chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: body aches are awful; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced body aches are awful while 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 a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious body aches are awful (pain) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Corrective treatment was not reported for the event (body aches are awful).  Outcome was Unknown for the event body aches are awful.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick as a dog each time; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who got sick as a dog each time after receiving vaccine Influenza vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, formulation, route, expiry date and administration site not reported for flu (Influenza).  On an unknown date the patient had the flu shot 3 times in life, got sick as a dog each time (illness)" (unknown latency) following the administration of  Influenza vaccine.  It was reported that "I have also had the flu 3 times WITHOUT the flu shot. I am healthier without it."   It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Muscular weakness, Pain
Clinical narrative: muscle weakness; severe pain; flu symptoms; Initial information received on 18-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who had flu symptoms, muscle weakness and severe pain after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2022, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On 28-Sep-2022 the patient had a non-serious event of flu symptoms (influenza) (latency:1 day) following the administration of Influenza Vaccine.  On an unknown date the patient had non-serious events of muscle weakness (muscular weakness) and pain (unknown latency) following the administration of Influenza Vaccine.  It was reported "It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (flu symptoms, muscle weakness, severe pain).  At time of reporting, the outcome was Unknown for the event flu symptoms, was Unknown for the event muscle weakness and was Unknown for the event severe pain.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Sick with flu anyway; Initial information received on 16-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health Care professional   This case involves an unknown age and unknown gender patient who was sick with flu anyway after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient experienced any additional symptoms/events   It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included COVID-19 VACCINE and PNEUMOCOCCAL VACCINE for Prophylactic vaccination.  On an unknown date, the patient received a suspect Influenza vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination   On an unknown date the patient developed a non-serious event sick with flu anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick with flu anyway).  At time of reporting, the outcome was Unknown for the event sick with flu anyway.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Patient got Yes and still got the worst flu in years; Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a Patient   This case involves an unknown age and unknown gender patient who experienced patient got yes and still got the worst flu in years after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination   On an unknown date the patient developed a non-serious event patient got yes and still got the worst flu in years (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action Taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient got Yes and still got the worst flu in years).  At time of reporting, the outcome was Unknown for the event patient got yes and still got the worst flu in years.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got my flu shot.. but still got flu B . Been in hospital four days; Initial information received on 17-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported got my flu shot. but still got flu B. been in hospital four days after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date got my flu shot. But still got flu B. Been in hospital four days (influenza) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  Seriousness criteria: Hospitalized for this event; Sender's Comments: Sanofi company comment dated 22-Dec-2022: This case involves an unknown age and unknown gender patient who reported got my flu shot. but still got flu B. been in hospital four days after receiving vaccine influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event ( flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu, happens every time; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves an unknown age and unknown gender patient who got the flu, happens every time after receiving influenza vaccine.  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient got the flu, happens every time (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event ( got the flu, happens every time).  At time of reporting, the outcome was Unknown for the event got the flu, happens every time.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves an unknown age/gender patient who experienced got the flu after being vaccinated with 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route, administration site, expiry date: Unknown) for flu vaccination (Influenza immunization).  On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  Outcome: Unknown for the event got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: paralyzed; severe Guillian Barre Syndrome; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who was had severe guillian barre syndrome and paralyzed after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu. Information on batch number and expiry date was requested.  On an unknown date the patient had events of severe guillian barre syndrome (guillain-barre syndrome) and paralyzed (paralysis) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown.  Seriousness criteria: Medically significant for both the events.; Sender's Comments: Sanofi company comment dated 22-Dec-2022: This case involves Adult and unknown gender patient who was had severe guillian barre syndrome and paralyzed after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age of male patient who experienced flu after receiving 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 a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength,lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3-1/2 year old erroneously received Quadracel with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3-1/2 years old and unknown gender patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 19-Dec-2022, the patient received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On 19-Dec-2022, (same day) the patient developed a non-serious event "3-1/2 year old erroneously received quadracel with no reported adverse event (product administered to patient of inappropriate age) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  It is unknown if there were lab data/results available.   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 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: 68.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired tenivac,with no reported adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 68 years old male patient who was administered an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] and experienced no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Dec-2022, the patient received a dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (with lot U6831AA, expiry date: 08-Oct-2022, strength, formulation: unknown) via intramuscular route in the left deltoid (expired product administered).  Action taken : Not Applicable.  At time of reporting, the outcome was Unknown for the event received an expired tenivac,with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dysstasia, Feeling cold, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: tip of her nose and tongue were numb; fully incontinent of urine; unable to lift her arms; throat hurting; could not swallow; feeling cold; shaking; weakness in legs; difficult to stand up; Initial information was received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves 79 years old female patient who experienced unable to lift her arms, throat hurting, could not swallow, feeling cold, shaking, weakness in legs, difficult to stand up, tip of her nose and tongue were numb and fully incontinent of urine after receiving vaccine Influenza Quadrival A-B high dose HV Vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Tetanus Vaccine after which she did have a bad reaction 25 years ago. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sjogren's syndrome.  On 05-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with lot UJ875AC, expiry date: 30-Jun-2023, strength, formulation: unknown) via unknown route in unknown administration site for prophylaxis.  On 05-Oct-2022 (latency: same day) the patient developed non-serious events of unable to lift her arms (limb discomfort), throat hurting (oropharyngeal pain), could not swallow (dysphagia), feeling cold, shaking (tremor), weakness in legs (muscular weakness), difficult to stand up (dysstasia) following the administration of influenza quadrival A-B high dose HV vaccine.  On 06-Oct-2022 (latency: 1 day) the patient developed non-serious events of tip of her nose and tongue were numb (hypoaesthesia) and fully incontinent of urine (urinary incontinence) following the administration of influenza quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Muscular weakness, Oropharyngeal pain, Tremor
Clinical narrative: tip of her nose and tongue were numb; fully incontinent of urine; unable to lift her arms; throat hurting; could not swallow; feeling cold; shaking; weakness in legs; difficult to stand up; Initial information was received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves 79 years old female patient who experienced unable to lift her arms, throat hurting, could not swallow, feeling cold, shaking, weakness in legs, difficult to stand up, tip of her nose and tongue were numb and fully incontinent of urine after receiving vaccine Influenza Quadrival A-B high dose HV Vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Tetanus Vaccine after which she did have a bad reaction 25 years ago. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sjogren's syndrome.  On 05-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with lot UJ875AC, expiry date: 30-Jun-2023, strength, formulation: unknown) via unknown route in unknown administration site for prophylaxis.  On 05-Oct-2022 (latency: same day) the patient developed non-serious events of unable to lift her arms (limb discomfort), throat hurting (oropharyngeal pain), could not swallow (dysphagia), feeling cold, shaking (tremor), weakness in legs (muscular weakness), difficult to stand up (dysstasia) following the administration of influenza quadrival A-B high dose HV vaccine.  On 06-Oct-2022 (latency: 1 day) the patient developed non-serious events of tip of her nose and tongue were numb (hypoaesthesia) and fully incontinent of urine (urinary incontinence) following the administration of influenza quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: tip of her nose and tongue were numb; fully incontinent of urine; unable to lift her arms; throat hurting; could not swallow; feeling cold; shaking; weakness in legs; difficult to stand up; Initial information was received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves 79 years old female patient who experienced unable to lift her arms, throat hurting, could not swallow, feeling cold, shaking, weakness in legs, difficult to stand up, tip of her nose and tongue were numb and fully incontinent of urine after receiving vaccine Influenza Quadrival A-B high dose HV Vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Tetanus Vaccine after which she did have a bad reaction 25 years ago. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sjogren's syndrome.  On 05-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with lot UJ875AC, expiry date: 30-Jun-2023, strength, formulation: unknown) via unknown route in unknown administration site for prophylaxis.  On 05-Oct-2022 (latency: same day) the patient developed non-serious events of unable to lift her arms (limb discomfort), throat hurting (oropharyngeal pain), could not swallow (dysphagia), feeling cold, shaking (tremor), weakness in legs (muscular weakness), difficult to stand up (dysstasia) following the administration of influenza quadrival A-B high dose HV vaccine.  On 06-Oct-2022 (latency: 1 day) the patient developed non-serious events of tip of her nose and tongue were numb (hypoaesthesia) and fully incontinent of urine (urinary incontinence) following the administration of influenza quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased
Clinical narrative: blood pressure spike so high and so quickly; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 71 years old female patient who experienced blood pressure spike so high and so quickly while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Nov-2022, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On 05-Nov-2022 the patient developed a non-serious event of blood pressure spike so high and so quickly (blood pressure increased) (latency: 1 day) following the administration of influenza vaccine.  It was reported that "She did receive medication at the ER that brought her blood pressure back down down, however two days later it shot up again and she went back to the ER. Her PCP doubled her blood pressure medications and it now controlled. Caller also stated her cardiologist wants her to take some tests, but she is not sure she needs them now. Patient did say she was on blood pressure medications prior to receiving the shot, but has never had her blood pressure spike so high and so quickly".   Relevant laboratory test results included: Blood pressure measurement - On an unknown date: [shot up to 208/111]; on an unknown date: [was at 230/144]; on an unknown date: [back down down]; on an unknown date: [it shot up again]  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (blood pressure spike so high and so quickly).  At time of reporting, the outcome was Recovered on an unknown date for the event blood pressure spike so high and so quickly.; Sender's Comments:  US-SA-2022SA514521:
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased
Clinical narrative: blood pressure also spike 24 hours after receiving a flu vaccine; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received via consumer/non-hcp.  This case involves an unknown age male patient whose blood pressure also spike 24 hours after receiving a flu vaccine while 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 for Immunization  On an unknown date the patient diagnosed with a non-serious blood pressure also spike 24 hours after receiving a flu vaccine (blood pressure increased) (unknown latency) following the administration of influenza vaccine.  It was reported "Caller stated her friend is a male and he was born in 1947. She states his blood pressure also spike 24 hours after receiving a flu vaccine".   Relevant laboratory test results included:  Blood pressure measurement - On an unknown date:  [also spike 24 hours]   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: 6.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL were exposed to highest temperature of 25.26 degrees C for 3 hours due to unknown reason with no reported adverse event; IPOL were used post excursion with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health Care professional   This case is linked to case 2022SA512590.  This case involves a 6 years old male patient and  it was reported ipol were exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported adverse event and were used 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel),measles vaccine, mumps vaccine, rubella vaccine (mmr),varicella zoster vaccine (varicella vaccine) and hepatitis b vaccine (hepatitis b vaccine) for Prophylactic vaccination  On 29-Nov-2022 the IPV (VERO) [IPOL]. Vaccine were exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported adverse event (product storage error), were used post excursion with no reported adverse event (poor quality product administered).  On 08-Dec-2022, the patient received a (series: unknown) suspect IPV (VERO)(Formulation- Suspension for injection)( Strength = standard) (Lot Number- V1B901M)(Expiry date-Jun-2024)( Dose: unknown) via unknown route in unknown administration site for Immunization  It was reported This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.Reporter was the one who administered the vaccine Caller mentioned that IPOL was used to 5 patients. Patient information not available at the time of call, future follow-up for other 4 patients accepted.   Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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:  case 01410480 for GENERAL VACCINES:
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Off label use
Clinical narrative: accidentally administered TENIVAC and Boostrix together with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 11 years old female patient who was accidentally administered tenivac and boostrix together with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 15-Dec-2022, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult 0.5 ML 1X and Drug Treatment Duration: ONCE (batch number: U7183AA) in unknown administration site for Immunization.  On 15-Dec-2022 the patient diagnosed with a non-serious accidentally administered tenivac and boostrix together with no reported adverse event (off label use) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired ACTHIB administered to a patient with no reported AE; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 14 months old male patient who reported that expired acthib administered to a patient with no reported ae after receiving 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 measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad); hepatitis a vaccine (HEPATITIS A); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 15-Dec-2022, the patient received a dose of 0.5 ml suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (Frequency: once, lot UJ611AA) via intramuscular route in the right thigh. for prophylactic vaccination(immunization)  On 15-Dec-2022 the patient developed a non-serious event of expired acthib administered to a patient with no reported ae (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (expired Acthib administered to a patient with no reported AE).  At time of reporting, the outcome was Not Recovered for the event expired acthib administered to a patient with no reported ae.  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: 0.17
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL being administered post excursion due to a refrigerator malfunction with no reported event; Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient whose ipol was administered post excursion due to a refrigerator malfunction with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) For Immunisation; Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) For Immunisation; Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) For Immunisation; Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) For Immunisation; Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) For Immunisation; Meningococcal Vaccine A/C/Y/W Conj (Dip Tox) (Menactra) For Immunisation; And Influenza Vaccine Inact Split 4v (Fluzone Quadrivalent) for Immunisation.  On 05-Oct-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (lot number: V1B901M and expiry date: 02-Jun-2024) via intramuscular route in the right thigh for immunisation.  On 05-Oct-2022 the patient had a non-serious event ipol being administered post excursion due to a refrigerator malfunction with no reported adverse event (latency: same day) (poor quality product administered) following the administration of IPV (VERO).  Action taken: not applicable.  Outcome: Not Recovered / Not Resolved.   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: 0.33
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered 4 times after the excursion with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old female patient who was administered Ipol (poliomyelitis vaccine (inactivated)) 4 times 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); rotavirus vaccine live reassort oral 5v (Rotateq) and HIB vaccine conj (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 07-Oct-2022, the patient received a  dose of suspect poliomyelitis vaccine (inactivated), Suspension for injection lot V1B901M via intramuscular route in unknown administration site for immunization (expiry date-02 Jun-2024).  On 07-Oct-2022 the patient was administered 4 times after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event administered 4 times after the excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: punchered and administered 4 times after the excursion with no reported adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 5 years old female patient who punchered and administered 4 times after the excursion with no reported adverse event while receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received a dose of 0.5 ml suspect ipv (VERO) (Suspension for injection) (lot V1B901M,expiry date:02-Jun-2024) via intramuscular route in the left deltoid for prophylactic vaccination(immunization).  On 10-Oct-2022 the patient punchered and administered 4 times after the excursion with no reported adverse event (poor quality product administered) (latency: same day)following the administration of ipv (VERO).  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event punchered and administered 4 times after the excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Bedridden, Disorientation, Influenza, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Pain; Flu symptoms; muscle weakness that was most pronounced in his hamstrings,muscle weakness has moved through his body and into his shoulders; bed-ridden; disoriented; Initial information was received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves a 81 years old male patient who experienced bed-ridden, disoriented, pain, muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders and flu symptoms after being vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IBUPROFEN (IBUPROFEN); and ACETYLSALICYLIC ACID (ASA).  On 27-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, route, administration site, formulation, expiry date: Unknown) for prophylactic vaccination (Immunization).  On 27-Sep-2022 the patient developed a non-serious bed-ridden (bedridden), disoriented (disorientation),  muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders (muscular weakness) on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 28-Sep-2022 the patient developed a non-serious pain and flu symptoms (influenza) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that "On the 2nd day after the vaccine, his symptoms improved and continued to improve on the 3rd day until he felt like he had made it through the follow up symptoms. However, about 30-35 days ago, the patient started to experience muscle weakness that was most pronounced in his hamstrings. The caller noted that he is in very good health and does triathlons. He thought that he could push through what he was experiencing. However, the muscle weakness has moved through his body and into his shoulders. Patient continued to work out, stretch and use the steam room at the gym. He has been swimming a lap or 2 since receiving the vaccine, when he normally would swim 8-10 laps per day. He takes an occasional Ibuprofen and a baby Acetylsalicylic acid every day. He uses heating pad and notes that those feel good."  Action taken: not applicable.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome: Unknown for all the events.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain; Flu symptoms; muscle weakness that was most pronounced in his hamstrings,muscle weakness has moved through his body and into his shoulders; bed-ridden; disoriented; Initial information was received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves a 81 years old male patient who experienced bed-ridden, disoriented, pain, muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders and flu symptoms after being vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IBUPROFEN (IBUPROFEN); and ACETYLSALICYLIC ACID (ASA).  On 27-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, route, administration site, formulation, expiry date: Unknown) for prophylactic vaccination (Immunization).  On 27-Sep-2022 the patient developed a non-serious bed-ridden (bedridden), disoriented (disorientation),  muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders (muscular weakness) on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 28-Sep-2022 the patient developed a non-serious pain and flu symptoms (influenza) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that "On the 2nd day after the vaccine, his symptoms improved and continued to improve on the 3rd day until he felt like he had made it through the follow up symptoms. However, about 30-35 days ago, the patient started to experience muscle weakness that was most pronounced in his hamstrings. The caller noted that he is in very good health and does triathlons. He thought that he could push through what he was experiencing. However, the muscle weakness has moved through his body and into his shoulders. Patient continued to work out, stretch and use the steam room at the gym. He has been swimming a lap or 2 since receiving the vaccine, when he normally would swim 8-10 laps per day. He takes an occasional Ibuprofen and a baby Acetylsalicylic acid every day. He uses heating pad and notes that those feel good."  Action taken: not applicable.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome: Unknown for all the events.