chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Body temperature increased
Clinical narrative: Took flu shot in 12 hrs running106 temp didn't knowwho I was for three days; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via Social Media.  This case involves a patient unknown age who "took flu shot in 12 hrs running106 temp didn't know who i was for three days" (pyrexia), while he/she received vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received influenza vaccine (lot number and expiry date) at unknown dose via unknown route at unknown administration site for prophylactic vaccination.   On an unknown date, (latency unknown) after administering suspect vaccination therapy, Took flu shot in 12 hrs running106 temperature didn't know who patient was for three days (pyrexia) said never take flu shot again. No patient was not allergic to chickens eggs or feathers my sun , same why so want take it.  No lab data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient got very sick; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious social media case from consumer (patient) via Social media.  This case was linked with 2020SA304713 and 2020SA282884.  This case involved a patient with unknown demographic who got very sick (Illness), while he/she 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 got very sick (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Patient reported that their explanation to the patient was that patient had contact with the flu before got the shot didn't make him/her feel better about getting the shot. They should also tell that patient could still get the flu it depends on the strain and if they guess the combination correctly.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: so sick after taking that shot; Initial information regarding this unsolicited valid non-serious case was received from a consumer (son-in-law of the patient) and transmitted to Sanofi on 27-Oct-2020.  This case was linked to cases 2020SA305170, 2020SA305230, 2020SA305222, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305545, 2020SA305591, 2020SA305629 and 2020SA305629.  This case involved a female patient of unknown age who was so sick (illness) after taking that shot, of vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that it just made people sick as hell and the patient was so sick after taking that shot (illness) unknown latency following the administration of INFLUENZA VACCINE. The reporter thought that she was a goner.  Relevant laboratory test was not reported.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Injection site warmth
Clinical narrative: Next day - difficulty in raising left arm, warmth at vaccination site. Sunday - shingles rash on arm approximately 2" long, 2" wide
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Pain
Clinical narrative: ache; feel crummy afterwards; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA305872, 2020SA305873, 2020SA305880, 2020SA305875, 2020SA305876, 2020SA305879, 2020SA305870, 2020SA305874, 2020SA305871, 2020SA305871.  This case involves a patient of an unknown age who experienced ache (pain) and feel crummy afterwards (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient experienced ache (pain) and feel crummy afterwards (feeling abnormal).  No laboratory data was 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 regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feel really horrible, feel bad; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 28-Oct-2020.  This case was linked to cases 2020SA305859, 2020SA305870, 2020SA305871, 2020SA305872, 2020SA305873, 2020SA305874, 2020SA305875, 2020SA305876, 2020SA305879 and 2020SA305880.  This case involved a patient of unknown demographics who felt really horrible, felt bad (feeling abnormal), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. It was reported that the patient received the vaccine for the past five years.  It was also reported that the patient felt really horrible (feeling abnormal) every time, the date after the administration of INFLUENZA VACCINE. But the patient was still getting them, also got the vaccine yesterday and was feeling bad today (feeling abnormal). But tomorrow would be ok. The patient guessed that the patient was not like everyone else  Relevant laboratory test was not reported.  Final diagnosis was feeling abnormal.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The flu shot gave patient the flu; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to cases 2020SA305873 and 2020SA305878.  This case involves a patient to whom flu shot gave the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  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, patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: get sick; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who gets sick (illness), when the patient 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 got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, every time the patient get sick after the flu 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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot and still got the virus; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from consumer (patient) via Social media.  This case is linked to cases 2020SA306301, 2020SA306300, 2020SA306303, 2020SA306304, 2020SA306305, 2020SA306306, 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306276, 2020SA306299, 2020SA306302.  This case involved a patient with unknown demographic who got the flu shot and still got the virus (Influenza), while he/she 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 got the flu shot and still got the virus (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via social media on 29-Oct-2020.  This case involved a patient of an unknown age and gender who experienced sore arm (Pain in extremity), 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 an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient developed sore arm (Pain in extremity) for couple of days.   No relevant laboratory details were provided.    It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: It gave me the flu twice; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who got the flu twice (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  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, patient who got the flu twice (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.    There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feeling lousy; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 24-Oct-2020.  This case was linked to cases 2020SA308167, 2020SA308168, 2020SA308169, 2020SA308170, 2020SA308171, 2020SA308172, 2020SA308173, 2020SA308174, 2020SA308163 and 2020SA308176.  This case involved a patient of unknown demographics who was feeling lousy (feeling abnormal), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. The patient did finally get all the important shots.  On an unknown date, the patient was feeling lousy (feeling abnormal), unknown latency following the administration of INFLUENZA VACCINE. The patient would be ok.  No laboratories details 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.  There would be no information available on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Had two flu shots, was sicker than patient have ever been in my life; Initial information received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case is linked to case 2020SA308167, 2020SA308168, 2020SA308169, 2020SA308170, 2020SA308163, 2020SA308172, 2020SA308173, 2020SA308174, 2020SA308175 and 2020SA308171 (same reporter).  This case involves a patient of unknown age who had two flu shots, was sicker than patient had ever been in his/her life (illness), while patient was treated with Influenza Vaccine.  Medical history included pneumonia after pneumonia vaccination.   Medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine of unknown manufacturer [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, was sicker than patient had ever been in his/her life (illness).  No laboratory data was reported.  No corrective treatment (preventive medicine) was received.  At the time of reporting, outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: And had the flu,all Winter; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who had the flu all winter (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  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, patient who had the flu all winter (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick for over a week; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case is linked to case 2020SA314441 (same reporter).  This case involves a male patient (unknown age) who got sick for over a week (illness), after receiving 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 got sick for over a week (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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick for 2 weeks; 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 patient age and gender unspecified] who got sick for 2 weeks (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 got sick for 2 weeks (illness) (non-serious) 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: Malaise, Vaccine positive rechallenge
Clinical narrative: sick; Initial information was received on 09-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 was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations 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 was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient every time got sick after flu shot.   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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick; Initial information was received on 09-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 got 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 prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got 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: Vomiting
Clinical narrative: Puking sick for a month; Initial information was received on 10-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 was puking sick for a month (illness), while the patient 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 who puking sick for a month (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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 13-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 sick (illness), while the patient 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 got 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 report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was sick as a dog; Initial information was received on 13-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 was sick as a dog (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations 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 was sick as a dog (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient had not got one since and had been fine every flu season.   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: Malaise
Clinical narrative: got very ill; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case involves female patient (unknown age) who got very ill (illness), while she 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 developed non-serious got very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, she stopped taking flu shots and did much better without getting them. No one could ever explain why she got so ill after getting a flu shot.  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: Malaise
Clinical narrative: got very ill; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves female patient (unknown age) who got very ill (illness), while she 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 developed non-serious got very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, she stopped taking flu shots and did much better without getting them. No one could ever explain why she got so ill after getting a flu shot.  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: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of Pentacel was administered on 11/16 but expired on 11/03/20 /No AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Medical Information (Reference number- 00363926) and transmitted to Sanofi on 18-Nov-2020 via call-center.  This case involves a patient of an unknown demographic who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 16-Nov-2020 which was expired on 03-Nov-20 via unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).  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 of PENTACEL for this case.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: One episode of fever 101 F; Initial information regarding this unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 26-Oct-2020.  This case involved a 48 year old male patient who experienced one episode of fever 101 F (pyrexia), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 26-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed one non-serious episode of fever 101 F (pyrexia) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 28-Oct-2020, relevant laboratory test results of COVID-19 showed negative.  Final diagnosis was pyrexia.   No fever medication was given as corrective treatment.  On an unknown date, the patient had recovered from the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Lymph node abscess, Lymphadenopathy
Clinical narrative: Got a swollen lymph node in my groin with abscesses after flu shot; Initial information regarding an unsolicited valid serious case received from a consumer (patient) via social media on 03-DEC-2020.  This case involves a patient of unknown demographics who developed a swollen lymph node in groin with abscesses (Lymph node abscess), 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 and expiration date unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect INFLUENZA VACCINE  the patient got a swollen lymph node in groin with abscesses (Lymph node abscess).  Seriousness: The event was medically significant.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The outcome was recovered for lymph node abscess.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a patient of unknown demographics who presented with Lymph node abscess after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: My husband got the flu shot the very next day he was in the hospital, made him so sick; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a non-health care professional (patient's wife) via social media.  This case involves a male patient of unknown age who was so sick (illness), while he received Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of suspect vaccine, reporter reported that her husband got the flu shot the very next day he was in the hospital (seriousness criteria), made him so sick (illness).  No laboratory data was 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 regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who was hospitalized with sickness after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, 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: got the flu and nearly died; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).   This case involves an adult patient who got the flu and nearly died (Influenza), while patient received vaccine INFLUENZA VACCINE.  Patient had received INFLUENZA VACCINE in past and got flu (Influenza).  The patient's medical history, past medical treatment(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 expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu and nearly died (Influenza) (non-serious), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown the event Influenza at the time of reporting.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: My late husband would be sick for 2 weeks after getting flu shots; Initial information was received on 03-Dec-2002 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient's wife) via social media.  This case involves a male patient (age unspecified) who experienced sickness for 2 weeks, after vaccination with INFLUENZA VACCINE [flu shots].  Medical history, medical treatment, vaccination, family history and concomitant medication 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 non-serious sickness (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.  on an unknown date, the patient was recovered from illness (sickness for 2 weeks).  The patient was already died at the time of reporting, the cause of death was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: within couple of hours the patient started getting sick, and within 6-7 hours patient was sicker'n hell; High Fever; puking my guts up; Initial information was received on 03-Dec-2020 regarding an unsolicited valid serious social media case from a consumer (patient) via social media.  This case involved a patient with unknown demographic who experienced high fever (Pyrexia), puking his/her guts up (Vomiting) and within couple of hours the patient started getting sick and within 6-7 hours patient was sicker'n hell (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza Vaccine for prophylactic vaccination and ended up in the hospital with High fever, puking guts up and it was within couple of hours the patient started getting sick and within 6-7 hours patient was sicker as hell. The patient's past medical history, medical treatment(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed high fever (Pyrexia), puking his/her guts up (Vomiting) (Unknown latency for both) and within couple of hours the patient started getting sick and within 6-7 hours patient was sicker'n hell (Illness) following the administration of INFLUENZA VACCINE. The patient was hospitalized for all the events.  Laboratory test data was not reported.   Intravenous in arm was received as corrective treatment for puking guts up and unknown for rest of the events.  At the time of reporting the event outcome was reported as unknown for all the events.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns a patient with unknown demographic who presented with pyrexia, vomiting, sickness after vaccination with  INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, concomitant medication and laboratory tests were not reported. The patient took INFLUENZA VACCINE two years ago as required, ended up in the hospital with same events. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: serious allergic reaction; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient (demographics unknown) who had a serious allergic reaction (hypersensitivity), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), past 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 (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 1992, the patient developed a serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient could not get one anymore. The allergy specialist said the next one could actually kill the patient.  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.  Information on batch number was requested for this case.; Sender's Comments: This poorly documented case from social media concerns a patient who had hypersensitivity after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and 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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick as hell; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient [age and gender unspecified] who experienced sick as hell (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 developed a non-serious sick as hell (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: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had his flu shot since the 80's (military). Only had the flu 2 times. Only hospitalized once.; Initial information received on 05-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an 80's (military) male patient who had the flu 2 times. Only hospitalized once (influenza), while he was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient who had the flu 2 times. Only hospitalized (seriousness) once (influenza)  No laboratory data was 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 regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who had flu after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pneumonia
Clinical narrative: pnuemonia; sick; Initial information received on 05-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer.   This case involved adult female patient who got pneumonia (Pneumonia) and got sick (Illness), while she received INFLUENZA VACCINE.   the patient got sick every time she got the flu shot. The patient's medical history, 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 expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got pneumonia (Pneumonia) and got sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events, at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an adult female patient who got pneumonia (Pneumonia) and got sick (Illness), after vaccination with INFLUENZA VACCINE. Time to onset is unknown. Morever, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient died within 3 hours of the jab; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who died within 3 hours after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 1976, 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.  In 1976, the patient died within 3 hours following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The reporter also reported that vaccine manufacturers cannot be held liable for death or injury from a flu vaccine. Would you buy tires from someone knowing they do not stand behind their product? Why would you inject toxins, poison, aborted baby fetal tissue into your bloodstream to avoid getting a virus with a 99.7 percent survival rate? More people die of the side effects of the vaccine than the disease itself.  The details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment before he died.  It was unknown if an autopsy was done. The cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a male patient (age not reported) who died within 3 hours after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient died within 3 hours of the jab