chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: diluent had previously expired with no reported adverse event; dose of ACTHIB was administered to a patient. The powder portion was within date. the diluent had previously expired with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 2 months old Infant  male patient who experienced diluent had previously expired with no reported adverse event and dose of acthib was administered to a patient. the powder portion was within date. the diluent had previously expired with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine  ,pneumococcal vaccine 13v  ,diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) for Prophylactic vaccination.  On 19-Dec-2022, the patient received a (dose 1)suspect HIB (PRP/T) VACCINE(Dose-0.5mL)(Frequency-Total)( Powder Lot # UJ635AA, Expiration date: 27JAN2023 ,Diluent Lot #U7178AD, Expiration date: 30NOV2022)(Formulation- Powder and solvent for solution for injection)( Strength = standard) via intramuscular route in right leg for Immunization  On 19-DEC-2022 the patient developed a non-serious  events diluent had previously expired with no reported adverse event (expired product administered)and dose of acthib was administered to a patient. the powder portion was within date. the diluent had previously expired with no reported adverse event (product preparation error) following the administration of HIB (PRP/T) VACCINE.(Latency- same day)  It was reported Treatment: The caller was not aware of any treatment required post administration. If baby was delivered: delivery date and if baby experienced an adverse event Inform that they will be receiving a follow up questionnaire If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is a requirement.  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for both events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered ACTHIB post excursion with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 1 years old male patient who received vaccine HIB (PRP/T) vaccine [ACT-HIB] post excursion with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 16-Dec-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine dose 4 (Powder and solvent for solution for injection) (lot U7261AA and expiry date: 07-Apr-2023) via intramuscular route in the right thigh for Immunization.  On 16-Dec-2022, (latency: same day) due to a refrigerator malfunction temperature excursion occurred at a low of 31.1F for 1 day, 22 hours, and 7 minutes and patient was administered ACTHIB post excursion with no reported adverse event (poor quality product administered).    Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Max/Low Temperature reached and for what period of time 52F for 1 hour and 37 minutes with no reported adverse event; 3 different patient's were administered the IPOL (opened) after the excursion with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered IPOL vaccine (poliomyelitis vaccine (inactivated)) which had reached max/low temperature reached and for what period of time 52f for 1 hour and 37 minutes with no reported adverse event and 3 different patient's were administered the ipol (opened) after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation; and Hepatitis A vaccine INACT (havrix) for Immunisation.  On 19-Dec-2022, the patient received a dose of suspect poliomyelitis vaccine (inactivated) Suspension for injection lot V1A021M via intramuscular route in unknown administration site for immunization expiry date- 17-Feb-2024.  On an unknown date max/low temperature reached and for what period of time 52f for 1 hour and 37 minutes with no reported adverse event (product storage error) and 3 different patient's were administered the ipol (opened) after the excursion with no reported adverse event (circumstance or information capable of leading to medication error) (unknown latency)   Action taken: not applicable  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received 2 doses of the product fluzone HD QIV with no reported adverse event; Initial information received  on 20-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who received 2 doses of the product influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a second dose of suspect influenza quadrival A-B high dose HV vaccine  at a dose of 0.7 ml once  (lot UJ918AD and expiry date: 30-JUN-2023)(form and strength: unknown) via intramuscular route in the left deltoid for Immunization  On 12-DEC-2022 the patient received 2 doses of the product fluzone hd qiv with no reported adverse event (extra dose administered) same day following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, patient received 2 doses of the product fluzone HD QIV and is calling to get guidance moving forward. Patient did not experience any adverse reactions. Patient received a dose o f FLUZONE HD QIV in their office last week on 12-DEC-2022. However, they did not realize that the patient had received a previous dose in Oct-2022.   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 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Adverse event, Tic
Clinical narrative: Facial tics and it's getting progressively worse; Side effects after the vaccine; This spontaneous case was received on 13-Dec-2022, from other non-healthcare professional (consumer) (reference number: SEQW22-06435) and concerned a 16-year-old male patient.  The patient's medical history was not reported. The patient was not taking any concomitant medications.  On 30-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported), for prevention of seasonal influenza. The batch number and expiry date were not reported.  On 30-Nov-2022, the same day, an unreported amount of time after receiving Flucelvax Quadrivalent, the patient experienced side effects (not specified). Furthermore, the patient suffered facial tics and it was getting progressively worse.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: A 16-year-old male patient experienced adverse event following vaccination and facial tics on the same day, an unreported amount of time after vaccination with Flucelvax Quadrivalent vaccine. The patient's medical history was not reported. The patient was not taking any concomitant medications. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.; Sender's Comments: A 16-year-old male patient experienced adverse event following vaccination and facial tics on the same day, an unreported amount of time after vaccination with Flucelvax Quadrivalent vaccine. The patient's medical history was not reported. The patient was not taking any concomitant medications. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on plausible temporal relationship.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alpha-1 acid glycoprotein increased, Alpha-2 macroglobulin increased, Autonomic nervous system imbalance, Blindness, Blood brain barrier defect
Clinical narrative: Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebral disorder, Cognitive disorder, Costochondritis, Dysbiosis
Clinical narrative: Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Eosinophilia, Fatigue, Guillain-Barre syndrome, Heavy menstrual bleeding
Clinical narrative: Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatopulmonary syndrome, Lymphadenopathy, Memory impairment, Menstruation irregular, Photophobia
Clinical narrative: Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post viral fatigue syndrome, Thrombocytosis, Ventricular extrasystoles, Vestibular neuronitis
Clinical narrative: Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date).    No concomitant medication information was reported.  The vaccine was received at the clinic on 07-Jun-2022.  The vaccine beyond use date was reported as 07-Jul-2022.  No treatment information was provided.
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD).     Concomitant medication was not provided.  Vaccine was received at vaccination centre on 07-Jun-2022 and before use date was reported as 07-Jul-2022.  Treatment information was not reported.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD).    Concomitant medication was not provided. Vaccine was received at vaccination centre on date 07-Jun-2022 and before use date was reported as 07-Jul-2022. Treatment information was not reported.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered beyond expiry date; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond expiry date) and NO ADVERSE EVENT (No adverse event) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided. Treatment medication information was not provided by the reporter. Vaccine received on 07-Jun-2022. Vaccine BUD date reported as 07-Jul-2022.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date).    No concomitant medication information was reported. The vaccine received date reported as 13-Sep-2022 and beyond use date was reported as 13-Oct-2022. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (NO adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (NO adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    Concomitant medications were not reported.  Patient age was reported as 74 years and 1 months.  NDCID number was reported Reportedly, the number of patients at facility that received this Moderna vaccine between 08Apr2022 and 15Dec2022.  Treatment medications were not reported
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  The vaccine beyond use date was 07Jul 2022.  No treatment information was provided.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported.  The vaccine beyond use date was 07Jul 2022.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient).    Patient age was reported as 68 Year 11 Months.  No concomitant medication was provided.  NDC ID number was reported.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient age was reported as 79 Year 1 Month.  No concomitant medication was provided.  NDC ID number was reported.  It was reported that patients received vaccine at facility between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    No concomitant medicine were reported. Age of the patient is 63 Year 7 Month. Patient received Moderna vaccine on 08Apr2022 and 15Dec2022. Completion date provided as 19-Jul-2022. NDC ID  No treatment medicine were reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu, lasted 2 weeks; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received  via consumer.  This case involves an unknown age and unknown gender patient who got flu, lasted 2 weeks after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site.  On an unknown date the patient diagnosed with a non-serious got flu, lasted 2 weeks (influenza) (2 weeks latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, Poor quality product administered
Clinical narrative: patient's were administered the IPOL (opened) after the excursion; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced patient's were administered the ipol (opened) after the excursion while receiving vaccine poliomyelitis vaccine (inactivated) (ipv (vero)) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect poliomyelitis vaccine (inactivated) Suspension for injection (strength, frequency, dose, expiration date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious patient's were administered the ipol (opened) after the excursion (poor quality product administered) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Corrective treatment was not reported for the event.  Outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Confusional state, Dizziness, Flushing, Head injury, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted and bumped his head on the counter after receiving flu vaccine. paramedics came and vitals were checked. Pt refused to go to hospital and had friend pick patient up from pharmacy.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted and bumped his head on the counter after receiving flu vaccine. paramedics came and vitals were checked. Pt refused to go to hospital and had friend pick patient up from pharmacy.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cerebellar atrophy, Cerebral atrophy, Cerebral ischaemia, Cognitive disorder
Clinical narrative: Discharge Provider: MD  Primary Care Provider: MD  Admission date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM:  COVID [U07.1] Toxic metabolic encephalopathy [G92.8]   HOSPITAL COURSE: 92-year-old gentleman with medical history of chronic obstructive pulmonary disease/asthma, gout, hypertension, cognitive impairment and BPH presenting with encephalopathy 12/19.  Patient was found to be positive for influenza A and COVID 19. Patient did not require any supplemental oxygen, No signs of respiratory distress thus He was not started on steroids/antivirals.  His encephalopathy was considered metabolic in the setting of viral infections, delirium due to underlying history of cognitive impairment.  12/20 patient had a witnessed fall in his room when he wanted to go use the restroom and refused to get assistance from hospital staff.  Patient did not hit his head or lost consciousness.  Underwent noncontrast CT head that did not show any intracranial hemorrhage or acute intracranial abnormality, showed mild white matter hypoattenuation consistent with chronic microvascular ischemic disease and mild cerebral/cerebellar atrophy.  CT spine showed mild T2 endplate compression fracture and moderate degenerative changes foraminal stenosis at multiple levels.  Patient did not have any pain or tenderness in the spine.  No focal deficits.  Moving all extremities spontaneously.  Discussed with Dr. from Ortho who did not recommend any brace since patient not having any symptoms.  PT/OT evaluated, recommended discharge home with home health.  SLP evaluated, patient found to have severe cognitive-communication impairment.  Patient will require distant 24 hour supervision.  He lives with his wife at home.  Discussed with wife that given his severe cognitive impairment, any subtle changes including infections can cause significant decline in mental status.  Informed that he will need to be formally assessed for dementia by Neurology/neuropsychology.  Informed by his PCP will be able to send referrals for that.  Discussed with wife how comfortable she be taking him.  His wife stated that she would be okay taking him home.  Her brother lives about 20 minutes away and can be at their house if she needs extra help.  Mover our Case Management provided extensive list of resources in case if family wants to pursue long-term placement for patient given his dementia. Patient was discharged home in stable condition. All questions from the family answered
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Communication disorder, Computerised tomogram head abnormal, Computerised tomogram spine, Condition aggravated, Delirium
Clinical narrative: Discharge Provider: MD  Primary Care Provider: MD  Admission date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM:  COVID [U07.1] Toxic metabolic encephalopathy [G92.8]   HOSPITAL COURSE: 92-year-old gentleman with medical history of chronic obstructive pulmonary disease/asthma, gout, hypertension, cognitive impairment and BPH presenting with encephalopathy 12/19.  Patient was found to be positive for influenza A and COVID 19. Patient did not require any supplemental oxygen, No signs of respiratory distress thus He was not started on steroids/antivirals.  His encephalopathy was considered metabolic in the setting of viral infections, delirium due to underlying history of cognitive impairment.  12/20 patient had a witnessed fall in his room when he wanted to go use the restroom and refused to get assistance from hospital staff.  Patient did not hit his head or lost consciousness.  Underwent noncontrast CT head that did not show any intracranial hemorrhage or acute intracranial abnormality, showed mild white matter hypoattenuation consistent with chronic microvascular ischemic disease and mild cerebral/cerebellar atrophy.  CT spine showed mild T2 endplate compression fracture and moderate degenerative changes foraminal stenosis at multiple levels.  Patient did not have any pain or tenderness in the spine.  No focal deficits.  Moving all extremities spontaneously.  Discussed with Dr. from Ortho who did not recommend any brace since patient not having any symptoms.  PT/OT evaluated, recommended discharge home with home health.  SLP evaluated, patient found to have severe cognitive-communication impairment.  Patient will require distant 24 hour supervision.  He lives with his wife at home.  Discussed with wife that given his severe cognitive impairment, any subtle changes including infections can cause significant decline in mental status.  Informed that he will need to be formally assessed for dementia by Neurology/neuropsychology.  Informed by his PCP will be able to send referrals for that.  Discussed with wife how comfortable she be taking him.  His wife stated that she would be okay taking him home.  Her brother lives about 20 minutes away and can be at their house if she needs extra help.  Mover our Case Management provided extensive list of resources in case if family wants to pursue long-term placement for patient given his dementia. Patient was discharged home in stable condition. All questions from the family answered
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall, Gait disturbance, Influenza A virus test positive, SARS-CoV-2 test positive, Spinal compression fracture
Clinical narrative: Discharge Provider: MD  Primary Care Provider: MD  Admission date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM:  COVID [U07.1] Toxic metabolic encephalopathy [G92.8]   HOSPITAL COURSE: 92-year-old gentleman with medical history of chronic obstructive pulmonary disease/asthma, gout, hypertension, cognitive impairment and BPH presenting with encephalopathy 12/19.  Patient was found to be positive for influenza A and COVID 19. Patient did not require any supplemental oxygen, No signs of respiratory distress thus He was not started on steroids/antivirals.  His encephalopathy was considered metabolic in the setting of viral infections, delirium due to underlying history of cognitive impairment.  12/20 patient had a witnessed fall in his room when he wanted to go use the restroom and refused to get assistance from hospital staff.  Patient did not hit his head or lost consciousness.  Underwent noncontrast CT head that did not show any intracranial hemorrhage or acute intracranial abnormality, showed mild white matter hypoattenuation consistent with chronic microvascular ischemic disease and mild cerebral/cerebellar atrophy.  CT spine showed mild T2 endplate compression fracture and moderate degenerative changes foraminal stenosis at multiple levels.  Patient did not have any pain or tenderness in the spine.  No focal deficits.  Moving all extremities spontaneously.  Discussed with Dr. from Ortho who did not recommend any brace since patient not having any symptoms.  PT/OT evaluated, recommended discharge home with home health.  SLP evaluated, patient found to have severe cognitive-communication impairment.  Patient will require distant 24 hour supervision.  He lives with his wife at home.  Discussed with wife that given his severe cognitive impairment, any subtle changes including infections can cause significant decline in mental status.  Informed that he will need to be formally assessed for dementia by Neurology/neuropsychology.  Informed by his PCP will be able to send referrals for that.  Discussed with wife how comfortable she be taking him.  His wife stated that she would be okay taking him home.  Her brother lives about 20 minutes away and can be at their house if she needs extra help.  Mover our Case Management provided extensive list of resources in case if family wants to pursue long-term placement for patient given his dementia. Patient was discharged home in stable condition. All questions from the family answered
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Spinal osteoarthritis, Toxic encephalopathy, Vertebral foraminal stenosis, Viral infection
Clinical narrative: Discharge Provider: MD  Primary Care Provider: MD  Admission date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM:  COVID [U07.1] Toxic metabolic encephalopathy [G92.8]   HOSPITAL COURSE: 92-year-old gentleman with medical history of chronic obstructive pulmonary disease/asthma, gout, hypertension, cognitive impairment and BPH presenting with encephalopathy 12/19.  Patient was found to be positive for influenza A and COVID 19. Patient did not require any supplemental oxygen, No signs of respiratory distress thus He was not started on steroids/antivirals.  His encephalopathy was considered metabolic in the setting of viral infections, delirium due to underlying history of cognitive impairment.  12/20 patient had a witnessed fall in his room when he wanted to go use the restroom and refused to get assistance from hospital staff.  Patient did not hit his head or lost consciousness.  Underwent noncontrast CT head that did not show any intracranial hemorrhage or acute intracranial abnormality, showed mild white matter hypoattenuation consistent with chronic microvascular ischemic disease and mild cerebral/cerebellar atrophy.  CT spine showed mild T2 endplate compression fracture and moderate degenerative changes foraminal stenosis at multiple levels.  Patient did not have any pain or tenderness in the spine.  No focal deficits.  Moving all extremities spontaneously.  Discussed with Dr. from Ortho who did not recommend any brace since patient not having any symptoms.  PT/OT evaluated, recommended discharge home with home health.  SLP evaluated, patient found to have severe cognitive-communication impairment.  Patient will require distant 24 hour supervision.  He lives with his wife at home.  Discussed with wife that given his severe cognitive impairment, any subtle changes including infections can cause significant decline in mental status.  Informed that he will need to be formally assessed for dementia by Neurology/neuropsychology.  Informed by his PCP will be able to send referrals for that.  Discussed with wife how comfortable she be taking him.  His wife stated that she would be okay taking him home.  Her brother lives about 20 minutes away and can be at their house if she needs extra help.  Mover our Case Management provided extensive list of resources in case if family wants to pursue long-term placement for patient given his dementia. Patient was discharged home in stable condition. All questions from the family answered
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Hypersensitivity, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient was prescribed oral steroids for 5 days and given steroid cream to use as needed for rash
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Systemic: Patien did not have any reaction but did not seems to understand the difference of boostrix and MMR-Mild, Additional Details: The patient tech she wanted boostrix. Before boostrix was given the rph explained to patient about the vaccine that it is given approximately every 10 years and patientt said she never had it before. patient had a 3 months old girl baby with her and was told by rph that anyone visiting the home needed to be updated with a boostrix vaccine. Patient did not have any reaction(other) but after boostrix said she wanted mmr. This patient appears to understand but not full
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the Bivalent vaccine instead of the Monovalent vaccine for the first dose of the primary series
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received expired influenza vaccine (exp 6/30/2022). Patient notified of event and need for repeated vaccination with 2022-23 Seasonal vaccine.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received expired influenza vaccine (exp 6/30/2022). Patient notified of event and need for repeated vaccination with 2022-23 Seasonal vaccine.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received expired influenza vaccine (exp 6/30/2022). Patient notified of event and need for repeated vaccination with 2022-23 Seasonal vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Biopsy uterus abnormal, Endometrial hyperplasia, Laboratory test, Menstrual disorder
Clinical narrative: No period for 6-8 months, then brutal period for 1 month. I had a biopsy of the uterine lining that came back positive for endometrial hyperplasia.