chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: my mother got it every year and was sick for a week afterwards; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) .  This case involved a female patient of an unknown age who got it every year and was sick for a week afterwards (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that patient got it every year and was sick for a week afterwards (Illness). No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of illness was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I get the flu; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) .  This case involved a patient of an unknown age and gender who get the flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(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, unknown latency, the patient got the flu (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got very ill; Initial information was received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves a patient (unknown demography) who got very ill (illness), while the patient received INFLUENZA VACCINE.  The patient's past vaccination(s) included Flu shot [Influenza vaccine] from which got sick.  Medical history, medical treatments, concomitant medications 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got very ill (illness) (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.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: always get the light sniffles and a very low grade fever after I get one; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a female patient of an unknown age who always get the light sniffles and a very low-grade fever (Pyrexia), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that patient always get the light sniffles and a very low-grade fever (Pyrexia) after receiving the suspect vaccine.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of pyrexia.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got INFLUENZA VACCINE every year but a few times patient was sick with the flue all winter; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media (and transmitted to Sanofi on 01-Nov-2020.  This case involves an unknown age patient got INFLUENZA VACCINE every year but a few times patient was sick with the flue all winter (Influenza).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date every year, the patient received INFLUENZA VACCINE (produced by unknown manufacturer) (lot number Unknown) via unknown route in unknown administration site for prophylactic vaccination but a few times patient was sick with the flue all winter (Influenza).  Final diagnosis was Influenza.   No laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  Lot number was not reported for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get bad flu; Initial information was received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case from the non-health care professional.  This case involves patient with unknown demographics who experienced bad flu (influenza), while he/she received INFLUENZA VACCINE.   The patient get bad flu everytime when take it. The patient's medical history, medical treatment(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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get bad flu (influenza) (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.  The outcome of the event was Unknown for bad flu.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The Flu shot always gave me the flu; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious social media case from the non-health care professional.  This case involves patient with unknown demographics who experienced the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (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, the outcome of the events was not reported.   The Flu shot always gave the flu that's why patient stop taking them, take his/her chances with the elements and doing fine.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: patient was so sick; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).    This case involves patient (age and gender unspecified) who was so sick (illness), 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 for prophylactic vaccination.  On an unknown date, the patient was so sick (illness) (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: Illness
Clinical narrative: I got my flu shot last year and was sick for over a week after; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a patient of an unknown age and gender who get the Sickness (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(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, unknown latency, the patient got the flu shot last year and was sick for over a week after (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of Illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Illness, Malaise
Clinical narrative: sick; it felt pretty bad; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case from a patient via Social Media.   This case involves a patient of unknown demographics who complained of getting sick after a shot (illness) and that the patient felt pretty bad (feeling abnormal) while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date in 2019 (reported last year), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date in 2019 when the patient had received a shot and got sick (illness) and that the patient had felt pretty bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. The events continued for 4 weeks as reported by the patient.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was recovered for the events at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Therapeutic product ineffective
Clinical narrative: first shot i ever got I got sick; bad strain shots were not very effective; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case from a patient child. The case is related case ID 2020SA313237 (case of father).  This case involves a patient of unknown demographics who complained of getting sick after the first shot (illness) and that it was bad strain shots that were not very effective (therapeutic product ineffective) while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date in 2016 (reported about 4 years ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date in 2016, when the patient had received the first ever shot, the patient had got sick (illness) and that it was a bad strain sot which was not very effective (therapeutic product ineffective), (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown for sickness and not applicable for therapeutic product ineffective.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick after one of his shots; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case from patient's child via Social Media.  This case involves an adult male patient of unknown age who got sick after one of his shot (illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got sick after one of his shot (illness), (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: flu after everytime got the shot; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via Social Media.  This case involved an adult patient of an unknown age and gender who  experienced flu after everytime got the shot (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient got the flu after everytime the patient got the shot (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: worst flu ever had; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via social media.  This case involved an adult patient of an unknown age and gender who got the worst flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date in 1974, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient stated that the patient got. A flu shot in 1974 , it was the worst flu the patient  ever had , no flu since that time (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media.  This case involved an adult patient of an unknown age and gender who experienced arm was really sore (Limb discomfort), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported Just got the flu shot ist day may arm was really sore, but that was the only symptom (Limb discomfort).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: 102 fever; sicker than a dog; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via Social Media.  This case involved an adult patient of an unknown age and gender who experienced 102 fever (pyrexia) and sicker than a dog (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient got a flu shot years ago and had 102 fever (pyrexia) and was sicker than a dog (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events were reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Flu shots make me sick; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case from patient via social media.  This case involves a patient of unknown demographics who reported that flu shot made sick (illness) while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, patient reported that flu shots had made sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The patient had received the vaccine while being at work.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case from patient via Social Media.  This case involves a patient of unknown demographics who had flu (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  The patient reported of not having any trouble with the shot but then on an unknown date, patient had flu (influenza) later on the season, (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE as prophylactic vaccination. The patient's medical history, concomitant therapy, medical treatment(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 flu (influenza) (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, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got very sick from the flu shot; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who got very sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's 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 got very sick (illness) (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, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was sicker than a dog for up to 6 weeks; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who was sicker than a dog for up to 6 weeks (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included Influenza vaccine as prophylactic vaccination The patient's medical history, concomitant therapy, medical treatment(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 was sicker than a dog for up to 6 weeks (illness) (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, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: patient arm was awfully sore; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender whose arm was awfully sore (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's 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's arm was awfully sore (pain in extremity) (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, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: flu; ill; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced flu (influenza) and ill (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and ill (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: patient became sick; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.    This case involves a female patient (age unspecified) who became sick (illness), while patient the 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) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (illness) (non-serious) next day for couple of days (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: Illness, Malaise
Clinical narrative: patient took one flu shot and was sick; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient (age and gender unspecified) who was sick (illness), 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 for prophylactic vaccination.  On an unknown date, the patient experienced sick (illness) for 6 days (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: flu; Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious case via consumer or non-health care professional (patient).   This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious 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 was unknown.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Initial information received on 28-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves patient (unknown demographics) who had Guillain-Barre Syndrome-nearly died (Guillain-Barre syndrome) (GBS), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date (reported as in 1974), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre Syndrome (Guillain-Barre syndrome) (latency unknown) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported all vaccines had side effects from near zero to severe.  No laboratory data reported.  It was not reported if the patient was receiving any corrective treatment.  At the time of reporting, the outcome was not reported for the event Guillain-Barre syndrome.  Information on the batch number to be requested.; Sender's Comments: Sanofi Company Comment dated 06-Dec-2020 : This poorly documented social media case concerns a patient of unknown demographics who had Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE. Time to onset is unkwnon. Also, patient's medical condition at the time of vaccination, concomitant medications and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: gotten the pneumonia three times as year; flu; Initial information was received on 29-Nov-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media (Facebook).  This case involves a patient (unknown demographics) who experienced pneumonia three times as year (pneumonia) and flu (influenza), while the patient received vaccine INFLUENZA VACCINE and PNEUMOCOCCAL 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 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 pneumonia up to 3 times as year (serious) and always got flu (influenza)(non-serious) (unknown latency) after the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. Pneumonia was assessed as medically significant  It was reported that, the patient did not had these vaccine for two years and did not experienced these events.   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.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from Facebook involves a patient (unknown demography) 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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 29-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who became sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine as prophylactic vaccination.  The patient's past medical history, concomitant therapy, medical treatment(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 became sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for three to seven days once in extensive care 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 report, the outcome of event was unknown.  Information on the batch number was requested; Sender's Comments: This case involves a patient (unknown age and gender) who experienced illness 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: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; flu; Initial information was received on 28-Nov-2020 regarding an unsolicited valid serious social media case from the patient.  This case involved an unknown demographic patient who experienced pneumonia and flu (influenza), after the patient received vaccine INFLUENZA VACCINE.  The patient had received influenza vaccine in the past (reported as the patient always get flu shot).  The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date (about 3 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed serious pneumonia and non serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, people may not get it from the shot but still can get it.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly document social media case concerns an unknown demographic patient who had pneumonia and influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Influenza, Nasopharyngitis
Clinical narrative: bronchitis; bad colds; sick with the flu; Initial information was received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) .  This case involves a female patient (age unspecified) who had bronchitis, bad colds (nasopharyngitis) and was sick with the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bronchitis, bad colds (nasopharyngitis) and was sick with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE every year. She stopped taking the shots and hasn't been sick at all  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: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: she had a reaction; Initial information received on 20-Nov-2017 regarding an unsolicited valid non-serious case from a non-healthcare professional (medical representative).  This case involves an adult female patient of an unknown age who experienced she had a reaction (adverse reaction), while she received vaccine influenza usp trival a-b high dose subvirion vaccine [Trivalent Influenza Vaccine].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect 0.5 mL once a day influenza usp trival a-b high dose subvirion vaccine (formulation: unknown) (batch number: UH898AC and expiry date: 30-Jun-2014) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, (Latency: unknown) in the 2013-2014 season reporter was only aware that the patient stated she had a reaction (adverse reaction) she had no information further to provide on what the reaction was or the patients allergy profile or even patient's name after speaking with her.  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was resolved on an unknown date.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sickness; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).    This case involves patient (age unspecified) who experienced sickness (illness), 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) [batch 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 sickness (illness) (the next day) 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.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Fluzone Quadrivalent standard dose in error instead of Fluzone High Dose due to their ages/ No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via call center via The agency (Reference number- 00334255) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 73 years old female patient who received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot UJ428AA, expiry date not reported] via an intramuscular route at an unknown administration site on 20-Oct-2020 for prophylactic vaccination  in error instead of fluzone high dose (lot number and expiry date not reported) due to their ages (wrong product administered).  Medical history, medical treatments, past vaccinations and family history were not provided.  Patient did not receive any other concomitant vaccines.   It was a case of an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  It was reported that, caller requested one type of flu vaccine (High Dose) and did not get the vaccine.   Product used : Used  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: injection site reaction; Initial information regarding an unsolicited valid non-serious case was received from a physician via call center via Agency (Reference number- US-SANOFI-00335573) and transmitted to Sanofi on 28-Oct-2020. This case involves female patient (age unspecified) who experienced injection site reaction (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number, expiry date not reported)(single use vials and pre-filled pens) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection site reaction (vaccination site reaction) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: multiple increased body aches; multiple increased fever and body aches; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 16 years old patient who experienced multiple increased body aches and fever (pyrexia)and body aches (pain), after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and suspect TRUMENBA not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious multiple increased body aches (pyrexia) and body aches (pain) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was not reported for the evens pyrexia and pain.  There will be no information on the batch number or this case.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: second dose for pre-exposure was not available for administration with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via The Agency (Reference number- 00351800) and transmitted to Sanofi on 09-Nov-2020.  This case involves a male patient who did not received second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] for pre-exposure as it was not available for administration with no adverse event, (lot number not reported, expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination, on an 9-Nov-2020 (product dose omission issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to missed dose (latency same day).  No lab test was reported. Action taken was not applicable. Corrective treatment was not reported. The outcome of the event was not applicable. At the time of reporting, 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 holders 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 on the batch number for this case.