chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Nov-2020 regarding an unsolicited valid serious case received from social media consumer (patient) .  This case involves patient (unknown demographics) who experienced flu (influenza), when received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient (unknown demographics) who had influenza, after and despite vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, immune status, product brand name would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, Upper respiratory tract infection
Clinical narrative: severe flu type symptoms; severe upper respiratory infection; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient (with unknown demographics) who experienced severe flu type symptoms (influenza like illness) and severe upper respiratory infection (upper respiratory tract infection), while he/she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was reported that patient had never been sicker and may be allergic to flu shot.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed severe flu type symptoms (influenza like illness) and severe upper respiratory infection (upper respiratory tract infection) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome was unknown for the events.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: it gave flu to patient; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional.  This case involves patient of unknown demographics who got flu (influenza), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an  unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.   This case involves a patient (unknown demography) who experienced Guillain barre syndrome, when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medication 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 and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain barre syndrome, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory data was not reported.  The patient reported that she will never get another flu shot again it was a waste of time.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly document case received from Facebook concerns a patient with unknown demography who experienced Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: patient ended up in the hospital; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media. This case involves patient (unknown demographic) ended up in the hospital (hospitalisation), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient ended up in the hospital (hospitalisation) (serious, unknown latency) after the administration of INFLUENZA VACCINE.  The reporter stated that Flu shot trying to kill and never again will get any kind of vaccine  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.; Sender's Comments: This case concerns patient (unknown demographic) who had hospitalisation after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; flue; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non health professional via social media.   This case involves a male patient (unknown age) who experienced flu (influenza) and pneumonia, while he received vaccine INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Medical history, past medical treatment(s), concomitant medications, 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 and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported for both suspect) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had serious flu (influenza) and pneumonia right after the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was hospitalized for both the events. Pneumonia was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment. It was reported as he had a caregiver who is taking care of him.  At the time of report, the outcome was unknown for the events.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from Facebook involves a male patient (unknown age) who had influenza and pneumonia after vaccination with INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. Time to onset is unknown. Additional information regarding patient's medical history, health condition at time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the individual vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Leukaemia, Weight decreased
Clinical narrative: diagnosed with leukemia; began losing weight; flu; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non health professional.  This case involves male patient (unknown age) who experienced flu (influenza) within 3 days, then 2 weeks later he began losing weight (weight decreased) and leukaemia, while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a flu (influenza) within 3 days, then 2 weeks later he began losing weight (weight decreased) and leukaemia following the administration of INFLUENZA VACCINE. The event leukaemia and weight decreased were assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case involves a male patient (unknown age) who had influenza, weight decreased and leukaemia after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is too short to be compatible for leukemia or vaccine failure. Based upon the reported information, the role of the vaccine is unlikely.
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic shock, Feeling abnormal
Clinical narrative: anaphylactic shock; 2 months of misery; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case from a consumer/non health professional via social media.   This case involves male patient (unknown age) who had anaphylactic shock and 2 months of misery (feeling abnormal), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic shock (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed 2 months of misery (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from Facebook involves a male patient (unknown age) who had anaphylactic shock and was feeling abnormal after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's medical history, health condition at time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: Last time got shot and was sick with flu for 2 weeks; Last time got shot and was sick with flu for 2 weeks; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient with unknown demography who was sick with flu for two weeks (illness and influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medication 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 and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious was sickness with flu for two weeks (illness and influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events was unknown.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre syndrome; paralyzed after taking a flu shot; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case is linked to cases 2020SA331005 and 2020SA331006 (same reporter).  This case involves a male patient (age unspecified) who had Guillain Barre syndrome (GBS) and become paralyzed (paralysis), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had Guillain Barre syndrome (GBS) and become paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient (age unspecified) who experienced Guillain Barre Syndrome and paralysis after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Initial information regarding this unsolicited valid serious social media case received from a consumer (daughter-in-law of the patient) and transmitted to Sanofi on 18-Nov-2020.  This case is linked to cases 2020SA331005 (husband) and 2020SA330951 (father).  This case involved a female patient who had a stroke (cerebrovascular accident), while she received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was reported that the patient had 5 years with no sickness and very good health.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a serious stroke (cerebrovascular accident), less than a month following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant as per important medical event (IME) list.  Flu shots are dangerous.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: Sanofi company comment dated 27-Nov-2020: This case concerns a female patient who presented with cerebrovascular accident after vaccination with INFLUENZA VACCINE. The time to onset is compatible. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional .  This case involves patient of unknown demographics who experienced flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site prophylactic vaccination.   It was reported that, 30 years ago patient received flu shot in October.   On an unknown date, the patient developed a non-serious patient got the flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient of unknown demographics who experienced flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise
Clinical narrative: sick with flu like symptoms; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (demographics unknown) who was sick with flu like symptoms (influenza like illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 1992, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient was sick with flu like symptoms (influenza like illness) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  In the fall of year 1992, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient was deathly sick for several weeks with flu like symptoms (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE. He reported that he will never take another one.  Normally he does not get sick. He decided not to take another one for several years and just as always he did not get very sick. He had a heart valve replacement surgery in Aug-2006 and had to go back and repair it in Jan-2007.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis
Clinical narrative: bronchitis; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional via social media.  This case involves a patient (unknown age) who experienced bronchitis, while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious bronchitis (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, patient had recovered from the event (last about 4-6 weeks).  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Renal failure
Clinical narrative: kidney failure; Initial information was received on 20-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media and additional information recieved on 23-Nov-2020  This case involves a patient (age unspecified) who had kidney failure (renal failure), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious kidney failure (renal failure) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and patient was hospitalized for this event.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (age unspecified) who experienced renal failure after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death, Mechanical ventilation
Clinical narrative: died from the 2x flu vaccines and ventilator; Initial information was received on 25-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient's relative) via social media.  This case involves a male patient (unknown age) who was died from the 2x flu vaccines and ventilator (death), while he received INFLUENZA VACCINE.  Medical history, past medical treatment(s), concomitant therapy, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was on ventilator was died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from social media involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. The patient was on ventilator. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Severe flu symptoms; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to cases 2020SA342078 and 2020SA342079 (same reporter).  This case involves a male patient age not reported who experienced severe flu symptoms (influenza), while he received INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe flu symptoms (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Lung disorder
Clinical narrative: pulmonary problem; Initial information received on 16-Nov-2020 regarding an unsolicited valid serious social media case from a non-health care professional (patient's wife).   This case is linked to cases 2020SA342066 and 2020SA342079 (same reporter).  This case involves a male patient (age was not reported) who had pulmonary problem (lung disorder), after he received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing medical history of diabetes mellitus.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious pulmonary problem (lung disorder), (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was hospitalized for this event on an unknown date.  Details of laboratory data were not reported.  It was reported that, the patient had to retire early due to this event.  It was not reported if the patient received any corrective treatment.  On an unknown date, 6 months later the patient had recovered from the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient who had lung disorder, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer) and PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur). The time to onset is unknown.  The patient's past vaccination and tolerance, allergic history, concomitant medication and lab tests ruling out alternate etiologies were not reported. Moreover, two different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Influenza
Clinical narrative: Bells Palsy; Severe flu symptoms; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer.  This case is linked to case 2020SA342066 (Father).  This case involves female patient who experienced bells palsy (facial paralysis) and severe flu symptoms (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication 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 and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bells palsy (facial paralysis), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious severe flu symptoms (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested; Sender's Comments: This poorly documented case concerns a female patient with unknown demography who experienced bells palsy and severe flu symptoms after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: large bruise at the injection site of the left deltoid; tenderness of the site the same day of the injection; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 year old female patient who experienced tenderness of the site the same day of the injection (Vaccination site pain) and large bruise at the injection site of the left deltoid (Vaccination site bruising), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 25-Sep-2020, the patient received a 1 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ516AA expiration date: 30-Jun-2021) via unknown route in the left deltoid for immunisation.  On 25-Sep-2020, the patient developed a non-serious tenderness of the site the same day of the injection (vaccination site pain) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed a non-serious large bruise at the injection site of the left deltoid (vaccination site bruising) 72 hours after following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Bruising was the size of a softball and located more toward the lateral side or back of the arm. Patient reported that the bruise was located more toward the area of the skin was bunched up to give the injection and that the bruise was healing but was still taking up a large area.  Final diagnosis was tenderness of the site the same day of the injection and large bruise at the injection site of the left deltoid.  No relevant laboratory tests were reported.   It was not reported if the patient received a corrective treatment.  Event outcome was reported as not resolved for both the events
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Nerve injury, Pain in extremity, Radiculopathy
Clinical narrative: Radiculopathy; tender to touch; disrupted sleep; left arm  pain; damaged nerves in her neck, going all the way up the side of her neck; red bumps; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 71 year old female patient who experienced radiculopathy, tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder), left arm pain (Pain in extremity), damaged nerves in her neck going all the way up the side of her neck (Nerve injury) and red bumps (Injection site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past vaccinations included Tetanus 5 years ago.  Medical history, medical treatments, concomitant medications and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U6628AA) via unknown route in unknown administration site for immunisation.  On an unknown date, The patient had a reaction of a whole left arm pain (Pain in extremity), damaged nerves in her neck, going all the way up the side of her neck (Nerve injury) and having been diagnosed as Radiculopathy, red bumps (Injection site swelling), tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder) and continues to be red (latency unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No relevant laboratory tests were unknown.  She received steroids for all the events.  Event outcome was reported as not resolved Pain in extremity and Injection site swelling, as resolving for Tenderness and Non-24-hour sleep-wake disorder and as Unknown for Nerve injury and Radiculopathy.
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder, Tenderness
Clinical narrative: Radiculopathy; tender to touch; disrupted sleep; left arm  pain; damaged nerves in her neck, going all the way up the side of her neck; red bumps; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 71 year old female patient who experienced radiculopathy, tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder), left arm pain (Pain in extremity), damaged nerves in her neck going all the way up the side of her neck (Nerve injury) and red bumps (Injection site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past vaccinations included Tetanus 5 years ago.  Medical history, medical treatments, concomitant medications and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U6628AA) via unknown route in unknown administration site for immunisation.  On an unknown date, The patient had a reaction of a whole left arm pain (Pain in extremity), damaged nerves in her neck, going all the way up the side of her neck (Nerve injury) and having been diagnosed as Radiculopathy, red bumps (Injection site swelling), tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder) and continues to be red (latency unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No relevant laboratory tests were unknown.  She received steroids for all the events.  Event outcome was reported as not resolved Pain in extremity and Injection site swelling, as resolving for Tenderness and Non-24-hour sleep-wake disorder and as Unknown for Nerve injury and Radiculopathy.
Sex: F
Vaccine: TD
Symptoms: Disturbance in attention, Lethargy, Local reaction, Somnolence
Clinical narrative: mental confusion; extreme difficulty concentrating; lethargic; patient slept constantly; she had a reaction after receiving the Tenvac; Initial information was received on 13-Oct-2020 regarding an unsolicited valid serious case from a consumer or other non-professional.  This case involves a 75 year old female patient who experienced mental confusion (confusional state), extreme difficulty concentrating (disturbance in attention), lethargic (lethargy) and patient slept constantly (somnolence), had a reaction after receiving the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (local reaction).  It was reported that, a years ago, the patient had to receive TETANUS VACCINE and had symptoms of mononucleosis.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a second dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious mental confusion (confusional state), extreme difficulty concentrating (disturbance in attention), lethargic (lethargy) and patient slept constantly (somnolence) (unknown latency) and had a reaction (local reaction) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from all reported event. (duration for the events: 48 hours plus)  There will be no information available on the batch number for this case.  Additional information was received on 13-Oct-2020 regarding an unsolicited valid serious case from a consumer or other non-professional.  Event local reaction was added.  corresponding fields and narrative updated accordingly.
Age: 68.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered Fluzone Quadrivalent Instead Of Fluzone High Dose Quadrivalent/no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via agency (Reference number- 00315344) and transmitted to Sanofi on 14-Oct-2020.  This case involves a 68 year old male patient was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot number and expiry date not reported] via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [lot number, expiry date and other dosing details were not applicable] (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due wrong product administered. (latency: on the same day of vaccination).  It was reported that, reporter wanted to known if the patient can be revaccinated with another dose of the FLUZONE QUADRIVALENT or given the full dose of FLUZONE HIGH-DOSE QUADRIVALENT.   At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: product was given to patient, the product was expired by 3 days with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00315549) was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case involved a patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: NAUJ134AA, expiry date: 11-Oct-2020), on 14-Oct-2020, which expired by 3 days (Expired product administered), via unknown route in unknown administration site for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   It was a case of actual medical error as expired vaccine used.  No adverse event was reported at the time of reporting.  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 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: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 38 years old patient received a dose of Fluzone High Dose with no AE; a 38 years old patient received an expired dose of Fluzone High Dose by mistake with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via Medical Information (Reference number: 00315664) .  This case involves a 38 years old male patient who received an expired 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] by mistake (lot: UJ268AA, expiry date: 10-May-2020), via intramuscular route in left deltoid on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age) and (expired product administered).  The patient's medical treatments, vaccinations and family history were not provided.   The patient's medical history included transplant.  No Concomitant medications were given.  It was a case of an actual medication error due to the expired vaccine used and inappropriate age at vaccine administration (latency same day on the day of vaccination).   Reporter wants to know if there are any known adverse effects. The Fluzone High Dose that was give was the 2019-2020 formula. They have already given the patient Fluad.  At the time of report no adverse event was reported.  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 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: 70.0
Sex: F
Vaccine: FLU4, HIBV, IPV, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Lowest temperature was -17C degrees.Total excursion time was for 63 hour and  45 minutes, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via the Agency (Reference number- 00316028) and transmitted to Sanofi on 14-Oct-2020.  This case is linked to cases 2020SA290000, 2020SA288477, 2020SA288422 and 2020SA288639 (same reporter).  This case involves a 70 year old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021) (Strength = High Dose) once via unknown route in the left deloid for prophylactic vaccination. Along with IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] on 09-Oct-2020 reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was an actual medication error due to the Product storage error temperature too low.   At the time of reporting, the patient had no 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 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.