chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the influenza A; Initial information received on 23-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an adult male patient who experienced got the influenza a after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient got the influenza a (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the influenza A).  At time of reporting, the outcome was Unknown for the event got the influenza a.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Sinusitis
Clinical narrative: still have a sinus infection; still got paa flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves Adult and unknown gender patient who still have a sinus infection and still got paa flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious still have a sinus infection (sinusitis) and still got paa flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: now sick with some sort of flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient of unknown age and demographics who experienced now sick with some sort of flu after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event now sick with some sort of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (now sick with some sort of flu).  At time of reporting, the outcome was Unknown for the event now sick with some sort of flu.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis, Pneumonia
Clinical narrative: paralyzed totally; pneumonia; gbs; Initial information was received on 25-Dec-2022 (processed as a non-case) and follow up information regarding this unsolicited valid social media serious case received from a consumer/non-hcp on same day.  This case involves male patient who experienced paralyzed totally, pneumonia and GBS  (guillain-barre syndrome) after receiving influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination (Immunisation).   On an unknown date patient got GBS (guillain-barre syndrome) from flu shot which left him paralyzed totally(paralysis) for 10 months. He would get better - boom pneumonia (onset and latency: unknown). On and on for 10 months. He finally took himself off of life support. There are many lawsuits now. Searched Guillian Barre Syndrome related to the flu shot. COVID shot is having the same effect.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.  Seriousness criteria: Medically Significant for all events.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves male patient who experienced paralyzed totally, pneumonia and GBS  (guillain-barre syndrome) after receiving influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Fatigue, Illness, Rhinorrhoea
Clinical narrative: cough; runny nose; sick; tired; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves adult patient of unknown age who experienced cough, runny nose, sick and tired after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious cough, runny nose (rhinorrhoea), sick (illness) and tired (fatigue) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pneumonia
Clinical narrative: bilateral pneumonia; Initial information received on 24-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves Adult and unknown gender patient who experienced bilateral pneumonia after receiving vaccines INFLUENZA VACCINE and COVID-19 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and had all the COVID-19 VACCINE boosters not produced (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for COVID-19 vaccination (COVID-19 immunisation).  On an unknown date, the patient developed a serious event of bilateral pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was reported, patient just home from hospital after 6 days. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (bilateral pneumonia).  At time of reporting, the outcome was Recovering / Resolving for the event bilateral pneumonia.; Sender's Comments: company comment dated 28-Dec-2022: This case involves an Adult and unknown gender patient who experienced bilateral pneumonia after receiving vaccines INFLUENZA VACCINE and COVID-19 VACCINE. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, concomitant medications and lab investigations, underlying medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: me too had guillian barre; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received via consumer.  This case involves Adult and unknown gender patient who stated me too had guillian barre after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had an event of me too had guillian barre (guillain-barre syndrome) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.  Seriousness Criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves Adult and unknown gender patient who stated me too had guillian barre after receiving influenza vaccine. The clinical course of the event was not provided. Furthermore, information regarding latency to onset, condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillian barre; Initial information received on 24-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp via Social Media, Flu page.  This case involves patient of unknown age and gender who experienced guillian barre after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient experienced a serious event of guillian barre (guillain-barre syndrome) (unknown latency) following the administration of influenza vaccine.   It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This event was assessed as medically significant.; Sender's Comments: Sanofi company comment for information received on 27-Dec-2022: This case involves patient of unknown age and gender who experienced guillian barre after receiving vaccine influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome, Pain, Paralysis
Clinical narrative: died a painful death from Gillian barre, all from flu shot; my wife took the flu shot and was paralyzed two weeks later from it; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received from from a non-health care professional.  This case involves an unknown age female patient who took the flu shot and was paralyzed two weeks later from it and died a painful death from Guillain-Barre after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect Influenza vaccine produced by unknown manufacturer (strength ,dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious events died a painful death from Guillain-Barre, all from flu shot (Guillain-Barre syndrome) and my wife took the flu shot and was paralyzed two weeks later from it (paralysis) (Latency- 2 weeks) following the administration of Influenza vaccine.   Action Taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (my wife took the flu shot and was paralyzed two weeks later from it, died a painful death from Gillian barre, all from flu shot).  At time of reporting, the outcome was Unknown for the event my wife took the flu shot and was paralyzed two weeks later from it and was Fatal for the event died a painful death from gillian barre, all from flu shot.  No autopsy was done. The cause of death was reported as Guillain Barre syndrome.  Seriousness Criteria: Medically Significant for both events and leading to death for event Guillain Barre syndrome.; Sender's Comments: Sanofi Company Comment dated 28-Dec-2022 : The source of information about the case is social media, from non-HCP person. This case involves an unknown age female patient who was paralyzed two weeks later after influenza vaccination (manufacturer unknown). The patient died 2 weeks after influenza vaccination from Guillain-Barre syndrome. Lack of information of past and concomitant medication, event onset, any family history, any relevant medical history of patient, any concurrent conditions precludes comprehensive case assessment. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: Gillian barre syndrome
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 23-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-HCP.  This case is linked to case 2022SA520918(CLUSTER).  This case involves an unknown age male patient who got flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via subcutaneous route in unknown administration site for Prophylactic vaccination  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; got both strains of flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid social media serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced pneumonia and got both strains of flu after receiving vaccine influenza vaccine.  The patient's past  medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot, expiry date: not reported) via unknown route at unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date (unknown latency) the patient developed a serious pneumonia and got both strains of flu (influenza) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for both the events.  Seriousness criteria: Medically significant for pneumonia.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving vaccine influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu shot but it didn't keep me from getting this lousy flu that's going around; Initial information received on 25-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Social Media page.  This case involves adult patient of unknown age and gender who had influenza vaccine but it didn't keep patient from getting this lousy flu that's going around.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient had the flu shot but it didn't keep patient from getting this lousy flu that's going around (influenza) (unknown latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick as a dog; Initial information received on 26-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got sick as a dog after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient got sick as a dog (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got sick as a dog.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu xmas day; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who had the flu xmas day after receiving influenza vaccine  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  In October 2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  In Dec-2022 the patient had the flu xmas day (influenza) (latency: 2 months approximately) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu xmas day).  At time of reporting, the outcome was Unknown for the event had the flu xmas day.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received from on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the shot. now have the flu; Initial information regarding an unsolicited valid social media non-serious case received from via consumer/non-hcp on 26-Dec-2022.  This case involves an unknown age and unknown gender patient who experienced got the shot. now have the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination.  On an unknown onset and latency after getting the shot, the patient has a flu (influenza).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: Yes I did and I got the flu; Have been sick for over a week; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the flu and have been sick for over a week after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect  Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Patient reported that "i got the flu (influenza) and have been sick for over a week (illness) during Christmas following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.   Outcome: Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder, Influenza, Malaise
Clinical narrative: have two autoimmune diseases; caught the flu and been very ill; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who have two autoimmune diseases and caught the flu and been very ill after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s)were not provided. Family history : mother with 4th stage COPD   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed two autoimmune diseases (autoimmune disorder) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious event "caught the flu and been very ill" (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi Company Comment dated 26-Dec-2022: This case involves an unknown age and gender patient who have two autoimmune diseases after receiving Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history,  concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: gotten sick was the years when got a flu shot; Initial information received on 26-Dec-2022 regarding an unsolicited valid  non-serious Social Media case received from consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with gotten sick was the years when got a flu shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious gotten sick was the years when got a flu shot (illness) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feel like Crapola; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown gender who experienced feel like crapola after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, expiry date, formulation, strength: not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed a non-serious feel like crapola (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the shot . But still ended up in the hospital with the flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid social media serious case received from a patient   This case involves an unknown age and unknown gender patient who experienced 'i got the shot . but still ended up in the hospital with the flu' after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient experienced any additional symptoms/events   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (strength , dose, formulation, frequency, lot number, route,  administration site and expiry date: not reported) for Flu    On an unknown date the patient developed a serious event i got the shot but still ended up in the hospital with the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It is unknown if there were lab data/results available.   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the shot . But still ended up in the hospital with the flu).  At time of reporting, the outcome was Unknown for the event i got the shot . but still ended up in the hospital with the flu.  Seriousness Criteria: Event leading to hospitalization; Sender's Comments: Sanofi Company Comment dated 25-Dec-2022: This case involves an unknown age and unknown gender patient who experienced 'i got the shot but still ended up in the hospital with the flu' after receiving vaccine Influenza vaccine. The time to onset is compatible with the role of the product. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Social Media.  This case involves patient of unknown age and gender who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient experienced flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 26-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, every time the patient got the flu shot, he/she got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: received the vaccine post excursion with no reported adverse event; Initial information received on 22-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case is linked to case 2022SA518461.  This case involves a 4 months old female patient who  received the vaccine post excursion with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE (HIB) for Immunization.  On 04-Oct-2022, the patient received a (series: 2nd dose) suspect IPV (VERO) (Batch/lot number -U1A451M)(Dose-0.5mL)(Frequency-Total/once )(Expiry date-20-FEB-2023)( Strength = standard)(Formulation- Suspension for injection) via intramuscular route in the right thigh for Immunization .  On 04-OCT-2022 the patient developed a non-serious event received the vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).(Latency- same day)  It was reported The caller advised there were 3 patients that received the vaccine post excursion. Caller advised a couple months ago she called in reporting a temperature excursion at their facility where IPOL was concluded to no longer be viable.  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the event received the vaccine post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  case number 01312315:
Age: 0.92
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Power outage Max/Low Temperature reached: 47.60 F Duration out of labelled range: 3 hours with no reported adverse event; vaccine was adminsitered post excursion with no reported adverse event; Initial information was received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 11 months old female patient who was adminsitered post excursion with no reported adverse event and power outage max/low temperature reached: 47.60 f duration out of labelled range: 3 hours with no reported adverse event ,after receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel) for Immunisation.   On 16-Dec-2022, the patient received a dose number 3 of suspect ipv (VERO) (lot V1B901M  and expiration date: 02-Jun-2024) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On an unknown date , the reporter stated the vaccine had temperature excursion due to power outage max/low temperature reached: 47.60 f duration out of labelled range: 3 hours with no reported adverse event (product storage error).  On 16-Dec-2022(latency: same day),  the patient developed a non-serious event " vaccine was adminsitered post excursion with no reported adverse event "(poor quality product administered)same day following the first dose administration.    Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received a dose of fluzone hd qiv in November and then another in December with no reported adverse event; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Elderly male patient who received a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in november and then another in december with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength = High-Dose) at a dose 0.7 ml total (lot UT7715BA) (form, expiry date: unknown) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in november and then another in december with no reported adverse event (extra dose administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea
Clinical narrative: Nauseous starting approximately 17 hours after shot; still nauseous 15 hours later
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Tdap administered to patient instead of Gardasil
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP administered a Modena Monovalent vaccine 36 hours after the vial has been punctured.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered a Modena Monovalent vaccine 36 hours after the vial has been punctured.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown if the patient had other medical condition.     On 24-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Dec-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered a Modena Monovalent vaccine 36 hours after the vial has been punctured.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered a Modena Monovalent vaccine 36 hours after the vial has been punctured.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP administered a Modena Monovalent vaccine 36 hours after the vial has been punctured.).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Monovalent administered after 12 hours, 36 after the vial has been punctured. It was unknown if the patient undergone tests. No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C i) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose).    No concomitant medications were reported.   No treatment details were reported.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2022 Reporter's comments:  The reporter reported that an expired dose of Havrix was administered to a female patient.  The reporter was consented to follow-up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Memory impairment, Syncope
Clinical narrative: This spontaneous report received from a consumer via other company concerned a 71 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drugs included: fluticasone propionate/salmeterol xinafoate (inhalation powder, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for chronic obstructive pulmonary disease (COPD). No concomitant medications were reported.  On 20-JAN-2022, the patient experienced covid and on 11-OCT-2022 the patient had covid again (coded as covid twice). It was reported that the patient had a high probability of getting epilepsy from this. On an unspecified date, the patient had black out/fainting episodes. The patient continued to have side effects from it and her memory has been affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of fluticasone propionate/salmeterol xinafoate was not changed. The outcome of the covid twice, black out or fainting episodes and memory has been affected was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221251348- black out or fainting episodes. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.