and scarring involving the left costophrenic angle. IV Lasix Nitropaste Plavix, statin Heparin infusion for 48 hour  Continue home spironolactone Seen by cardiology " Patient without chest pain.  Can continue heparin gtt for 48 hrs post peak troponin.  Confirmed that patient is DNR CCA as documented in the ED admission notes. Suspect troponin type II leak from the hypoxia and COVID infection.  No additional testing needed . Continue current medical management, plavix and statin. "        COPD Chronic hypoxemic respiratory failure: COVID-19 pneumonia Low flow oxygen protocols Spiriva and Dulera Albuterol PRN Consult ID, started on remdesivir Start on dexamethasone 6 mg IV daily, received for 5 days we will discontinue at  discharge    Generalized weakness and Debilitation  PT/OT consult  DC to ECF
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperlipidaemia, Hypertension, Hypoxia, Myocardial ischaemia, Prohormone brain natriuretic peptide increased
Clinical narrative: Patient is a 88 y.o. male patient of MD with history of HTN, HLD, COPD, chronic hypoxemic respiratory failure, who presented to Hospital with SOB.   Acute CHF: Elevated troponin: Type II Demand ischemia secondary to hypoxia from COVID, MI ruled out CAD: HTN: HLD: Troponin 326 Pro-BNP 534 CXR demonstrates changes consistent with COPD and scarring involving the left costophrenic angle. IV Lasix Nitropaste Plavix, statin Heparin infusion for 48 hour  Continue home spironolactone Seen by cardiology " Patient without chest pain.  Can continue heparin gtt for 48 hrs post peak troponin.  Confirmed that patient is DNR CCA as documented in the ED admission notes. Suspect troponin type II leak from the hypoxia and COVID infection.  No additional testing needed . Continue current medical management, plavix and statin. "        COPD Chronic hypoxemic respiratory failure: COVID-19 pneumonia Low flow oxygen protocols Spiriva and Dulera Albuterol PRN Consult ID, started on remdesivir Start on dexamethasone 6 mg IV daily, received for 5 days we will discontinue at  discharge    Generalized weakness and Debilitation  PT/OT consult  DC to ECF
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary fibrosis, Respiratory failure, Troponin increased
Clinical narrative: Patient is a 88 y.o. male patient of MD with history of HTN, HLD, COPD, chronic hypoxemic respiratory failure, who presented to Hospital with SOB.   Acute CHF: Elevated troponin: Type II Demand ischemia secondary to hypoxia from COVID, MI ruled out CAD: HTN: HLD: Troponin 326 Pro-BNP 534 CXR demonstrates changes consistent with COPD and scarring involving the left costophrenic angle. IV Lasix Nitropaste Plavix, statin Heparin infusion for 48 hour  Continue home spironolactone Seen by cardiology " Patient without chest pain.  Can continue heparin gtt for 48 hrs post peak troponin.  Confirmed that patient is DNR CCA as documented in the ED admission notes. Suspect troponin type II leak from the hypoxia and COVID infection.  No additional testing needed . Continue current medical management, plavix and statin. "        COPD Chronic hypoxemic respiratory failure: COVID-19 pneumonia Low flow oxygen protocols Spiriva and Dulera Albuterol PRN Consult ID, started on remdesivir Start on dexamethasone 6 mg IV daily, received for 5 days we will discontinue at  discharge    Generalized weakness and Debilitation  PT/OT consult  DC to ECF
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLUC4, VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainted, briefly lost consciousness following vaccinations.
Age: 53.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Dizziness, Hyporesponsive to stimuli, Vomiting
Clinical narrative: PATIENT WAS GIVEN FLUZONE FIRST THEN THEN ENGERIX-B , WITHIN 1 MINUTE OF ENEGERIX B INJECTION PT STATED HE WAS FEELING LIGHT HEADED . HE THEN START SHOWING SIGNS OF BECOMING UNRESPONSIVE  AT WHICH TIME EMS WAS CALLED , AFTER ABOUT 2 MINUTES  HE  WAS VERBALLY UNRESPONSIVE BUT  WAS ABLE TO MOVE EYES  WHEN TALKED TO  FOR ABOUT 30 SECONDS THEN HE VOMITED . AFTER THAT HE REAGAINED  RESPONSIVNESS , PARAMEDICS ARRIVED 4 TO 5 MINUTES AFTER  BEING CALLED . AT THAT TIME  VITALS WERE GOOD AND HE VOLUNTARILY WENT WITH PARAMEDICS TO ER.  TOTAL TIME OF THIS EVENT FROM INJECTIONS TO  LEASVING WITH PARAMEDICS  WAS ABOUT 12 MINUTES
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site redness/burning/itching - large goose egg at injection site.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Blood pH decreased, COVID-19, Cachexia, Chest X-ray abnormal
Clinical narrative: Patient is a 73 y.o. female patient of, MD with history of severe COPD steroid-dependent, hypertension,  presented to Hospital with worsening shortness of breath admitted for acute hypoxic respiratory failure secondary to COPD exacerbation and COVID.   Discharge Diagnoses:   Acute respiratory failure hypoxic and hypercapnic Severe COPD exacerbation Symptom onset x3 days (9/6/2023) positive COVID test at home and in the hospital O2 sats 84% on room air with exertion, VBG pH of 7.31 with a PCO2 of 70.8 On BiPAP at bedtime; 2 L during the day Chest x-ray: severe emphysema Started on IV Solu-Medrol 80 every 6 hours, DuoNebs, Dulera, oral Zithromax Will complete steroid taper as outpatient   Troponin above reference range Troponins increased from 140-201 with a positive delta Denies chest pain, no new EKG changes Echo: EF~60%, grade I diastolic dysfunction, no significant valvular heart disease Cardiology consulted, demand ischemia favored etiology for elevated troponin No further ischemic testing indicated at this time   Covid-19 Virus Infection ? Sepsis due to covid-19, POA Date of onset of symptoms: 9/6/2023 Symptoms present on admission: Cough, worsening shortness of breath Date of covid positive test: Home COVID test positive on 9/6 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: BiPAP/heated high flow Current oxygen requirements: BiPAP/2 L Medical therapy: steroids Prescribed Paxlovid but patient developed diarrhea, stopped taking after 1 day and does not want to continue Consultants following: Pulmonary Anticipated special isolation end date: Until symptom improved/10 days of symptom onset Empiric Lasix given to maintain dry lung strategy   Hypertension Continued lisinopril   Severe malnutrition with cachexia POA BMI of 14.7, dietary consult Nutritional supplements provided
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Cough, Diastolic dysfunction, Dyspnoea
Clinical narrative: Patient is a 73 y.o. female patient of, MD with history of severe COPD steroid-dependent, hypertension,  presented to Hospital with worsening shortness of breath admitted for acute hypoxic respiratory failure secondary to COPD exacerbation and COVID.   Discharge Diagnoses:   Acute respiratory failure hypoxic and hypercapnic Severe COPD exacerbation Symptom onset x3 days (9/6/2023) positive COVID test at home and in the hospital O2 sats 84% on room air with exertion, VBG pH of 7.31 with a PCO2 of 70.8 On BiPAP at bedtime; 2 L during the day Chest x-ray: severe emphysema Started on IV Solu-Medrol 80 every 6 hours, DuoNebs, Dulera, oral Zithromax Will complete steroid taper as outpatient   Troponin above reference range Troponins increased from 140-201 with a positive delta Denies chest pain, no new EKG changes Echo: EF~60%, grade I diastolic dysfunction, no significant valvular heart disease Cardiology consulted, demand ischemia favored etiology for elevated troponin No further ischemic testing indicated at this time   Covid-19 Virus Infection ? Sepsis due to covid-19, POA Date of onset of symptoms: 9/6/2023 Symptoms present on admission: Cough, worsening shortness of breath Date of covid positive test: Home COVID test positive on 9/6 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: BiPAP/heated high flow Current oxygen requirements: BiPAP/2 L Medical therapy: steroids Prescribed Paxlovid but patient developed diarrhea, stopped taking after 1 day and does not want to continue Consultants following: Pulmonary Anticipated special isolation end date: Until symptom improved/10 days of symptom onset Empiric Lasix given to maintain dry lung strategy   Hypertension Continued lisinopril   Severe malnutrition with cachexia POA BMI of 14.7, dietary consult Nutritional supplements provided
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram normal, Emphysema, Malnutrition
Clinical narrative: Patient is a 73 y.o. female patient of, MD with history of severe COPD steroid-dependent, hypertension,  presented to Hospital with worsening shortness of breath admitted for acute hypoxic respiratory failure secondary to COPD exacerbation and COVID.   Discharge Diagnoses:   Acute respiratory failure hypoxic and hypercapnic Severe COPD exacerbation Symptom onset x3 days (9/6/2023) positive COVID test at home and in the hospital O2 sats 84% on room air with exertion, VBG pH of 7.31 with a PCO2 of 70.8 On BiPAP at bedtime; 2 L during the day Chest x-ray: severe emphysema Started on IV Solu-Medrol 80 every 6 hours, DuoNebs, Dulera, oral Zithromax Will complete steroid taper as outpatient   Troponin above reference range Troponins increased from 140-201 with a positive delta Denies chest pain, no new EKG changes Echo: EF~60%, grade I diastolic dysfunction, no significant valvular heart disease Cardiology consulted, demand ischemia favored etiology for elevated troponin No further ischemic testing indicated at this time   Covid-19 Virus Infection ? Sepsis due to covid-19, POA Date of onset of symptoms: 9/6/2023 Symptoms present on admission: Cough, worsening shortness of breath Date of covid positive test: Home COVID test positive on 9/6 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: BiPAP/heated high flow Current oxygen requirements: BiPAP/2 L Medical therapy: steroids Prescribed Paxlovid but patient developed diarrhea, stopped taking after 1 day and does not want to continue Consultants following: Pulmonary Anticipated special isolation end date: Until symptom improved/10 days of symptom onset Empiric Lasix given to maintain dry lung strategy   Hypertension Continued lisinopril   Severe malnutrition with cachexia POA BMI of 14.7, dietary consult Nutritional supplements provided
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myocardial ischaemia, PCO2 increased, Positive airway pressure therapy, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Patient is a 73 y.o. female patient of, MD with history of severe COPD steroid-dependent, hypertension,  presented to Hospital with worsening shortness of breath admitted for acute hypoxic respiratory failure secondary to COPD exacerbation and COVID.   Discharge Diagnoses:   Acute respiratory failure hypoxic and hypercapnic Severe COPD exacerbation Symptom onset x3 days (9/6/2023) positive COVID test at home and in the hospital O2 sats 84% on room air with exertion, VBG pH of 7.31 with a PCO2 of 70.8 On BiPAP at bedtime; 2 L during the day Chest x-ray: severe emphysema Started on IV Solu-Medrol 80 every 6 hours, DuoNebs, Dulera, oral Zithromax Will complete steroid taper as outpatient   Troponin above reference range Troponins increased from 140-201 with a positive delta Denies chest pain, no new EKG changes Echo: EF~60%, grade I diastolic dysfunction, no significant valvular heart disease Cardiology consulted, demand ischemia favored etiology for elevated troponin No further ischemic testing indicated at this time   Covid-19 Virus Infection ? Sepsis due to covid-19, POA Date of onset of symptoms: 9/6/2023 Symptoms present on admission: Cough, worsening shortness of breath Date of covid positive test: Home COVID test positive on 9/6 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: BiPAP/heated high flow Current oxygen requirements: BiPAP/2 L Medical therapy: steroids Prescribed Paxlovid but patient developed diarrhea, stopped taking after 1 day and does not want to continue Consultants following: Pulmonary Anticipated special isolation end date: Until symptom improved/10 days of symptom onset Empiric Lasix given to maintain dry lung strategy   Hypertension Continued lisinopril   Severe malnutrition with cachexia POA BMI of 14.7, dietary consult Nutritional supplements provided