chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu within the same week of getting the shot/Every year she got the shot she came down with the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (daughter of the patient) via social media (public post on the Sanofi flu shot campaign) on 14-Oct-2020.  This case is linked to case 2020SA294157, 2020SA294125 (same source).  This case involved a 58-year-old female patient who had the flu within the same week of getting the shot/every year she got the shot she came down with the flu (Influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient 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 and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu within the same week of getting the shot/every year she got the shot she came down with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Last time I got the flu shot I was sick 5 days; Initial information regarding an unsolicited valid non-serious case received from a consumer via Social Media and transmitted to Sanofi on 10-Oct-2020.  This case is linked to case 2020SA294157.  This case involves patient with unknown demographics who reported last time i got the flu shot i was sick 5 days (illness), while he/she received vaccine influenza vaccine.  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 produced by unknown manufacturer lot number not reported.  On an unknown date, (latency unknown) the patient reported last time i got the flu shot i was sick 5 days (Illness) after the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient via social media.  This case is linked to 2020SA294157 (same reporter).  This case involves an unknown demographic patient who got the flu (influenza) after the patient received the flu shot [INFLUENZA VACCINE].  Medical history, concomitant medication, past 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, batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) the patient got the flu (influenza) (non serious) following administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  The event outcome was unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: felt like crap soon after I got the shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a patient via social media.  This case is linked to case 2020SA294157, 2020SA294125 (same source).  This case involves an unknown demographic patient who felt like crap (Feeling abnormal) soon after receiving of vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date, the patient felt like crap (Feeling abnormal) soon after (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for felt like crap (Feeling abnormal).  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The year my dad got flu shot he got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (son of the patient) via social media on 10-Oct-2020.  This case is linked to case 2020SA294157(same source).  This case involved an unknown age male patient for whom it was reported that the year my dad got flu shot he got the flu (Influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient 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 and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the year the patient got flu shot the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  it was reported that the vaccine is only about 40% effective.   No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown at the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: rarely sick in life until she took that flu shot; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non healthcare professional.  This case is linked to case 2020SA294157 and 2020SA294125.  This case involves a female patient (unknown age) who was rarely sick in life until she took that flu shot (Illness), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt sick (illness) (unknown latency) (non serious) following the administration of INFLUENZA VACCINE.  It was reported that reporter's family (reporter and mother) had good immune systems and never had flu, and rarely sick in life until she took flu shot.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was Unknown for illness., at the time of reporting.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got extremely sick from the shots; Initial information regarding this unsolicited valid non-serious case was received from a consumer via social media on 08-Oct-2020.  This case is linked to case 2020SA294157, 2020SA294125 (same source).  This case involved an unknown age male patient who got extremely sick from the shots (Illness), while he received vaccine influenza vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient had several shots when the patient was in the military.  On an unknown date, the patient got extremely sick from the shots (Illness), (unknown latency) following the administration of INFLUENZA VACCINE.  The patient said he was never sicker in his whole life.   It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gets the flu; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious social media via a consumer.  This case is linked to case 2020SA294157.  This case involves an unknown age male patient who got the flu (Influenza), while he received vaccine INFLUENZA VACCINE.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route for prophylactic vaccination.  On an unknown date, 3 days, the patient got the flu (Influenza) following the administration of INFLUENZA VACCINE.  Final diagnosis was he gets the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for the event 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: patient Took it once, that was the absolute sickest year patient ever had; patient have had a true flu 4 times in the last 15 years and the shot is only 40-60% effective most years.; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA294157.  This case involves unknown demographics patient who took it once, that was the absolute sickest year patient ever had (illness) and have had a true flu 4 times in the last 15 years and the shot is only 40-60% effective most years. (therapeutic product effect incomplete), 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 took it once, that was the absolute sickest year patient ever had (illness) and have had a true flu 4 times in the last 15 years and the shot is only 40-60% effective most years. (therapeutic product effect incomplete) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for illness and not applicable for therapeutic product effect incomplete.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: 3 days later came down with the flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case is linked to cases 2020SA294157 and 2020SA294125 (same reporter).  This case involved an unknown demographic patient who reported that 3 days later came down with the flu (Influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date about 10 years ago, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that 3 days later came down with the flu (Influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  The event outcome was reported as unknown for the event, 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: the patient sure get sick everytime he/she give in and take one; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 10-Oct-2020.  This case was linked to case 2020SA294157.  This case involved a patient of unknown demographics who sure get sick everytime he/she give in and take one (illness), while he/she received INFLUENZA VACCINE.  Medical history, 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 (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that he/she surely get sick everytime he/she gave in and take one (illness), (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was the patient sure get sick everytime he/she give in and take one.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Normally it's a very mild case but sometimes it a full blown case of the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer and transmitted to Sanofi on 11-Oct-2020.  This case is linked to case 2020SA294157 and 2020SA294125.  This case involves an unknown age patient reported normally it's a very mild case but sometimes it a full blown case of the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On an unknown date, (latency unknown) the patient reported normally it's a very mild case but sometimes it a full blown case of the flu (Influenza) after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Rhinorrhoea
Clinical narrative: felt fatigued; runny nose; Initial information regarding an unsolicited valid non-serious case received from a other health professional (Son of patient) on 18-Oct-2020.  This case involves an 81 years old male patient who experienced felt fatigued (fatigue) and runny nose (rhinorrhoea), while he received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2020, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route.  On an unknown day, unknown latency after vaccination, the patient developed a non-serious felt fatigued (fatigue) and runny nose (rhinorrhoea).   It was not reported if the patient received a corrective treatment.  The outcome was Unknown for both events.  No further relevant information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I GET SICK; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case is linked to case 2020SA296074.  This case involved patient with unknown demographics who get.sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  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 produced by unknown manufacturer lot number not reported.  On unknown date, (unknown latecy) patient reported every time patient get the shot patient get sick  No lab data reported.  Final diagnosis was i.get.sick.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) experienced flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.   Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) experienced flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; This case involves a patient with unknown demography who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  The patient reported that he/she have not had the flu since he/she quit getting the flu shot 5 years ago.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: severely sick for 6 weeks; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got severely sick for 6-weeks (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient got severely sick for 6-weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: made sicker than ever been in life; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.  This case is linked to case 2020SA296404 (same reporter).  This case involves an unknown demographic patient who became sicker (malaise), after the patient received INFLUENZA VACCINE.  The patient's past vaccination included flu shot (influenza vaccine) for prophylactic vaccination.   The patient's medical history, past medical treatment(s), 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, the patient became sicker than ever before (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had no influenza vaccine over ten years and never had the flu since and will never get another shot.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got so sick; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient (unknown age) who got so sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s) concomitant therapy and family history were not provided. Patient's vaccine included Influenza vaccine for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got so sick which kept him down for 3 days (illness) on the same day (an hours after) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: parent noticed significant redness and slight swelling at injection site; parent noticed significant redness and slight swelling at injection site; Child received Fluzone subcutaneous injection in upper arm.; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient's mom).  This case involves a 4 years old patient for whom parent noticed significant redness and slight swelling at injection site (Injection site erythema and injection site swelling) and child received fluzone subcutaneous injection in upper arm. (incorrect route of product administration), while child received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  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 USP TRIVAL A-B SUBVIRION VACCINE lot number not reported via subcutaneous route  in the upper arm, for prophylactic vaccination.  On an unknown date (unknown latency), Patient's mom reported that Child received Fluzone subcutaneous injection (incorrect route of product administration) in upper arm. 24 hours later, parent noticed significant redness and slight swelling at injection site (Injection site erythema  and injection site swelling), a circle of about 3 inches in diameter. Red area took up child's entire biceps. Child had no other symptoms and no discomfort at injection site. Redness resolved within 72 hours without any over the counter (OTC) interventions.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was not applicable for incorrect route of product administration and as unknown for injection site swelling at the time of reporting.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pruritus
Clinical narrative: itching at Flublok injection site; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional via sales specialist at call center as an inquiry (reference number: US-SANOFI-00336397).  This case involved a 54-year old female patient who experienced itching at Flublok injection site (Injection site pruritus), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 21-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ509AA, expiry date: 10-May-2021) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, unknown latency, the patient developed itching at Flublok injection site (Injection site pruritus).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of injection site pruritus.
Sex: U
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: little sore; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 28-Oct-2020.  This case involved a patient with unknown demographics who had little sore (pain), while the patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious little sore (pain), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was little sore.   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: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer/non-health professional.  This case involves patient (unknown demography) who got sick, while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (within a week) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: was sick all winter; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case involves patient (unknown demography) who was sick all winter (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick all winter (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick about 9 months; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who got sick about 9 months (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick about 9 months (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: running a 103 fever all over; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an unknown demographic patient who had running 103 fever and all over  (pyrexia)/ it was a reaction of the INFLUENZA VACCINE which the patient received.  Medical history, concomitant conditions, 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 (batch number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had running 103 fever and all over  (pyrexia)few hours following the administration of INFLUENZA VACCINE.went to the doctor the next day was told it was a reaction of the shot.  Reporter reported that not had one since, nor the flu.   Other relevant laboratories details not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Flu/flu like symptoms; got the sicker than hell; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves patient (unknown demography) who got flu/flu like symptoms (influenza) and got the sickest have ever been after (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date 17 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 at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu/flu like symptoms (influenza) and got the sickest have ever been after, sicker like heck (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of the events was unknown.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (about 2 weeks) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: might have gotten one dose within the last one year with no adverse event; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from the other health professional via phone at call center (reference number: US-SANOFI-00344458).  This case involved a 36-year old female patient who might have gotten one dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) within the last one year with no adverse event (Extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 03-Nov-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5757AA, expiry date: 21-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Nov-2020, on the same day of vaccine administration, it was reported that patient might have gotten one dose within the last one year with no adverse event (Extra dose administered). Patient thought that patient might have received a DTaP vaccine within the last 1 year. Patient was given Adacel today and then mentioned that she might have gotten one within the last 1 year.  It was an potential medication error due to the extra dose administered.   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agenecy (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Non Viable Vaccine Administered with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 05-Nov-2020 via email. This case involves patient of an unknown demographics who had non viable vaccine administered (wrong product administered), while he/she received vaccine influenza usp trival a-b high dose subvirion vaccine [fluzone high dose] (QIV 120-65 ) of 1 dose via unknown route with batch number : UJ541AA and expiry date: unknown  for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event Wrong product administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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: FLU4
Symptoms: Pain in extremity
Clinical narrative: arms are sore; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA320485 (same reporter).  This case involves a 40 years old female patient who experienced arms are sore (pain in extremity), while she received vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (strength and formulation: unknown) (batch number: LUT7007NA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after the initiation of suspect drug the patient's arms are sore (pain in extremity), and reporter was asking for recommendations with that. The pharmacist was referred to the prescribing information, and to the physician for recommendations.  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient of unknown demographics who got flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date in 2015 and 2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: deathly ill (the flu); deathly ill (the flu); Initial information was received on 13-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional.  This case involves a patient in late 70's (age unspecified) who got deathly ill (the flu) (influenza) (Illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got deathly ill (the flu) (influenza) (Illness) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of events were unknown.  There will be no information available on lot number.; Sender's Comments: This case concerns an elderly patient (late 70's) (exact age unspecified) who got deathly ill with flu after vaccination with INFLUENZA VACCINE. The time to onset is unknown with the role of the vaccine. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.