chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain
Clinical narrative: achy; tired; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an 80-year-old female patient who had achy (pain) and tired (fatigue), after receiving INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  The patient's past medical history included feeling abnormal. The patient reported that she had not been feeling good.  At the time of the event, the patient had ongoing secondary pulmonary arterial hypertension.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included WARFARIN SODIUM.  On 22-Sep-2021, 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 in March and April, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (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 achy (pain) and tired (fatigue) (unknown latency) following the administration of INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  It was reported "On an unreported date, the patient experienced events of achy (pain) and tired (fatigue). Co-suspect included Moderna COVID vaccine (elasomeran) and Flu shot (influenza vaccine). The patient reported that she had not been feeling good (feeing abnormal previously reported). She received the Moderna COVID vaccine in March and April and the Flu shot on 22 Sep 2021."  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 events.  At time of reporting, the outcome was unknown for both the events.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal pain, Chills, Feeling cold, Headache, Influenza
Clinical narrative: Achy and tummy hurt not sick; I got the flu; headache; chills; very low fever 99.1; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a 65-year-old patient of unknown gender who had achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), after receiving INFLUENZA VACCINE.  The patient had no 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 achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Hello, the following potential adverse event has been found on a public post for Flu Shot Fridays page. 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. I have got the shot every year never got the flu I told my doctor I am not taking it because I think they are going to trick us and give us the one for the virus which I will not get the jab. So he assured me they cannot do that .so I got the flu shot.Sure enough I think I got the flu.I had a headache chills, Achy and tummy hurt not sick, very low fever99.1 nothing then the next day that afternoon I felt fine and the chills was not bad I just could not get warm.I feel asleep.If it was from that it was not bad at all.I have heard this year they are making it stronger for the elderly and I am 65."  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 any corrective treatment for the events.  On an unknown date (the next day) that afternoon, the patient was recovering from chills and was recovered from all other reported events.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Achy and tummy hurt not sick; I got the flu; headache; chills; very low fever 99.1; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a 65-year-old patient of unknown gender who had achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), after receiving INFLUENZA VACCINE.  The patient had no 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 achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Hello, the following potential adverse event has been found on a public post for Flu Shot Fridays page. 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. I have got the shot every year never got the flu I told my doctor I am not taking it because I think they are going to trick us and give us the one for the virus which I will not get the jab. So he assured me they cannot do that .so I got the flu shot.Sure enough I think I got the flu.I had a headache chills, Achy and tummy hurt not sick, very low fever99.1 nothing then the next day that afternoon I felt fine and the chills was not bad I just could not get warm.I feel asleep.If it was from that it was not bad at all.I have heard this year they are making it stronger for the elderly and I am 65."  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 any corrective treatment for the events.  On an unknown date (the next day) that afternoon, the patient was recovering from chills and was recovered from all other reported events.  There will be no information available on the lot number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-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-SAC20211019001069).  This case involves female patient (unknown age) who experienced flu (influenza), 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 flu (influenza) (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: Vaccination complication
Clinical narrative: Flu vaccination injury; Initial information was received on 15-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced flu vaccination injury (vaccination complication) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, 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 (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 flu vaccination injury (vaccination complication) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  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.  The event outcome was unknown for the event.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an adult (unknown gender) patient who experienced vaccination complication (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: He gets some what sick; Initial information was received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via the social media.  This case involves male patient of unknown age who got somewhat sick (illness) 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) and family history were not provided.  No concomitant medications were reported.   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 an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "gets somewhat sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu starts every year with the flu shots. What a coincidence. I have a friend who gets and every time he gets somewhat sick after it and spreads it around so we all get a share."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory 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.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I end up with the flu; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case from consumer/non-healthcare professional via Digital Media.  This case involves patient (unknown age and gender) who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 were not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date, the patient had flu (influenza, non-serious) (unknown latency) following the administration of vaccine.  It was reported "Not getting it period everytime I get it I end up with the flu"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: Rash; swollen throat; Arm hurt for months, right arm never did come back to normal; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any 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 non-serious rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I would rather not get a shot that's gonna make my arm hurt for months breaking out in a rash with swollen throat and misery for a month or two. My right arm never did come back to normal. The doctor for. 10 years retired and nobody knows where my records are to prove that I'm allergic."  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 event pain in extremity was not resolved while outcome of other events were unknown.  The reporter did not report the causality of events with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: every time he gets some what sick after it; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Digital Media.  This case involves a patient (unknown age and gender) who was sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness, non-serious) (unknown latency) following the administration of vaccine.  It was reported "Flu starts every year with the flu shots. What a coincidence. I have a fried who gets and every time he gets some what sick after it and spreads it around so we all get a share."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sickest; Initial information received on 15-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 sickest (illness) 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 unknown route at an unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious sickest (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "patient had a swine flu shot in 1976, said it would be dire if we didn't, next day sickest I had ever been, none since and no flu either."  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event sickest.  At time of reporting, the outcome was unknown for the event sickest.  There would be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: No reactions other than a sore arm; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case received via a consumer/non-health care professional (under reference number: US-SA-SAC20211020001115).  This case involves Adult and unknown gender patient who experienced no reactions other than a sore arm (pain in extremity) while 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 no reaction other than a sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine and covid (coronavirus disease) booster."  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.  There will be no information on lot number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Blindness unilateral
Clinical narrative: blind in one eye for almost 2 weeks; Initial information was received on 16-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional under (reference US-SA-SAC20211021000134).  This case involves a female patient (unknown age) who experienced blind in one eye for almost 2 weeks (blindness unilateral) after 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 serious blind in one eye for almost 2 weeks (blindness unilateral) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Social media, reporter's sister-in-law was blind in one eye for almost 2 weeks after the jab.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, the patient recovered from the event (blindness unilateral).  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a female patient of (unknown age) who experienced blindness unilateral (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Wrong product administered
Clinical narrative: Covid injection instead of flu shots with no adverse event; Initial information received on 16-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 received corona virus (covid ) injection instead of INFLUENZA VACCINE (wrong product administered).  The patient 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 unknown route at an unknown administration site for Prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "pharmacy gave a whole family the corona virus (covid) injection instead of flu shots."  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.  There would be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: never so sick in my life; Initial information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involved unknown demographic patient (unknown age and gender) who experienced never so sick in my life (illness), after receiving vaccine INFLUENZA VACCINE.  The patient 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 non-serious event never so sick in my life (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  It was reported "no flu or colds in 5 years, Google it, Kills viruses, had a flu shot once years ago. Never so sick in my life".  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: Illness, Malaise, Pneumonia, Pyrexia
Clinical narrative: 104 fever; pneumonia in lungs; so sick; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves a (unknown demographic) patient who experienced 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included COVID-19 (Coronavirus disease 2019) with last year & body pushed it out like a common cold.  The patient's past medical treatments, vaccinations, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Pneumonia event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  Relevant laboratory test results included: Body temperature - On an unknown date: 104  An unknown corrective treatment was received for the events.  The event outcome was unknown for the events.  Lot number had been requested.; Sender's Comments: This case concerns a (unknown demographic) patient who experienced pyrexia, pneumonia and illness (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is past medical history included COVID-19 (Coronavirus disease 2019)  was reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; Initial information received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 64-year-old female patient for whom it was reported "64 year old patient stated she was 65 years old received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]" (product administered to patient of inappropriate age and overdose).   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE).    On 07-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ750AB, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment 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: 2.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: received expired TYPHIM VI  vaccination with no reported adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from a physician via consumer/non-health care processional (Reference number- 00805095).  This case is linked to 2021SA336821 (same reporter).  This case involves a two-year-old male patient who was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.   Patient had no other vaccines.  On 30-Sep-2021, the patient received a 0.5 ml first dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number and expiry date: not reported) (Frequency: Once) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Doctor states that two patients received expired TYPHIM VI vaccinations in his practice 9 days ago. Doctor states that the date was approximately 30SEP2021. Doctor states that neither of these patients experienced any adverse events and that he was calling to find out if Sanofi had any safety or efficacy data related to expired products. Doctor also asked if the patients should be re-vaccinated"  Doctor states that specific information regarding lot number of TYPHIM VI and date of birth (DOB) of patients is not available at this time. Doctor states that he may be contacted in the future at the phone number provided if this information is required.  At the time of reporting, 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 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.  There will be no information available on the batch number for this case.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Facial paralysis
Clinical narrative: face drooped; garbled speech; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (patient's husband) via Medical Information (Reference number- 00806677) and transmitted to Sanofi on 11-Oct-2021.  This case involves a 79-year-old female patient who experienced face drooped (facial paralysis) and garbled speech (dysarthria) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 08-Oct-2021, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 08-Oct-2021 the patient developed a serious very-very, violent reaction as face drooped (facial paralysis) and garbled speech (dysarthria) same day (about an hour later) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  facial paralysis event was assessed as medically significant.  Additionally, it was reported that fearing a stroke her husband called ambulance, the admitted her into the hospital and after about 2 hours of observation her stroke signs disappeared and she was discharged, she was instructed to follow up with a neurologist.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the events.  Patient was recovered from both events on an unknown date.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns 79-year-old female patient who experienced facial paralysis and dysarthria after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. 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. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Fluzone Quad was administered to a patient instead of the Fluzone HD with no AE; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong product administered [Latency: on the same day].  It was reported "caller stated that a nurse was supposed to administer FLUZONE HD to a patient, but instead administered FLUZONE QUAD".  Details of laboratory data were not reported.  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.  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 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Wrong product administered
Clinical narrative: they were suppose to giving a HD, but gave a regular strength instead with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00807032).  This case involves a patient (unknown age and gender) who were suppose to receive a QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but received a regular strength of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) instead (wrong product administered).  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 FLUZONE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  At time of reporting, no adverse event 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 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.  There will be no information available on the batch number for this case.
Age: 10.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product appearance confusion, Wrong product administered
Clinical narrative: A 10-year-old patient received FLUBLOK QIV with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flubloks are similar to the colors used for Fluzone Quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via agency (Reference number- 00807209) and transmitted to Sanofi on 11-Oct-2021.  This case is linked to case 2021SA337747 (same reporter).  This case involves a 10-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age), instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) as FLUBLOK QIV and FLUZONE QUADRIVALENT were similar to the colors (Product appearance confusion).  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 QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2128, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product appearance confusion (latency same day).  It was reported "Two children under the age of 18 years old were administer with Flublok. The nurse (reporter) advised the Sanofi Representative that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent. It was reported that the children's parents have been notified. Both children were administered a dose from the same lot number."  No other 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 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: 0.42
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 5 month old patient received FLUZONE QIV vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (Reference number- 00808894) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 5 month old patient (unknown gender) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (product administered to patient of inappropriate age).  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 QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "Nurse manager calling in regard to FLUZONE quadrivalent (QIV) pre-filled syringe (PFS). Nurse would like to know if there are any studies or information available for administration to patients less than 6 months of age? Caller states they may have administered a dose to a 5 month old that is turning 6 months in 2 weeks, but they are unsure if it happened. Caller states they wanted preliminary information just in case it was administered. Caller also stated they do not have any patient or visit related information at this time."  No other adverse event 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 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired IPOL vaccine/ NO AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received expired IPV (VERO) [IPOL] vaccine (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number not reported and expiry date: 03-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was potential medication error case due to expired vaccine used (latency: same day).  Healthcare professional wanted to know what should be done. The nurse was asked for additional adverse event information but she did not have time.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: A patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccine had already received a flu vaccine this season no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory Authority (Reference number- 00809130) and transmitted to Sanofi on 12-Oct-2021.  This case involves an 86-year-old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] had already received a flu vaccine this season [extra dose administered].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included coronavirus disease-2019 (COVID-19) VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency same day).  It was reported "Pharmacist states that a patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccination in her pharmacy may have already received a flu vaccine this season, according to the patient's daughter. Pharmacist asked if there was any information available on how to proceed if the patient did receive a second flu vaccine in 2021. Pharmacist states that her pharmacy only has records of the FLUZONE HIGH-DOSE QUADRIVALENT that was given to the patient on 11Oct2021, and that the patient may have received the other flu vaccine at a different location."  No other 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 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: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Irritability
Clinical narrative: irritable; baby was not eating much; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non via health care professional via the Agency number: 00809296.  This case involves a six months old male patient who was irritable (irritability) and baby was not eating much (decreased appetite) after receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)].  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation prophylactic vaccination respectively.  On 06-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ496AB and expiry date: 29-MAY-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  On 06-OCT-2021 the patient developed a non-serious events irritable (irritability), baby was not eating much (decreased appetite) on a same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  No lab data was reported.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the event outcome was Unknown from the events.