chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: U
Vaccine: HIBV, UNK
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: pentacel instead of acthib was administered in error with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] instead of 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 diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine Inact 3v (VERO), tetanus vaccine toxoid (Pediarix) and Rotavirus Vaccine for Prophylactic vaccination, chlorphenamine maleate, naphazoline hydrochloride (Flucur).  On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ805AA expiry date: 17-feb-2024 via intramuscular route in the right thigh for prophylactic vaccination (immunization) instead of HIB (PRP/T) VACCINE in error with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel instead of acthib was administered in error with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient had third dose (two doses of Menactra prior to MENQUADFI that he was given today) with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old male patient who received third dose (two doses of menactra prior to meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] that he was given today) 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 HPV vaccine (HPV vaccine) for Immunisation.  On 20-Jun-2023, the patient received 0.5 mL dose 3 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7616AB; expiry date: 11-Apr-2025) via intramuscular route in the right deltoid for immunization (two doses of menactra prior to menquadfi that he was given today) with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient had third dose (two doses of menactra prior to menquadfi that he was given today) 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.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Product preparation error
Clinical narrative: product was mixed with another diluent instead of the saline that it comes with no reported adverse event; product was mixed with another diluent instead of the saline that it comes with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient and it was reported HIB (PRP/T) vaccine [ACT-HIB] was mixed with another diluent instead of the saline that it comes 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, it was reported HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (batch/lot number, expiry date, strength, route: not reported) was mixed with another diluent instead of the saline that it comes and administered in an unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (product preparation error; latency: unknown) (incorrect product formulation 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.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Flublok qiv that expired on 14Jun2023 was administered to a patient on 19Jun2023 with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] that expired on 14-Jun-2023 was administered to a patient on 19-Jun-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jun-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrivalent recombinant vaccine (formulation; lot number) (strength: standard; expiry date: 14-Jun-2023) via intramuscular route in the left deltoid for Immunization. Information regarding batch number was requested in the case.  On 19-Jun-2023 the patient was administered flublok qiv that expired on 14-Jun-2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Medical assistant asks if there is any extension on the expiration date?"   Action taken was 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.
Age: 48.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: received a YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information was received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 48 years old female patient who received a yellow fever vaccine [Yf-Vax] intramuscularly rather than subcutaneously 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 meningococcal vaccine and polio vaccine for Prophylactic vaccination.  On 21-Jun-2023, the patient received a 0.5 ml, total dose of suspect yellow fever vaccine  Solution for injection (lot: UJH20AB, expiry date: 28-May-2024, strength: Standard) via intramuscular route in  Left deltoid for Immunization.  On 21-Jun-2023 the patient received a yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) (Latency: same day) following the administration of yellow fever vaccine.  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.
Age: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Product dose omission issue, Wrong product administered
Clinical narrative: they have given adacel to a patient instead of daptacel with no reported adverse event; they have given adacel to a patient instead of daptacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient and it was reported they have given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to the patient instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-JUN-2023, they have given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] Suspension for injection(batch/lot number: 2CA18C1; expiry date: 29-Nov-2024; frequency= once; Strength = Standard) via intramuscular route in the left arm for prophylactic vaccination (immunization) to the patient instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection with no reported adverse event (wrong product administered) (product dose omission issue) (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:  US-SA-2023SA191728:01662712
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, chills, tiredness
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Cold symptoms -feverish. Runny nose,. Headache. Sore throat. Cough for three plus days
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Cold symptoms -feverish. Runny nose,. Headache. Sore throat. Cough for three plus days
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Fatigue, Headache
Clinical narrative: 1/14/2021 pain, fatigue, headache and fever- took night off due to reaction subsequently within days, fatigue, lethargy, headache, swollen joints (hips, knees ,left foot) Vaginal bleeding and pain (I'm post Menopausal) total body weakness, stomach pain, . I have gained a lot of weight, chest pains, can't get out of bed many days and I applied for assistance which is under review,
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Joint swelling, Laboratory test, Lethargy, Mobility decreased
Clinical narrative: 1/14/2021 pain, fatigue, headache and fever- took night off due to reaction subsequently within days, fatigue, lethargy, headache, swollen joints (hips, knees ,left foot) Vaginal bleeding and pain (I'm post Menopausal) total body weakness, stomach pain, . I have gained a lot of weight, chest pains, can't get out of bed many days and I applied for assistance which is under review,
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaginal haemorrhage, Vulvovaginal pain
Clinical narrative: 1/14/2021 pain, fatigue, headache and fever- took night off due to reaction subsequently within days, fatigue, lethargy, headache, swollen joints (hips, knees ,left foot) Vaginal bleeding and pain (I'm post Menopausal) total body weakness, stomach pain, . I have gained a lot of weight, chest pains, can't get out of bed many days and I applied for assistance which is under review,
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: 1/14/2021 pain, fatigue, headache and fever- took night off due to reaction subsequently within days, fatigue, lethargy, headache, swollen joints (hips, knees ,left foot) Vaginal bleeding and pain (I'm post Menopausal) total body weakness, stomach pain, . I have gained a lot of weight, chest pains, can't get out of bed many days and I applied for assistance which is under review,
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Disturbance in attention, Erythema, Fatigue, Musculoskeletal stiffness, Swelling
Clinical narrative: Swelling, redness, stiffness, tiredness lack of focus from 06/12 to 06/24 23.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, itching, redness will be very extensive.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Hypersensitivity, Pruritus, Throat tightness, Urticaria
Clinical narrative: Persistent itchiness, welts, environmental allergies, hair loss, throat closure (different from asthma) Began shortly after 2nd dose and has persisted for nearly two years
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: pt reports head pressure and  acute stabbing pain in head.  Also, numbness on head.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Erythema, Fatigue, Injection site swelling
Clinical narrative: Extreme itchiness all over body, welts/hives, swelling of hands, feet, throat, shortness of breath,  hives/redness/swelling at injection site, fatigue, cough from swelling of throat
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Extreme itchiness all over body, welts/hives, swelling of hands, feet, throat, shortness of breath,  hives/redness/swelling at injection site, fatigue, cough from swelling of throat
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, warmth, redness at L deltoid vaccination site
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly. Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: patient came into the pharmacy and showed me  his arm and it was red around the injection site.  i asked when he had gotten the vaccine and he said it had been a week. upon further investigation it had been 2 days. i told him that you can have pain swelling and redness around the injection site. I asked had he done any cold compresses or anything to it and he said no. he actually still had the bandaid on his arm. he said he would try that for the next couple of days and if it didnt get better he would go to his doctors office.
Age: 57.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient requested Shingrix and was administed Menveo by mistake
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever of 102 on day after vaccine; day 2 after vaccine, broke out in hives, lasted 2 days
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: inflamed injection site with redness
Age: 86.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient requested Shingrix and received Menveo by mistake.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Red blood cell sedimentation rate, Visual impairment, Vitreous detachment
Clinical narrative: visual changes vitreous detachment
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Myalgia, Nausea, Pain in extremity
Clinical narrative: ARM PAIN, CHILLS, SEVERE MYALGIA, NAUSEA, ABDOMINAL PAIN
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Patient started to not feel well about 15 minutes after shot. He was sweating profusely and feeling dizzy. I gave him some water and had him sit down. He finished his first water and we gave him another. Then his wife showed up and I realized he is diabetic. I gave him a couple of glucose tablets and his wife gave him a couple of bottles of orange juice. He said he felt a little better but was still dizzy so his with took him home.
Age: 52.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Abdominal discomfort, Chest pain, Diarrhoea, Dizziness
Clinical narrative: The patient reported dizziness, lightheaded, and felt like he was about to pass out. He also said he had some stomach upset and diarrhea.  He later reported chest pain. He went to the ER, and we are awaiting further information.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: PAIN IN RIGHT ARM. PATIENT TAKE TYLENOL #4 ALREADY. PATIENT CAME TO PHARMACY 6/24/23 AND ALERTED PHARMACIST OF ONGOING PAIN THAT SHE BELIEVES IS FROM PREVNAR 20 VACCINE RECEIVED ON 10/1/22.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore and tender arm, fever, chills, headache, nausea, extreme fatigue
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Tenderness
Clinical narrative: Sore and tender arm, fever, chills, headache, nausea, extreme fatigue
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain fog, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: Approximately 3 weeks after the second vaccine I started having balance issues, numbness, squeezing around waist, personality changes , fatigue, insomnia, brain fog and some speech issues.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Personality change, Sensory disturbance, Speech disorder
Clinical narrative: Approximately 3 weeks after the second vaccine I started having balance issues, numbness, squeezing around waist, personality changes , fatigue, insomnia, brain fog and some speech issues.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time prolonged, Arrhythmia, Atrioventricular block complete, Basophil percentage increased, Blood test abnormal
Clinical narrative: Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Cardiac ablation, Catheterisation cardiac normal, Differential white blood cell count abnormal, Echocardiogram
Clinical narrative: Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Granulocyte percentage, Lymphocyte count, Monocyte percentage increased, Myocardial infarction
Clinical narrative: Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count decreased, Neutrophil percentage decreased, Supraventricular tachycardia, Surgery, Surgical failure
Clinical narrative: Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin T increased, Troponin increased
Clinical narrative: Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Disorientation, Fatigue, Injection site pain, Pain
Clinical narrative: Significant fatigue, mild body aches, slight disorientation, slightly elevated temperature (did not measure) for 18 hours after initial onset of symptoms.  Tenderness at injection site 72 hrs after injection.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Headache, nausea, severe diarrhea. Headache starting approx 2 hours after injection. Nausea and diarrhea starting approx 14 hours after injection.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Aphasia, Brain empyema, Depression, Dizziness
Clinical narrative: Severre migraines started happening daily about 2 weeks after vaccination, causing vomiting and light headedness. Pressure in head and behind right eye, attempted to treat with pain meds such as morphine which did not work, MRI scan showed a subdural empyema on the frontal lobe of brain which needed immediate surgery, broad spectrum antibiotics were given which did not help as the infection spread whilst I waited for surgery, outcome of the infection caused me to have a seizure resulting in loss of speech and movement before the emergency surgery, and also a seizure after the surgery. The second surgery was successful and I was put on the correct antibiotics, alot of morphine and anti-epileptic medication. Had multiple therapists to help recover and regain my movement and speech. These events(subdural empyema induced by vaccination) has heavily effected my memory & mental health (depression, anxiety, bpd), left me on permemant medication, changed my personality and has crippled my confidence & trust.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Magnetic resonance imaging head abnormal, Memory impairment, Mental disorder, Migraine
Clinical narrative: Severre migraines started happening daily about 2 weeks after vaccination, causing vomiting and light headedness. Pressure in head and behind right eye, attempted to treat with pain meds such as morphine which did not work, MRI scan showed a subdural empyema on the frontal lobe of brain which needed immediate surgery, broad spectrum antibiotics were given which did not help as the infection spread whilst I waited for surgery, outcome of the infection caused me to have a seizure resulting in loss of speech and movement before the emergency surgery, and also a seizure after the surgery. The second surgery was successful and I was put on the correct antibiotics, alot of morphine and anti-epileptic medication. Had multiple therapists to help recover and regain my movement and speech. These events(subdural empyema induced by vaccination) has heavily effected my memory & mental health (depression, anxiety, bpd), left me on permemant medication, changed my personality and has crippled my confidence & trust.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Ocular discomfort, Personality change, Seizure, Surgery
Clinical narrative: Severre migraines started happening daily about 2 weeks after vaccination, causing vomiting and light headedness. Pressure in head and behind right eye, attempted to treat with pain meds such as morphine which did not work, MRI scan showed a subdural empyema on the frontal lobe of brain which needed immediate surgery, broad spectrum antibiotics were given which did not help as the infection spread whilst I waited for surgery, outcome of the infection caused me to have a seizure resulting in loss of speech and movement before the emergency surgery, and also a seizure after the surgery. The second surgery was successful and I was put on the correct antibiotics, alot of morphine and anti-epileptic medication. Had multiple therapists to help recover and regain my movement and speech. These events(subdural empyema induced by vaccination) has heavily effected my memory & mental health (depression, anxiety, bpd), left me on permemant medication, changed my personality and has crippled my confidence & trust.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severre migraines started happening daily about 2 weeks after vaccination, causing vomiting and light headedness. Pressure in head and behind right eye, attempted to treat with pain meds such as morphine which did not work, MRI scan showed a subdural empyema on the frontal lobe of brain which needed immediate surgery, broad spectrum antibiotics were given which did not help as the infection spread whilst I waited for surgery, outcome of the infection caused me to have a seizure resulting in loss of speech and movement before the emergency surgery, and also a seizure after the surgery. The second surgery was successful and I was put on the correct antibiotics, alot of morphine and anti-epileptic medication. Had multiple therapists to help recover and regain my movement and speech. These events(subdural empyema induced by vaccination) has heavily effected my memory & mental health (depression, anxiety, bpd), left me on permemant medication, changed my personality and has crippled my confidence & trust.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Illness, Pancreatitis
Clinical narrative: After receiving  Moderna Covid vaccine (047B21A) my brother became ill. He had to be hospitalized for Pancreatitis. He was treated by a Doctor after and never recovered. He passed away on 9/15/21.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, DTPPVHBHPB, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with the combo vaccine; therefore they received double dose of IPV.; The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine, instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with combo vaccine.; 5-year-old child; Mother notified and watched for any adverse reactions. We have not been notified there have been any.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577243-1. The original narrative from the sender is as follows:  The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine. The label was not fully read; Instead of just DTaP the patient received the combination vaccine that has DTaP, /IPV/HIB/Hep B. Pt was also due & given IPV along with combo vaccine; therefore, they received double dose of IPV. Mother notified and watched for any adverse reactions. We have not been notified there have been any.  Due to the nature of the event the causal relationship between Vaxelis and the events, "no adverse event, extra dose administered, and wrong product administered" is not applicable.  The case is considered as "off-label use" (Product use in unapproved population).  No further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, DTPPVHBHPB, IPV
Symptoms: Extra dose administered, Off label use, Wrong product administered
Clinical narrative: Instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with the combo vaccine; therefore they received double dose of IPV.; The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine, instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with combo vaccine.; 5-year-old child; Mother notified and watched for any adverse reactions. We have not been notified there have been any.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577243-1. The original narrative from the sender is as follows:  The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine. The label was not fully read; Instead of just DTaP the patient received the combination vaccine that has DTaP, /IPV/HIB/Hep B. Pt was also due & given IPV along with combo vaccine; therefore, they received double dose of IPV. Mother notified and watched for any adverse reactions. We have not been notified there have been any.  Due to the nature of the event the causal relationship between Vaxelis and the events, "no adverse event, extra dose administered, and wrong product administered" is not applicable.  The case is considered as "off-label use" (Product use in unapproved population).  No further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Full blood count, Hypophagia, Irritability, Laboratory test
Clinical narrative: Decreased oral intake; There was a little local reaction only slight tenderness; He had diarrhea; Was very fussy; Within 4 hours baby had a fever of 102.9; Full blood count; Laboratory Test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577947-1. The original narrative from the sender is as follows:  Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "diarrhea, hypophagia, irritability, tenderness and pyrexia". The causal relationship between Vaxelis and the events of "full blood count, laboratory test and urine analysis" was not applicable due to the nature of the events.  No further information is expected.