chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: The pt had trouble breathing and chest tightness; The pt had trouble breathing and chest tightness; This spontaneous report was received from a consumer referring to a 60-year-old female patient.      On an unknown date in 2019, the patient was vaccinated for prophylaxis with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage regimen, route of administration, lot number and expiration date were not provided.         On an unknown date, the patient had trouble breathing and chest tightness. The outcome of the events was not reported. Causality assessment was not provided.  The litigation case refers the patient had claimed suffered herpes zoster due to zoster vaccine live (ZOSTAVAX) (captured on MARRS # 2002USA003324).; Sender's Comments:  US-009507513-2002USA003324:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diverticulitis, Incomplete course of vaccination
Clinical narrative: Diagnosed with diverticulitis after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of diverticulitis in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced diverticulitis (serious criteria GSK medically significant). Shingrix was interrupted. On an unknown date, the outcome of the diverticulitis was unknown.   The reporter considered the diverticulitis to be unrelated to Shingrix.  Additional details were provided as follows: The patient was not able to get the second dose due to health issues. The pharmacist stated patient was diagnosed with diverticulitis after first dose of Shingrix but that was not due to vaccine. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: the only time patient got sick the only time patient got the poison; The only time I got the flu was the only time I got sick, never again; Based on the additional information received on 05-Nov-2020, the case became valid due o the addition of the suspect vaccine.  Initial information regarding an unsolicited non-valid non-serious case received from a consumer from social media on 29-Sep-2020.  This case involves a patient of an unknown age who got sick (illness) the only time patient got the poison and the only time the got the flu (influenza), never again, while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medicatrions and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route and administration site unknown) for prophylactic vaccination.  On an unknown date, the patient developed a non-serious the only time patient got sick the only time patient got the poison (illness) and the only time the patient got the flu, never again (influenza).  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for both events.  There will be no information available on the batch number for this case.  Additional information regarding unsolicited valid non-serious case was received on 05-nov-2020.  The case became valid due to the addition of the suspect vaccine and the event (flu) was also added.  Corresponding fields and narrative were updated accordingly.
Age: 17.0
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; sick; Based on the additional information received on 08-Oct-2020, the case was initially assessed as non-valid was amended to valid since the suspect vaccine was incorrectly selected as Sanofi Product NOs in the initial version.    Initial information received on 02-Oct-2020 regarding an unsolicited non-valid non-serious social media case through global digital media received from a consumer (Patient).  This case is linked to case 2020SA297232, 2020SA297338, 2020SA297344, 2020SA297203, 2020SA297183, 2020SA297189, 2020SA297215, 2020SA297267, 2020SA297198, 2020SA297259, 2020SA297264, 2020SA297224, 2020SA297197, 2020SA297275, 2020SA297193, 2020SA297278, 2020SA297301, 2020SA297294, 2020SA295993, 2020SA290234, 2020SA285105, 2020SA289150, 2020SA297267 and 2020SA297164 (same source, cluster)  This case involved a 17 years old patient of unknown gender who was sick for two weeks (illness) with flu (influenza) while patient had 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 in 1969, the patient had a blood test done and the doctor said that the patient needed to be vaccinated with the flu vaccine.   On an unknown date in 1969, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date in 1969, reported 3 days post-vaccination the patient was sick (illness) due to flu (influenza) for two weeks. The patient also said that since then the patient had never received the INFLUENZA VACCINE again and thus never suffered from flu also.   It was not reported if the patient received a corrective treatment.  The event outcome was resolved at the time of reporting.  There will be no information available on the batch number for this case.  Additional information received on 08-Oct-2020.   The case amended as valid as company suspect product was added. new event flu was added. The lowest level term coding for event sickness was amended. Age of the patient was updated. the year of vaccination and the year of event was also updated. The event outcome was updated to recovered.   Corresponding fields and narrative updated accordingly.
Sex: M
Vaccine: FLUX
Symptoms: Chills, Malaise
Clinical narrative: some chills; did not feel that well; Initial information regarding an unsolicited valid non-serious case was received from a non-healthcare professional (son/daughter of patient) on 23-Oct-2020.  This case concerns an unknown age male patient who had some chills (Chills) and did not feel that well (Malaise), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), past medical history, concomitant vaccination (s), vaccination(s) and family history were not provided.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer [lot number and expiry date not reported] via an unknown route in an unknown administration site for prophylactic vaccination.  On 19-Oct-2020, after few hours on the same day following administration of the suspect vaccine dose, the patient had some chills (Chills) and did not feel that well (Malaise).  No laboratory details were reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the reported events on an unknown date.  There will be no information on the batch number to be requested for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: My son and I got the flu shot and still got the  virus; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from an consumer.  This case involves unknown age male patient who experienced flu (Influenza) while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route.  On an unknown date the patient experienced a non-serious flu (Influenza) following the administration of INFLUENZA VACCINE.  Other relevant tests included no lab data.  Final diagnosis was Influenza.  An unknown corrective treatment was received.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: had  worse side effects from it each year I get it; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via Social media.  This case is linked to case 2020SA308845.  This case involves an Adult patient with unknown demographics who had worse side effects from it each year the patient get it (adverse drug reaction), while the patient received vaccine INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, after started vaccine it was reported that,they may not give you the flu but, the patient had worse side effects from it each year the patient get it (adverse drug reaction). It was terrible this year  (latency unknown), following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  Final diagnosis was adverse drug reaction.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for adverse drug reaction.  There will be no information available on the batch number for this case
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 05-Nov-2020 regarding an unsolicited non-valid non-serious social media case through global digital media received from a patient.  This case involves a patient of unknown demographics who reported of suffering from flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history included flu.  Information about past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.   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 as a prophylactic vaccination.  On an unspecified date, (latency unknown) after the administration of vaccine, the patient reported of suffering from flu (influenza). The patient also reported that after each administration of INFUENZA VACCINE, the patient suffers from flu.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information regarding the batch number of the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: the patient had gotten one and had gotten the flu; Initial information regarding this unsolicited valid non-serious social media case received from a patient and transmitted to Sanofi on 05-Nov-2020.  This case involved a patient of unknown demographics who had gotten one INFLUENZA VACCINE and had gotten the flu (influenza).  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, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. It was reported that the patient was healthy as a horse if the patient did not get it.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
Sex: F
Vaccine: FLUX
Symptoms: H1N1 influenza
Clinical narrative: swine flu; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient relative).  This case is linked to case 2020SA313336 (same reporter).  This case involves an Adult female patient who had swine flu (h1n1 influenza), while she received vaccine INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown), the patient developed a non-serious swine flu (h1n1 influenza) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for h1n1 influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: H1N1 influenza, Illness
Clinical narrative: came down with it immediately after ,and she was diagnosed with Swine flu; She was sick for several weeks; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA313295.  This case involved an adult female patient who was diagnosed with Swine flu (H1N1 influenza) and was sick for several weeks (Illness), while she received(INFLUENZA VACCINE (MONOVALENT).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE MONOVALENT(INFLUENZA VACCINE (MONOVALENT) (Unknown)  produced by unknown manufacturer( lot number not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, immediately after the vaccination the patient was diagnosed with Swine flu (H1N1 influenza) and was sick for several weeks (Illness), (unknown latency) following the administration of INFLUENZA VACCINE MONOVALENT.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 year old patient was injected with Flublok with no AE; received a 0.5mL dose of Flublok Vaccine in error instead of the appropriate Fluzone Quadrivalent 0.5ml with no AE; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved a 17 year old male patient who was vaccinated with 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] via intramuscular route at right arm for prophylactic vaccination (lot number UJ509AA and expiry date 10-May-2021) on 01-Nov-2020 in error instead of the appropriate INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no adverse event (AE) (product administered to patient of inappropriate age and wrong product administered).   The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was a potential medication error due to product administered to patient of inappropriate age and wrong product administered (latency same day). The reporter reported that she went to grab the vaccine the INFLUENZA QUADRIVAL A-B VACCINE but as both INFLUENZA QUADRIVAL A-B VACCINE and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  were side by side and the 180 and over was not circled and also the trade names of the vaccines namely Flublok and Fluzone were too similar and the boxes were very similar and she was in a hurry and accidentally grabbed the wrong box.   The patient has not exhibited any AE as a result.  There was no treatment received by the patient. The patient also received no other series of vaccines.   The event outcome was not applicable for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful, swollen and red at the injection site; Painful, swollen and red at the injection site; Painful, swollen and red at the injection site; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves an adult female patient who experienced painful, swollen and red at the injection site, (injection site erythema, injection site pain and injection site swelling) while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.the patient developed a non-serious painful, swollen and red at the injection site (injection site erythema, injection site pain and injection site swelling) of her annual flu shot this year.  Final diagnosis was injection site erythema, injection site pain and injection site swelling.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for injection site erythema, injection site pain and injection site swelling.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Feeling abnormal, Feeling cold, Illness, Influenza
Clinical narrative: Felt rough for a few hours; had cold chills; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case. This case involved a patient with unknown demographics who had cold chills (Chills) and felt rough for a few hours (Feeling abnormal), 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 (Influenza) and sick for over a week (Illness) (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 both 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: Influenza
Clinical narrative: Had horrible case of flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient of unknown demographic who had flu (influenza), while the patient received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received an unknown  dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route and administration site unknown) for prophylactic vaccination.  On an unknown date, the patient had flu (influenza) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Feverish; cold chills; feel rough; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  The case was related to 2020SA314462 and 2020SA314438 (cluster case).   This case involves adult patient of unknown gender who reported of feeling feverish (Pyrexia), cold chills (chills) and felt rough (feeling abnormal), after being vaccinated with 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 and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that every time the patient received a shot felt feverish (Pyrexia), experienced cold chills (chills) and felt rough (feeling abnormal), 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 all 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: Chills, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Felt feverish, then had cold chills and felt rough for a few hours; patient feel bad after a flu shot; Felt feverish, then had cold chills; Felt feverish, then had cold chills; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a unknown demographics patient feel bad after a flu shot (feeling abnormal), felt feverish, then had cold chills and felt rough for a few hours (pyrexia), (chills), (discomfort), 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, the patient feel bad after a flu shot (feeling abnormal), felt feverish, then had cold chills and felt rough for a few hours (pyrexia), (chills), (discomfort) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was feeling abnormal, pyrexia, chills, discomfort.   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: Influenza
Clinical narrative: got back to back Flu after influenza vaccine last 2 years; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Nov-2020.  This case involves a patient of an unknown demographics who had got back to back flu (influenza), while patient received Influenza vaccine last 2 years.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Past vaccination included a dose of INFLUENZA VACCINE and patient got flu.  Concomitant medication was not reported.   On an unspecified date in 2019, 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 prophylactic vaccine.  On an unspecified date in 2019, the patient got flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that patient got back to back flu after influenza vaccine last 2 years and not long after getting the flu shot. Hence the patient did not go for the flu shot present year.  Lab details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was not reported.  There will be no information regarding the batch number of the case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's past vaccinations included INFLUENZA VACCINE taken it last 6 years. The patient's medical history, past medical treatment(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 and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: fever; stiffness in my arm for a week; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who experienced fever (pyrexia) and stiffness in his/her arm for a week (musculoskeletal stiffness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past 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 and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed fever (pyrexia) and stiffness in his/her arm for a week (musculoskeletal stiffness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for 1 and half days after getting this year flu shot; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of unknown demographic who was sick for 1 and half days, while the patient received Influenza vaccine.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (batch number, expiry date route and administration site not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) after administration of Influenza vaccine the patient was sick for 1 and half days (illness).  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (Non-Healthcare Professional) (patients husband) via social media.  This case involves a female patient of an unknown age who was sick (Illness), while received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergic to egg products. Concomitant medications were not reported.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient was sick (Illness) (unknown latency) most of the time, following the administration of INFLUENZA VACCINE. It was reported that the patient was sick because she was allergic to sick.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Pneumonia
Clinical narrative: pneumonia; arms swollen; arms hurting; Initial information was received on 06-Nov-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographic who experienced pneumonia, swollen arms (peripheral swelling) and hurting arms (pain in extremity), while patient was treated with INFUENZA 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 produced by unknown manufacturer [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), the patient experienced pneumonia (serious event), arms swollen (peripheral swelling) and arms hurting (pain in extremity) (non-serious events) following administration of INFUENZA VACCINE. The event pneumonia was assessed as medically significant.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the pneumonia was unknown and recovered for peripheral swelling and pain in extremity (duration was reported as two days).  Information on the batch number was requested.; Sender's Comments: Sanofi company comment dated 11-Dec-2020: This case concerns a patient of unknown age who was presented event pneumonia, hand swelling and arm pain after vaccination with company suspect Influenza Vaccine. The time to onset was compatible. However, patient's medical condition, concomitant medication ruling out alternate etiologies, laboratory tests were not reported. One vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: so sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past 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 and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient got the shot twice and both times he/she was sick and not had shot since then.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional on 08-Nov-2020.  This case was linked to case 2020SA314739 (same reporter).  This case involved patient (with unknown demographics) who got the flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, 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 prophylactic vaccination.  On an unknown date it was reported that, the patient caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information regarding an unsolicited valid non-serious social media case received from a consumer (patient) on 08-Nov-2020.  This case was linked to case 2020SA314728 (same reporter).  This case involved seven patients (with unknown demographics) who got the flu (influenza), when received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date 45 years ago, all the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date (45 years ago) it was reported that, all the seven patients caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that vaccine was never administered again and over 45 years without a shot was doing fine.  Laboratory details were not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got the shots I was horribly sick; Initial information was received on 06-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via social media.  This case involves adult patient with an unknown demography details for whom it was reported that got the shots and was horribly sick (illness), while being received vaccine influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication 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, (latency: unknown) after starting the suspect vaccine therapy, the patient was horribly 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. No further relevant information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: it gave me the flu; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional.  This case involves adult patient with an unknown demography details for whom it was reported that it gave the flu (influenza), while being received vaccine influenza vaccine.  This case is linked to case 2020SA314745 (same reporter).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication 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, (latency: unknown) after starting the suspect vaccine therapy, the patient had flu (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. No further relevant information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: When patient got a flu shot it seems to build my immune system against cold, patient got them but not severe; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age and when patient got a flu shot it seems to build patient's immune system against cold, patient got them but not severe (nasopharyngitis), 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, when patient got a flu shot it seems to build patient's immune system against cold, patient got them but not severe (nasopharyngitis).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Illness, Mouth breathing
Clinical narrative: sick; patient could not breath in through his nose for months; Initial and follow up information received on 07-Nov-2020 and 09-Nov-2020 regarding an unsolicited valid non-serious social media  case received from a consumer (patient).This case was linked to case 2020SA314884 (same reporter).  This case involves a male patient (age not reported) who was sick (illness) and could not breath in through his nose for months (Mouth breathing), while he received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient was allergic to several medications, penicillin, amoxicillin and did not know what else might react on him.  On an unknown date (reported as 30 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) and could not breath in through his nose for months (Mouth breathing) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that he had to live on nasal spray to breath. Had no flu shot ever again. His doctor tried every year to get him to take a flu shot, but like he said never again he would rather take any chances.  Other relevant tests not reported.  At the time of reporting, outcome for events was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional.  This case was linked to case 2020SA314855 (same reporter).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date (reported as 30 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: diagnosed with the flu 14 years in a row; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer/ non healthcare professional (patient's mother).  This case involves a male patient of an unknown age who diagnosed with the flu 14 years in a row (influenza), after he received INFLUENZA VACCINE.  The patient's medical history, past 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 and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE, the patient spent 14 years working and he was diagnosed with the flu 14 years in a row (influenza) Not 1 single time since he got out. By the way he was forced to take the flu shot.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for influenza was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who had flu (influenza), after he/she received INFLUENZA VACCINE.  The patient's medical history, past 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 and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Patient mentioned that he/she would not take another dose.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for influenza was unknown.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got very sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional.   This case involves a female patient (age not reported) who got very sick (illness), after she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history was not provided. At the time of the event, the patient had an egg allergy.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that reporter just got on here to warn people about egg allergy. He/she was allergic and there are many people who are but are still getting the flu shot.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional on 08-Nov-2020. This case involves patient (with unknown demographics) who got the flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, 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 prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient stopped vaccine 15 years ago haven't had the flu since.  Laboratory details were not reported.  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.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: slight fever; not feel good; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who had slight fever (pyrexia) and not feel good (malaise), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had slight fever (pyrexia) and not feel good (malaise), (unknown latency), following the administration of INFLUENZA VACCINE for few days. It was reported that events were experienced twice.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown for both the events at the time of reporting.  There will be no information available on the batch number for this case.