chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number FA53D, expiry date 11th February 2024) for prophylaxis.   On 3rd February 2023, the patient received the 2nd dose of Shingrix. On 3rd February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient only received the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Patient received an expired dose; Administered a 2nd dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27G, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix  (received 1st dose on an unknown date).   On 2nd February 2023, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and extra dose administered. On an unknown date, the outcome of the expired vaccine used and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Feb-2023 and 6-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Kinrix in right arm after expiration date in order to complete the Dtap-ipv series, which led to expired vaccine used and extra dose administered.
Age: 60.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 3rd February 2023, the patient received Havrix. On 3rd February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up via postal mail. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Havrix. On 31st January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 77-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The caller consented to follow-up from safety. The caller consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo administered with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The patient was administered Menveo by another health care professional. The caller did not had any additional information regarding the patient.  The reporter did not consent to follow-up. Additional supportive information: The patient was administered Menveo powder component after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received the booster dose instead of the primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the booster dose instead of the primary dose) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 03-Feb-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (patient received the booster dose instead of the primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received the booster dose instead of the primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received the booster dose instead of the primary dose).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:2nd recipient.     On 07-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs).    No concomitant and treatment medication were reported. Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs. It was drawn up in a syringe 06Feb2023 & administered on 07Feb2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-709077 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709077:JC DOB- 3-MAR-1964
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACT-HIB that expired on 26-OCT-2022 with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that expired on 26-oct-2022 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; and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination.  On 20-Dec-2022, the patient was administered 0.5 mL of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (1X; batch/lot number: UJ594AAA; strength, dose: unknown) via intramuscular route in the left deltoid for immunization that expired on 26-oct-2022 (expired 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 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.; Sender's Comments:  01481406: 01481498: 01481505: 01481508:
Age: 49.0
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: administered a fluzone quadrivalent injection to a patient who has already had a influenza shot this season on 22dec2022 with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old and unknown gender patient to whom administered a INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] injection who has already had a influenza shot this season on 22dec2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 07-Feb-2023, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE(strength, formulation was unknown, lot UT7680NA via intramuscular route in the right deltoid for Immunization.  On 07-Feb-2023 the patient developed a non-serious event of administered a fluzone quadrivalent injection to a patient who has already had a influenza shot this season on 22dec2022 with no reported adverse event (inappropriate schedule of product administration, Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with 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: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2023, the patient was vaccinated with PROQUAD subcutaneous injection, 0.5 milliliter, lot #W028564, expiration date: 06-MAR-2024, administered for prophylaxis (strength and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vx don´t work, know from experience/suspected vaccination failure; Vx don´t work, know from experience; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the vaccine did not work and reported he/she knew from experience. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: ACTHIB was administered via the subcutaneous route instead of the recommended intramuscular route with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 year old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] was administered via the subcutaneous route instead of the recommended intramuscular route 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 a vaccine inact (Vaqta); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Immunisation.  On 07-Feb-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (with unknown lot number and expiry date) via subcutaneous route instead of the recommended intramuscular route in back of right arm with no reported adverse event (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib was administered via the subcutaneous route instead of the recommended intramuscular route 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 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 08/03 Janssen, dose #1 08/11 pt cc: cough, chills, fatigue, headache, loss of taste or smell, myalgias, rhinorrhea, nausea exposure: unknown 08/13 COVID swab, result: detected 08/13 SARS-COV-2 LINEAGE B.1.617.2 08/13 SARS-COV-2 CLADE 21A DELTA
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Rhinorrhoea
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 08/03 Janssen, dose #1 08/11 pt cc: cough, chills, fatigue, headache, loss of taste or smell, myalgias, rhinorrhea, nausea exposure: unknown 08/13 COVID swab, result: detected 08/13 SARS-COV-2 LINEAGE B.1.617.2 08/13 SARS-COV-2 CLADE 21A DELTA
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 08/03 Janssen, dose #1 08/11 pt cc: cough, chills, fatigue, headache, loss of taste or smell, myalgias, rhinorrhea, nausea exposure: unknown 08/13 COVID swab, result: detected 08/13 SARS-COV-2 LINEAGE B.1.617.2 08/13 SARS-COV-2 CLADE 21A DELTA
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: fatigue, pain at injection site Narrative:
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received the first dose with dose with Engerix-B pediatric volume; received the first dose with dose with Engerix-B pediatric volume; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 30-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comments: The pharmacist asked for information on Engerix B, an adult patient received the first dose with dose with Engerix-B pediatric volume in instead of an adult, should the patient receive another additional dose to complete the first or restart the schedule. No more information provided. The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B pediatric instead of Engerix B adult, which led to underdose and adult use of a child product.   Follow-up information received on 23-JAN-2023. Reporter's Comments: At the time of reporting, the reporter was asked two times from where he was calling from, but he refused to answer and directly answered the inquiry and ignored the  question.  Summary of Changes: Country of occurrence, reporters country, product details and narrative updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Got COVID despite being vaccinated.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Contracted COVID despite being vaccinated
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Came down with COVID even though vaccinated.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: COVID
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Second covid booster shot (unsure of manufacturer) given in left arm. Localized redness, swelling, pain and itchiness.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/5/21, 4/26/21, 12/3/21. Positive on 2/10/23
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/17/21, 4/7/21. Positive on 2/9/23. (pos.)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/26/21, 4/16/21, 10/19/21, 10/5/22. Positive on 2/12/2023
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/9/21, 3/9/21. Positive on 2/10/2023
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Bacterial test positive, Blood glucose normal, Brain natriuretic peptide normal, Chest X-ray normal
Clinical narrative: Events are described by patient and her husband at time or emergency room evaluation on the day following injection. Patient described malaise and hot flushes 3 hours following immunization.  On awakening the following morning she experienced and episode of dizziness and weakness requiring holding on to the kitchen counter.  At this time her husband observed her to have diaphoresis and chills.  The husband helped the patient back to her bed and assister her to lie down to recover.  Symptoms improved within several minutes and the husband then assisted the patient to the car and drove to the emergency room for evaluation.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Dizziness, Electrocardiogram normal, Haematocrit normal, Hot flush
Clinical narrative: Events are described by patient and her husband at time or emergency room evaluation on the day following injection. Patient described malaise and hot flushes 3 hours following immunization.  On awakening the following morning she experienced and episode of dizziness and weakness requiring holding on to the kitchen counter.  At this time her husband observed her to have diaphoresis and chills.  The husband helped the patient back to her bed and assister her to lie down to recover.  Symptoms improved within several minutes and the husband then assisted the patient to the car and drove to the emergency room for evaluation.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Hyperhidrosis, Laboratory test, Malaise, Troponin normal, Urinary tract infection
Clinical narrative: Events are described by patient and her husband at time or emergency room evaluation on the day following injection. Patient described malaise and hot flushes 3 hours following immunization.  On awakening the following morning she experienced and episode of dizziness and weakness requiring holding on to the kitchen counter.  At this time her husband observed her to have diaphoresis and chills.  The husband helped the patient back to her bed and assister her to lie down to recover.  Symptoms improved within several minutes and the husband then assisted the patient to the car and drove to the emergency room for evaluation.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Urine analysis abnormal
Clinical narrative: Events are described by patient and her husband at time or emergency room evaluation on the day following injection. Patient described malaise and hot flushes 3 hours following immunization.  On awakening the following morning she experienced and episode of dizziness and weakness requiring holding on to the kitchen counter.  At this time her husband observed her to have diaphoresis and chills.  The husband helped the patient back to her bed and assister her to lie down to recover.  Symptoms improved within several minutes and the husband then assisted the patient to the car and drove to the emergency room for evaluation.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Conjunctivitis, Ear pain, Eye discharge, Migraine
Clinical narrative: I was having conjunctivitis in eye and that started getting worse. By the 7th I had a sore throat with white pullups in the back of my throat, my ears were hurting, and I was nauseated. I could not lift my head up and get out of bed because how bad the migraine was, and I have to rinse my eyes out and get them cleared out to be able to open them as well. My grandson has acute bronchitis, and I was worried that I may have gotten that, but I also took a COVID-19 home test even though I had just had COVID-19 in December but it was negative. I was put on an eye drop for the issue in my eye but since things have not really gotten better, I am going to go back to my doctor as well.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Nausea, Oropharyngeal blistering, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: I was having conjunctivitis in eye and that started getting worse. By the 7th I had a sore throat with white pullups in the back of my throat, my ears were hurting, and I was nauseated. I could not lift my head up and get out of bed because how bad the migraine was, and I have to rinse my eyes out and get them cleared out to be able to open them as well. My grandson has acute bronchitis, and I was worried that I may have gotten that, but I also took a COVID-19 home test even though I had just had COVID-19 in December but it was negative. I was put on an eye drop for the issue in my eye but since things have not really gotten better, I am going to go back to my doctor as well.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Blood magnesium, Breast cancer female, Chemotherapy, Full blood count
Clinical narrative: Received Both doses of the Pfizer Covid vaccine. 4/16/21 and 5/14/21 (lot: EW0169) Then in December I was diagnosed with Breast Cancer.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Infusion, Mammogram, Mastectomy, Metabolic function test, Radiotherapy
Clinical narrative: Received Both doses of the Pfizer Covid vaccine. 4/16/21 and 5/14/21 (lot: EW0169) Then in December I was diagnosed with Breast Cancer.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast
Clinical narrative: Received Both doses of the Pfizer Covid vaccine. 4/16/21 and 5/14/21 (lot: EW0169) Then in December I was diagnosed with Breast Cancer.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyarrhythmia, COVID-19, Cardiac arrest, Death, Dyspnoea
Clinical narrative: Pt had a positive COVID test 6/13/22; was hospitalized for COVID infection; dc'd to home; began to have worsening SOB, syncope; back to the hospital; admitted with severe sepsis secondary to bilateral pneumonia; IV steroids and ABX; required mechanical ventilation; failed attempts to wean off mechanical ventilation; tracheostomy created; bradyarrhythmia; poor prognosis; pt's condition declined; family transitioned pt to DNR but continued on full therapeutic regimen; pt's condition deteriorated; worsening respiratory failure; PEA arrest; pt passed away in the hospital
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Mechanical ventilation, Pneumonia, Pulseless electrical activity, Respiratory failure
Clinical narrative: Pt had a positive COVID test 6/13/22; was hospitalized for COVID infection; dc'd to home; began to have worsening SOB, syncope; back to the hospital; admitted with severe sepsis secondary to bilateral pneumonia; IV steroids and ABX; required mechanical ventilation; failed attempts to wean off mechanical ventilation; tracheostomy created; bradyarrhythmia; poor prognosis; pt's condition declined; family transitioned pt to DNR but continued on full therapeutic regimen; pt's condition deteriorated; worsening respiratory failure; PEA arrest; pt passed away in the hospital
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Syncope, Tracheostomy
Clinical narrative: Pt had a positive COVID test 6/13/22; was hospitalized for COVID infection; dc'd to home; began to have worsening SOB, syncope; back to the hospital; admitted with severe sepsis secondary to bilateral pneumonia; IV steroids and ABX; required mechanical ventilation; failed attempts to wean off mechanical ventilation; tracheostomy created; bradyarrhythmia; poor prognosis; pt's condition declined; family transitioned pt to DNR but continued on full therapeutic regimen; pt's condition deteriorated; worsening respiratory failure; PEA arrest; pt passed away in the hospital
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Pfizer bivalent SDV received on 2/3/23. Patient received vaccine on 2/6/23. On 2/9/23 clinic received notification that the product is bad due to temperature excursion. Vaccine was being delivered during bad weather/ice storm. Spoke with Pfizer Medical Information and told to follow CDC guidelines for revaccination. Revaccination due immediately. Parent of patient contacted with this information.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspepsia, Herpes simplex oesophagitis, Orthostatic intolerance, Pyrexia
Clinical narrative: Evening of injection patient developed fever to 104.5 F, 3 weeks later severe heartburn diagnosed as HSV esophagitis, hospitalize 11/23-1127/2022, then developed PE hospitalized 11/30-12/1 and subsequently developed orthostatic intolerance, being evaluated for POTS.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Pfizer bivalent SDV received on 2/3/23. Patient received vaccine on 2/6/23. On 2/9/23 clinic received notification that the product is bad due to temperature excursion. Vaccine was being delivered during bad weather/ice storm. Spoke with Pfizer Medical Information and told to follow CDC guidelines for revaccination. Revaccination due immediately. Parent of patient contacted with this information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen, red, very sore arm
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: KINRIX vaccine was wrongly administered to 1-year-old patient.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given the vaccine after the beyond use date of 1/25/23
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Pfizer bivalent SDV received on 2/3/23. Patient received vaccine on 2/6/23. On 2/9/23 clinic received notification that the product is bad due to temperature excursion. Vaccine was being delivered during bad weather/ice storm. Spoke with Pfizer Medical Information and told to follow CDC guidelines for revaccination. Revaccination due immediately. Parent of patient contacted with this information.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given the COVID vaccine after the beyond use date of 1/25/23.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Discharge Provider: MD  Primary Care Provider :MD    Admission Date: 2/2/2023 Discharge Date: 2/6/2023   HOSPITAL COURSE:   She presented with fatigue, cough, shortness of breath.  Who has 2 to COVID pneumonia and acute exacerbation of chronic obstructive pulmonary disease.  She was treated with dexamethasone, remdesivir, nebulizers.  Debilitating cough is the main issue for her.   She also has hypothyroidism, hypertension, hyperlipidemia, coronary artery disease, CKD 3B, GERD, anxiety.   She was discharged with 2 liters/minute of oxygen.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Discharge Provider: MD  Primary Care Provider :MD    Admission Date: 2/2/2023 Discharge Date: 2/6/2023   HOSPITAL COURSE:   She presented with fatigue, cough, shortness of breath.  Who has 2 to COVID pneumonia and acute exacerbation of chronic obstructive pulmonary disease.  She was treated with dexamethasone, remdesivir, nebulizers.  Debilitating cough is the main issue for her.   She also has hypothyroidism, hypertension, hyperlipidemia, coronary artery disease, CKD 3B, GERD, anxiety.   She was discharged with 2 liters/minute of oxygen.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CHILD WAS ADMINITSTERED PROQUAD AND VARRICELLA DURING WELL CHILD VISIT.  SHOULD NOT HAVE BEEN GIVEN EXTRA VARICELLA.  NO ADVERSE EFFECTS WERE NOTED DURING OFFICE VISIT.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given this vaccine after the beyond use date of 1/25/23.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Dermatitis acneiform, Eczema, Pruritus, Urticaria
Clinical narrative: She got her vaccine, started getting really itchy and started to scratch and looked like her hives on the inside her left forearm.  She would scratch and it would come up again.  Then it started on the other forearm in the same place, and then on her back.  She then saw her doctor as she had at the wasteline of her underwear really bad, and on the lower stomach and looked like hives when she would scratch them.  When they went down they looked more like pimples.  Her doctor and thought that it was scabies as she had it in the top part of her buttocks, and then it went everywhere.  She was then sent to a dermatologist who said it was eczema, and she saw him 3-4 times, and it wasn't going away.  He put her on a cream, which did not help, and started using it twice a day.  She went back to see him again about 2 weeks later and it was not going away.  He continued her on the same medication and told her not to scratch it.  She was getting frustrated and said that he was too old, and saw another dermatologist.  She felt that it possibly could be eczema and she put her on another cream, and she did not know what it was.  The cream was a steroid cream which did not work, she wasn't any better.  She then wanted to do a lot of testing and when she went to get the blood work and Medicare was not going to pay for it, which she could not afford it.  She could not get the allergy testing done, and went to an allergist.  He did not know what it was, and was put on different creams, and then put on Prednisone as she could not take the itch anymore, which stopped.  She was on a short course of that, tapering dose and when she was finished with that the itch started again.  She continued with the rash.  The last time she saw the allergist he told her to do a chest x-ray to see if she has a tumor which causes an itch, which she is going for tomorrow.  The itch is really bad, and went to see her dermatologist and wanted to send her to another state, which she could not afford, and increased the steroid cream which takes the itching away for about 4 hours.  The cream gets her through the day and takes a shower, and then breaks out more.  She is considering to go to away as she is at the end of her rope, and does not know what else to do.  She is supposed to do a scraping of her skin to see what it is, and doing that this afternoon.  She is going to try and get some blood work tomorrow.    She says that the rash looks like chicken pox, and she scratches in the night during her sleep and has sores due to it.  The itching is driving her crazy.   She also has pimples in her hairline at the bottom and said it was not psoriasis.  She never had this type of reaction in her life prior to the vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itching rash after administration of second dose of Moderna Covid-19.  Rash / itching on head, neck, shoulders, back and partial chest for approximately 2 weeks after dose.   In addition, itching rash has periodically re-appeared on lower legs since that time.  No previous history of rash/skin issues.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given the COVID vaccine after the beyond use date of 1/25/23.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There were no adverse events reported by the patient. The incorrect vaccine was administered to the patient, inconsistent to her age. The patient was 4 years old and received the Pfizer-BioNTech 5 years+ vaccine.
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Product storage error
Clinical narrative: 84 patients involved Moderna Bivalent Booster was given to 84 patients on 1/11/23. The vaccine vials were in the refridgerator for 41 days, 11 days longer than it was supposed to be. Moderna was contacted and the site filled out the temperature excursion tool assessment. Modernas response was the vials affected maintained activity necessary to protect againt SARs-Vov2-COVID19 virus. But ultimately would be up to the provider that the patients are under. They also recommended we report to VAERS.  After the incident was identified, patients were notfied of the incident on 1/18/23. Interventions are in place for vaccine storage and handleing education. Please see below for more Site: Facility withheld 84 patients involved Moderna Bivalent Booster was given to 84 patients on 1/11/23.  The vaccine vials were in the refridgerator for 41 days, 11 days longer than it was supposed to be.  Vials were placed in fridge from freezer on 12/1/22. Adminsistered 1/11/23.  Moderna was contacted and the site filled out the temperature excursion tool assessment. Modernas response was the vials affected maintained activity necessary to protect againt SARs-Vov2-COVID19 virus. But ultimately would be up to the provider that the patients are under. They also recommended we report to VAERS.  Our provider agreed and decided no additonal booster was needed. After the incident was identified, patients were notfied of the incident on 1/18/23. Interventions are in place for vaccine storage and handleing education.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid-19 Vaccine dose #1 after BUD-expiration date. Doctor recommendation is for patient to be revaccinated. Patient's parents were informed of the adverse event and Doctor recommendations.  No symptoms or sign were reported by parents in reference to this event.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: C-reactive protein, Chest X-ray, Electrocardiogram, Full blood count, Influenza virus test
Clinical narrative: Sepsis,  fever, sinus tachycardia, tachypnea
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Metabolic function test, Protein C, Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test
Clinical narrative: Sepsis,  fever, sinus tachycardia, tachypnea
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Sepsis, Sinus tachycardia, Tachypnoea, Troponin
Clinical narrative: Sepsis,  fever, sinus tachycardia, tachypnea
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient arrived in clinic to receive her second dose of Novavax. Once she received the vaccines she stated that she had an instant headache an felt dizzy. She then informed staff that she had similar symptoms with her first dose, but did not tell us because she had also received the flu vaccine the same day as her first dose of Novavax and thought her symptoms were from the flu vaccine. Patient vitals were obtained, patient was monitored in a room. After 10 minutes patient expressed a shooting pain down her left arm to her thumb. Patient was monitored in clinic or 45 minutes. She took Ibuprofen at that time (10:00am) and patient reported that her dizzyness and arm pain had subsided. Patient was released home.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Bedridden, COVID-19, Death
Clinical narrative: 8/12/22 pt brought to Hospital for generalized weakness, dyspnea, hypotension; found to be positive for COVID; UTI, AKI, sepsis, pneumonia, hypoxic respiratory failure; O2 supplementation; dc'd to hospice care; bed confined; unable to meet needs; pt passed away in the hospice facility
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypotension, Pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: 8/12/22 pt brought to Hospital for generalized weakness, dyspnea, hypotension; found to be positive for COVID; UTI, AKI, sepsis, pneumonia, hypoxic respiratory failure; O2 supplementation; dc'd to hospice care; bed confined; unable to meet needs; pt passed away in the hospice facility
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Urinary tract infection
Clinical narrative: 8/12/22 pt brought to Hospital for generalized weakness, dyspnea, hypotension; found to be positive for COVID; UTI, AKI, sepsis, pneumonia, hypoxic respiratory failure; O2 supplementation; dc'd to hospice care; bed confined; unable to meet needs; pt passed away in the hospice facility
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given the vaccine after the beyond use date of 1/25/23.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test normal, COVID-19
Clinical narrative: About five days after receiving the vaccine I started having stomach pains it was persistent and nothing would help it so I knew it was the vaccine that caused my stomach problems. My doctor recommended to a Gastroenterologist. Nothing came of that so my regular medical doctor prescribe CYMBALTA and it got better but then I got COVID-19 and the stomach pains came back.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: 2 doses of Pfizer Bivalent were given. 1st booster was 9-20-2022
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Swollen injection area. Redness, pain, and itching. Chills, fever, body aches. Treated with Tylenol and ibuprofen, as well kept hydrated. Also took OTC anti histamine medication for 4 days.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Swollen injection area. Redness, pain, and itching. Chills, fever, body aches. Treated with Tylenol and ibuprofen, as well kept hydrated. Also took OTC anti histamine medication for 4 days.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac monitoring, Echocardiogram, Heart rate decreased, Pulse abnormal
Clinical narrative: On 11/11/2022 I received my Covid-19 vaccine. On 01/21/2023 I had an alarm stated that I had a very low heartbeat that lasted 10 mins. My pulse then returns back to the normal beat however during the day it started fluctuating again. I reached out to my doctor with concerns and started testing. Still in the process of getting results from the test done.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Feeding disorder, Pain, Pyrexia
Clinical narrative: I had low grade fever and body aches, pain all over my body. I wasn't able to eat because I couldn't keep anything, I had loose stool.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac failure congestive, Death, General physical health deterioration
Clinical narrative: 3RD DOSE PFIZER COVID VACCINE GIVEN 11/26/21, LOT #FJ1620 8/9/22 Pt to hospital and had a positive COVID test; hyponatremia; CHF; underwent paracentesis; pneumonia; given ABX; developed Atrial Fibrillation with RVR; tx with medication; pt's condition deteriorated; DNR; 8/19/22 pt transfered to another Hospital; condition continued to worsen; hepatorenal syndrome; transitioned to comfort measures and pt passed away in the hospital
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatorenal syndrome, Hyponatraemia, Paracentesis, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: 3RD DOSE PFIZER COVID VACCINE GIVEN 11/26/21, LOT #FJ1620 8/9/22 Pt to hospital and had a positive COVID test; hyponatremia; CHF; underwent paracentesis; pneumonia; given ABX; developed Atrial Fibrillation with RVR; tx with medication; pt's condition deteriorated; DNR; 8/19/22 pt transfered to another Hospital; condition continued to worsen; hepatorenal syndrome; transitioned to comfort measures and pt passed away in the hospital
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: General aches and pain, nausea, severe abdominal pain, chills, diarrhea
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose decreased, Cerebrovascular accident, Cold sweat, Computerised tomogram, Delirium
Clinical narrative: Loss of control of movement of limbs on both sides, delirious, cold and hot sweats, left side facial droop, trouble swallowing by Friday the following day.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Facial paralysis, Feeling hot, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Loss of control of movement of limbs on both sides, delirious, cold and hot sweats, left side facial droop, trouble swallowing by Friday the following day.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV
Symptoms: Wrong product administered
Clinical narrative: this child was supposed to get a DTaP (Infanrix) and received a Pediarix instead