chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation, Pain, Pyrexia
Clinical narrative: burning up; achy; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media under (reference US-SA-SAC20211019001210).  This case involves a patient of (unknown demographics) who experienced burning up and achy (pyrexia, pain) 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious burning up and achy (pyrexia , pain) (1 day) following the administration of INFLUENZA VACCINE.  It was reported "Yeah, I just got my flu shot yesterday and today I am burning up and achy. Thanks. I would have been the same with the flu (if I got it)".  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for the events (burning sensation, pain).  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Initial information was received on 17-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional via the social media.   This case involves a patient (unknown demographics) who reported that 22 years ago he/she experienced Guillain-Barre Syndrome after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre Syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported that patient got Guillain-Barre Syndrome from a flu shot 22 years ago from the time of reporting.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had Guillain-Barre Syndrome, after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu every time patient took a shot; Initial information received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who had got the flu every time the patient took a shot (influenza) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu every time the patient took a shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My stupid dad got the flu every time the patient took a shot. No the patient was not a lib sheep, but just listened to them I guess. the patient would get the flu every time for listening to them. Maybe it was not as intense with a shot first, but I rarely had the flu in 70 years without a shot."  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   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 got the flu every time the patient took a shot.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu; Initial information was received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211021001175).  This case involves an adult patient with an unknown gender who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Definitely got my had the flu trust me please."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: got mine last week and it hurt like the dickens for 2w days; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved a patient (unknown demographic) who reported that "got mine last week and it hurt like the dickens for 2w days" (pain) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "got mine last week and it hurt like the dickens for 2w days" (pain) (unknown latency) duration 2 week days following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   It was not reported if the patient received a corrective treatment for the event of pain.  At time of reporting, the outcome was unknown for the event pain.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre, Attacked his immune system Neurological disorder; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211021001514).  This case involves adult male patient (unknown age) who experienced Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain Barre syndrome), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No additional laboratory data was reported.  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.  There will be no information available on batch number for this case.; Sender's Comments: This case involves an adult male patient (unknown age) who presented with Guillain Barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Initial information received on 18-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.   This case involves an unknown age male patient who had guillain-barre syndrome after receiving vaccine INFLUENZA VACCINE.  The patient's medical history included Cardiovascular disease, unspecified (Cardiovascular disorder).  At the time of the event, the patient had ongoing Diabetes (Diabetes mellitus).  The patient's past medical treatment(s), vaccination(s), concomitant medication(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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious guillain-barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns an an unknown age male patient who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. The patient's medical history included Cardiovascular disorder. At the time of the event, the patient had ongoing Diabetes mellitus and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; Initial information was received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves a 84-year-old female patient who experienced flu-like symptoms (influenza like illness) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On 14-Oct-2021, the patient developed a non-serious flu-like symptoms (influenza like illness) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It is unknown if patient's physician provided consent to be contacted.  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Malaise
Clinical narrative: bad cough; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves adult and unknown gender patient who experienced bad cough (cough) and is still sick after receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad cough (cough) and was sick (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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 cough.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Got reaction first time ever; Initial information received on 19-Oct-2021 regarding an unsolicited non-valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who got reaction first time ever (vaccination complication) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a reaction first time ever (vaccination complication, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Unevaluable event
Clinical narrative: fighting for his life; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown age male patient who experienced fighting for his life (unevaluable event) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fighting for his life (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "wow good luck! My dad is fighting for his life after getting the vaccine!!!"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media..  This case involves adult female patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "no flu shot, no flu".  It was unknown if there were lab data/results available.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Coma, Meningitis
Clinical narrative: meningitis; coma; Initial information was received on 20-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2021SA352054, 2021SA352053 and 2021SA351848 (same reporter)  This case involves adult and unknown gender patient who experienced meningitis and coma while receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious meningitis and coma (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns adult and unknown gender patient who suffered from meningitis and coma after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. However, the rationale or medical condition of the patient leading to consideration of the events as life-threatening or descriptions of the specific nature of events being life threatening was not provided. Based upon the reported information the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves Adult and unknown gender patient who experienced been not feeling well (malaise) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, 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 expire date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious been not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved adult patient who experienced sore arm (pain in extremity) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was reported "Got my flu shot last week. I had no side effects at all. I didn't even have a sore arm this time."  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Infection
Clinical narrative: Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had got bad infection last year (infection),  after receiving 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), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious got bad infection last year (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The case received from Social media. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Got bad infection last year antibiotics for seven days never again."   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I was so sick; almost killed me; Initial information received on 21-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (unknown demographic) was so sick (illness) and almost killed me (unevaluable event) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious had so sick (illness) (unknown latency) and almost killed me (unevaluable event) 2 days following the administration of INFLUENZA VACCINE.   The patient was hospitalized for this event illness at 5 day.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient (unknown demographic) who had illness and unevaluable event after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown for illness and compatible for unevaluable event.The patient was hospitalized for this event illness at 5 day.Additional information regarding patient's lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: usually get sick; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211026000316).   This case involves an unknown age and unknown gender patient who experienced usually get sick (illness), after receiving vaccine INFLUENZA VACCINE.   The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious usually get sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  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.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm was terribly sore; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.   This case involves a patient (unknown demographics) who had arm was terribly sore (pain in extremity) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm was terribly sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Death, Feeling abnormal
Clinical narrative: felt miserable for days; Initial information received on 21-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves an 83 year old male patient who experienced felt miserable for days (feeling abnormal) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's vaccination included Influenza Vaccine (He got a flu shot from this late 60 year to when he turned 80 year).  The patient's medical treatment, 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.  In 2010, patient said he was no longer going to get the flu shot because he always felt miserable for days (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was fatal for the reported event.  It is unknown if an autopsy was done. The cause of death was reported as Feeling abnormal.  Information on the batch number to be requested.; Sender's Comments: This poorly documented social media case concerns an 83 year old male patient who had feeling abnormal and died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.; Reported Cause(s) of Death: felt miserable for days
Sex: U
Vaccine: FLUX
Symptoms: Dehydration
Clinical narrative: severe dehydration; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case is linked to cases 2021SA350364 and 2021SA355220 (same reporter).  This case involves a patient (unknown demographics) who had severe dehydration (dehydration) after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine (two times) for prophylactic vaccination and the patient had flu (influenza) as a reaction to the vaccine.  The patient's other past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a third dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious severe dehydration (dehydration) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "every time I have gotten the flu shot I ended up in the hospital that week from severe dehydration. Not everyone's bodies are the same! My brother gets it and does well! Swears by it keeping him from getting flu bad! So people do end up in the hospital from the flu vaccine. No one should be pressured to make medical decisions for themselves! The first two times I had the flu vaccine I thought it was coincidence that I ended up with the flu that bad same week. After the third time I ended up in the hospital after I said to myself never again! I have not had the flu bad like that since. Same for my kids. They got sick bad every year after getting it. Have gone a couple of years now without getting it! No 105 fevers, No throwing up, no diarrhea bad at the same time! I have triplets so when they all get bad sick like that and I do too it is exhausting! Never again! They had to go to the emergency room also because their fevers were so high and kept going up after flu shot! One of my triplets has peanut tree nut allergies so not taking chances anymore."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arms; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case involves a adult patient (unknown gender) who had sore arms (pain in extremity) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received two doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got both shots on the same day. I am glad I got them. But, don't recommend doing them together 2 sore arms!"  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Extra dose administered, Medication error, Muscle spasms
Clinical narrative: spasms of the opposite arm; rapid increase of blood pressure; extra dose of FLUZONE QIV MDV being administered to a patient; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via agency (under the reference 00810876).  This case involves a 45 years old female patient had spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased) after receiving extra dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (extra dose administered).  The patient's past vaccination(s) included FLUZONE QUADRIVALENT with once had a previous dose on 27-SEP-2021 (0.5 ml, total) for prophylactic vaccination.   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 12-Oct-2021, the patient received a second dose of suspect FLUZONE (0.5 ml, total, once, lot UJ705AB and expiration date not provided) via intramuscular route in the left deltoid for prophylactic vaccination.  On 12-OCT-2021 the patient developed a non-serious spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased), same day following the administration of vaccine.  It was an actual medication error due to extra dose administered (same day latency)  No laboratory data reported.  It was reported "Nurse calling in regards to a extra dose of FLUZONE QIV MDV being administered to a patient. Nurse would like to know which adverse events to look out for in the patient? Patient received a second dose of the flu vaccine at a doctors office, patient did seem to exhibit adverse reactions and was transported to the ER (emergency room) where they were treated and discharged"  An unknown corrective treatment was received for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and consumer or non-health professional via Medical Information (Reference number: 00812383) and transmitted to Sanofi on 14-Oct-2021.  This case involved a 56-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Solution for injection in pre-filled syringe, frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ769AC, expiry date: 30-Jun-2022]  via an intramuscular route in the right deltoid for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter "caller reported last night a family of 4 who are all under the age of 65 were giving the FLUZONE HIGH-DOSE VACCINE. Caller reported there are no AE's at this time, but wanted to make sure there was nothing to expect and what they should do from here."  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician and non-health care professional via Global Medical Information (GMI) - 00812680 in the United States.  This case is linked to case 2021SA344205 (same reporter).  This case involves a 63 year-old female patient who inadvertently received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and overdose)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given  On 13-Oct-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported; frequency-once; strength- High Dose) via an intramuscular route at the deltoid for prophylactic vaccination.  It was reported "Administrative agent reported that two patients under the age of 65 received a dose of Fluzone Quadrivalent High-Dose. She requested information on the use of the vaccine for this population."  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good  Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: swelling in her left armpit, Swollen lymph nodes; The injection site was slightly achey; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (Reference number- 00812694) and transmitted on 14-Oct-2021. This case involves a 65-year-old female patient who had swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and the injection site was slightly achey (vaccination site pain) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and coronavirus disease of 2019 (COVID-19) VACCINE. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 12-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported, formulation: solution for injection) via intramuscular route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On 13-Oct-2021 the patient developed non-serious swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and injection site was slightly achey (vaccination site pain) 1 day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and (unknown latency) COVID-19 VACCINE. It was reported "Caller has questions about possible side effects of FLUBLOK QUADRIVALENT. Caller states that she received the FLUBLOK QUADRIVALENT vaccine. The injection site is fine; slightly achey, but there is a swelling in her left armpit. She noticed the swelling about 30 hours after getting the vaccine; she believes that it is a swollen lymph node. She states that she feels fine, she is having no other side effects. She has spoken with multiple pharmacists and her doctor, who have given her different answers about whether the swollen lymph node could be related to receiving the vaccine. Caller states that her arm was really bad after receiving the Covid vaccine." No laboratory data was reported. The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymphadenopathy and vaccination site pain. At time of reporting, the outcome of the event was unknown. The reporter did not report the causality of events with FLUBLOK QIV. There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received quadracel instead of pentacel with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via Medical Information (MI) (Reference number: 00812771) and transmitted to Sanofi on 14-Oct-2021.  This case involves a four-year-old male patient received quadracel instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 08-Oct-2021, the patient received a o.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml, Strength: standard except for Fluzone, dosage form: solution, lot UJ458AB, expiry date: 21-May-2022] via an intramuscular route in the right deltoid for Prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported  "medical assistant states pentacel was given to a patient accidently when quadracel was the vaccine they were trying to administer."   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.